Systems and methods for controlling the timing of sequential biological samples

Abstract

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) indicating the identity of the patient and a first sample time point (t0) indicating the time at which a first biological sample (s0) is to be obtained from the patient at a first time point (t0); and a processing system (20) communicatively connected to the recording device (30), configured to receive the patient ID (PID) and the first sample time point (t0) from the recording device (30), determine a protocol rule (R) for the medical test (T) related to timing requirements for obtaining the biological samples (s0, s1) from the patient according to the medical test (T), determine sample timing according to the protocol rule (R) and the first sample time point (t0), and indicate when to obtain a second biological sample (s1) from the patient in accordance with the protocol rule (R).

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 not only based on current symptoms but also on the results of various medical tests, particularly for various medical biomarkers. Depending on the results of such tests, the patient's future treatment is determined, especially when a particular condition requires rule-out, rule-in, or long-term monitoring. For example, when non-ST-segment elevation myocardial infarction (NSTEMI) is suspected, an electrocardiogram (ECG) typically does not provide reliable information. In such cases, the patient's biological sample, particularly a blood sample, is tested for troponin, an indicative medical biomarker for NSTEMI.

[0003] Typically, a test for a particular biomarker is not performed just once at a given time, but rather at least two measurements are taken to analyze the development of the biomarker over time.

[0004] Lack of precise sample timing control of biological samples when ruling patients in or out regarding 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 a different order of the disclosed steps without departing from the respective method embodiments, unless explicitly stated below to the contrary.

[0007] Terminology is implemented using common sense. When 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 present invention, a system for controlling the timing of successive biological samples from a patient for a medical test comprises a recording device configured to determine a patient ID indicating the identity of the patient and a first sample time point indicating a time at which a first biological sample is to be obtained from the patient at a first time point, the system further comprises a processing system communicatively coupled 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 regarding timing requirements for obtaining biological samples from the patient in accordance with the medical test, and determine a sample timing indicating when a second biological sample is to be obtained from the patient in accordance with the protocol rules in accordance with the protocol rules and the first sample time point.

[0008] As used herein, the term "patient ID" includes any form of patient identification. 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 a patient or a biological sample. For example, a 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 patient assignment 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 additional 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 the additional devices via a computer network, for example a local area network. Thus, the processing system manages the patient data and 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 a biological sample from a 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. The protocol rule includes conditions that must be met to perform the medical test. In particular, the protocol rule includes timing requirements for obtaining a biological sample from a patient. In other words, the protocol rule determines when a biological sample should be obtained 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 the first biological sample and obtaining the second biological sample must be at least one hour. If the protocol rule is not followed, the test result is flagged as not conforming to 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 / brain type (CKMB), myoglobin (Myo), human brain natriuretic peptide precursor N-terminal fragment (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, starting from the first sample time point, at which a second biological sample must be obtained from a patient in order to comply with the protocol rules of the intended medical test. Preferably, the sample timing includes the time at which the second biological sample should be obtained. Alternatively, the sample timing includes the remaining time during which the second biological sample must not be obtained in order to comply with the protocol rules.

[0015] Thus, the system provides the user or clinician, particularly the nurse, with an indication of when to obtain a second biological sample from the patient to comply with the protocol rules of the medical test. For example, the indication of when to obtain a second biological sample from the patient can be queried from the processing system and / or the recording device. Thus, the nurse has the option of checking whether obtaining a second biological sample from the patient at this moment is too early and / or too late to comply with the protocol rules, which can be reduced. As a result, the results of the medical test become more reliable.

[0016] As such, an improved system for controlling the timing of successive biological samples from a patient for medical testing is provided, which may provide better guidance to medical personnel when assessing the patient's health status and, in particular, when ruling in or out specific 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 prevents the user from noticing any additional information regarding the timing of the medical test or the acquisition of the first biological sample. The user only needs to acknowledge the given warning, which, for example, indicates positive or negative feedback regarding the collection of the second biological sample. Therefore, the probability that the nurse collects the second biological sample from the patient too early to comply with 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 includes 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 obtaining a second biological sample from the patient in order to comply with the rules of the protocol. More preferably, this indication includes a clock time by which 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 includes at least one lamp, particularly an LED, configured to display the color code. For example, a green light can indicate that a second biological sample can be obtained in order to comply with protocol rules. A red light can indicate that a second biological sample should not yet be obtained in order to comply with protocol rules.

[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 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 values ​​of medical biomarkers from biological samples for medical testing, 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 user ignores or misinterprets any warnings provided, the system should ensure that the biospecimen that is not in accordance with the medical protocol is not used in clinical decisions.

