Methods and analyzers for analyzing blood samples

Abstract

This invention provides an accurate and rapid method for analyzing blood samples in a care setting to determine the level of free hemoglobin in the blood sample. [Solution] The method includes arranging a cuvette having a sampling cavity and a sample analysis cavity on a rotatable member. The method includes rotating the rotatable member at a second speed in a second rotational cycle after a first rotational cycle to separate the blood portion from the plasma in a blood sample. The method includes using a photometer to acquire second absorbance data indicating the absorbance in the plasma during the second rotational cycle. The method includes determining a second blood parameter, which is the plasma free hemoglobin level of the blood sample, based on the second absorbance data. The method includes providing an output indicating the second blood parameter.

Description

Technical Field

[0001] The present disclosure relates to the field of blood analysis. The present disclosure relates to methods and analyzers for analyzing blood samples.

Background Art

[0002] Hematology is a medical field covering diseases related to blood and its components, including treatment methods, diagnostic methods, analysis methods, etc. Hematology encompasses a plurality of different evaluations that can be performed on blood and / or components of blood. One or more of the evaluations may require the preparation of a blood sample prior to the actual evaluation.

[0003] Typical hematology analysis is performed in a laboratory setting and requires the transportation of blood samples to the laboratory. As a result, there is a significant time delay between receiving a blood sample and providing an analysis, which can delay the necessary patient care.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Therefore, there is a need for an accurate and rapid hematology analysis for quickly evaluating and analyzing the components of a patient's blood. In particular, there is a need for an accurate and rapid point-of-care hematology analysis. In particular, there is a need for an accurate and rapid point-of-care analysis of a blood sample, i.e., the level of plasma free hemoglobin (PfHgb) in a blood sample from a patient supported by an extracorporeal membrane oxygenation device (ECMO) or a ventricular assist device (VAD).

Means for Solving the Problems

[0005] A method for analyzing a blood sample is disclosed. The method includes arranging a cuvette having a sampling cavity and a sample analysis cavity on a rotatable member. The sampling cavity contains the blood sample to be analyzed. The method includes rotating the rotatable member at an initial speed in an initial rotation cycle prior to a first rotation cycle, the initial speed being insufficient for the transfer of the blood sample from the sampling cavity to the sample analysis cavity. The method includes using a photometer to acquire initial absorbance data during the initial rotation cycle, indicating the absorbance in or through the sample analysis cavity of the cuvette. The method includes determining cuvette parameters related to the cuvette based on the initial absorbance data. The method includes providing an output indicating the cuvette parameters. The method includes rotating the rotatable member at a first speed, such as a first maximum speed, in a first rotation cycle for the transfer of the blood sample from the sampling cavity to the sample analysis cavity. The method includes rotating a rotatable member at a second speed in a second rotation cycle after a first rotation cycle to separate the blood portion from the plasma in a blood sample. The method includes using a photometer to acquire second absorbance data indicating the absorbance in the plasma during or after the second rotation cycle. The method includes determining a second blood parameter, which is the plasma free hemoglobin level of the blood sample, based on the second absorbance data. The method includes providing an output indicating the second blood parameter.

[0006] A key advantage of this disclosure is that centrifugation and analysis of blood samples can be performed in a single method. This can potentially reduce the time required to perform the analysis because the cuvette containing the blood sample does not need to be transported to a different device for centrifugation and analysis of the body fluid sample. Furthermore, since the blood sample does not need to be transported between devices, such as between the centrifuge and the analysis unit, the risk of contamination of the blood sample may be reduced, thereby improving the quality of the analysis. The method of this disclosure further allows multiple blood parameters, such as total hemoglobin and plasma free hemoglobin, to be determined in a continuous analysis cycle without the need to remove and / or replace the blood sample. Therefore, a key advantage of this disclosure is that the method can provide fast and accurate analysis / hematological analysis of blood samples. In addition, a key advantage is that the method can provide hematological results in the care setting, rather than requiring the blood to be transported to a laboratory setting.

[0007] A blood analyzer comprising a housing, a rotatable member, a photometer, and a controller is disclosed. The rotatable member is rotatably positioned within the housing and includes a receptacle for receiving a cuvette comprising a sampling cavity and a sample analysis cavity. The receptacle may, depending on use, be an integral part of the rotatable member or a separate body attached to the rotatable member. If the receptacle is in the form of a separate body, it may be removed from the rotatable member for replacement or for easy cleaning. The sampling cavity of the cuvette contains the blood sample to be analyzed. The photometer is configured to acquire absorbance data related to the sample analysis cavity of the cuvette. The controller is configured to rotate the rotatable member at an initial speed in an initial rotation cycle prior to a first rotation cycle, the initial speed being insufficient for the transfer of the blood sample from the sampling cavity to the sample analysis cavity. The controller is configured to control the photometer during the initial rotation cycle to acquire initial absorbance data indicating the absorbance in the sample analysis cavity of the cuvette. The controller is configured to determine cuvette parameters related to the cuvette based on initial absorbance data. The controller is configured to provide an output indicating the cuvette parameters. The controller is configured to rotate a rotatable member at a first speed, such as a first maximum speed, in a first rotational cycle for the transfer of a blood sample from the sampling cavity to the sample analysis cavity. After the first rotational cycle, the controller is configured to rotate the rotatable member at a second speed in a second rotational cycle to separate the blood portion from the plasma within the blood sample. During or after the second rotational cycle, the controller is configured to control the photometer to acquire second absorbance data indicating the absorbance in the plasma of the separated blood sample. Based on the second absorbance data, the controller is configured to determine a second blood parameter, which is the plasma free hemoglobin level of the blood sample. The controller is configured to provide an output indicating the second blood parameter.

[0008] A key advantage of this disclosure is that centrifugation and analysis of blood samples can be performed in a single analytical device. This is because the cuvette containing the blood sample does not need to be transported to a different device for centrifugation and analysis. This can reduce the time required to perform the analysis. Furthermore, since the blood sample does not need to be transported between devices, such as between a centrifuge and an analytical unit, the risk of contamination of the blood sample can be reduced, thereby improving the quality of the analysis. The analyzer of this disclosure further enables the determination of multiple blood parameters, such as total hemoglobin and plasma free hemoglobin, in a continuous analytical cycle without the need to remove and / or replace body fluid samples. Therefore, a key advantage of this disclosure is that the analyzer can provide fast and accurate analysis / hematological analysis of blood samples. In addition, a key advantage of the analyzer is that it can provide on-site hematological results without requiring blood to be transported to a laboratory setting.

[0009] The above and other features and advantages of this disclosure will be readily apparent to those skilled in the art by the following more detailed description of exemplary embodiments of this disclosure with reference to the attached sections. [Brief explanation of the drawing]

[0010] [Figure 1A] This figure shows a method for analyzing a blood sample according to this disclosure. [Figure 1B] This figure shows a method for analyzing a blood sample according to this disclosure. [Figure 1C] This figure shows a method for analyzing a blood sample according to this disclosure. [Figure 1D] This figure shows a method for analyzing a blood sample according to this disclosure. [Figure 2] This figure shows an analyzer for analyzing blood samples according to this disclosure. [Figure 3]This figure shows a photometer for analyzing blood samples according to this disclosure. [Figure 4] This is a perspective view of the example cuvette provided in this disclosure. [Figure 5] This is a schematic diagram of an example cuvette disclosed herein. [Figure 6] This is a schematic diagram of an example cuvette, including a cutting line showing a cross-sectional view of the example cuvette disclosed herein. [Figure 7] Figure 7A is a first schematic section of an example cuvette along cutting line AA disclosed herein. Figure 7B is a first schematic cross section of an example cuvette along cutting line AA disclosed herein. [Figure 8] Figure 8A is a second schematic section of an example cuvette along the cutting line BB disclosed herein. Figure 8B is a second schematic cross-sectional view of an example cuvette along the cutting line BB disclosed herein. [Figure 9] This is a third approximate cross-sectional view of an example cuvette along the cutting line CC disclosed herein. [Figure 10] This is a fourth approximate cross-sectional view of an example cuvette along the cutting line DD disclosed herein. [Modes for carrying out the invention]

[0011] Various exemplary embodiments and details are described hereafter with reference to the figures, where relevant. It should be noted that the figures may or may not be drawn according to a constant proportional scale, and that elements of similar structure or function are indicated by similar reference numerals throughout the figures. It should also be noted that the figures are intended solely to facilitate the description of the embodiments. The figures are not intended as an exhaustive description of the disclosure or as a limitation on the scope of the disclosure. Furthermore, the embodiments shown do not necessarily have to have all the aspects or advantages shown. Aspects or advantages described in conjunction with a particular embodiment are not necessarily limited to that embodiment and may be implemented in any other embodiment even if not shown or expressly described as such.

[0012] The figures are schematic and simplified for clarity, and they merely illustrate details that help to understand this disclosure, while other details are omitted. Throughout, the same reference figures are used for identical or corresponding parts.

[0013] A method for analyzing a blood sample is disclosed. The method may be carried out using a blood analyzer. A blood analyzer may be seen herein as an analytical device for analyzing blood.

[0014] The method involves arranging a cuvette having a sampling cavity and a sample analysis cavity on a rotatable member. In one or more example methods, for example, as further described herein and shown in Figures 4-10, the cuvette comprises a sampling cavity, a discharge cavity, and a sample analysis cavity. The sampling cavity contains a blood sample to be analyzed. The method may include arranging the cuvette such that its opening faces radially inward toward the axis of rotation of the rotatable member, and the sample analysis cavity of the cuvette is positioned radially outward from the sampling cavity of the cuvette.

[0015] In one or more example methods, the method can include rotating a rotatable member at an initial speed in an initial rotation cycle that is insufficient for transferring a blood sample from a sampling cavity to a sample analysis cavity. The initial speed can generate an initial centrifugal force acting on the blood sample during the initial rotation cycle, and the initial centrifugal force is less than the capillary force acting on the blood sample in the sampling cavity. In other words, the initial speed is insufficient for transferring the blood from the sampling cavity to the sample analysis cavity. Thereby, the blood sample will be retained within the sampling cavity during the initial rotation cycle. As a result, the sample analysis cavity will remain empty, and as used herein, empty means free of blood. In one or more example methods, the initial rotation cycle is performed prior to a first rotation cycle.

[0016] In one or more example methods, the method can include obtaining initial absorbance data indicative of absorbance within or through a sample analysis cavity of a cuvette using a photometer and during an initial rotation cycle. Since the blood sample is retained within the sampling cavity during the initial rotation cycle, the initial absorbance data can be absorbance data indicative of absorbance through an empty sample analysis cavity. Obtaining the initial absorbance data can include measuring the absorbance of the sample analysis cavity using one or more wavelengths, such as one, two, three, four, five, six, or more wavelengths.

[0017] In one or more example methods, the method may include determining cuvette parameters based on initial absorbance data. In one or more example methods, the cuvette parameters may indicate the level of contamination associated with the cuvette. The level of contamination associated with the cuvette may include, for example, scratches on the surface, such as the inner and / or outer surfaces of the cuvette, discoloration of the cuvette, contamination of the cuvette, and / or any other imperfections of the cuvette in the sample analysis cavity area of ​​the cuvette. In other words, the level of contamination associated with the cuvette may indicate defects in the cuvette, for example, the material or surface of the cuvette, which may adversely affect the analysis of blood samples. Contamination may be caused, for example, by blood, fingerprints, or other debris added to the sample analysis cavity area due to improper handling of the cuvette by the operator. In one or more example methods, the cuvette parameters may indicate whether the cuvette has been replaced from a previous analysis or whether a cuvette that has already been centrifuged is present in the analyzer. The cuvette parameters can indicate whether a cuvette is present in a receptacle, or whether it is present in a receptacle, in one or more example methods. The cuvette parameters can indicate the initial absorbance data of an empty cuvette, in one or more example methods.

[0018] In one or more example methods, the method includes providing an output indicative of cuvette parameters. In one or more example methods, providing the output can include displaying a message indicative of the cuvette parameters to an operator. The message can indicate, for example, that the contamination level of the cuvette is above a predetermined contamination threshold or that the contamination level is less than the predetermined contamination threshold. A contamination level above the contamination threshold can indicate to the operator that analysis of a blood sample using the cuvette cannot be performed. A contamination level less than the contamination threshold can indicate to the operator that the operator can proceed with analysis of the blood sample using the cuvette. In one or more example methods, upon determining that the cuvette parameters are less than a cuvette detection threshold, providing the output can include displaying a message indicating that the cuvette has not been detected. The cuvette detection threshold can be less than the contamination threshold. In one or more example methods, providing the output can include providing the cuvette parameters to a compensation function, which can compensate for the contamination level during subsequent measurement and determination of blood parameters using the cuvette.

[0019] The method involves rotating a rotatable member at a first speed, such as a first maximum speed, in a first rotational cycle for the transfer of a blood sample from a sampling cavity to a sample analysis cavity. The first speed, such as a first maximum speed, may be configured to create a first centrifugal force greater than a third capillary force generated by the sampling cavity of the cuvette. The first centrifugal force transfers the blood sample from the sampling cavity to the sample analysis cavity. In one or more example methods, the first rotational cycle is performed after an initial rotational cycle. The use of the terms “first speed” or “first rotational cycle” herein is used to identify individual elements and not to suggest any particular order relating to “second” and “third” speeds and / or “second” and “third” rotational cycles. In other words, in one or more example methods, the method may include a first rotational cycle without necessarily including a second rotational cycle, and may rotate at a first speed without necessarily having to rotate at a second speed. However, in one or more example methods involving multiple rotational cycles described herein, it may be beneficial to carry out the rotational cycles in the order indicated by “first,” “second,” and / or “third.”

