System and method for controlling timing of consecutive biological samples
The system addresses the challenge of controlling the timing of consecutive biological samples by using a recording device and processing system to adhere to protocol rules, thereby enhancing the reliability of medical testing results.
Patent Information
- Application Number
- JP2025006797
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-11-28
- Filing Date
- 2025-01-17
- Publication Date
- 2025-04-10
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Lack of control over the timing of consecutive biological samples can lead to misdiagnosis, treatment errors, or false negative results in medical testing.
A system that includes a recording device to determine patient ID and sample time points, and a processing system to determine protocol rules for medical tests, ensuring accurate timing of consecutive biological samples.
The system provides reliable guidance for healthcare professionals, reducing the risk of misdiagnosis and treatment errors by ensuring that biological samples are taken according to established protocol rules.
Smart Images
Figure 2025061437000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to controlling the timing of successive biological samples, and more particularly to a system and method for controlling the timing of successive biological samples from a patient for medical testing. [Background technology]
[0002] Typically, a patient's health status is determined based not only on current symptoms, but also on the results of various medical tests, especially for various medical biomarkers. Depending on the results of such tests, the patient's future treatment is determined, especially if a certain condition needs to be ruled out, ruled in, or observed in the long term. For example, when non-ST-elevation myocardial infarction (NSTEMI) is suspected, an electrocardiogram (ECG) usually does not give reliable information. In such cases, the patient's biological samples, especially blood samples, are tested for troponin, which is an indicative medical biomarker for NSTEMI.
[0003] Typically, testing for a particular biomarker is not done just once at a given time, but rather at least a second measurement is taken to analyze the development of the biomarker over time.
[0004] Lack of precise sample timing control of biosamples in ruling in or out patients with respect to clinical criteria can result in misdiagnosis, mistreatment of patients, or even sending patients home with false negatives. Summary of the Invention [Problem to be solved by the invention]
[0005] Therefore, there is a need for an improved system for controlling the timing of successive biological samples from a patient for medical testing. [Means for solving the problem]
[0006] This problem is solved by the subject matter of the independent claims. The dependent claims, the following description and the drawings show preferred embodiments and further advantages of the invention. Furthermore, it should be noted that all embodiments of the present invention relating to methods may be carried out in the order of steps explicitly described herein. However, this need not be the only required order of steps of the methods described herein. The methods presented herein may be carried out in another order of steps disclosed without departing from the respective method embodiments, unless expressly stated to the contrary below.
[0007] Terminology is implemented using common sense. Where a specific meaning is conveyed through a term, the definition of the term is given below in the context in which the term is used. According to one aspect of the invention, a system for controlling timing of successive biological samples from a patient for a medical test comprises a recording device configured to determine a patient ID indicative of an identity of the patient and a first sample time point indicative of a time to obtain a first biological sample from the patient at a first time point, the system further comprises a processing system communicatively connected to the recording device and configured to receive the patient ID and the first sample time point from the recording device, determine protocol rules for the medical test relating to timing requirements for obtaining biological samples from the patient in response to the medical test, and determine a sample timing indicative of when to obtain a second biological sample from the patient in accordance with the protocol rules in response to the protocol rules and the first sample time point.
[0008] As used herein, the term "patient ID" includes any form of identification of a patient. Preferably, the patient ID includes a code that can be interpreted by a processing system to identify the patient. Thus, the combination of the patient ID and the biological sample can be used to associate the biological sample with a patient, preferably one already on file at the processing system.
[0009] Preferably, the recording device is configured as a portable or stationary device. The recording device is preferably configured to scan a code associated with the patient or the biological sample. For example, the patient ID is obtained or determined by the recording device by scanning a code on the patient's medical record or by scanning a code on a container intended for a particular patient's biological sample. Similarly, the first sample time point is obtained or determined by the recording device by scanning a code on a container intended for the biological sample. Preferably, the container itself includes a container ID that can be scanned by the recording device. In this way, the allocation of a patient to a particular biological sample in the container can be determined.