[0028] The processing system preferably determines the time difference between the first and second sample time points, which must comply with protocol rules to enhance 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 medical biomarker value of the second biological sample is marked as incompatible and, as a result, is not used in clinical decisions. In this way, the incompatible medical biomarker value is considered to be incompatible with the protocol rules and is thereby prevented from affecting clinical decisions. Alternatively, the medical biomarker value of the second biological sample is ignored or deleted to prevent its value from affecting clinical decisions.

[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, medical test protocol rules stipulate a minimum time difference between the acquisition of a first biological sample and the acquisition of a second biological sample. Generally, collecting the second biological sample later than the ideal time point in the protocol rules does not have a greater adverse effect on the reliability of the biological sample than collecting 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 according to the medical test.

[0034] Protocol rules are preferably predetermined according to 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, particularly via a recording device. However, the medical test to be performed may also be automatically determined from various input variables, such as patient ID, container ID, and / or biological sample. For example, the processing system may be provided with information on which patient is scheduled for which medical test. Alternatively, the processing system may be provided with information on which specific biological sample container is scheduled for which medical test. Alternatively, the type of medical biomarker analyzed in the biological sample may indicate which medical test the patient will be administered. Preferably, a combination of manual entry and automatic determination of the medical test to be performed is provided. Furthermore, preferably, a 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 retrieved from the processing system, particularly by the clinician, for complete control of the medical test. The system may already include a protocol that prescribes a third, fourth or further sample to be taken, for example, three hours after the start time point, e.g., two more 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 present invention, a method for controlling the timing of successive biological samples from a patient for a medical test includes the following steps: In a first step, a patient ID indicating the 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 related to timing requirements for obtaining the biological samples from the patient in accordance with the medical test is determined; 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. [Brief explanation of the drawings]

[0039] [Figure 1] FIG. 1 shows a schematic representation of the progression of troponin concentration over time. [Figure 2] FIG. 1 is a schematic representation of a progression of troponin concentrations over time, highlighting sample timing. [Figure 3] FIG. 10 is a schematic diagram illustrating a sample timing control method. [Figure 4] 1 is a schematic diagram of a system for controlling the timing of and providing alerts for sequential biological samples from a patient for medical testing. [Figure 5] 1 is 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 INVENTION

[0040] Figure 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 patient is suspected of having non-ST-segment elevation myocardial infarction (NSTEMI). Therefore, in a medical examination, the patient's blood is tested for troponin, an indicator of NSTEMI. A so-called 0-hour / 1-hour rule-in and rule-out algorithm is implemented. Essentially, the patient's blood troponin concentration (CT) is tested at least twice, specifically at a first time point and after 1 hour. To determine whether the troponin concentration (CT) indicates NSTEMI, predetermined protocol rules for this medical examination, specifically the accelerated protocol of the ESC 2015 ACS-MI guidelines, are followed. Depending on the measured troponin concentration (CT) and the change in the troponin concentration (CT) over time t, such as troponin delta Δ0-1h between the troponin concentration (CT) at the first time point (t0) and the troponin concentration (CT) at the second time point (t1), it is determined whether the patient's NSTEMI can be ruled out, ruled in, or requires observation. Preferably, the second point in time t1 is one hour after the first point in time t0.

[0041] The ESC 2015 ACS-MI guidelines define five thresholds: 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 when troponin delta Δ0-1h is greater than or equal to a fifth threshold E. Signs of NSTEMI may not be present but should be observed otherwise.

[0044] As shown in the diagram of Figure 1, the troponin concentration CT in a patient's blood is measured at a first time point t0. This first sample data set 0h has a value of approximately 3 ng / L. At a second time point t1, the troponin concentration CT in the patient's blood is again measured. 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 because 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, highlighting sample timing. Alternatively, sample timing can be further utilized to prevent misuse of the test. As shown in FIG. 2, at the second time point t1, troponin delta Δ0-1h has a specific value. However, to compare this value with a rule set such as the aforementioned architected technique, the timing of the second time point t1 needs to be as close as possible to one hour after the first time point t0. Therefore, it is particularly important that the timing of the second time point t1 be more than one hour after the first time point t0. In other words, in general, the second time point t1 may be too early in relation to the first time point t0 to comply with the protocol rules, but it is unlikely to be too late in relation to the first time point t0 to comply with the protocol rules.

[0047] Thus, as shown in Figure 2, if the second blood sample is taken too early, an invalid or incompatible troponin delta Δinv will be obtained, which should be ignored for clinical judgment. As can be seen in this example, obtaining an invalid troponin delta Δinv occurs too early within the invalid period F inv to comply with the rule set. Such an invalid troponin delta Δinv will lead to a misdiagnosis by the clinician, as the troponin level in the patient's blood has not had enough time to rise to account for the medical test that should be performed. Therefore, it is necessary to ensure that the second time sample t1 is within the valid period F v.