[0020] In one or more example methods, the method may include obtaining first absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of a cuvette using a photometer and during or after a first rotational cycle. Obtaining first absorbance data may include measuring the absorbance of the blood sample within the sample analysis cavity using two or more wavelengths, such as two, three, four, five, six, or more wavelengths.

[0021] In one or more example methods, the method includes determining a filling parameter, such as a fill level, indicating the amount of blood in the sample analysis cavity of a cuvette, based on first absorbance data. In one or more example methods, the filling parameter may indicate one or more of the following: the sample analysis cavity is underfilled, the sample analysis cavity is improperly filled, and the sample analysis cavity is properly filled. In one or more example methods, the sample analysis cavity may be determined to be underfilled when the first absorbance data is less than a first blood level threshold. A blood level that is too low, such as in an underfilled cuvette, may cause the absorbance data to be lower than when the sample analysis cavity is properly filled. An improperly filled sample analysis cavity may be seen herein as not being filled with blood, such as being filled with a fluid other than blood.

[0022] In one or more example methods, the method includes providing an output indicating filling parameters, such as the amount of blood in the sample analysis cavity of the cuvette. In one or more example methods, the output may indicate that further analysis of the blood sample is not possible, such as when the filling parameters indicate that the cuvette is underfilled and / or improperly filled. In one or more example methods, the output may indicate that further analysis of the blood sample is possible, such as when the filling parameters indicate that the cuvette is properly filled. In one or more example methods, the output may be a signal that prevents further analysis of the blood sample, such as when the filling parameters indicate that the cuvette is underfilled and / or improperly filled. In one or more example methods, the output may be a signal that enables further analysis of the blood sample, such as when the filling parameters indicate that the cuvette is properly filled.

[0023] In one or more example methods, the method may include determining a first blood parameter, which is the total hemoglobin level of a blood sample, based on first absorbance data. In one or more example methods, the total hemoglobin level may be determined by measuring the isoabstract wavelength between oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb), and a compensation wavelength for unchanged whole blood or plasma. In one or more example methods, the total hemoglobin level may be determined without measuring the isoabstract wavelength between oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) by measuring using further wavelengths and by calculating the ratio of the measured wavelengths.

[0024] In one or more example methods, the method includes providing an output indicating a first blood parameter, such as a total hemoglobin level. Providing an output may include providing an output to a display for showing the total hemoglobin level to an operator.

[0025] The method involves rotating a rotatable member at a second speed, such as a second maximum speed, in a second rotational cycle to separate the blood portion from the plasma in a blood sample. The second rotational cycle may be performed after the first rotational cycle. The blood portion may be one or more of, for example, blood cells (such as red blood cells and / or white blood cells), fibrinogen, buffy coat, and lipids. In other words, the blood portion separated from the plasma may be one or more of, blood cells, red blood cells, white blood cells, fibrinogen, buffy coat, and lipids. In one or more example methods, the second speed, such as a second maximum speed, is faster than the first speed, such as a first maximum speed. In one or more example methods, the second speed, such as a second maximum speed, may be equal to the first speed, such as a first maximum speed, and the second rotational cycle may be longer than the first rotational cycle. In other words, to separate the blood portion from the plasma, the rotatable member may be rotated at a second speed faster than the first speed, or during a second rotational cycle longer than the first rotational cycle. The use of the terms “second speed” or “second rotational cycle” herein is used to identify individual elements and does not imply any particular order relating to the “first” and “third” speeds and / or the “first” and “third” rotational cycles. In other words, in one or more example methods, the method may include a second rotational cycle without necessarily including a first rotational cycle, and may rotate at a second speed without necessarily having to rotate at a first speed. However, in one or more example methods involving multiple rotational cycles described herein, it may be beneficial to perform the rotational cycles in the order indicated by “first,” “second,” and / or “third.”

[0026] Fibrinogen is a glycoprotein complex produced in the liver that circulates in the blood. During tissue and vascular injury, fibrinogen can be enzymatically converted to fibrin by thrombin, and then to fibrin-based blood clots. Fibrin clots primarily function to occlude blood vessels to stop bleeding. Buffy coat is the anticoagulant-treated portion of a blood sample, containing most of the white blood cells and platelets, following centrifugation of the blood sample. Lipids are the fats found in the blood.

[0027] The method involves using a photometer to acquire second absorbance data during or after a second rotational cycle. The second absorbance data indicates the absorbance in the plasma. Acquiring the second absorbance data may include measuring the absorbance of the plasma in the sample analysis cavity using two or more wavelengths, such as two, three, four, five, six, or more wavelengths.

[0028] The method includes determining a second blood parameter based on second absorbance data. The second blood parameter is the plasma free hemoglobin (PfHgb) level of the blood sample. In one or more example methods, second absorbance data, such as plasma free hemoglobin level, is acquired continuously during a second rotation cycle so that when all, for example, substantially all blood cells have left the measuring eye and the remaining sample material is substantially pure plasma (possibly with free hemoglobin), the photometer detects a stable detection signal, such as a signal indicating stable, unchanging absorbance data. During the second rotation cycle, the plasma, as well as blood components such as blood cells, fibrinogen, buffy coat, and lipids, will continuously separate from each other, thereby causing the acquired absorbance data to change continuously. When plasma and blood components such as blood cells, fibrinogen, buffy coat, and lipids are completely separated, the absorbance data will stop changing, and stable absorbance data may be detected. Therefore, stable absorbance data indicates that separation is complete. Upon detection that the detection signal, such as the acquired second absorbance data, is stable, the acquired PfHgb level may be presented. Upon detection that the detection signal is stable, the acquisition of the second absorbance data may be terminated. Terminating the acquisition of the second absorbance data may include stopping the second rotation cycle, reducing the speed of the second rotation cycle, acquiring the third absorbance data and / or the first imaging data, and advancing another rotation cycle, such as the third rotation cycle described herein. By terminating the acquisition of the second absorbance data upon detection that the detection signal is stable, the turnaround time (TAT) of the analysis may be reduced compared to when a given measurement time is used.

[0029] The rotational cycles defined herein may be defined in one or more example methods by the maximum speeds permitted during each rotational cycle. For example, the initial maximum speed may be lower than the first maximum speed, the first maximum speed may be lower than the second maximum speed, and the second maximum speed may be lower than the third maximum speed. However, speeds such as the rotational speed of the rotatable member may vary during each rotational cycle.

[0030] In one or more exemplary methods, the rotatable member may be stopped between different rotational cycles, such as an initial rotational cycle, a first rotational cycle, a second rotational cycle, and / or a third rotational cycle. In other words, the different rotational cycles may be separated by periods during which the rotatable member is stationary. Thus, the rotation of the rotatable member may be interrupted between rotational cycles.

[0031] In one or more exemplary methods, a rotatable member can transition between different rotational cycles, such as an initial rotational cycle, a first rotational cycle, a second rotational cycle, and / or a third rotational cycle, without stopping. In other words, the rotatable member can transition between different rotational cycles while rotating continuously. Therefore, the initial rotational cycle, the first rotational cycle, the second rotational cycle, and / or the third rotational cycle can be seen as subcycles within a single continuous rotational cycle.

[0032] The method includes providing an output indicating a second blood parameter. In one or more example methods, providing an output may include providing instructions to an operator, the instructions indicating a second blood parameter, such as the PfHgb level of a blood sample. Providing instructions may include displaying a message to the operator indicating the PfHgb level.

[0033] In one or more example methods, the method may include using a photometer to acquire third absorbance data during a second rotational cycle. The third absorbance data may indicate the separation time of red blood cells from plasma. Acquiring the third absorbance data may include measuring the absorbance of a blood sample in a sample analysis cavity using two or more wavelengths, such as two, three, four, five, six, or more wavelengths.

[0034] In one or more example methods, the method may include determining a third blood parameter, which is the erythrocyte sedimentation rate (ESR) of a blood sample, based on third absorbance data and first absorbance data. ESR is a type of blood test that measures how quickly red blood cells, also called erythrocytes, settle to the bottom of a test tube, such as a cuvette, containing a blood sample. Normally, red blood cells settle relatively slowly. A faster-than-normal rate may indicate inflammation in the body. Inflammation is part of the immune response system. Inflammation can be a reaction to infection or injury.

[0035] In one or more example methods, the method may include providing an output indicating a third blood parameter. In one or more example methods, providing an output may include providing instructions to the operator of a blood analyzer. Providing instructions may include displaying a message to the operator indicating the third blood parameter. The message may, for example, indicate that the ESR is higher or lower than the ESR threshold. The ESR threshold may be an ESR that represents a normal ESR, such as the ESR range for a healthy person.

[0036] In one or more example methods, the method may include acquiring first image data after a second rotational cycle using an imaging device. Acquiring the first image data may include capturing the first image data using an imaging device. The first image data may show an image of at least a portion of the blood sample within a sample analysis cavity, such as the interface between separated blood cells and separated plasma of the blood sample. The first image data may show the location of the interface along the length of the sample analysis cavity, such as a percentage position along the length of the sample analysis cavity. The imaging device may be a camera.

[0037] In one or more example methods, the method may include determining a fourth blood parameter based on first image data. The fourth blood parameter may be the hematocrit level of the blood sample. To determine the hematocrit level, the first image data should show at least a portion of the blood sample where the interface between plasma (e.g., blood plasma) on the one hand and red blood cells on the other hand is expected. The first imaging data may show the location of the interface between separated red blood cells and blood plasma within the sample analysis cavity. In one or more example methods, such an interface is expected to be within the range of 30–60% of the length of the sample analysis cavity. In one or more example methods, the hematocrit level may be determined based on the location of the interface, and the percentage location of the interface along the length of the sample analysis cavity may indicate a percentage level of hematocrit. Lower or higher hematocrit levels with the same PfHgb concentration may indicate a more serious patient condition that may require further medical examination.

[0038] In one or more example methods, the method may include providing an output indicating a fourth blood parameter.

[0039] In one or more exemplary methods, the method may include rotating a rotatable member at a third speed, such as a third maximum speed, in a third rotational cycle, where the third speed is faster than a first speed, such as a first maximum speed, a second speed, such as a second maximum speed, and an initial speed, such as an initial maximum speed. The third rotational cycle may be performed after a second rotational cycle. The third speed may be configured to induce a decrease in fragile red blood cells. The use of the terms “third speed” or “third rotational cycle” herein is used to identify individual elements and does not imply any particular order relating to the “first” and “second” speeds and / or the “first” and “second” rotational cycles. In other words, in one or more exemplary methods, the method may include a third rotational cycle without necessarily including a first and / or second rotational cycle, and may rotate at a third speed without necessarily having to rotate at the first and / or second speeds. However, in one or more example methods involving multiple rotational cycles described herein, it may be beneficial to carry out the rotational cycles in the order indicated by “first,” “second,” and / or “third.”

[0040] In one or more example methods, the method may include obtaining a fourth absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette using a photometer and during a third rotational cycle. Obtaining the fourth absorbance data may include measuring the absorbance of the blood sample within the sample analysis cavity using two or more wavelengths, such as two, three, four, five, six, or more wavelengths.

[0041] In one or more example methods, the method may include determining a fifth blood parameter based on a fourth absorbance data. The fifth blood parameter may be a second plasma free hemoglobin level indicating fragile blood cells in the blood sample. The difference between the second plasma free hemoglobin level and the first plasma free hemoglobin level indicates a level of fragile red blood cells in the blood sample, which may also be called irisrocyte fragility or irisrocyte mechanical fragility. A level of fragile red blood cells may indicate further medical conditions such as sickle cells or thalassemia.

[0042] In one or more example methods, the method includes providing an output indicating a fifth blood parameter. In one or more example methods, providing an output may include displaying a message to the operator indicating a fifth blood parameter. The message may indicate a fifth blood parameter and instruct the operator that further medical examination is required, for example, for a disease such as sickle cell anemia and / or thalassemia.

[0043] In one or more example methods, an error code may indicate to the operator when the acquired absorbance level indicates an excessively high hematocrit level, instead of providing an incorrect result. This may be the case, for example, when it is not possible to obtain a sufficient amount of plasma due to a very large volume of blood cells, thereby bringing undesirable blood cells into the area of ​​the sample analysis cavity of the cuvette covered by the photometer.

[0044] In one or more example methods, the method may include detecting various types of misfilled cuvettes and / or bubbles in a blood sample based on one or more of initial absorbance data, first absorbance data, second absorbance data, third absorbance data, first image data, and fourth absorbance data. In one or more example methods, the method includes determining a blood level parameter indicating the blood level, such as indicating the fill level, in the sample analysis cavity of the cuvette, based on the first absorbance data. In one or more example methods, the blood level parameter may indicate one or more of the following: the sample analysis cavity is underfilled, the sample analysis cavity is overfilled, and the sample analysis cavity is properly filled.

[0045] In one or more example methods, obtaining initial absorbance data, first absorbance data, second absorbance data, third absorbance data, and / or fourth absorbance data involves measuring absorbance using one, two, or three or more wavelengths, for example, three wavelengths, four wavelengths, five wavelengths, six wavelengths, or more. The wavelengths may be selected from the range between 300 nm and 1000 nm. In one or more example methods, the wavelengths may be two or more of 355 nm, 360 nm, 365 nm, 385 nm, 390 nm, 392 nm, 451 nm, 452 nm, 455 nm, 584 nm, 585 nm, 590 nm, 655 nm, and 860 nm. However, other wavelengths selected from the ranges shown above may also be used.

[0046] In one or more example methods, absorbance data may be measured using a first wavelength, a second wavelength, a third wavelength, and a fourth wavelength. In one or more example methods, the first wavelength is 585 nm, the second wavelength is 860 nm, the third wavelength is 385 nm, and the fourth wavelength is 655 nm. In one or more example methods, the first wavelength is 585 nm, the second wavelength is 860 nm, the third wavelength is 455 nm, and the fourth wavelength is 655 nm.