[0010] Preferably, the processing system comprises a computer or any suitable data processing system used for processing and / or storing data, in particular patient data and / or medical data. The processing system further preferably comprises at least one terminal for inputting or outputting data. Furthermore, the processing system is connected to further devices, in particular devices for acquiring data, in particular patient data and / or medical data. An example of such a device is the aforementioned recording device. The processing system is preferably connected to further devices via a computer network, for example a local area network. Thus, the processing system manages the patient data and the associated medical data. Further preferably, the agreement with the sampling time requirements is relayed to a middleware central IT system for possible authorization purposes.
[0011] As used herein, the term "obtaining a biological sample" preferably includes taking a blood sample from a patient, which blood sample is analyzed for a medical test. Preferably, when obtaining the biological sample from the patient, the sample time point, in particular the first sample time point, is determined directly at the patient.
[0012] Preferably, a protocol rule is predefined for each medical test. Thus, the protocol rule includes the conditions to be met in order to perform the medical test. In particular, the protocol rule includes the timing requirements for obtaining a biological sample from a patient. In other words, the protocol rule determines when to obtain a biological sample from a patient to accommodate the medical test. For example, a medical test for troponin in a biological sample to determine NSTEMI has a protocol rule that the time between obtaining a first biological sample and obtaining a second biological sample is at least 1 hour. If the protocol rule is not followed, the test result is flagged as not complying with the protocol rule. Thus, the protocol rule includes a predetermined range of sample timings depending on the medical test.
[0013] Preferably, the medical biomarkers include troponin I (TnI), troponin T (TnT), creatine kinase muscle type / brain type (CKMB), myoglobin (Myo), human N-terminal fragment of precursor brain natriuretic peptide (NT-proBNP), procalcitonin (PCT), C-reactive protein (CRP), D-dimer, and beta-human chorionic gonadotropin (βhCG).
[0014] As used herein, the term "sample timing" describes the time point, starting from the first sample time point, at which a second biological sample should be taken from a patient in order to comply with the protocol rules of an intended medical test. Preferably, the sample timing includes the time point at which the second biological sample should be obtained. Alternatively, the sample timing may be the time point at which the second biological sample should be obtained in order to comply with the protocol rules. The remaining time during which a second biological sample should not be obtained in order to
[0015] Thus, the system gives the user or clinician, especially the nurse, an indication of when to obtain the second biological sample from the patient to meet the protocol rules of the medical test. For example, the indication of when to obtain the second biological sample from the patient can be queried from the processing system and / or the recording device. Thus, the nurse has the option to check whether taking the second biological sample from the patient at this moment is too early and / or too late to meet the protocol rules, and the time required can be reduced. As a result, the result of the medical test becomes more reliable.
[0016] Thus, an improved system is provided for controlling the timing of successive biological samples from a patient for medical testing, such that better guidance may be provided to medical personnel in assessing the patient's health status and, in particular, in ruling in or out certain diseases.
[0017] In a preferred embodiment, the processing system is configured to provide a warning if the acquisition of the second biological sample at the current time point does not comply with protocol rules that depend on the determined sample timing.
[0018] The warning blinds the user to any additional information regarding the timing of the medical test or the acquisition of the first biological sample. The user only needs to confirm the given warning, which indicates, for example, a positive or negative feedback on the collection of the second biological sample. Thus, the probability that the nurse collects the second biological sample from the patient too early to meet the protocol rules can be reduced. As a result, the results of the medical test become more reliable.
[0019] Thus, an improved system is provided for controlling the timing of successive biological samples from a patient for medical testing. In a preferred embodiment, the recording device comprises a display configured to display warnings provided by the processing system.
[0020] To provide rapid feedback from the processing system to the user, the recording device is equipped with a display for visual feedback of the alert. The alert preferably includes an indication of when to obtain a second biological sample. This indication preferably includes a waiting time before it is permitted to obtain a second biological sample from the patient in order to comply with the rules of the protocol. More preferably, this indication includes a time on the clock when the second biological sample should be obtained in order to comply with the rules of the protocol.