[0048] 3 schematically illustrates a method for controlling the timing of successive biological samples s0, s1 from a patient for a medical test T. In a first step S10, a patient ID (PID) is determined by the recording device 30, which indicates the patient's identity and a first sample time point t0 indicating the time at which a first biological sample s0 is to be obtained from the patient. In a second step S20, the patient ID (PID) and the first sample time point t0 are received from the recording device 30 by the processing system 20, which is communicatively connected to the recording device 30. In a third step S30, a protocol rule R for the medical test T is determined, which relates to the timing requirements for obtaining the biological samples s0, s1 from the patient in accordance with the medical test T. In a fourth step S40, sample timing is determined in accordance with the protocol rule R and the first sample time point t0, indicating when to obtain 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 medical testing. The system includes a processing system 20, a recording device 30, and an analyzing device 40. In this case, a patient should be examined for NSTEMI. Therefore, the troponin concentration in the patient's blood should be measured. Therefore, the biological samples s0 and s1 obtained from the patient are blood samples s0 and s1.

[0050] A clinician collects a first blood sample s0 from a patient. The first blood sample s0 is collected from the patient and placed in a container 50. The first blood sample s0 and the container 50 need to be associated with the treated patient. Therefore, the clinician or any type 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 includes a barcode 51 containing information about the patient's identity. For example, in the previous step, the barcode 51 on the container 50 was assigned to a specific patient. In this case, the recording device 30 includes a recording unit 31, particularly a scanner, configured to scan the barcode 51 on 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 a 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 entering 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 sample, e.g., the time of the recording device's internal clock, at the time when the barcode 51 is scanned by the recording device 30. 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 drawn 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 containing 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, stored in which container 50, and at what time t0 it was obtained.

[0054] The analysis device 40 is configured to analyze a provided first blood sample s0, in this case for the biomarker troponin. Accordingly, the analysis device 40 determines from the first blood sample s0 a first sample data set 0h representing 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 a processing system together with an associated first container ID (CID0).

[0055] The processing system 20 uses the provided information to determine the best time to obtain a second blood sample s1 from the patient. In this case, the patient is being tested for NSTEMI. Therefore, the troponin concentration of the patient's blood must be tested at two different time points, i.e., the first sample time t0 and the second sample time t1, separated by at least one hour. In other words, depending on the change in troponin concentration in the patient's blood collected at the two different time points, a clinical estimate of whether the tested patient has NSTEMI can be made. The time difference between the first sample time t0 and the second sample time t1 required for a reliable estimate is defined in the protocol rules. The protocol rules depend on the medical test being performed on 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 associated protocol rule R from the database 22. Therefore, the processing unit 21 needs to recognize 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, if the processing system 21 obtains information about which container 50 is used for which medical test T, the processing system 21 can determine the medical test T from the first container ID (CID0). Alternatively, the processing system 21 is provided with information about which patient is scheduled for which medical test T. Therefore, the processing system 21 can 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 dataset 0h. In other words, the processing system 21 may be able to determine the medical test T based on the type of biomarker 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 means of 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 in order to comply with protocol rule R. Thus, processing unit 21 determines 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 drawing the second blood sample s1 from the patient to ensure compliance with the protocol rule R. For example, the warning W includes the time remaining before drawing the second blood sample s1. In this way, the clinician obtains valuable information regarding whether the blood samples s0, s1 comply with the protocol rule 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 comprises interconnecting a number of clinical and / or communication devices such as analyzers, middleware systems, phones, PDAs and scanners. The analytical device 40 may for example be a mobile analytical device, e.g. an AQT-analyzer, or a stationary analyzer in a laboratory.

[0061] In the case of cutoff scenarios, i.e., when the prediction P that a patient has NSTEMI is close, an increase in the reliability of the system provided leads to an improvement in the decision-making process. In other words, an improvement in the 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 required.

[0062] Thus, the provided system reduces the amount of false positive and false negative predictions. FIG. 5 also shows schematically a system 10 for controlling the timing of successive biological samples s0, s1 from a patient for a medical test T.

[0063] 4, in this case, the second blood sample s1 has already been obtained from the patient. In accordance with the above description, the recording device 30 scans the first barcode 51a of the first container 50a containing 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 containing 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, because both blood samples have already been analyzed, no warning W is provided to the recording device 30. Rather, the processing unit 21 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 rule R. If the sample time points t0 and t1 do not comply with the protocol rule R, the processing unit 21 flags the provided sample data sets 0h and 1h. In particular, if the processing unit determines that the second sample time point t1 does not comply with the protocol rule R, it marks the second sample data set 1h as non-compliant. Thus, the clinician can still decide whether to use the second sample data set 1h as the basis for clinical decision-making.