[0047] In one or more examples of the method, obtaining initial absorbance data, first absorbance data, second absorbance data, third absorbance data, or fourth absorbance data includes measuring absorbance during multiple rotations of the rotatable member.

[0048] In one or more example methods, determining one or more of the first blood parameter, second blood parameter, third blood parameter, fourth blood parameter, fifth blood parameter, and cuvette parameter involves integrating absorbance data acquired during multiple rotations of a rotatable member.

[0049] When measuring at high rotational speeds of a rotating member, there is a very short time during each rotation when the cuvette is within the photometer's optical path. Therefore, there is a limited time during each rotation when the photometer can acquire absorbance data from the cuvette and / or the blood sample within the cuvette. To ensure that sufficient absorbance data is acquired to analyze the blood sample, measurement data from subsequent rotations can be stored and integrated over multiple rotations. This means that the more the rotatable member rotates, the larger the signal acquired can become. Once a sufficient signal has been acquired over multiple rotations, integration can be stopped, and digitization, such as analog-to-digital (A / D) conversion, can be performed to obtain intensity values ​​such as the absorbance value of the measurement.

[0050] The initial rotation cycle, the first rotation cycle, the second rotation cycle, and / or the third rotation cycle may be performed sequentially. This allows multiple blood parameters, such as the first, second, third, fourth, and / or fifth blood parameters, including whole blood plasma free hemoglobin, total hemoglobin, and sedimentation rate, to be obtained in a continuous analysis using a single blood sample, thus providing faster and more accurate results.

[0051] A blood analyzer is disclosed. The blood analyzer comprises a housing, a rotatable member, a photometer, and a controller. In one or more examples of the blood analyzer, the blood analyzer may include a display configured to visually provide information to the operator of the blood analyzer, such as visually displaying information indicating cuvette parameters, a first blood parameter, a second blood parameter, a third blood parameter, a fourth blood parameter, and / or a fifth blood parameter. In one or more examples of the blood analyzer, the blood analyzer may include a drive unit, such as an electric motor for rotating the rotatable member.

[0052] The housing may be a single housing. The housing may accommodate any and / or all of the modules discussed herein, such as rotatable members, photometers, controllers, displays, and / or drive units.

[0053] The housing can be made of plastic, metal, ceramic, or a combination thereof, and the specific material of the housing is not limited. The housing may include one or more ports. The housing may include one or more slots. The housing may include one or more outlets. The housing may serve as a frame for holding different modules, such as multiple parts of a blood analyzer.

[0054] The rotatable member is rotatably positioned within the housing. The rotatable member may be rotatably positioned around a pivot axis. The rotatable member comprises a receptacle for receiving cuvettes. Depending on the application, the receptacle may be an integral part of the rotatable member or a separate body attached to the rotatable member. If the receptacle is in the form of a separate body, it may be removed from the rotatable member for replacement or for easy cleaning. In one or more example analyzers, the receptacle may be configured to receive cuvettes having a particular shape or form. In one or more example analyzers, the receptacle may be selected from a plurality of different receptacles for receiving each type of cuvette. In one or more example analyzers, the rotatable member may be removed from the analyzer for replacement or for easy cleaning. In one or more example analyzers, the rotatable member may be selected from a plurality of rotatable members comprising different receptacles for receiving each type of cuvette. The cuvette may comprise a sampling cavity and a sample analysis cavity, the sampling cavity of the cuvette containing the blood sample to be analyzed. The rotatable member may be a circular member such as a disk. The receptacle may be positioned on the rotatable member at a distance r from the axis of rotation, thereby generating a centrifugal force F = mω 2 r is added to the cuvette placed in the receptacle, where m is the mass of the cuvette, r is the distance of the rotating member from the axis of rotation, and ω is the angular velocity, such as the speed at which the rotating member rotates.

[0055] The analyzer may include a drive unit, such as an electric motor, for rotating a rotatable member. The controller may be configured to control the drive unit to control the speed of the rotatable member. In one or more examples of blood analyzers, the controller may include a computer program product. The computer program product may include a non-temporary computer-readable medium. The non-temporary computer-readable medium may have a computer program on it. The computer program may include program instructions. The computer program may be loaded into a data processing unit. The computer program may be configured, for example, so that when the computer program is executed by the data processing unit, it results in the execution of the steps, processes, and / or modules discussed above.

[0056] The rotatable member may be equipped with a measuring eye, such as an opening, to allow light, such as light from a light source, to pass through the rotatable member. The opening may be positioned within the receptacle so as to overlap with the sample analysis cavity of the cuvette when the cuvette is placed within the receptacle. In one or more example analyzers, the rotatable member may be equipped with a blanking hole for measuring the intensity of a light source, such as an LED. The blanking hole may be a through-hole positioned within the rotatable member to allow light from the light source to pass through the rotatable member to the photometer. The blanking hole may be positioned at the same radial distance from the center of rotation of the rotatable member as the measuring eye, but with an angular displacement. In one or more example analyzers, the blanking hole may be positioned 180 degrees displaced from the measuring eye. This allows the photometer to alternately measure the intensity of the sample analysis cavity and the light source at equal time intervals. By measuring the intensity of a light source through a blanking hole, drifting of the light source's light intensity can be detected, and this drift can be used to compensate for the drifting light intensity during measurements against the sample analysis cavity.

[0057] A photometer can be a multi-wavelength photometer. A photometer may comprise multiple light sources, such as two or more light sources, for emitting light at different wavelengths, and one or more optical sensors, such as photodiodes, for measuring how much light is absorbed by an object located between the multiple light sources and one or more optical sensors. The multiple light sources and one or more optical sensors may be arranged on opposing sides of a rotatable member, so that the light emitted from the light sources passes through the apertures of the rotatable member and cuvettes placed within the receptacles of the rotatable member before reaching the optical sensors. In other words, the multiple light sources may be arranged on a first side of the rotatable member, and one or more optical sensors may be arranged on a second side of the rotatable member. The first side and the second side of the rotatable member may be opposing sides of the rotatable member. The photometer may comprise a separate optical sensor for each light source, or a single optical sensor for multiple light sources. In one or more examples of blood analyzers, the multiple light sources, such as two or more light sources, are light-emitting diodes (LEDs). In one or more examples of a blood analyzer, the photometer may include a plurality of first optical guides for directing light emitted by a plurality of light sources to a cuvette, and one or more second optical guides for directing light passing through the cuvette to one or more optical sensors. In one or more examples of a blood analyzer, the photometer includes at least two light sources and at least two corresponding optical sensors, each light source emitting light at a different wavelength.

[0058] The photometer is configured to acquire, for example, measure, absorbance data related to the sample analysis cavity of the cuvette.

[0059] In one or more examples of blood analyzers, the blood analyzer is equipped with a display for providing information to the operator of the blood analyzer, for example, visually.

[0060] Therefore, the advantage of the analyzer disclosed herein is that centrifugation and analysis of blood samples can be performed within a single device. This can reduce the time required to perform the analysis. Furthermore, since blood samples do not need to be transported between devices, such as between the centrifuge and the analysis unit, the risk of contamination of blood samples can be reduced, thereby improving the quality of the analysis.

[0061] The controller is configured to rotate a rotatable member at a first speed, such as a first maximum speed, in a first rotational cycle for the transfer of a blood sample from the sampling cavity to the sample analysis cavity. The controller may be configured to control a drive unit to rotate the rotatable member at a first speed, such as a first maximum speed. The first speed, such as a first maximum speed, may be configured to create a first centrifugal force greater than the capillary force generated by the sampling cavity of the cuvette. The capillary force of the sampling cavity is referred herein to as the third capillary force associated with the cuvette described herein. The first centrifugal force transfers the blood sample from the sampling cavity to the sample analysis cavity.

[0062] The controller may be configured to control the photometer to acquire first absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette during a first rotational cycle. The controller may be configured to acquire first absorbance data by controlling the photometer to measure the absorbance of the blood sample within the sample analysis cavity using two or more wavelengths, such as two, three, four, five, six, or more wavelengths.

[0063] A controller may be configured to determine a first blood parameter, which is the total hemoglobin level of a blood sample, based on first absorbance data. A controller may be configured to determine the total hemoglobin level by measuring the isoabsorptural wavelengths between oxyhemoglobin (HbO2) and / or deoxyhemoglobin (Hb), and / or the compensation wavelengths for unchanged whole blood or plasma, using a photometer. In one or more example analyzers, a controller may be configured to determine the total hemoglobin level by measuring further wavelengths, for example, multiple wavelengths, and by calculating the ratio of the measured wavelengths. Therefore, in one or more example analyzers, a controller may be configured to determine the total hemoglobin level without measuring the isoabsorptural wavelengths between oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb).

[0064] In one or more examples of blood analyzers, the controller is configured to provide an output indicating a first blood parameter.

[0065] The controller is configured to rotate a rotatable member at a second speed, such as a second maximum speed, in a second rotation cycle after a first rotation cycle, in order to separate the blood portion from the plasma within a blood sample. The blood portion separated from the plasma may be one or more of the following: blood cells, red blood cells, white blood cells, fibrinogen, buffy coat, and lipids.

[0066] The controller is configured to control the photometer to acquire second absorbance data indicating the absorbance in the plasma of the separated blood sample during the second rotation cycle. The controller may be configured to control the photometer to acquire second absorbance data by measuring the absorbance of the plasma in the sample analysis cavity using two or more wavelengths, such as two, three, four, five, six, or more wavelengths.

[0067] The controller is configured to determine a second blood parameter based on second absorbance data. The second blood parameter may be the plasma free hemoglobin level (PfHgb) of the blood sample. The controller may be configured to detect when all blood cells have left the measuring eye by detecting that a stable detection signal, such as stable second absorbance data, is provided from the photometer, such as a stable signal indicating unchanging absorbance data.

[0068] In one or more examples of analyzers, the controller may be configured to control the photometer and / or rotatable member to continuously acquire second absorbance data during a second rotation cycle to detect when all, for example substantially all, blood cells have left the measuring eye and the remaining sample material is substantially pure plasma (possibly having free hemoglobin). When the controller detects that a detection signal, such as the acquired second absorbance data, is stable, for example, immutable, the controller may be configured to provide the acquired PfHgb level. When the controller detects that the detection signal is stable, it may be configured to terminate the acquisition of the second absorbance data. Terminating the acquisition of the second absorbance data may include one or more of the following: stopping the second rotation cycle, reducing the speed of the second rotation cycle, acquiring third absorbance data and / or first imaging data, and advancing another rotation cycle, such as the third rotation cycle described herein. By detecting that the detection signal is stable and terminating the acquisition of the second absorbance data, the turnaround time (TAT) can be reduced compared to the time that can be achieved when a predetermined measurement time is used.

[0069] The controller is configured to provide an output indicating a second blood parameter. In one or more exemplary methods, the controller may be configured to control a display unit to provide the operator with an indication of a second blood parameter, such as a PfHgb level.

[0070] In one or more examples of blood analyzers, the controller is configured to rotate a rotatable member at an initial speed in the initial rotation cycle that is insufficient for the transfer of the blood sample from the sampling cavity to the sample analysis cavity.

[0071] In one or more examples of blood analyzers, the controller is configured to control the photometer to acquire initial absorbance data indicating the absorbance in the sample analysis cavity of the cuvette during the initial rotation cycle. In one or more examples of blood analyzers, the controller is configured to perform the initial rotation cycle before the first rotation cycle.

[0072] In one or more examples of blood analyzers, the controller is configured to determine, based on initial absorbance data, a cuvette-related contamination level, such as a cuvette parameter indicating it. The cuvette-related contamination level may include scratches on the surface of the cuvette, discoloration of the cuvette, or contamination of the cuvette within the area of ​​the cuvette's sample analysis cavity.

[0073] In one or more examples of blood analyzers, the controller is configured to provide an output indicating the cuvette parameters. The controller may be configured to provide an output indicating the cuvette parameters on a display for showing the operator a message indicating the cuvette parameters. The controller may be configured to display a message indicating that the contamination level of the cuvette is above a predetermined contamination threshold, or that the contamination level is below a predetermined contamination threshold. A contamination level above the contamination threshold can indicate to the operator that analysis of the blood sample using the cuvette cannot be performed. A contamination level below the contamination threshold can indicate to the operator that analysis of the blood sample using the cuvette can be performed.

[0074] In one or more examples of blood analyzers, the controller can provide an output indicating the cuvette parameters to a compensation function, which can compensate for contamination levels during subsequent measurements and determination of blood parameters using the cuvette.

[0075] In one or more examples of blood analyzers, the controller is configured to control the photometer to acquire third absorbance data indicating the separation time of red blood cells from plasma in the sample analysis cavity of the cuvette during a second rotational cycle. The controller may be configured to acquire third absorbance data by controlling the photometer to measure the absorbance of the blood sample in the sample analysis cavity using two or more wavelengths, such as two, three, four, five, six, or more wavelengths.

[0076] In one or more examples of blood analyzers, the controller is configured to determine a third blood parameter, such as the ESR of the blood sample in the sample analysis cavity of the cuvette, based on third absorbance data and first absorbance data.

[0077] In one or more examples of blood analyzers, the controller is configured to provide an output indicating a third blood parameter. The controller may be configured to provide an output indicating the third blood parameter on a display for displaying a message indicating the third blood parameter to the operator. The controller may be configured to control the display to show a message indicating whether the ESR is higher or lower than the ESR threshold. The ESR threshold may be an ESR that represents a normal ESR, such as the ESR range for a healthy person.

[0078] In one or more examples of blood analyzers, the analyzer includes an imaging device such as a camera. The controller may be configured to control the imaging device to acquire a first image showing an image of at least a portion of the blood sample in the sample analysis cavity of the cuvette after a second rotation cycle.