[0021] For example, the recording device may include a request button that is configured to be pressed to display an alert provided by the processing system. Thus, an improved system is provided for controlling the timing of successive biological samples from a patient for medical testing.
[0022] In a preferred embodiment, the display is arranged to display the warning in the form of a colour code, in particular a traffic light code. For easy implementation of the warning, the recording device is configured to display a color code. For example, the recording device comprises at least one lamp, in particular an LED, configured to display a color code. For example, a green light can indicate that a second biological sample can be obtained in order to comply with a protocol rule. A red light can indicate that a second biological sample should not yet be obtained in order to comply with a protocol rule.
[0023] Therefore, the user only needs to check the color code of a predetermined color to determine whether a second biological sample should now be obtained. Thus, an improved system is provided for controlling the timing of successive biological samples from a patient for medical testing.
[0024] In a preferred embodiment, the recording device is configured to determine a patient ID and a second sample time point indicating a time at which a second biological sample is obtained from the patient at a second time point different from the first sample time point, and the processing system is configured to receive the patient ID and the second sample time point.
[0025] Thus, the processing system is provided with a first time point and a second time point associated with the patient and the biological sample, respectively, via the patient ID and preferably the container ID. Thus, the processing system knows the time when the first biological sample and the subsequent second biological sample were actually obtained from the patient.
[0026] In a preferred embodiment, the analyzer is configured to determine a value of a medical biomarker from a biological sample for a medical test, and the determined value of the medical biomarker of a second biological sample is marked as non-compliant if the second sample time point does not comply with the determined sample timing.
[0027] For example, if there is no warning indicating whether the second biospecimen can be obtained in accordance with the rules of the protocol, or if the warning given is ignored or misinterpreted by the user, the system should ensure that the biospecimen is not used in clinical decisions that are not in accordance with medical protocols.
[0028] The processing system preferably determines the time difference between the first and second sample time points, which must meet protocol rules to increase the reliability of the medical test.
[0029] If the time difference is determined to be incompatible with the protocol rules, for example if the second biological sample is obtained from the patient too early, the value of the medical biomarker of the second biological sample is marked as incompatible and is not used in the clinical decision. In this manner, the incompatible value of the medical biomarker is considered to be incompatible with the protocol rules and is thereby prevented from affecting the clinical decision. Alternatively, the value of the medical biomarker of the second biological sample is ignored or deleted to prevent the value from affecting the clinical decision.
[0030] Thus, unreliable values of medical biomarkers in biological samples are prevented from being used in clinical decisions. Thus, an improved system is provided for controlling the timing of successive biological samples from a patient for medical testing.
[0031] In a preferred embodiment, the sample timing includes a minimum time difference between a first sample time point and a second sample time point indicating the time to obtain a second biological sample from the patient at a second time point different from the first time point in order to comply with protocol rules.
[0032] Generally, the protocol rules of a medical test dictate a minimum time difference between the acquisition of a first biological sample and the acquisition of a second biological sample. Generally, acquiring a second biological sample later than the ideal time point of the protocol rules will not adversely affect the reliability of the biological sample as much as acquiring the second biological sample too early.
[0033] In a preferred embodiment, the system comprises a database including a plurality of protocol rules each associated with a medical test, and determining a protocol rule for the medical test includes selecting a protocol rule for the medical test from the plurality of protocol rules in the database in response to the medical test.
[0034] The protocol rules are preferably pre-determined depending on the medical test for which they are to be used. By storing all relevant protocol rules in a database, it is only necessary to determine the medical test to be performed and select the relevant protocol rule from the database. The medical test to be performed may be manually entered into the processing system, in particular via a recording device. However, the medical test to be performed may be automatically determined from various input variables, e.g. patient ID, container ID and / or biological sample. For example, the processing system was provided with information which patient is scheduled for which medical test. Alternatively, the processing system was provided with information which specific container for the biological sample is scheduled for which medical test. Further alternatively, the type of medical biomarkers analyzed in the biological sample indicates which medical test is to be performed on the patient. Preferably, a combination of manual input and automatic determination of the medical test to be performed is provided. Furthermore, preferably, the clinician can modify the protocol rules at any time. For example, an additional third sample data point, three hours after the first sample data point, may be manually entered into the processing system.