[0067] Thus, 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 and s1 are in accordance 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 Systems 20 Processing System 21 Processing Unit 22 Databases 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 Secondary 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 Rule 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) indicating the identity of the patient and a first sample time point (t0) indicating a time at which a first biological sample (s0) is obtained from the patient at the first sample time point (t0), wherein the first sample time point (t0) is determined directly at the patient when obtaining the biological sample from the patient, and the recording device (30) is configured to determine the patient ID (PID) and a second sample time point (t1) indicating a time at which a second biological sample (s1) is obtained from the patient at a second sample time point (t1) different from the first sample 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 test (T) relating to timing requirements for acquiring biological samples (s0, s1) from said patient according to said medical test (T); a processing system (20) communicatively connected to said recording device (30), configured to determine sample timing as a function of 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); Equipped with the processing system (20) is configured to receive the patient ID (PID) and the second sample time point (t1); an analyzer (40) configured to determine values ​​of medical biomarkers from the biological samples (s0, s1) for a medical test (T); the determined sample timing includes a minimum time difference between the first sample time point (t0) and a second sample time point (t1) indicating a time at which the second biological sample (s1) is obtained from the patient, the second sample time point (t1) being different from the first sample time point (t0), in order to comply with the protocol rule (R); If, based on the minimum time difference, the second sample time point (t1) of the second biological sample (s1) is earlier than the sample timing according to the protocol rule (R), the determined medical biomarker value of the second biological sample (s1) is marked as non-compliant. System (10).

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 (s1) at a current time point does not comply with the protocol rules (R) that depend on the determined sample timing.

3. 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 configured to display the warning (W) in the form of a color code, in particular a traffic light code.

5. a database (22) storing a plurality of protocol rules (R) each associated with a medical test (T), wherein determining the protocol rules (R) for the medical test (T) comprises: The system of any one of claims 1 to 4, comprising selecting the protocol rule (R) for the medical test (T) from the plurality of protocol rules (R) in the database (22) responsive to the medical test (T).

6. The system according to any one of claims 1 to 5, wherein the first biological sample (s0) and the second biological sample (s1) are blood samples.

7. A method for controlling the timing of successive biological samples (s0, s1) from a patient for a medical test (T), the biological samples (s0, s1) being stored in a container (50), the container (50) comprising a barcode (51) containing a patient ID (PID) identifying the patient; a step (S10) in which a recording device (30) determines a patient ID (PID) indicating the identity of the patient and a first sample time point (t0) indicating the time at which a first biological sample (s0) is obtained from the patient, the first sample time point (t0) being determined directly by the patient when obtaining the biological sample from the patient, and determines the patient ID (PID) and a second sample time point (t1) indicating the time at which a second biological sample (s1) is obtained from the patient at a second sample time point (t1) different from the first sample time point (t0), wherein the recording device includes a scanner, and the scanner determines the patient ID (PID) by scanning the barcode (51), and further the time of the scanning is determined as the first sample time point (t0); 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), the processing system (20) comprising a processing unit (21) and a database (22), the database including a plurality of protocol rules associated with medical tests; a step (S30) in which the processing system (20) determines a protocol rule (R) corresponding to the medical test to be performed from among protocol rules (R) of the medical test (T) related to timing requirements for acquiring biological samples (s0, s1) from the patient corresponding to the medical test (T), wherein determining the protocol rule (R) corresponding to the medical test to be performed comprises selecting a protocol rule for the medical test from a plurality of protocol rules in a database corresponding to the medical test; a step (S40) in which the processing system (20) determines sample timing according to the protocol rules (R) and the first sample time point (t0), indicating when to obtain a second biological sample (s1) from the patient in accordance with the protocol rules (R); an analyzer (40) determining values ​​of medical biomarkers from biological samples (s0, s1) for a medical test (T); Including, the determined sample timing includes a minimum time difference between the first sample time point (t0) and a second sample time point (t1) indicating a time at which the second biological sample (s1) is obtained from the patient, the second sample time point (t1) being different from the first sample time point (t0), in order to comply with the protocol rule (R); If, based on the minimum time difference included in the determined sample timing, the second sample time point (t1) of the second biological sample (s1) is earlier than the sample timing according to the protocol rule (R), the determined value of the medical biomarker of the second biological sample (s1) is marked as non-compliant. method.

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