[0079] In one or more examples of blood analyzers, the controller is configured to determine, for example, a fourth blood parameter indicating the hematocrit level of a blood sample, based on first image data.

[0080] In one or more examples of blood analyzers, the controller is configured to provide an output indicating a fourth blood parameter. The controller may be configured to provide an output indicating the hematocrit level on a display for displaying a message to the operator indicating the fourth blood parameter. In one or more examples of blood analyzers, the output may be an error code. The controller may be configured to present an error code when the fourth blood parameter exceeds the hematocrit threshold, instead of outputting an incorrect result. The hematocrit threshold may be, for example, the amount of blood cells at which it is not possible to obtain a sufficient amount of plasma, thereby resulting in undesirable blood cells in the measuring eye.

[0081] In one or more examples of blood analyzers, the controller is configured to rotate a rotatable member at a third speed in a third rotational cycle, the third speed being faster than the first speed, the second speed, and the initial speed. The controller may be configured to perform a third rotational cycle after a second rotational cycle.

[0082] In one or more examples of blood analyzers, the controller is configured to control the photometer to acquire a fourth absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette during a third rotational cycle.

[0083] In one or more examples of blood analyzers, the controller is configured to determine a fifth blood parameter, for example, a second plasma free hemoglobin level indicating vulnerable blood cells in a blood sample, based on a fourth absorbance data.

[0084] In one or more examples of blood analyzers, the photometer is configured to obtain initial absorbance data, first absorbance data, second absorbance data, third absorbance data, or fourth absorbance data by measuring absorbance using three or more wavelengths.

[0085] In one or more examples of blood analyzers, the controller is configured to control the photometer and any imaging device, respectively, to measure initial absorbance data, first absorbance data, second absorbance data, third absorbance data, or fourth absorbance data during multiple rotations of a rotatable member.

[0086] In one or more examples of blood analyzers, the controller is configured to integrate absorbance data acquired by the photometer during multiple rotations of a rotatable member.

[0087] A cuvette suitable for use in and in the methods of blood analysis and for blood analyzers as defined herein is disclosed below. The cuvette comprises a sampling cavity with a fluid inlet for drawing up, for example, acquiring a blood sample, a sample analysis cavity for analyzing the blood sample, and a discharge cavity.

[0088] The discharge cavity is in fluid communication with the sampling cavity and the sample analysis cavity, thereby allowing the blood sample to flow from the sampling cavity to the sample analysis cavity via the discharge cavity. The sampling cavity and the sample analysis cavity are not in direct fluid communication with each other. Therefore, in order for the blood sample to move from the sampling cavity to the sample analysis cavity, it must flow through the discharge cavity.

[0089] A cuvette is configured to transfer a blood sample from a sampling cavity to a sample analysis cavity via a discharge cavity when a force, such as centrifugal force, is applied to the cuvette. In one or more examples of cuvettes, the cuvette has a first interface that fluidly connects the discharge cavity to the sampling cavity. The first interface may be configured to allow the blood sample to flow through the first interface when a centrifugal force that overcomes a third capillary force is applied to the cuvette. In one or more examples of cuvettes, the cuvette has a second interface that fluidly connects the discharge cavity to the sample analysis cavity. The second interface may be configured to allow the blood sample to flow from the discharge cavity to the sample analysis cavity via the second interface, and to prevent flow from the sample analysis cavity to the discharge cavity. In one or more examples of cuvettes, the blood sample can flow automatically through the second interface, for example, because the first capillary force in the sample analysis cavity is greater than the second capillary force provided by the discharge cavity. In one or more examples of cuvettes, the cuvette lacks any means such as capillary channels and / or siphons configured to separate the blood sample from the sample analysis cavity.

[0090] A blood sample introduced into a cuvette via a sampling cavity may be separated within the sample analysis cavity by applying further centrifugal force once the blood sample enters the sample analysis cavity. For example, red blood cells or disturbing elements may be separated and removed from the whole blood sample. In other words, the blood sample may be separated and analyzed within the same cavity, such as within the sample analysis cavity. Thus, the sample analysis cavity can act as a centrifugal cavity. In other words, a cuvette may not have a centrifugal cavity for separating blood samples in addition to the sample analysis cavity. In one or more examples of cuvettes, the sample analysis cavity is the innermost cavity of the cuvette. This places the separated body fluid in the innermost cavity of the cuvette, which reduces the risk of contamination of the separated body fluid by contact with the outside of the cuvette.

[0091] In one or more examples of cuvettes, a first interface and a second interface are positioned at an angle to each other. The first interface may be positioned along a first axis, such as along the longitudinal axis of the cuvette. The second interface may be positioned along a second axis, such as along the transverse axis of the cuvette. The first and second interfaces may be positioned substantially perpendicular to each other, for example. Substantially perpendicular is understood herein to mean positioned at an angle to each other in the range of 80 to 100 degrees. However, other angles may also be considered. In one or more examples of cuvettes, the second interface may be positioned perpendicular to the longitudinal direction of the cuvette, such as perpendicular to the direction of the centrifugal force applied to the cuvette. In other words, when the cuvette is placed in an analyzer and a centrifugal force is applied to the cuvette, the centrifugal force can act in the longitudinal direction of the cuvette.

[0092] The sample analysis cavity is configured to provide a first capillary force, which is greater than a second capillary force provided by the discharge cavity. The first capillary force may be achieved by the height and / or width of the sample analysis cavity and less than the capillary force achieved by the height and / or width of the discharge cavity. The heights of the sample analysis cavity and the discharge cavity may be expressed herein as the distance between the first and second inner surfaces of each cavity in the vertical direction of the cuvette, as defined in Figure 4. The capillary force of the cavity can be increased by decreasing the distance between the inner surfaces of the cavities. By configuring the sample analysis cavity to have a greater capillary force than the discharge cavity, i.e., the first capillary force is greater than the second capillary force, the transport of blood samples from the discharge cavity to the sample analysis cavity can be increased, while the transport of fluid from the sample analysis cavity to the discharge cavity can be prevented. Therefore, the cuvette may be configured to prevent the blood sample from leaving the sample analysis cavity after the centrifugal force has been removed. This ensures that the entire volume of the blood sample remains in the sample analysis cavity after the centrifugal force has been removed from the cuvette. The entire volume may be expressed herein as at least 90%, such as 95%, 96%, 97%, 98%, 99%, or 100% of the volume of blood obtained by the sampling cavity.

[0093] The discharge cavity has an opening to the outside of the cuvette, and this opening may be referred to herein as the discharge opening. The discharge opening can form an outlet through which air can be discharged from the sample analysis cavity to the outside of the cuvette when the sample analysis cavity is filled with a blood sample. The cuvette may be configured to transport air from the sampling cavity to the outside of the cuvette via the discharge cavity and / or via the sampling cavity when blood is introduced into the sampling cavity, for example, when it is drawn up by the sampling cavity.

[0094] The discharge opening may be located at the first end of the cuvette in one or more examples. The discharge opening may cover the entire width of the discharge cavity, thereby allowing all sides of the discharge cavity to be open to the outside of the cuvette.

[0095] In one or more examples of cuvettes, the discharge opening is an opening through the outer wall of the cuvette. The discharge opening may extend across part or the entire width of the discharge cavity. The opening allows air to leak out of the cuvette through the discharge cavity from any cavity, such as the discharge cavity, sampling cavity, and / or sample analysis cavity, once the cavity is filled with a blood sample. In one or more examples of cuvettes, the outlet of the discharge cavity to the outside of the cuvette is located at a first end of the cuvette, such as at a first longitudinal end of the cuvette.

[0096] In one or more examples of cuvettes, the sampling cavity has an opening through the outer wall of the cuvette, which may be referred to herein as the sampling opening. The sampling opening may extend over part or the entire width of the sampling cavity. The sampling opening may allow air to leak out of the sampling cavity when the sampling cavity is filled with a blood sample, for example, when the sampling cavity is drawing up a blood sample. In one or more examples of cuvettes, the sampling opening of the sampling cavity to the outside of the cuvette is located at the first end of the cuvette. Thus, the sampling opening and the discharge opening may be located at the same end of the cuvette.

[0097] In one or more examples of cuvettes, discharge openings and / or sampling openings extending across the entire width of each cavity can allow for the removal of shaping tools used during cuvette production. This can facilitate cuvette production, potentially reducing the time and cost required to manufacture the cuvettes.

[0098] The sampling cavity may be configured to provide a third capillary force. This third capillary force may be greater than a second capillary force in the discharge cavity. Automatic transport of the blood sample from the sampling cavity can be prevented by configuring the cuvette such that the third capillary force is greater than the second capillary force. Automatic transport as used herein means transport without applying any external force, such as centrifugal force, to the cuvette. A greater capillary force in the sampling cavity can be achieved by having a lower height in the sampling cavity than in the discharge cavity. The cavity height may be expressed herein as the distance between two parallel inner surfaces of each cavity. The third capillary force in the sampling cavity may be the same as or different from a first capillary force, such as the capillary force in the sample analysis cavity. Because the cuvette is configured to prevent automatic transport of blood from the sampling cavity, the sampling cavity can be filled with the sample in several steps without acquiring excess fluid. Therefore, if the sampling cavity is not properly filled, more fluid may be drawn into the sampling cavity to fill it. Thus, if it is noted that the inlet cavity is not completely filled with fluid, the cuvette can come into contact with the fluid being sampled again, thereby drawing more fluid into the inlet cavity by capillary action within the sampling cavity. This ensures that a predetermined sample volume corresponding to the volume of the sampling cavity is always collected.

[0099] In one or more examples of cuvettes, the cuvette consists of a main body member, such as a single main body member, the main body member having an inner wall within the body defining a sampling cavity, a sample analysis cavity, and an exhaust cavity. A single body member as herein means that the cuvette is made in one piece, for example, by molding or casting. By making the cuvette in one piece, the cuvette does not have any joints / fittings through which blood could leak from the cuvette during centrifugation. This can reduce contamination of the cuvette and the outside of the blood analyzer, which reduces the time required between analyses to clean and prepare the analyzer to receive another cuvette.

[0100] The sampling cavity, sample analysis cavity, and discharge cavity may be located within the main body of the cuvette. The main body of the cuvette may be made of a material having low absorbance for radiation at wavelengths used during the analysis of blood samples. In one or more examples of cuvettes, the cuvette material may be a plastic such as polystyrene (PS), polymethyl methacrylate (PMMA), or polycarbonate (PC).

[0101] The centrifugal force applied to the cuvette can overcome the third capillary force that holds the blood sample in the sampling cavity. Therefore, the blood sample can leave the sampling cavity through the discharge cavity and enter the sample analysis cavity. The sample analysis cavity may be positioned offset from the sampling cavity in the longitudinal direction of the cuvette. This allows the centrifugal force to push the blood sample toward and into the sample analysis cavity.

[0102] The cuvette may be configured to transfer air from the sample analysis cavity to the outside of the cuvette via an exhaust cavity when centrifugal force is applied to the cuvette. When a blood sample enters the sample analysis cavity, the air inside the sample analysis cavity can leak out of the cuvette through a second interface and exhaust opening, thereby ensuring proper filling of the sample analysis cavity.

[0103] In one or more example cuvettes, the sampling cavity and the sample analysis cavity have substantially equal volumes, such as equal volumes. Thus, a predetermined volume of blood sample can be obtained through the sampling cavity, and the same volume of fluid can be analyzed in the sample analysis cavity.

[0104] The volume of the sampling cavity can be in the range of 10 to 100 microliters (μL) or 20 to 60 microliters (μL), for example, in the range of 30 to 50 μL, for example, in the range of 30 to 40 μL, for example, in the range of 30 to 35 μL, for example, in the range of 32 μL. The volume of the sample analysis cavity can be in the range of 10 to 100 microliters (μL) or 20 to 60 microliters (μL), for example, in the range of 30 to 50 μL, for example, in the range of 30 to 40 μL, for example, in the range of 30 to 35 μL, for example, in the range of 32 μL.

[0105] In one or more examples of cuvettes, the sample analysis cavity has a substantially uniform elongated shape extending in a first direction between a first end and a second end of the cuvette. The first and second ends of the cuvette may be located at the opposing longitudinal ends of the cuvette. The first direction may be parallel to the intended direction of centrifugal force applied to the cuvette, such as the direction of centrifugal force applied to the cuvette when the cuvette is analyzed using a blood analyzer configured to receive the cuvette.

[0106] In one or more examples of cuvettes, the total length of the cuvette, such as the longitudinal extension of the cuvette as defined in Figure 4, can be in the range of 30 to 50 mm or 36 to 44 mm, for example, in the range of 38 to 42 mm, for example, in the range of 39 to 40 mm. The total length can be measured from the tip of the first longitudinal end of the cuvette to the second longitudinal end of the cuvette.

[0107] In one or more examples of cuvettes, the total width of the cuvette, including the lateral extension of the cuvette as defined in Figure 4, can be in the range of 15 to 28 mm or 18 to 24 mm, for example, in the range of 19 to 23 mm, for example, in the range of 20 to 22 mm. In one or more examples of methods, the width of the cuvette can be 21 mm.

[0108] In one or more examples of cuvettes, the total width of the cuvette, including the vertical extension of the cuvette as defined in Figure 4, can be in the range of 1.9 to 2.4 mm, for example, in the range of 2.0 to 2.3 mm, for example, in the range of 2.1 to 2.2 mm.

[0109] In one or more example cuvettes, the sample analysis cavity may have a length such as the longitudinal extension of the cuvette as defined in Figure 4, within the range of 10 to 20 mm, for example, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm, and / or within any range limited by the dimensions discussed in this paragraph.