[0035] More preferably, the currently determined protocol rules may be read from the processing system, in particular by the clinician, to fully control the medical test. The system may already contain a protocol that prescribes a third, fourth or further sample to be taken, for example, 3 hours after the start time point, for example another 2 hours after the second sample time point, under certain circumstances, such as when the delta value does not clearly indicate whether the patient can be ruled in or out.
[0036] Thus, an improved system is provided for controlling the timing of successive biological samples from a patient for medical testing. In a preferred embodiment, the first and second biological samples are blood samples.
[0037] According to another aspect of the invention, a method for controlling timing of successive biological samples from a patient for a medical test includes the following steps: In a first step, a patient ID indicating an identity of the patient is received and a first sample time point indicating a time to obtain a first biological sample from the patient is received by a recording device. The patient ID and the first sample time point from the recording device are received by a processing system communicatively connected to the recording device. A protocol rule for the medical test is determined that is related to a timing requirement for obtaining the biological sample from the patient in accordance with the medical test. A sample timing is determined in accordance with the protocol rule and the first sample time point, indicating when to obtain a second biological sample from the patient in accordance with the protocol rule.
[0038] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. Exemplary embodiments of the invention are illustrated in the following drawings, which are purely schematic and are not drawn to scale, in which: [Brief description of the drawings]
[0039] [Figure 1] FIG. 1 shows a schematic representation of the progression of troponin concentration over time. [Diagram 2] FIG. 1 shows a schematic of a progression of troponin concentrations over time, highlighting sample timing. [Diagram 3] FIG. 13 shows a schematic diagram of a sample timing control method. [Figure 4] FIG. 1 is a schematic diagram of a system for controlling the timing and providing alerts for successive biological samples from a patient for medical testing. [Diagram 5] FIG. 1 illustrates a schematic diagram of a system for controlling the timing of successive biological samples from a patient for medical testing and providing medical results. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0040] FIG. 1 shows a schematic diagram of the measured troponin change CTm in relation to the progression of the troponin concentration CT over time t. In this case, a non-ST elevation myocardial infarction (NSTEMI) is suspected in a patient. In a medical examination, the patient's blood is then tested for troponin, which is an indicator of NSTEMI. A so-called 0 hour / 1 hour rule-in and rule-out algorithm is implemented. Essentially, the troponin concentration CT of the patient's blood is tested at least twice, in particular at a first time point and after 1 hour. In order to determine whether the troponin concentration CT indicates an indication of NSTEMI, certain protocol rules for this medical examination are followed, in particular the accelerated protocol of the ESC 2015 ACS-MI guidelines. Depending on the measured troponin concentration CT and the change in the troponin concentration CT over time t, such as the troponin delta Δ0-1h between the troponin concentration CT at a first time point t0 and the troponin concentration CT at a second time point t1, it is determined whether the NSTEMI in the patient can be ruled out, ruled in or needs to be observed. Preferably, the second point in time t1 is one hour after the first point in time t0.
[0041] In the ESC 2015 ACS-MI guidelines, five thresholds are defined: a first threshold A, a second threshold B, a third threshold C (which is troponin delta Δ0-1h), a fourth threshold D (not shown), and a fifth threshold E (not shown). For example, according to the Architect technique, the first threshold A has a value of 2 ng / l, the second threshold B has a value of 5 ng / l, the third threshold C has a value of 2 ng / l, the fourth threshold D has a value of 52 ng / l, and the fifth threshold E has a value of 6 ng / l.
[0042] NSTEMI may be ruled out if the first sample data set 0h, which is the troponin concentration CT at the first time point t0, is less than a first threshold value A. Alternatively, NSTEMI may be ruled out if the troponin concentration CT at the first time point t0 is less than a second threshold value B and the troponin delta Δ0-1h between the first sample data set 0h and the second sample data set 1h, which is the troponin concentration CT at the second time point t1.
[0043] NSTEMI may be ruled in when the first sample data set 0h is greater than or equal to a fourth threshold or troponin delta Δ0-1h is greater than or equal to a fifth threshold E. There may be no signs of NSTEMI, but should be observed otherwise.
[0044] As shown in the diagram of Figure 1, the troponin concentration CT in the patient's blood is measured at a first time point t0. This first sample data set 0h has a value of about 3 ng / l. At a second time point t1, the troponin concentration CT in the patient's blood is measured again. This second sample data set 1h has a value of 4.9 ng / l. This results in a troponin delta Δ0-1h of 1.9 ng / l.
[0045] According to the prescribed protocol rules, NSTEMI must be ruled out since troponin delta Δ0-1h has a value below the third threshold C. Since the test is negative, the patient can go home.
[0046] FIG. 2 shows a schematic diagram of the progression of the measured troponin concentration CTm over time t, with emphasis on sample timing. Alternatively, sample timing may be further refined to prevent misuse of the test. As shown in FIG. 2, at the second time t1, troponin delta Δ0-1h has a certain value. However, in order to compare this value with a rule set such as the architect technique described above, the timing of the second time t1 is required to be as close as possible to one hour after the first time t0. Therefore, it is particularly important that the timing of the second time t1 is more than one hour after the first time t0. In other words, in general, the second time t1 may be too early in relation to the first time t0 to follow the protocol rules, but it is unlikely that the second time t1 is too late in relation to the first time t0 to follow the protocol rules.
[0047] Thus, as shown in FIG. 2, if the second blood sample is taken too early, an invalid or incompatible troponin delta Δinv is obtained, which should be ignored for clinical judgment. As can be seen in this example, the acquisition of an invalid troponin delta Δinv occurs too early within the invalid period Finv to follow the rule set. Such an invalid troponin delta Δinv leads to a misdiagnosis by the clinician, since the troponin value in the patient's blood has not had enough time to rise to account for the medical test to be performed. Therefore, it must be ensured that the second time sample t1 is within the valid period Fv.
[0048] FIG. 3 shows a schematic diagram of a method for controlling the timing of successive biological samples s0, s1 from a patient for a medical study T. In a first step S10, a patient ID (PID) is determined by the recording device 30, which indicates the identity of the patient and a first sample time t0 indicating the time of acquiring a first biological sample s0 from the patient. In a second step S20, the patient ID (PID) and the first sample time t0 are received from the recording device 30 by the processing system 20 communicatively connected to the recording device 30. In a third step S30, a protocol rule R of the medical study T is determined, which relates to the timing requirements of acquiring biological samples s0, s1 from the patient according to the medical study T. In a fourth step S40, a sample timing is determined according to the protocol rule R and the first sample time t0, indicating when to acquire a second biological sample s1 from the patient in accordance with the protocol rule R.
[0049] FIG. 4 shows a schematic diagram of a system 10 for controlling the timing of successive biological samples s0, s1 from a patient for a medical test. The system comprises a processing system 20, a recording device 30 and an analysis device 40. In this case, a patient should be examined for NSTEMI. Therefore, the troponin concentration of the patient's blood should be measured. Thus, the biological samples s0, s1 obtained from the patient are blood samples s0, s1.