[0110] In one or more example cuvettes, the sample analysis cavity may have a width of 2 to 7 mm, for example, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm, and / or any range limited by the dimensions discussed in this paragraph, such as the lateral extension of the cuvette as defined in Figure 4.

[0111] In one or more example cuvettes, the sample analysis cavity may have a height such as the vertical extension of the cuvette as defined in Figure 4, in the range of 0.2 to 0.7 mm, for example, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, or 0.7 mm, and / or any range limited by the dimensions discussed in this paragraph. In one or more example cuvettes, the height of the sample analysis cavity may be 0.5 mm, for example, 500 μm.

[0112] In one or more example cuvettes, the sampling cavity may have a length such as an average length, within the range of 5 to 15 mm, for example, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, or 15 mm, and / or within any range limited by the dimensions discussed in this paragraph.

[0113] In one or more example cuvettes, the sampling cavity may have a width such as an average width, within the range of 5 to 15 mm, for example, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, or 15 mm, and / or within any range limited by the dimensions discussed in this paragraph.

[0114] In one or more example cuvettes, the sampling cavity may have a height such as the vertical extension of the cuvette as defined in Figure 4, in the range of 0.2 to 0.7 mm, for example, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, or 0.7 mm, and / or any range limited by the dimensions discussed in this paragraph. In one or more example cuvettes, the height of the sampling cavity may be in the range of 500 to 650 μm, for example, 575 μm.

[0115] In one or more example cuvettes, the discharge cavity may have a length in the range of 5 to 10 mm, for example, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm, and / or any range limited by the dimensions discussed in this paragraph.

[0116] In one or more example cuvettes, the discharge cavity may have a width in the range of 3 to 8 mm, for example, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, or 8 mm, and / or any range limited by the dimensions discussed in this paragraph.

[0117] In one or more examples of cuvettes, the discharge cavity may have a height such as the vertical extension of the cuvette as defined in Figure 4, in the range of 0.4 to 2 mm, for example, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2.0 mm, and / or within any range limited by the dimensions discussed in this paragraph. In one or more examples of cuvettes, the height of the discharge cavity may be 1 mm, for example, 1000 μm.

[0118] In one or more examples of cuvettes, the main body member is provided with a tip. A sampling cavity may be located at the tip of the main body member, thereby positioning the inlet of the sampling cavity at the tip of the cuvette. Positioning the inlet at the tip of the cuvette can facilitate the filling of the sampling cavity with the blood sample because the tip allows for precise positioning of the inlet of the sampling cavity in the blood sample being aspirated.

[0119] In one or more examples of cuvettes, the sampling cavity, such as the inner surface of the sampling cavity, is configured to incline toward the sample analysis cavity. Providing an incline toward the sample analysis cavity can improve the transport of blood samples from the sampling cavity to the sample analysis cavity. The sampling cavity may be configured to incline outward toward the opening to further facilitate the removal of shaping tools after shaping the cuvette.

[0120] In one or more examples of cuvettes, the cuvette, such as the sample analysis cavity, is reagent-free. When a cuvette is reagent-free, the analysis of a blood sample, such as a blood sample, can be performed by directly measuring the hemoglobin (Hb) derivative present in the body. In the case of blood, the hemoglobin derivative can be, for example, reduced hemoglobin (Hb), such as deoxyhemoglobin (reduced form), oxyhemoglobin (HbO2), methemoglobin (met-Hb), carboxyhemoglobin (HbCO), or other types of hemoglobin. Creating reagent-free cuvettes reduces the cost of manufacturing the cuvettes and also reduces the time required to manufacture them.

[0121] In one or more example cuvettes, the walls of the sampling cavity are coated with a wetting agent. The wetting agent can help draw the blood sample into the sampling cavity.

[0122] In one or more example cuvettes, the sample analysis cavity may include a reagent configured to react with a blood sample. The reagent may be placed on the inner surface of the sample analysis cavity so that it comes into contact with the blood sample when the blood sample enters the sample analysis cavity. The reagent may be coated onto the sample analysis cavity during the manufacture of the cuvette. Different reagents may be provided in the cavity depending on the analysis to be performed, thereby allowing the cuvette to be adapted for the analysis of different biological parameters of blood. The reagent may react different hemoglobin derivatives to form the same derivative, thereby reducing interference at different wavelengths, which can facilitate the analysis procedure of blood samples.

[0123] In one or more examples of cuvettes, each cuvette may include a unique identifier to identify each individual cuvette. The unique identifier may be a visual identifier such as a barcode or QR code, or a digital identifier such as a Radio Frequency Identification (RFID) tag. The unique identifier may be used to identify a cuvette used for a specific blood sample and / or analysis. In one or more examples of cuvettes, the identifier may be identified by a blood analyzer, and the measurements from the blood analyzer may be automatically stored along with the cuvette's unique identifier.

[0124] The cuvette can be disposable, or it can be a single-use cuvette, for example, a cuvette configured for single use, which is discarded after being used once for analysis.

[0125] The cuvettes can be manufactured by conventional means, for example, as disclosed in International Publication No. 2007 / 008137.

[0126] In the following, the methods for analyzing blood samples, analyzers for analyzing blood samples, and cuvettes for analyzing blood samples of this disclosure will be described in more detail with reference to the figures. The figures are inherently schematic and simplified for clarity, and they merely illustrate details that are helpful in understanding this disclosure, while other details are omitted. Throughout, the same reference figures are used for identical or corresponding parts.

[0127] Figure 1 shows a method 100 for analyzing a blood sample. The method may be carried out using a blood analyzer. A blood analyzer may be found herein as an analytical device for analyzing blood.

[0128] The method includes S102 arranging a cuvette having a sampling cavity and a sample analysis cavity on a rotatable member. The sampling cavity contains a blood sample to be analyzed.

[0129] In one or more example methods, the method may include rotating a rotatable member at an initial speed in an initial rotation cycle that is insufficient for transferring the blood sample from the sampling cavity to the sample analysis cavity S104. The initial speed can create an initial centrifugal force acting on the blood sample during the initial rotation cycle, which is smaller than the capillary force acting on the blood sample in the sampling cavity. In other words, the initial speed can be insufficient for transferring the blood sample from the sampling cavity to the sample analysis cavity. Thereafter, the blood sample will be held in the sampling cavity during the initial rotation cycle. Thus, the sample analysis cavity will remain empty, and empty here means not containing blood, which allows an initial measurement to be performed on the empty sample analysis cavity of the cuvette to detect any contamination or damage to the cuvette that may affect the analytical results of the blood sample. In one or more example methods, the initial rotation cycle is performed before the first rotation cycle.

[0130] In one or more example methods, the method may include obtaining initial absorbance data showing the absorbance in or through the sample analysis cavity of a cuvette using a photometer during the initial rotation cycle. Since the blood sample is held in the sampling cavity during the initial rotation cycle, the initial absorbance data may be absorbance data showing the absorbance through an empty sample.

[0131] In one or more example methods, the method may include determining cuvette parameters based on initial absorbance data S108. The cuvette parameters may be, for example, the level of contamination associated with the cuvette, the absorbance data of an empty cuvette, and the presence of the cuvette in the receptacle of a rotatable member. The level of contamination associated with the cuvette may include scratches on the surface of the cuvette, discoloration of the cuvette, contamination of the cuvette, and / or any other imperfections of the cuvette in the sample analysis cavity area of ​​the cuvette. Contamination may be caused, for example, by fingerprints added to the sample analysis cavity area due to improper handling of the cuvette by the operator.

[0132] In one or more example methods, the method may include providing an output indicating cuvette parameters S109. In one or more example methods, providing an output S109 may include displaying a message to the operator indicating cuvette parameters S109A. The message may indicate, for example, that the contamination level of the cuvette is above a predetermined contamination threshold, or that the contamination level is below a predetermined contamination threshold. A contamination level above the contamination threshold may indicate to the operator that analysis of the blood sample using the cuvette cannot be performed. A contamination level below the contamination threshold may indicate to the operator that analysis of the blood sample using the cuvette can be performed.

[0133] In one or more example methods, providing an output S109 may include providing cuvette parameters to a compensation function S109B, which can compensate for contamination level and / or absorbance data of an empty cuvette during subsequent measurement and determination of blood parameters using the cuvette.

[0134] The method includes rotating a rotatable member at a first speed in a first rotational cycle S110 for the transfer of a blood sample from a sampling cavity to a sample analysis cavity. The first speed may be configured to create a first centrifugal force greater than a third capillary force generated by the sampling cavity of the cuvette. The first centrifugal force transfers the blood sample from the sampling cavity to the sample analysis cavity. In one or more example methods, the first rotational cycle is performed after an initial rotational cycle.

[0135] In one or more example methods, the method may include obtaining first absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette, using a photometer and during a first rotational cycle.

[0136] In one or more example methods, the method may include determining a filling parameter indicating a blood level, such as a fill level, such as an amount of blood, in the sample analysis cavity of a cuvette, based on first absorbance data S113. In one or more example methods, the filling parameter may indicate one or more of the following: the sample analysis cavity is underfilled, the sample analysis cavity is improperly filled, and the sample analysis cavity is properly filled. In one or more example methods, the sample analysis cavity may be determined to be underfilled when the first absorbance data is less than a first blood level threshold. A blood level that is too low, such as in an underfilled cuvette, may cause the absorbance data to be lower than when the sample analysis cavity is properly filled. An improperly filled sample analysis cavity may be seen herein as not being filled with blood, such as being filled with a fluid other than blood.

[0137] In one or more example methods, the method may include providing an output indicating filling parameters, such as the amount of blood in the sample analysis cavity of the cuvette (S113A). In one or more example methods, the output may indicate that further analysis of the blood sample is not possible, such as when the filling parameters indicate that the cuvette is underfilled and / or improperly filled. In one or more example methods, the output may indicate that further analysis of the blood sample is possible, such as when the filling parameters indicate that the cuvette is properly filled. In one or more example methods, the output may be a signal that prevents further analysis of the blood sample, such as when the filling parameters indicate that the cuvette is underfilled and / or improperly filled. In one or more example methods, the output may be a signal that enables further analysis of the blood sample, such as when the filling parameters indicate that the cuvette is properly filled.

[0138] In one or more example methods, the method may include determining, for example, a first blood parameter indicating the total hemoglobin level of a blood sample, based on first absorbance data.

[0139] The method includes S116 rotating a rotatable member at a second speed in a second rotational cycle to separate the blood portion from the plasma in a blood sample. The second rotational cycle may be performed after the first rotational cycle.

[0140] The method includes acquiring second absorbance data during or after the second rotational cycle using a photometer (S118). The second absorbance data represents the absorbance in plasma.

[0141] The method includes determining a second blood parameter based on second absorbance data S119. The second blood parameter is the plasma free hemoglobin level of the blood sample, for example, shown.

[0142] The method includes providing an output indicating a second blood parameter (S120).

[0143] In one or more example methods, the method may include using a photometer to obtain third absorbance data indicating the separation time of red blood cells from plasma during a second rotational cycle.

[0144] In one or more example methods, the method may include determining a third blood parameter based on third absorbance data and first absorbance data. The third blood parameter is the erythrocyte sedimentation rate of a blood sample, for example, shown below.

[0145] In one or more example methods, the method includes providing an output indicating a third blood parameter (S123).

[0146] In one or more example methods, the method may include using an imaging device to acquire first image data showing an image of at least a portion of the blood sample in the sample analysis cavity after a second rotation cycle S124.

[0147] In one or more example methods, the method may include determining, for example, a fourth blood parameter indicating the hematocrit level of a blood sample, based on first image data S126.

[0148] In one or more example methods, the method may include providing an output indicating a fourth blood parameter (S128).

[0149] In one or more example methods, the method may include rotating a rotatable member at a third speed in a third rotational cycle after a second rotational cycle S130. In one or more example methods, the third speed is faster than the first speed, the second speed, and the initial speed. In one or more example methods, the third speed may be equal to the second speed. In one or more example methods, the third rotational cycle may be longer than the second rotational cycle in order to induce hemolysis in the blood sample. In other words, hemolysis may be induced in the blood sample during the third rotational cycle by centrifuging the blood sample at a faster speed or for a longer period of time than the second rotational cycle.

[0150] In one or more example methods, the method may include obtaining a fourth absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette during a third rotational cycle using a photometer.

[0151] In one or more example methods, the method may include determining a fifth blood parameter based on a fourth absorbance data S134. The fifth blood parameter may be a second plasma free hemoglobin level indicating fragile blood cells in the blood sample. The level of fragile blood cells in the blood sample may be determined by comparing the second plasma free hemoglobin level with a first plasma free hemoglobin level.

[0152] In one or more example methods, the method may include S136 providing an output indicating a fifth blood parameter, such as displaying information indicating a fifth blood parameter.

[0153] Figure 2 shows a schematic diagram of an example blood analyzer 100 according to this disclosure. The blood analyzer 100 may include a housing 110 capable of housing any and / or all of the parts of the blood analyzer 100 discussed herein, such as a rotatable member, a photometer, a controller, a display, and / or a drive unit.

[0154] The blood analyzer 100 comprises a rotatable member 200. The rotatable member 200 is rotatably positioned within the housing 110. The rotatable member 200 may be rotatably positioned around a pivot axis 202. The rotatable member comprises a receptacle 204 for receiving a cuvette. The cuvette comprises a sampling cavity and a sample analysis cavity. When the cuvette is positioned on the rotatable member, the sampling cavity of the cuvette is intended to contain the blood sample to be analyzed, while the sample analysis cavity is intended to be empty. Empty as used herein means that the sample analysis cavity may contain air instead of a blood sample. The rotatable member 200 may be a circular member, such as a disk. The receptacle 204 may comprise a measuring eye 206, such as an aperture, to allow light to pass through the rotatable member 200. The measuring eye 206 may be positioned within the receptacle 204 such that, when the cuvette is placed within the receptacle 204, the measuring eye 206 overlaps with the sample analysis cavity of the cuvette at at least a first angular position on the rotatable member 200. The measuring eye 206 may be positioned on the rotatable member 200 at a distance r from the rotation axis 202. The blood analyzer 100 may include a drive unit 208, such as an electric motor for rotating the rotatable member 200.