[0050] A clinician collects a first blood sample s0 from a patient. The first blood sample s0 is collected from the patient into a container 50. The first blood sample s0 and the container 50 need to be associated with the treated patient. Thus, the clinician or any kind of caregiver enters a patient ID (PID) associated with the patient into the recording device 30. Alternatively, as shown in this example, the container 50 comprises a barcode 51 that contains information about the patient's identity. For example, in the previous step, the barcode 51 of the container 50 was assigned to a specific patient. In this case, the recording device 30 comprises a recording unit 31, in particular a scanner, configured to scan the barcode 51 of the container 50. Thus, the recording device 30 obtains the patient ID (PID) associated with the first blood sample s0. Alternatively, the patient ID (PID) is obtained by the recording device 30 by scanning the barcode 51 placed on the patient's bed. Furthermore, for compliance reasons, preferably the nurse ID is obtained by the recording device 30 before the recording device 30 is used, in particular by inputting the nurse's identity, e.g. an identification code, into the recording device 30. In addition, the recording device 30 is configured to determine a first sample time t0 corresponding to the time when the barcode 51 is scanned by the recording device 30. In other words, the recording device 30 is configured to determine, e.g. an internal clock of the recording device, a first sample time t0 corresponding to the time when the barcode 51 is scanned by the recording device 30. The time of lock is configured to be sampled. Thus, the first sample time t0 represents the time when the container 50 is scanned, which should be very close to the time when the first blood sample s0 is taken from the patient.
[0051] In addition to the patient ID (PID), the barcode 51 includes information about the container 50 itself, stored in a first container ID (CID0), which identifies the container 50 that contains the first blood sample s0. Thus, when the first blood sample s0 is provided to the analysis device 40, the analysis device 40 can scan the barcode 51 to read the first container ID (CID0) and associate the first blood sample s0 with the particular container 50.
[0052] Thus, the recording device 30 is configured to obtain the patient ID (PID), the first container ID (CID0), the nurse ID, and the first sample time point t0. In other words, the recording device 30 is configured to obtain any necessary information regarding the blood sample s0 and its container, the patient, and the clinician or nurse handling the recording device 30 for analysis of the medical test.
[0053] Thus, the system 10 can associate the container 50 with the first blood sample s0 by the first container ID (CID0). Additionally, the system 10 can associate the first blood sample s0 with the patient by the patient ID (PID). Finally, the system 10 can associate the first sample time t0 with the patient and the first blood sample s0. Thus, it is known which blood sample s0 is from which patient, is stored in which container 50, and was obtained at which time t0.
[0054] The analysis device 40 is configured to analyze the provided first blood sample s0, in this case for the biomarker troponin. The analysis device 40 thus determines from the first blood sample s0 a first sample data set 0h representative of the concentration of troponin in the first blood sample s0 at a first sample time t0. The determined first sample data set 0h is provided to the processing system together with an associated first container ID (CID0).
[0055] The processing system 20 uses the provided information to determine when is the best time to obtain a second blood sample s1 from the patient. In this case, the patient is tested for NSTEMI. The troponin concentration of the patient's blood must therefore be tested at two different time points, at least one hour apart from each other, namely at a first sample time point t0 and a second sample time point t1. In other words, depending on the change in the troponin concentration in the patient's blood taken at the two different time points, it can be clinically estimated whether the tested patient has NSTEMI. The time difference between the first sample time point t0 and the second sample time point t1 required for a reliable estimation is defined in the protocol rules. The protocol rules depend on the medical tests applied to the patient.
[0056] Thus, the processing system 20 comprises a processing unit 21 and a database 22. The database 22 stores a number of protocol rules R, each associated with a medical test T.
[0057] The processing unit 21 requests the relevant protocol rule R from the database 22. Thus, the processing unit 21 needs to know the medical test T to be applied to the patient. Several possibilities are possible. The processing unit 21 may determine the medical test T based on the provided first container ID (CID0) if the processing system 21 previously associated the container ID with the medical test. In other words, when the processing system 21 has the information which container 50 is used for which medical test T, the processing system 21 may determine the medical test T based on the provided first container ID (CID0). The processing system 21 may determine the medical test T from the patient ID (PID) 0h. Alternatively, the processing system 21 is provided with information about which patient is scheduled for which medical test T. Thus, the processing system 21 may determine the medical test T from the patient ID (PID). Alternatively, the processing system 21 is configured to determine the medical test T based on the provided first sample data set 0h. In other words, the processing system 21 may be able to determine the medical test T based on the type of biomarkers provided. In this case, the processing system 21 may be able to determine that only troponin is used for the NSTEMI test. Alternatively, the medical test T is simply entered into the processing system, in particular by an input interface, for example a keypad.
[0058] In this case, protocol rule R determines that the first sample time t0 and the second sample time t1 must be at least one hour apart from each other in order to comply with protocol rule R. Thus, processing unit 21 determines a sample timing according to protocol rule R and the first sample time t0, indicating when to obtain the second blood sample s1 from the patient in accordance with protocol rule R. The sample timing in this case comprises the earliest time point at which the second blood sample s1 should be obtained from the patient.
[0059] Based on the sample timing, the processing unit 21 determines a warning W, which is returned to the recording device 30. The warning W is then displayed on the display 32 of the recording device 30. In this way, the clinician can check the recording device 30 before taking the second blood sample s1 from the patient to ensure that the protocol rules R are followed. For example, the warning W includes the time remaining before taking the second blood sample s1. In this way, the clinician obtains valuable information regarding whether the blood samples s0, s1 are following the protocol rules R. In this way, the reliability of the medical test T can be improved.
[0060] The described IT infrastructure between the recording device 30, the processing system 20 and the analytical device 40 includes interconnecting several clinical and / or communication devices such as analyzers, middleware systems, phones, PDAs and scanners. The analytical device 40 is for example a mobile analytical device, for example an AQT-analyser, or a stationary analyzer in a laboratory.
[0061] In the case of cut-off scenarios, in other words when the prediction P that a patient has NSTEMI is a close call, the increased confidence of the system provided leads to an improvement in the decision process. In other words, an improved accuracy of the prediction P leads to fewer false positive and false negative predictions. In the case of a false positive prediction, the patient is kept unnecessarily in the clinic for further testing. In the case of a false negative, the patient is sent home, although further medical care may be necessary.
[0062] Thus, the system provided reduces the amount of false positive and false negative predictions. FIG. 5 also illustrates diagrammatically a system 10 for controlling the timing of successive biological samples s0, s1 from a patient for a medical test T.
[0063] In contrast to the situation described in Fig. 4, in this case the second blood sample s1 has already been obtained from the patient. According to the above description, the recording device 30 scans the first barcode 51a of the first container 50a with the first blood sample s0 at the first sample time t0. At the second sample time t1, the recording device 30 scans the second barcode 51b of the second container 50b with the second blood sample s1. Thus, the first barcode 51a contains the first container ID (CID0) and the second barcode 51b contains the second container ID (CID1).
[0064] The analysis device 40 is provided with the respective first and second blood samples s0 and s1 and the associated first and second container IDs (CID0 and CID1), based on which the analysis device 40 determines a first sample data set 0h and a second sample data set 1h.
[0065] 4, the processing unit 21 is provided with the patient ID (PID), the respective container ID (CID0, CID1), the respective sample data sets 0h, 1h and the respective sample time points t0, t1. The processing unit 21 is further provided with the associated protocol rules R from the database 22 after determining the associated medical test T.
[0066] However, in this case, no warning W is given to the recording device 30 since already both blood samples have been analyzed. The processing unit 21 rather determines a prediction P, which is the outcome of the medical test T based on the first sample data set 0h and the second sample data set 1h. However, before determining the prediction P, the processing unit 21 checks whether the first sample time point t0 and the second sample time point t1 comply with the provided protocol rules R. If the sample time points t0, t1 do not comply with the protocol rules R, the processing unit 21 flags the provided sample data sets 0h, 1h. In particular, the processing unit marks the second sample data set 1h as non-compliant if it is determined that the second sample time point t1 does not comply with the protocol rules R. Thus, the clinician can still decide whether to use the second sample data set 1h as a basis for clinical decisions.