[0155] The blood analyzer 100 includes a photometer 300. The photometer 300 is configured to take, for example, measure absorbance data related to the blood sample in the sample analysis cavity and / or cuvette. The photometer 300 can be a multi-wavelength photometer. The photometer 300 may include a light source 302 for emitting light at each wavelength, and an optical sensor 304 such as a photodiode for measuring how much light is absorbed by an object located between the light source 302 and the optical sensor 304.

[0156] The blood analyzer 100 may include a display 500 configured to visually provide information to the operator of the blood analyzer 100, such as visually displaying information indicating cuvette parameters, first blood parameters, second blood parameters, third blood parameters, fourth blood parameters, and / or fifth blood parameters.

[0157] The blood analyzer 100 may be equipped with a display 500 for displaying information to the operator of the blood analyzer 100, for example, for visual presentation.

[0158] The blood analyzer 400 may be equipped with an imaging device 306, such as a camera, for taking images related to the blood sample in the sample analysis cavity and / or cuvette.

[0159] The blood analyzer may include a controller 400. The controller 400 may be configured to control the photometer 300, the imaging device 306, the rotatable member 200, the drive unit 208, and / or the display 500. The controller 400 may be configured to perform any one or more of the operations disclosed in Figures 1a to 1d (such as any one or more of S102, S104, S106, S108, S110, S112, S114, S116, S118, S119, S120, S121, S122, S123, S124, S126, S128, S130, S132, S134).

[0160] The controller 400 may be configured to control the drive unit 208 to control the speed of the rotatable member 200.

[0161] The controller 400 may be configured to rotate the rotatable member 200 at a first speed in a first rotational cycle in order to transfer the blood sample from the sampling cavity to the sample analysis cavity.

[0162] The controller 400 may be configured to rotate the rotatable member 200 at a second speed in a second rotation cycle after a first rotation cycle in order to separate the blood portion from the plasma in the blood sample.

[0163] The controller 400 may be configured to control the photometer 300 to acquire second absorbance data indicating the absorbance in the plasma of the separated blood sample during the second rotation cycle.

[0164] The controller 400 may be configured to determine a second blood parameter, such as the plasma free hemoglobin level of a blood sample, based on second absorbance data.

[0165] The controller 400 may be configured to provide an output indicating a second blood parameter to a display 500 or the like.

[0166] The controller 400 may be configured to rotate the rotatable member 200 at an initial speed in an initial rotation cycle before the first rotation cycle. The initial speed is insufficient for transferring the blood sample from the sampling cavity to the sample analysis cavity.

[0167] The controller 400 may be configured to control the photometer 300 to acquire initial absorbance data indicating the absorbance in the sample analysis cavity of the cuvette during the initial rotation cycle.

[0168] The controller 400 may be configured to determine, based on initial absorbance data, a contamination level associated with the cuvette, such as a cuvette parameter indicating it.

[0169] The controller 400 may be configured to provide an output indicating the cuvette parameters to a display 500 or the like.

[0170] The controller 400 may be configured to control the photometer 300 to acquire first absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette during a first rotation cycle.

[0171] The controller 400 may be configured to determine, for example, a first blood parameter that indicates the total hemoglobin level of a blood sample, based on first absorbance data.

[0172] The controller 400 may be configured to provide an output indicating a first blood parameter to a display 500 or the like.

[0173] The controller 400 may be configured to control the photometer 300 to acquire third absorbance data during the second rotation cycle, indicating the separation time of red blood cells from plasma in the sample analysis cavity of the cuvette.

[0174] The controller 400 may be configured to determine a third blood parameter, such as the erythrocyte sedimentation rate of the blood sample in the sample analysis cavity of the cuvette, based on the third absorbance data and the first absorbance data.

[0175] The controller 400 may be configured to provide an output indicating a third blood parameter to a display 500 or the like.

[0176] The controller 400 may be configured to control the imaging device 306 to acquire first image data showing an image of at least a portion of the blood sample in the sample analysis cavity of the cuvette after a second rotation cycle.

[0177] The controller 400 may be configured to determine, for example, a fourth blood parameter indicating the hematocrit level of a blood sample, based on the first image data.

[0178] The controller 400 may be configured to provide an output indicating a fourth blood parameter to a display or the like.

[0179] The controller 400 may be configured to rotate the rotatable member 200 at a third speed in a third rotation cycle after a second rotation cycle, wherein the third speed is faster than the first speed, the second speed, and the initial speed.

[0180] The controller 400 may be configured to control the photometer 300 to acquire a fourth absorbance data during the third rotation cycle, which indicates the absorbance in the blood sample within the sample analysis cavity of the cuvette.

[0181] The controller 400 may be configured to determine a fifth blood parameter, for example, a second plasma free hemoglobin level indicating vulnerable blood cells in the blood sample, based on the fourth absorbance data.

[0182] The controller 400 may be configured to control the photometer and any imaging device, respectively, to measure initial absorbance data, first absorbance data, second absorbance data, third absorbance data, image data, or fourth absorbance data during multiple rotations of the rotatable member 200.

[0183] The controller 400 may be configured to integrate absorbance data acquired by the photometer 300 during multiple rotations of the rotatable member 200.

[0184] Figure 3 shows a schematic diagram of an example photometer 300 according to the present disclosure. The photometer 300 may comprise a plurality of light sources 302, such as light sources 302A, 302B, 302C, and a plurality of optical sensors 304, such as optical sensors 304A, 304B, 304C. The light sources 302A, 302B, 302C and the corresponding optical sensors 304A, 304B, 304C may be arranged on opposing sides of a rotatable member 200, so that the light emitted from each of the light sources 302A, 302B, 302C passes through a measuring eye 202 in the rotatable member 200 and a cuvette located in a receptacle 204 of the rotatable member 200 before reaching the corresponding optical sensors 304A, 304B, 304C. In other words, multiple light sources 302A, 302B, 302C may be arranged on the first side of the rotatable member 200, and one or more optical sensors 304A, 304B, 304C may be arranged on the second side of the rotatable member 200. The first side and the second side of the rotatable member 200 may be opposing sides of the rotatable member. In one or more examples of blood analyzers, the light sources 302A, 302B, 302C may be LEDs. Each light source 302A, 302B, 302C may be configured to emit light of a different wavelength. The photometer 300 may be configured to obtain initial absorbance data, first absorbance data, second absorbance data, third absorbance data, and / or fourth absorbance data by measuring absorbance using three or more wavelengths.

[0185] Figure 4 shows a perspective view of cuvette 1 according to one or more examples of the present disclosure. Cuvette 1 comprises a sampling cavity 2, an discharge cavity 3, and a sample analysis cavity 4. Throughout this document, cuvettes will be described in relation to the coordinate system disclosed in Figure 4, where the X-axis defines the longitudinal direction, extending over the length of cuvette 1 (e.g., between the first longitudinal end 6 and the second longitudinal end 7 of cuvette 1), the Y-axis defines the transverse direction, extending over the width of cuvette 1, and the Z-axis defines the vertical direction, extending over the height of cuvette 1. The principal plane of cuvette 1 discussed herein is the plane extending over the longitudinal and transverse directions of cuvette 1. Planes perpendicular to the principal plane may, in this specification, be one or more of the planes extending over the longitudinal and transverse directions of cuvette 1 and the planes extending over the transverse and transverse directions of cuvette 1. Cuvette 1 may have extensions that are longer in the longitudinal and transverse directions compared to the vertical direction, and therefore may be called having a flat shape or a flat cuvette.

[0186] Figure 5 shows a cuvette 1 according to one or more examples of the present disclosure. The cuvette 1 comprises a sampling cavity 2, a sample analysis cavity 4, and a discharge cavity 3. The sampling cavity 2 comprises a fluid inlet 22 for collecting a blood sample. The cuvette 1 has a main body member 10 comprising a base portion 11. The base portion 11 may be solid and may be configured to be touched by an operator during handling of the cuvette without interfering with the results of blood analysis. In the cuvette according to one or more examples, the base portion 11 of the main body member 10 may have a different surface texture from the main body member 10 in the area of ​​the sampling cavity 2 and / or sample analysis cavity 4. Providing a base portion 11 with a different surface texture can provide the operator of the cuvette with a visual indication of an area that can be touched without interfering with the analysis results. The main body member 10 may include mounting elements 5 which can be configured to fit the cuvette holder into an analyzer. The mounting element 5 may be positioned such that the cuvette 1 can be positioned in only one way within the analyzer. In the example cuvette 1 shown in Figure 5, the mounting element 5 may be shaped as a recess within the main body member 10 of the cuvette 1.

[0187] The sampling cavity 2, sample analysis cavity 4, and discharge cavity 3 are located within the main body member 10 of the cuvette 1, and may be formed therein, for example. The cuvette 1 may consist of a single main body member 10, such as a single piece, having inner walls that define the sampling cavity 2, sample analysis cavity 4, and discharge cavity 3 within the main body member 10. The main body member 10 of the cuvette 1 may be made of a material having low absorbance for radiation at wavelengths used during the analysis of blood samples. The main body member 10 may be made of plastic such as polystyrene (PS), polymethyl methacrylate (PMMA), or polycarbonate (PC).

[0188] The discharge cavity 3 is fluidly connected to the sampling cavity 2 and the sample analysis cavity 4, thereby allowing blood to flow from the sampling cavity 2 to the sample analysis cavity 4 via the discharge cavity 3. The discharge cavity 3 can be fluidly connected to the sampling cavity 2 via a first interface 23. The first interface 23 can be positioned along the longitudinal axis of the cuvette 1. The discharge cavity 3 can be fluidly connected to the sample analysis cavity 4 via a second interface 34. The second interface 34 can be positioned along the transverse axis of the cuvette 1. The sampling cavity 2 and the sample analysis cavity 4 are not directly fluidly connected to each other. Therefore, in order for a blood sample to move from the sampling cavity 2 to the sample analysis cavity 4, the blood sample must flow through the discharge cavity 3, via the first interface 23 and the second interface 34, etc.

[0189] The sample analysis cavity 4 is configured to provide a first capillary force, which is greater than the second capillary force provided by the discharge cavity 3. This can be achieved by making the height of the sample analysis cavity 4 smaller than the height of the discharge cavity 3. The second interface 34 may be configured to allow the blood sample to flow from the discharge cavity to the sample analysis cavity through the second interface 34, and to prevent the blood sample from flowing from the sample analysis cavity 4 to the discharge cavity 3. This ensures that the entire volume of the blood sample enters the sample analysis cavity 4 and remains within it.

[0190] The first interface 23 and the second interface 34 may be positioned at a certain angle a relative to each other. For example, the first interface 23 and the second interface 34 may be positioned substantially perpendicular to each other.

[0191] The sampling cavity 2 is configured to provide a third capillary force, which is greater than the second capillary force. The third capillary force, which is greater than the second capillary force, prevents the automatic transport of the blood sample from the sampling cavity 2 to the discharge cavity 3. This can be achieved by making the height of the sampling cavity 2 less than the height of the discharge cavity 3. The third capillary force may be the same as or different from the first capillary force. The first interface 23 may be configured to allow the blood sample to flow through the first interface 23 when a centrifugal force that overcomes the third capillary force is applied to the cuvette 1. Thus, the cuvette 1 may be configured to transport the blood sample from the sampling cavity 2 to the sample analysis cavity 4 via the discharge cavity 3 when a centrifugal force is applied to the cuvette 1.

[0192] The blood sample introduced into the cuvette 1 via the sampling cavity 2 can be separated within the sample analysis cavity 4 by applying further centrifugal force once the blood sample enters the sample analysis cavity 4.

[0193] The discharge cavity 3 has an outlet 31 to the outside of the cuvette 1. The outlet 31 of the discharge cavity 3 may be located at a first end 6 of the cuvette 1, such as the first longitudinal end. The outlet 31 may be an opening through the first outer wall of the first end 6 of the cuvette 1, and the opening extends across the entire width of the discharge cavity 3. This allows all sides of the discharge cavity 3 to be open to the outside of the cuvette 1. The outlet 31 is configured to allow air to be discharged from the sample analysis cavity 4 to the outside of the cuvette 1 through the discharge cavity 3 once the sample analysis cavity 4 is filled with a blood sample. The outlet 31, which covers the entire width of the discharge cavity 3, also allows the shaping tool to be removed from the main body member 10 after the cuvette 1 has been manufactured.

[0194] The sampling cavity 2 has an opening 21 through the first outer wall of the first end 6 of the cuvette 1. The opening 21 extends across the entire width of the sampling cavity 2. The opening 21 of the sampling cavity 2 can allow air to leak out of the sampling cavity when the sampling cavity 2 is filled with a blood sample, for example, to draw up a blood sample. The opening 21 can further allow for the removal of shaping tools used during the manufacture of the cuvette 1. The opening 21 of the sampling cavity 2 may be located at the same end of the cuvette 1 as the outlet 31. The main body member 10 may have a tip 12. The tip 12 may be located at the first end 6. The side wall of the first end 6 may have a bend that forms the tip 12. The sampling cavity 2 may be located at the tip 12 of the main body member 10, thereby the inlet 22 of the sampling cavity 2 is located at the tip 12 of the cuvette 1. By positioning the inlet 22 at the tip 12 of the cuvette 1, the filling of the sampling cavity with a blood sample can be facilitated because the tip 12 allows for precise positioning of the inlet 22 in relation to the blood sample being drawn up. Once the tip 12 is immersed in the blood sample, the capillary force of the sampling cavity 2 draws the blood into the sampling cavity 2 through the inlet 22. The inlet 22 can be a section of the opening 21 located at the tip 2 of the cuvette 1. The sampling cavity 2, such as the inner surface 24 of the sampling cavity 2, can be configured to incline toward the sample analysis cavity 4. By providing the sampling cavity 2 with an inclined inner surface 24, the transport of the blood sample from the sampling cavity 2 to the sample analysis cavity 4 can be improved. The sampling cavity 2, such as the inner surface 24, can be configured to incline outward toward the opening 21. This can facilitate the removal of the shaping tool after shaping the cuvette 1.

[0195] The sample analysis cavity 4 may have a substantially uniform elongated shape extending in a first direction from a first end 6 of the cuvette 1 to / from the opposing second end 7 of the cuvette 1. The first end 6 and the second end 7 of the cuvette may be located at the opposing longitudinal ends of the cuvette 1. The first direction may be parallel to the intended direction of centrifugal force applied to the cuvette, such as the direction of centrifugal force applied to the cuvette when the cuvette 1 is analyzed using an analyzer configured to receive the cuvette 1.

[0196] In one or more example cuvettes, the sample analysis cavity 4 can be offset from the sampling cavity 2 in the longitudinal direction of cuvette 1. In one or more example cuvettes, the sample analysis cavity 4 can be offset from the sampling cavity 2 in the transverse direction of cuvette 1. In one or more example cuvettes, the sample analysis cavity 4 can be offset from the sampling cavity 2 in both the longitudinal and transverse directions of cuvette 1.

[0197] Figure 6 shows the locations of the first cross section AA, the second cross section BB, the third cross section CC, and the fourth cross section DD, which are used for the cross-sectional views in Figures 7-10. Cross section AA extends longitudinally through the sampling cavity 2 of the cuvette. The cross-sectional view of cross section AA is further illustrated with reference to Figures 7A and 7B. Cross section BB extends longitudinally through the discharge cavity 3 and the sample analysis cavity 4 of the cuvette. The cross-sectional view of cross section AA is further illustrated with reference to Figures 8A and 8B. Cross section CC extends transversely through the discharge cavity 3 and the sampling cavity 2 of the cuvette 1. The cross-sectional view of cross section CC is further illustrated with reference to Figure 9. Cross section DD extends transversely through the sample analysis cavity 4 of the cuvette 1. The cross-sectional view of cross section DD is further illustrated with reference to Figure 10.

[0198] Figure 7A shows a sectioned view, and Figure 7B shows a cross-sectional view of the cuvette 1 through the section AA. As can be seen in the sectioned view of Figure 7A, the sampling cavity 2 is located at the first end 6 of the cuvette 1 within the main body 11. The sampling cavity 2 has an opening 21 at the first end 6 through the outer wall of the cuvette 1.

[0199] The cross-sectional view in Figure 7B shows a cross-section of the cuvette facing the tip 12 of the cuvette 1. As can be seen, the opening 21 of the sampling cavity 2 extends across the entire width of the sampling cavity 2 to the inlet 22 located at the tip 12.

[0200] Figure 8A shows a cross-section, and Figure 8B shows a cross-section of cuvette 1 through the cross-section BB. The discharge cavity 3 is located at the first end 6 of cuvette 1 and extends between the first end 6 and the sample analysis cavity 4. The sample analysis cavity 4 extends longitudinally from the discharge cavity 3 toward the second end 7 of cuvette 1. As can be seen in the cross-section of Figure 8A, the sample analysis cavity 4 is narrower than the discharge cavity 3, for example, it is lower in height than the discharge cavity 3. Because the sample analysis cavity 4 is lower in height than the discharge cavity 3, the first capillary force is greater than the second capillary force. This can increase the transport of the blood sample from the discharge cavity 3 through the second interface 34 to the sample analysis cavity 4 because the first capillary force draws the blood sample into the sample analysis cavity 4. The fact that the first capillary force is greater than the second capillary force further prevents the fluid from flowing back from the sample analysis cavity 4 to the discharge cavity 3.

[0201] The cross-sectional view in Figure 8B shows a cross-section of the cuvette as seen facing the tip 12 of the cuvette 1. As can be seen, the opening 21 of the sampling cavity 2 and the outlet 31 of the discharge cavity 3 are connected such that the first outer wall of the cuvette at the first end 6 is open along the entire length of the sampling cavity 2 and the discharge cavity 3. This allows a shaping tool with a common shaping core for all cavities to be removed through the opening 21 and the outlet 31. The first interface 23 is positioned longitudinally in the cuvette and separates the sampling cavity 2 from the discharge cavity 3. As can be seen in Figure 5B, the height of the opening of the first interface 31 is lower than the height of the sample analysis cavity 4 and the sampling cavity 2.

[0202] Figure 9 shows a cross-sectional view of cuvette 1 through the cross-section CC. As discussed above, the height of the sampling cavity 3 is lower than the height of the discharge cavity 3. Because the sampling cavity 2 has a lower height than the discharge cavity, the third capillary force in the sampling cavity 2 is greater than the second capillary force. This can prevent the blood sample in the sampling cavity from automatically flowing from the sampling cavity 2 to the discharge cavity 3. The sampling cavity 2 and the discharge cavity 3 may be connected by a first interface 23. The height of the first interface 23 can be lower than both the sampling cavity 2 and the discharge cavity 3. Therefore, the first interface 23 can be an area adjacent to the sampling cavity 2 with a very narrow thickness to further ensure that there is no capillary transport from the sampling cavity 2 to the discharge cavity 3. Thus, the first interface can act as a lock to prevent the blood sample from flowing from the sampling cavity 2 to the discharge cavity 3. A centrifugal force may be applied to the cuvette 1 to transport the blood sample to the discharge cavity 3. When the centrifugal force applied to the cuvette 1 overcomes the third capillary force, the blood sample can leave the sampling cavity 2 through the first interface 23 and enter the discharge cavity 3, from which the blood sample can enter the sample analysis cavity 4.

[0203] Figure 10 shows a cross-sectional view of cuvette 1 through the cross-section DD. As can be seen in Figure 10, when comparing its cross-section with the cross-sectional view CC of Figure 9, the cross-sectional area of ​​the sample analysis cavity 3, including its height and width, is smaller than that of the discharge cavity 3, thereby giving the sampling cavity 4 greater capillary force than the discharge cavity 3. Furthermore, the lower height and narrower width of the sample analysis cavity 4 compared to the height and width of the discharge cavity 3 allows the part of the shaping tool that is furthest from the main body member 11 of the cuvette 1 during manufacturing, such as the part that shapes the sample analysis cavity 4, to be removed through the wider outer section of the cuvette 1, such as through the wider discharge cavity 3.

[0204] It should be noted that the features described in the embodiments shown in Figures 4-10 are not limited to these specific embodiments. Therefore, any features of the cuvette, and any components included in the cuvette and described in relation to Figures 4-10, such as the dimensions of the cuvette and / or cavity, are similarly applicable to the cuvette described in relation to the method and / or analyzer for analyzing blood samples in Figures 1-3, and vice versa.

[0205] Examples of methods and analyzers described herein are set forth in the following clauses:

[0206] Article 1. A method for analyzing a blood sample, - A step (S102) of placing a cuvette having a sampling cavity and a sample analysis cavity on a rotatable member, wherein the sampling cavity contains a blood sample to be analyzed, - A step (S110) of rotating the rotatable member at a first speed in a first rotation cycle for the transfer of the blood sample from the sampling cavity to the sample analysis cavity, - In order to separate the blood portion from the plasma in the blood sample, the rotatable member is rotated at a second speed in a second rotation cycle after the first rotation cycle (S116), - Using the above photometer, a second absorbance data indicating the absorbance in the plasma during the second rotation cycle is obtained (S118), - A step (S119) to determine a second blood parameter, which is the plasma free hemoglobin level of the blood sample, based on the second absorbance data described above. - A method comprising the step (S120) of providing an output indicating the second blood parameter described above.

[0207] Article 2. In the method described in Article 1, - A step (S104) in which the rotatable member is rotated at an initial speed in the initial rotation cycle before the first rotation cycle, wherein the initial speed is insufficient for the transfer of the blood sample from the sampling cavity to the sample analysis cavity. - A step (S106) of obtaining initial absorbance data showing the absorbance in the sample analysis cavity of the cuvette using a photometer and during the initial rotation cycle described above, A method comprising the step (S108) of determining a cuvette parameter, which is the level of contamination associated with the cuvette, based on the initial absorbance data described above.

[0208] Clause 3. In the method described in any one of Clauses 1 to 2, the acquisition step (S118) includes the step (S118A) of continuously acquiring the second absorbance data during the second rotation cycle, and the method is - When stabilization of the second absorbance data is detected, the process terminates the continuous acquisition of the second absorbance data (S118A). Methods that include...

[0209] Clause 4. In the method described in any one of Clauses 1 to 3, - Using the above photometer and during the above first rotation cycle, a first absorbance data is obtained indicating the absorbance in the blood sample in the above sample analysis cavity of the cuvette (S112), A method comprising the step (S114) of determining a first blood parameter, which is the total hemoglobin level of the blood sample, based on the first absorbance data described above.

[0210] Article 5. In the method described in Article 4, - Using the above photometer, a third absorbance data indicating the separation time of red blood cells from the plasma during the second rotation cycle is obtained (S121), - A step (S122) to determine a third blood parameter, which is the erythrocyte sedimentation rate of the blood sample, based on the third absorbance data and the first absorbance data mentioned above, - A method comprising the step (S123) of providing an output indicating the third blood parameter described above.

[0211] Article 6. In the method described in any one of Articles 1 to 5, - Using an imaging device, acquire first image data (S124) showing an image of at least a portion of the blood sample in the sample analysis cavity after the second rotation cycle, - A step (S126) to determine a fourth blood parameter, which is the hematocrit level of the blood sample, based on the first image data described above. - A method comprising the step (S128) of providing an output indicating the fourth blood parameter described above.

[0212] Article 7. In the method described in any one of Articles 1 to 6, - A step (S130) in which the rotatable member is rotated at a third speed in a third rotation cycle after the second rotation cycle, wherein the third speed is faster than the first speed, the second speed, and the initial speed. - Using the above photometer and during the above third rotation cycle, a fourth absorbance data is obtained indicating the absorbance in the blood sample in the above sample analysis cavity of the cuvette (S132), A method comprising the step (S134) of determining a fifth blood parameter, which is a second plasma free hemoglobin level indicating fragile blood cells in the blood sample, based on the fourth absorbance data described above.

[0213] Clause 8. A method according to any one of Clauses 1 to 7, wherein the step of obtaining initial absorbance data, first absorbance data, second absorbance data, third absorbance data, or fourth absorbance data includes the step of measuring absorbance using three or more wavelengths.

[0214] Clause 9. A method according to any one of Clauses 1 to 8, wherein the step of obtaining initial absorbance data, first absorbance data, second absorbance data, third absorbance data, or fourth absorbance data includes the step of measuring absorbance data during multiple rotations of the rotatable member.

[0215] Clause 10. A method according to any one of Clauses 1 to 9, wherein the step of determining one or more of the first blood parameter, the second blood parameter, the third blood parameter, the fourth blood parameter, the fifth blood parameter, and the cuvette parameter includes the step of integrating absorbance data obtained during multiple rotations of the rotatable member.

[0216] Clause 11. A method according to any one of Clauses 1 to 10, wherein the blood portion separated from the plasma is one or more of blood cells, red blood cells, white blood cells, fibrinogen, buffy coat, and lipids.

[0217] Clause 12. A blood analyzer comprising a housing, a rotatable member, a photometer, and a controller, - The rotatable member is rotatably disposed within the housing and comprises a receptacle for receiving a cuvette having a sampling cavity and a sample analysis cavity, wherein the sampling cavity of the cuvette contains a blood sample to be analyzed. - The above photometer is configured to acquire absorbance data related to the above sample analysis cavity of the above cuvette, The above controller is - To transfer the blood sample from the sampling cavity to the sample analysis cavity, the rotatable member is rotated at a first speed in the first rotation cycle, - In order to separate the blood portion from the plasma in the blood sample, the rotatable member is rotated at a second speed in a second rotation cycle after the first rotation cycle, - During the second rotation cycle described above, the photometer is controlled to acquire second absorbance data indicating the absorbance in the plasma of the separated blood sample. - Based on the second absorbance data described above, a second blood parameter, which is the plasma free hemoglobin level of the blood sample, is determined. - To provide an output showing the second blood parameter mentioned above. A blood analyzer configured to do the following.

[0218] Clause 13. In the blood analyzer described in Clause 12, the controller is: - Before the first rotational cycle, the rotatable member is rotated at an initial speed in the initial rotational cycle, wherein the initial speed is insufficient for the transfer of the blood sample from the sampling cavity to the sample analysis cavity. - During the initial rotation cycle described above, the photometer is controlled to acquire initial absorbance data indicating the absorbance in the sample analysis cavity of the cuvette. - Based on the initial absorbance data above, determine the cuvette parameter, which is the contamination level associated with the cuvette, - Provide an output showing the above cuvette parameters. A blood analyzer configured to do the following.

[0219] Clause 14. A blood analyzer according to Clause 12 or 13, wherein the controller is configured to control the photometer to continuously acquire the second absorbance data during the second rotation cycle, and to control the photometer to terminate the continuous acquisition of the second absorbance data when stabilization of the second absorbance data is detected.

[0220] Clause 15. In the blood analyzer described in Clauses 12-14, the controller is: - Control the photometer to acquire first absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette during the first rotation cycle described above, - Based on the above first absorbance data, determine the first blood parameter, which is the total hemoglobin level of the above blood sample, - To provide an output showing the first blood parameter described above. A blood analyzer configured to do the following.

[0221] Clause 16. In the blood analyzer described in Clause 15, the controller is: - Control the photometer to acquire a third absorbance data indicating the separation time of red blood cells from the plasma in the sample analysis cavity of the cuvette during the second rotation cycle described above. - Based on the above third absorbance data and the above first absorbance data, a third blood parameter is determined, which is the erythrocyte sedimentation rate of the blood sample in the sample analysis cavity of the cuvette. - To provide an output showing the third blood parameter mentioned above. A blood analyzer configured to do the following.

[0222] Clause 17. In a blood analyzer described in any one of Clauses 12 to 16, the analyzer is equipped with an imaging device, and the controller is, - After the second rotation cycle described above, the imaging device is controlled to acquire first image data showing an image of at least a portion of the blood sample in the sample analysis cavity of the cuvette, - Based on the first image data above, determine the fourth blood parameter, which is the hematocrit level of the blood sample above, - To provide an output showing the fourth blood parameter mentioned above. A blood analyzer configured to do the following.

[0223] Clause 18. In a blood analyzer described in any one of Clauses 12 to 17, the controller is: - After the second rotation cycle described above, the rotatable member is rotated at a third speed in a third rotation cycle, wherein the third speed is faster than the first speed, the second speed, and the initial speed. - Control the photometer to acquire a fourth absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette during the third rotation cycle described above. - Based on the above fourth absorbance data, a fifth blood parameter is determined, which is a second plasma free hemoglobin level indicating fragile blood cells in the above blood sample. A blood analyzer configured to do the following.

[0224] Clause 19. A blood analyzer as described in any one of Clauses 12 to 18, wherein the photometer is configured to obtain initial absorbance data, first absorbance data, second absorbance data, third absorbance data, or fifth absorbance by measuring absorbance using three or more wavelengths.

[0225] Clause 20. The blood analyzer described in Clause 19, wherein the photometer comprises at least two light sources and at least two corresponding optical sensors, each light source emitting light at a different wavelength.

[0226] Clause 21. A blood analyzer as described in Clause 20, wherein at least two of the light sources are light-emitting diodes.

[0227] Clause 22. A blood analyzer according to any one of Clauses 12 to 21, wherein the controller is configured to control the photometer and any imaging device, respectively, to measure initial absorbance data, first absorbance data, second absorbance data, third absorbance data, first image data, or fourth absorbance data during multiple rotations of the rotatable member.

[0228] Clause 23. A blood analyzer as described in Clause 22, wherein the controller is configured to integrate absorbance data acquired by the photometer during multiple rotations of the rotatable member.

[0229] Clause 24. A blood analyzer according to any one of Clauses 12 to 23, wherein the blood portion separated from the plasma is one or more of blood cells, red blood cells, white blood cells, fibrinogen, buffy coat, and lipids.

[0230] The use of terms such as “first,” “second,” “third,” and “fourth,” “primary,” “secondary,” and “tertiary” is included to identify individual elements, not to suggest any particular order. Furthermore, the use of terms such as “first,” “second,” “third,” and “fourth,” “primary,” “secondary,” and “tertiary” does not indicate any order or importance; rather, the terms “first,” “second,” “third,” and “fourth,” “primary,” “secondary,” and “tertiary” are used to distinguish one element from another. Note that the terms “first,” “second,” “third,” and “fourth,” “primary,” “secondary,” and “tertiary” are used herein and elsewhere simply for labeling purposes and are not intended to indicate any particular spatial or temporal ordering. Furthermore, labeling the first element does not suggest the existence of the second element, and vice versa.

[0231] It should be noted that the word "comprising" does not necessarily exclude the existence of elements or steps other than those listed.

[0232] It should be noted that the preceding words "a" or "an" do not exclude the existence of multiple such elements.

[0233] While the features have been shown and described, it will be understood that these features are not intended to limit the claimed disclosure, and it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the scope of the claimed disclosure. Therefore, this specification and the drawings should be considered illustrative, not restrictive. The claimed disclosure is intended to cover all substitutes, modifications, and equivalents.

[0234] It can be recognized that Figures 1-10 include some features, components, or method steps shown with solid lines, and some features, components, or method steps shown with dashed lines. The features, components, or method steps shown with solid lines are those included in the broadest examples. The features, components, or method steps included with dashed lines are examples of additional features, components, or method steps that may be included in, or are part of, the solid-line examples, in addition to the features, components, or method steps that may be adopted. It should be recognized that not all method steps need to be performed. The features, components, or method steps included with dashed lines may be considered optional.

[0235] It should be noted that the word "comprising" does not necessarily exclude the existence of elements or steps other than those listed.

[0236] It should be noted that the preceding words "a" or "an" do not exclude the existence of multiple such elements.

Claims

1. A method for analyzing blood samples, - A step (S102) of positioning a cuvette having a sampling cavity and a sample analysis cavity on a rotatable member, wherein the sampling cavity contains a blood sample to be analyzed, - A step (S104) in which the rotatable member is rotated at an initial speed in an initial rotation cycle prior to the first rotation cycle, wherein the initial speed is insufficient for the transfer of the blood sample from the sampling cavity to the sample analysis cavity, - A step (S106) of using a photometer to obtain initial absorbance data indicating the absorbance in or through the sample analysis cavity of the cuvette during the initial rotation cycle, - A step (S108) of determining the cuvette parameters related to the cuvette based on the initial absorbance data, - The step of providing an output indicating the cuvette parameters (S109), - A step (S110) of rotating the rotatable member at a first speed in a first rotation cycle for the transfer of the blood sample from the sampling cavity to the sample analysis cavity, - In order to separate the blood portion from the plasma within the blood sample, the rotatable member is rotated at a second speed in a second rotation cycle after the first rotation cycle (S116), - Using the photometer, a second absorbance data indicating the absorbance in the plasma during the second rotation cycle is obtained (S118), - A step (S119) to determine a second blood parameter, which is the plasma free hemoglobin level of the blood sample, based on the second absorbance data, A method comprising the step (S120) of providing an output indicating the second blood parameter.

2. In the method according to claim 1, the cuvette parameter is: - Contamination level related to the aforementioned cuvette, - Absorbance data of empty cuvettes, and - The presence of a cuvette within the receptacle of the rotatable member. A method of showing one or more of the following.

3. The method according to any one of claims 1 to 2, wherein the acquisition step (S118) includes the step of continuously acquiring the second absorbance data during the second rotation cycle (S118A), and the method is - Step (S118A) to terminate the continuous acquisition of the second absorbance data when stabilization of the second absorbance data is detected. Methods that include...

4. In the method according to any one of claims 1 to 3, - A step (S112) of obtaining first absorbance data indicating the absorbance in the blood sample in the sample analysis cavity of the cuvette using the photometer and during the first rotation cycle, A method comprising the step of determining a first blood parameter, which is the total hemoglobin level of the blood sample, based on the first absorbance data (S114).

5. In the method according to claim 4, - Using the photometer and during the second rotation cycle, a third absorbance data indicating the separation time of red blood cells from the plasma is obtained (S121), - A step (S122) to determine a third blood parameter, which is the erythrocyte sedimentation rate of the blood sample, based on the third absorbance data and the first absorbance data, A method comprising the step of providing an output indicating the third blood parameter (S123).

6. In the method according to any one of claims 1 to 5, - Using an imaging device, acquire first image data showing an image of at least a portion of the blood sample in the sample analysis cavity after the second rotation cycle (S124), - A step (S126) of determining a fourth blood parameter, which is the hematocrit level of the blood sample, based on the first image data, A method comprising the step of providing an output indicating the fourth blood parameter (S128).

7. In the method according to any one of claims 1 to 6, - A step (S130) in which the rotatable member is rotated at a third speed in a third rotation cycle after the second rotation cycle, wherein the third speed is faster than the first speed, the second speed, and the initial speed. - A step (S132) of obtaining a fourth absorbance data indicating the absorbance in the blood sample in the sample analysis cavity of the cuvette using the photometer and during the third rotation cycle, A method comprising the step (S134) of determining a fifth blood parameter, which is a second plasma free hemoglobin level indicating fragile blood cells in the blood sample, based on the fourth absorbance data.

8. A method according to any one of claims 1 to 7, wherein the step of obtaining initial absorbance data, first absorbance data, second absorbance data, third absorbance data, or fourth absorbance data includes the step of measuring absorbance using three or more wavelengths.

9. A method according to any one of claims 1 to 8, wherein the step of obtaining initial absorbance data, first absorbance data, second absorbance data, third absorbance data, or fourth absorbance data includes the step of measuring absorbance data during multiple rotations of the rotatable member.

10. A method according to any one of claims 1 to 9, wherein the step of determining one or more of the first blood parameter, the second blood parameter, the third blood parameter, the fourth blood parameter, the fifth parameter, and the cuvette parameter includes the step of integrating absorbance data obtained during multiple rotations of the rotatable member.

11. A method according to any one of claims 1 to 10, wherein the blood portion separated from the plasma is one or more of blood cells, red blood cells, white blood cells, fibrinogen, buffy coat, and lipids.

12. A blood analyzer comprising a housing, a rotatable member, a photometer, and a controller, - The rotatable member is rotatably disposed within the housing and comprises a receptacle for receiving a cuvette having a sampling cavity and a sample analysis cavity, wherein the sampling cavity of the cuvette contains a blood sample to be analyzed. - The photometer is configured to acquire absorbance data related to the sample analysis cavity of the cuvette, The aforementioned controller, - Before the first rotation cycle, in the initial rotation cycle, the rotatable member is rotated at an initial speed, wherein the initial speed is insufficient for the transfer of the blood sample from the sampling cavity to the sample analysis cavity. - Control the photometer to acquire initial absorbance data indicating the absorbance in the sample analysis cavity of the cuvette during the initial rotation cycle, - Based on the initial absorbance data, determine the cuvette parameters related to the cuvette, - To provide an output showing the cuvette parameters, - To transfer the blood sample from the sampling cavity to the sample analysis cavity, the rotatable member is rotated at a first speed in the first rotation cycle, - In order to separate the blood portion from the plasma within the blood sample, the rotatable member is rotated at a second speed in a second rotation cycle after the first rotation cycle, - Control the photometer to acquire second absorbance data indicating the absorbance in the plasma of the separated blood sample during the second rotation cycle, - Based on the second absorbance data, a second blood parameter, which is the plasma free hemoglobin level of the blood sample, is determined. - To provide an output indicating the second blood parameter mentioned above. A blood analyzer configured to do the following.

13. A blood analyzer according to claim 12, wherein the controller is configured to control the photometer to continuously acquire the second absorbance data during the second rotation cycle, and to control the photometer to terminate the continuous acquisition of the second absorbance data when it detects that the second absorbance data has stabilized.

14. In the blood analyzer according to any one of claims 12 to 13, the controller is: - Control the photometer to acquire first absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette during the first rotation cycle, - Based on the first absorbance data, a first blood parameter, which is the total hemoglobin level of the blood sample, is determined. - To provide an output showing the first blood parameter mentioned above. A blood analyzer configured to do the following.

15. In the blood analyzer according to claim 14, the controller is: - Control the photometer to acquire a third absorbance data indicating the separation time of red blood cells from the plasma in the sample analysis cavity of the cuvette during the second rotation cycle, - Based on the third absorbance data and the first absorbance data, a third blood parameter is determined, which is the erythrocyte sedimentation rate of the blood sample in the sample analysis cavity of the cuvette. - To provide an output indicating the third blood parameter mentioned above. A blood analyzer configured to do so.

16. A blood analyzer according to any one of claims 12 to 15, comprising an imaging device, wherein the controller is - Controlling the imaging device to acquire first image data showing an image of at least a portion of the blood sample in the sample analysis cavity of the cuvette after the second rotation cycle, - Based on the first image data, a fourth blood parameter, which is the hematocrit level of the blood sample, is determined. - To provide an output showing the fourth blood parameter mentioned above. A blood analyzer configured to do the following.

17. In the blood analyzer according to any one of claims 12 to 16, the controller is: - After the second rotation cycle, the rotatable member is rotated at a third speed in a third rotation cycle, wherein the third speed is faster than the first speed, the second speed, and the initial speed. - Control the photometer to acquire a fourth absorbance data indicating the absorbance in the blood sample within the sample analysis cavity of the cuvette during the third rotation cycle, - Based on the fourth absorbance data, determine a fifth blood parameter which is a second plasma free hemoglobin level indicating fragile blood cells in the blood sample. A blood analyzer configured to do the following.

18. A blood analyzer according to any one of claims 12 to 17, wherein the photometer is configured to obtain initial absorbance data, first absorbance data, second absorbance data, third absorbance data, or fifth absorbance by measuring absorbance using three or more wavelengths.

19. A blood analyzer according to claim 18, wherein the photometer comprises at least two light sources and at least two corresponding optical sensors, each light source emitting light at a different wavelength.

20. A blood analyzer according to claim 19, wherein the at least two light sources are light-emitting diodes and LEDs.

21. A blood analyzer according to any one of claims 12 to 20, wherein the controller is configured to control the photometer and an optional imaging device, respectively, to measure initial absorbance data, first absorbance data, second absorbance data, third absorbance data, first image data, or fourth absorbance data during multiple rotations of the rotatable member.

22. A blood analyzer according to claim 21, wherein the controller is configured to integrate absorbance data acquired by the photometer during multiple rotations of the rotatable member.

23. A blood analyzer according to any one of claims 12 to 22, wherein the blood portion separated from the plasma is one or more of blood cells, red blood cells, white blood cells, fibrinogen, buffy coat, and lipids.

Images