[0067] In this way, when a prediction P for the outcome of a medical test T is provided, the clinician receiving the prediction P can be confident that the blood samples s0, s1 are in line with the protocol rules R and are relatively reliable. Thus, the clinician can make improved clinical decisions based on the provided prediction. [Explanation of symbols]
[0068] 0h First sample data set 1h Second sample data set t0 First sample time point t1 Second sample time point A. First Threshold B. Second Threshold CT troponin concentration CTm Measured troponin change Δ0-1h Troponin Delta Δinv Invalidated troponin delta Fv Validity Period Finv invalid period 10. System 20 Processing System 21 Processing Unit 22 Database 30 Recording Devices 31 Recording Unit 32 Display 40 Analytical Devices 50 containers 51 Barcode s0 First biological sample (first blood sample) s1 Second biological sample (second blood sample) PID Patient ID CID0 First container ID CID1 Second container ID R Protocol Rules T Medical Test W Warning P prediction S10 Determine patient ID and first sample time point S20 Receive patient ID and first sample time point S30 Protocol Rules Determination S40 Sample timing determination
Claims
1. A system (10) for controlling the timing of successive biological samples (s0, s1) from a patient for a medical test (T), comprising: a recording device (30) configured to determine a patient ID (PID) indicative of the identity of the patient and a first sample time point (t0) indicative of the time of obtaining a first biological sample (s0) from the patient at a first time point (t0); receiving the patient ID (PID) and the first sample time point (t0) from the recording device (30); determining protocol rules (R) for said medical study (T) related to timing requirements for acquiring biological samples (s0, s1) from said patient according to said medical study (T); a processing system (20) communicatively connected to said recording device (30), configured to determine a sample timing in response to said protocol rules (R) and said first sample time point (t0) and indicate when to obtain a second biological sample (s1) from said patient in accordance with said protocol rules (R); A system (10) comprising:
2. 2. The system of claim 1, wherein the processing system is configured to provide a warning (W) if the acquisition of the second biological sample (s2) at a current time point does not comply with the protocol rules (R) that depend on the determined sample timing.
3. The system of claim 2 , wherein the recording device (30) comprises a display (32) configured to display the warning (W) provided by the processing system (20).
4. 4. The system according to claim 3, wherein the display (32) is adapted to display the warning (W) in the form of a color code, in particular a traffic light code.
5. the recording device (30) is configured to determine the patient ID (PID) and a second sample time (t1) indicating a time of obtaining the second biological sample (s1) from the patient at a second time (t1) different from the first sample time (t0); The system of any one of claims 1 to 4, wherein the processing system (20) is configured to receive the patient ID (PID) and the second sample time point (t1).
6. an analyzer (40) configured to determine values of medical biomarkers from biological samples (s0, s1) for a medical test (T), The system of claim 5, wherein the determined value of the medical biomarker of the second biological sample (s1) is marked as non-compliant if the second sample time point (t1) of the second biological sample (s1) does not comply with the determined sample timing.
7. 7. The system of claim 1, wherein the sample timing comprises a minimum time difference between the first sample time (t0) and a second sample time (t1) indicating a time at which the second biological sample (s1) is obtained from the patient at a second sample time (t1) different from the first sample time (t0) in order to comply with the protocol rules (R).
8. The method includes the steps of: determining a protocol rule (R) for a medical test (T); selecting said protocol rule (R) for said medical examination (T) from said plurality of protocol rules (R) in said database (22) responsive to said medical examination (T).
8. A system according to any one of claims 1 to 7.
9. The system according to any one of claims 1 to 8, wherein the first biological sample (s0) and the second biological sample (s1) are blood samples.
10. 1. A method for controlling the timing of successive biological samples (s0, s1) from a patient for a medical test (T), comprising: Determining (S10) by a recording device (30) a patient ID (PID) indicating the identity of said patient and a first sample time point (t0) indicating the time of obtaining a first biological sample (s0) from said patient; receiving (S20) the patient ID (PID) and the first sample time point (t0) from the recording device (30) by a processing system (20) communicatively connected to the recording device (30); - determining (S30) protocol rules (R) of said medical study (T) related to timing requirements for acquiring biological samples (s0, s1) from said patient according to said medical study (T); determining (S40) a sample timing in response to said protocol rules (R) and said first sample time point (t0) to indicate when in accordance with said protocol rules (R) to obtain a second biological sample (s1) from said patient; A method comprising: