Extraction of laboratory, clinical or diagnostic information from clinical tests

Abstract

Aspects relate to a method, a data processing system, a laboratory instrument, a computer program, and a computer readable medium. The method includes obtaining, by a computing device, a relationship result of a first clinical test. A first clinical test is performed on a biological sample by a first laboratory instrument, the biological sample being in a sample container. The relationship result includes first information and second information, the first information specifying that a laboratory result of the first clinical test is outside a reliability range of the first clinical test performed by the first laboratory instrument, and the second information specifying one or more of an upper bound and a lower bound of the reliability range. The method further includes evaluating, by the computing device, whether a condition of the laboratory rule is determinable by using the first information and the second information. The laboratory rule specifies one or more actions to be taken depending on the result of the determination of the condition. At least one of the one or more actions is to be taken on one or more of the biological sample, the sample container, and the relationship result, and / or the one or more actions include displaying information about one or more of the biological sample, the sample container, the relationship result, and the patient. If the condition may be determined and one or more actions are to be taken according to a result of the determination of the condition, the method includes causing, by the computing device, the one or more actions to be taken.

Description

Cross-references to related applications

[0001] This application claims priority to provisional patent application EP23290037.3, entitled "Extracting Laboratory, Clinical or Diagnostic Information From a Clinical Test," filed on October 12, 2023, with the European Patent Office, and this application is a non-provisional patent application of that provisional patent application. That application is incorporated herein by reference in its entirety. Background Technology

[0002] The technical field is laboratory operation. More specifically, aspects involve the control and operation of laboratory instruments (e.g., laboratory analyzers).

[0003] Traditionally, when a laboratory instrument performs clinical testing on a biological sample and the laboratory results of the clinical test are outside the reliability range of the clinical test performed by the laboratory instrument, the laboratory results may be unavailable or difficult to use. In some cases, when laboratory results are outside the reliability range, the laboratory instrument reports no result or incorrect laboratory results. Additionally or alternatively, there may be no way to further manipulate the laboratory results, for example, because the numerical results provided by the analyzer are unreliable and cannot be used to determine whether the conditions of laboratory rules that trigger certain actions are met.

[0004] Therefore, after performing clinical tests on biological samples using laboratory instruments, it may be desirable to obtain clinical test results, which include values ​​that can be further manipulated. Summary of the Invention

[0005] According to a first aspect, a method is provided. The method includes obtaining a relational result of a first clinical test via a computing device. The first clinical test is performed on a biological sample in a sample container using a first laboratory instrument. The relational result includes first information and second information, the first information indicating that the laboratory result of the first clinical test is outside the reliability range of the first clinical test performed by the first laboratory instrument, and the second information indicating one or more of an upper bound (i.e., upper limit) and a lower bound (i.e., lower limit) of the reliability range. Specifically, the second information indicates either an upper bound (i.e., upper limit) or a lower bound (i.e., lower limit) of the reliability range.

[0006] The method also includes using a computing device to assess whether the conditions of a laboratory rule are determinable (i.e., deterministic) by using first and second information. The laboratory rule specifies one or more actions to be taken depending on the deterministic outcome of the conditions. At least one of one or more actions (e.g., each action) is to be taken for one or more of the biological sample, sample container, and relational outcome, and / or one or more actions include displaying information about one or more of the biological sample, sample container, relational outcome, and patient. For example, information about the patient may specify the patient's condition or status associated with the biological sample. The patient's condition or status may specify a disease or syndrome affecting the patient.

[0007] If the conditions are determinable, and one or more actions are to be taken based on the determination of the conditions, then the method includes having a computing device cause one or more actions to be taken.

[0008] Therefore, the one or more actions to be taken can include:

[0009] - To take at least one of one or more actions on one or more of the biological sample, sample container, and relational results, and / or

[0010] - Displays information about biological samples, sample containers, relationship outcomes, and one or more patients.

[0011] Specifically, assessing whether the conditions for laboratory rules can be determined includes comparing the relationship results with reference values.

[0012] The results of the first clinical trial can be obtained after the first run of the first clinical trial.

[0013] Biological samples can be associated with patients. For example, the sample container may include a machine-readable code (e.g., a barcode) that identifies the patient. Therefore, surgical procedures can be scheduled and can only be performed after laboratory results have been received and evaluated (e.g., using relational results). Furthermore, a patient's life may depend on the ability to evaluate laboratory results within a specified completion time, for example, enabling the execution of life-saving surgical procedures.

[0014] Clinical testing (e.g., primary clinical testing) can be diagnostic and / or medical. Clinical testing (i.e., clinical laboratory testing) can include the use of chemical and / or biological processes to determine or measure the levels of chemical components in a biological sample (e.g., body fluids and / or body tissues). Chemical components can include blood glucose, electrolytes, enzymes, hormones, lipids (fat), another metabolite, proteins, or any other measurable analyte. Clinical testing can be used to identify signs of nutritional deficiencies in a patient, detect changes in a patient's health, assess a patient's physical functions (e.g., kidney function, liver function, or thyroid function), monitor a patient's treatment, or monitor the progression of a patient's disease. In particular, clinical testing can include physical procedures, biological procedures, optical procedures, mechanical procedures, immunological procedures, and / or chemical procedures. For example, a clinical test can be an immunoassay. Biological samples can be materials or specimens and can include blood, urine, tissues, cells, saliva, etc.

[0015] This method can be used to control and / or operate a first laboratory instrument. This method can be used to improve the extraction of laboratory, clinical, or diagnostic information from clinical tests. More specifically, this method can lead to improvements in the extraction of laboratory, clinical, or diagnostic information from clinical tests when the execution of a clinical test produces laboratory results that exceed the reliability range of a first clinical test performed by the first laboratory instrument.

[0016] Laboratory results from laboratory instruments (e.g., the first laboratory instrument) may include measurements taken by the laboratory instrument.

[0017] For example, when the concentration of the substance to be measured in the first clinical test (i.e., the analyte) in a biological sample is too high or too low to be measured (i.e., too high or too low to be measured accurately), the laboratory results may be outside the reliability range of the first clinical test performed by the first laboratory instrument.

[0018] The primary laboratory instrument can be an analyzer, i.e., a device used in a clinical laboratory to perform laboratory tests on biological samples. Laboratory instruments can be designed to measure clinical parameters, such as chemical substances, cellular components, or biomarkers. Laboratory instruments can be designed to assist in one or more aspects of the diagnosis, monitoring, and treatment of a medical condition. In particular, the primary laboratory instrument may be included in an automated laboratory system (ALS).

[0019] This method enables the testing of laboratory rules using all available information about laboratory results, thereby maximizing the availability of laboratory results provided by the first laboratory instrument and expanding the applicability of workflows that include the use of the first laboratory instrument.

[0020] For example, one or more actions may include moving a sample container to an incorrect area. Additionally or alternatively, one or more actions may include marking a relationship result as unreliable and / or displaying the relationship result. These actions do not include commercial or administrative activities (e.g., pricing or fulfilling contractual obligations). For example, laboratory rules may look like this:

[0021] IF (result of CSF glucose concentrations <= 18 mg / dL) THEN (flag result as “High risk of bacterial meningitis”)

[0022] The condition is "CSF glucose concentration result <18 mg / dL", and the action is "label the result as "high risk of bacterial meningitis". In this example, the action is taken if the condition is met (i.e., true). For example, the laboratory rule could be as follows:

[0023] (Mark the result as “High risk of bacterial meningitis”) EXCEPT IF (result of CSF glucose concentrations ≥18 mg / dL)

[0024] In this case, the condition is "CSF glucose concentration > 18 mg / dL", and the action is "to label the result as "high risk of bacterial meningitis". In this case, if the condition is not met (i.e., false), the action is taken.

[0025] Making one or more actions can include, for example, providing instructions to a first laboratory instrument or another laboratory instrument different from the first laboratory instrument to perform one or more actions, initiating one or more actions, or performing one or more actions.

[0026] A laboratory can be a technical system comprising one or more laboratory instruments. A laboratory can be a clinical laboratory or a medical laboratory. A laboratory may include one or more laboratory instruments, such as an ALS comprising multiple analyzers. A laboratory may include at least one computer.

[0027] A laboratory can be configured to receive biological samples from a clinical or medical facility, such as a hospital. Alternatively, the laboratory can be part of a clinical or medical facility and can receive biological samples from another part of the facility. Laboratory instruments can be able to communicate with each other and / or with other devices, such as computers. Laboratory instruments may also be referred to as laboratory equipment or laboratory gear and may include laboratory automation.

[0028] The first clinical test can be performed in a laboratory.

[0029] Obtaining relational results may include converting (i.e., transforming) laboratory results into relational results using a first laboratory instrument. In particular, obtaining relational results may include generating relational results using laboratory results.

[0030] The computing device may be part of or connected to the first laboratory instrument. Alternatively or additionally, the computing device may be communicatively coupled to the first laboratory instrument. In some cases, the computing device may be physically separate from the first laboratory instrument.

[0031] Specifically, if the first and second information allow for determining whether a condition corresponds to a laboratory result that is verifiable (i.e., provable to be true) or falsifiable (i.e., provable to be false), then the condition can be determined by using the first and second information. Specifically, if it is possible to determine whether a condition corresponds to a laboratory result that is true or false by using the first and second information, then the condition can be determined by using the first and second information. For example, if the condition is of the type (laboratory result < 100 mL / l), and the first and second information specify that the laboratory result is less than 50 mL / l, then the condition corresponds to a laboratory result that is true, and therefore it is verifiable. For example, if the condition is of the type (laboratory result > 100 mL / l), and the first and second information specify that the laboratory result is less than 50 mL / l, then the condition corresponds to a laboratory result that is false, and therefore it is falsifiable. Exemplarily, if the condition is of the type (laboratory result > 100 mL / l), and the first and second information specify that the laboratory result is less than 150 mL / l, then the condition is indeterminate because it is impossible to determine whether the condition corresponds to a laboratory result that is true or false.

[0032] For example, assessing whether the conditions of laboratory rules can be determined by computing devices includes evaluating whether the conditions are true or false by using first information and second information.

[0033] In particular, this invention allows for the extraction of more information from the first clinical test than would otherwise be possible; that is, by examining whether conditions associated with laboratory rules can be determined using information included in the relational information. In some cases, the relational results can allow for the exemption of further clinical testing or the use of less capable laboratory equipment to perform the first clinical test. Furthermore, the relational results can enable faster access to information about a patient's condition and / or earlier provision of such information to medical personnel, allowing for more swift action regarding the patient's condition.

[0034] For example, if the conditions are indeterminate, the method may further include, for instance, causing one or more other actions to be taken by a computing device. For example, one or more other actions may include performing a second clinical test. Specifically, the second clinical test may be more specific, more accurate, and / or have a wider reliability range than the first clinical test. Thus, the more specific and / or more accurate and / or test with a wider reliability range is performed only when practically necessary, i.e., when the first clinical test does not allow for determination of whether the conditions are met, thereby improving the allocation of laboratory and / or ALS resources. In other words, by improving the extraction of information from the laboratory results of the first clinical test, the relational results make it possible to abandon or exempt additional clinical testing, thereby allowing ALS resources intended for additional clinical testing to be used for other purposes.

[0035] For example, one or more other actions include diluting the biological sample and rerunning the first clinical test on the diluted biological sample. For example, one or more other actions include notifying the user that the condition is undetermined and / or storing information specifying that the condition is undetermined in a computer-readable medium.

[0036] In particular, one or more actions may include performing a third clinical test.

[0037] The first clinical test can differ from the second and / or third clinical tests. For example, the second and / or third clinical tests can be more specific than the first clinical test. More specifically, the first clinical test may involve whether the concentration of the test substance is above or below a threshold, and the second and / or third clinical tests may involve testing conditions that occur only when the concentration of the substance is above (or below) the threshold, respectively. Therefore, the second and / or third clinical tests can be more specific than the first clinical test because the relevance of the second and / or third clinical tests depends on the laboratory results of the first and / or third clinical tests. In particular, the second and third clinical tests can be equivalent to each other, i.e., the same clinical test.

[0038] In some cases, the second and / or third clinical tests may be confirmatory tests to confirm a diagnosis. Additionally or alternatively, the second and / or third clinical tests may involve determining a patient’s condition or status in relation to a biological sample. For example, a biological sample may include bodily fluids from a patient (e.g., blood or urine). Determining a patient’s condition or status may include determining whether the patient has a disease or syndrome.

[0039] A testing methodology can be based on established scientific principles and may involve biology, chemistry, and / or physics. A testing methodology can define a process (i.e., a procedure) that includes one or more steps and is used to test a biological sample against one or more analytes. One or more steps of a testing methodology may involve the use of one or more reagents. Different methods can be used to test the same analyte. For example, a testing methodology can be used to test for the presence of an antigen in a biological sample. The reaction of the antigen present in the biological sample with a first antibody is compared to a reaction at a known concentration, and the amount of antigen is reported. In different testing methodologies, different antibodies can be used to test for the same antigen. As another example, biological samples with varying degrees of endogenous interference from hemoglobin, bilirubin, and lipids can be used with different methods. For example, a second testing methodology can differ from a first testing methodology because the former uses reagents different from those used in the latter.

[0040] A first clinical test may include measuring a first clinical parameter using a first testing methodology. Specifically, the first clinical test is configured to measure the first clinical parameter using the first testing methodology. A second clinical test may include measuring the first clinical parameter using a second testing methodology. Specifically, the second clinical test is configured to measure the first clinical parameter using the second testing methodology. The first testing methodology may differ from the second testing methodology. A third clinical test may include measuring the first clinical parameter using a third testing methodology. Specifically, the third clinical test is configured to measure the first clinical parameter using the third testing methodology. The first testing methodology may differ from the third testing methodology.

[0041] The first clinical test may include measuring a first clinical parameter (e.g., a first analyte), the second clinical test may include measuring a second clinical parameter (e.g., a second analyte), and / or the third clinical test may include measuring a third clinical parameter (e.g., a third analyte). The first clinical parameter may be different from the second and / or third clinical parameter.

[0042] Specifically, a clinical test (e.g., a first clinical test) could be a glucose test, such as a test used to determine (e.g., measure) the concentration of glucose in a biological sample.

[0043] More specifically, the first clinical test may be a fasting plasma glucose test or a random plasma glucose test. Therefore, the second and / or third clinical tests may involve confirmation, further evaluation, or typology based on the first clinical test. For example, the second and / or third clinical tests may be tests to confirm diabetes or to confirm a specific type of diabetes; for instance, the second and / or third clinical tests may be an oral glucose tolerance test or a hemoglobin A1c test to confirm diabetes. Alternatively, the second and / or third clinical tests may confirm hypoglycemia based on the hypoglycemic level determined in the first clinical test. Therefore, the second and / or third clinical tests may include a glucose tolerance test or continuous glucose monitoring to assess glucose levels over a period of time.

[0044] In another example, the first clinical test could be a glucose challenge test. An abnormal result on the glucose challenge test may indicate gestational diabetes. Therefore, a second and / or third clinical test can confirm the diagnosis of gestational diabetes; for example, the second and / or third clinical test could be an oral glucose tolerance test. The second and / or third clinical tests can be used to diagnose and / or determine the appropriate management of the diagnosed condition.

[0045] In another example, the first clinical test could be a fasting plasma glucose test, which can indicate elevated glucose levels. Therefore, a second and / or third clinical test can be used to confirm Cushing's syndrome. Specifically, the second and / or third clinical test could be a dexamethasone suppression test or a 24-hour urinary free cortisol test to assess cortisol levels.

[0046] As another example, the first clinical test could be a fasting plasma glucose test. Abnormal results may indicate pancreatic dysfunction. Therefore, second and / or third clinical tests can be used to test lipase and / or amylase levels, perform pancreatic imaging, or perform endoscopic procedures, such as endoscopic ultrasound or endoscopic retrograde cholangiopancreatography, for further evaluation.

[0047] The reliability range of a clinical test (e.g., a first clinical test) performed by a laboratory instrument (e.g., a first laboratory instrument) can be referred to as the analytical measurement range. Specifically, the analytical measurement range is typically provided by the manufacturer of the laboratory instrument. In particular, the reliability range of a clinical test (e.g., a first clinical test) performed by a laboratory instrument (e.g., a first laboratory instrument) can be a range within which the clinical test can accurately and / or precisely measure the corresponding clinical parameter in one or more of the following: accuracy within a given accuracy range, precision within a given precision range, specificity within a given specificity range, and sensitivity within a given sensitivity range. The reliability range of a clinical test performed by a laboratory instrument can specify the lowest and / or highest concentration of the analyte that the clinical test performed by the laboratory instrument can detect and quantify in one or more of the following: accuracy within a given accuracy range, precision within a given precision range, specificity within a given specificity range, and sensitivity within a given sensitivity range.

[0048] Precision (i.e., the precision component of a reliability range) measures the consistency of laboratory results when the same biological sample is repeatedly tested. Specifically, in-run precision measures the consistency of laboratory results when the same biological sample is repeatedly tested within the same day. More specifically, intra-laboratory precision measures the consistency of laboratory results when the same biological sample is repeatedly tested over multiple days, for example, for a specified number of days set for an experiment. For example, the precision or imprecision of multiple biological samples can be assessed. For each clinical test, two biological samples can be selected: one with a low concentration of interfering substances (e.g., about 0.3 g / L to 0.5 g / L hemoglobin for hemolysis or about 50 μmol / L to 100 μmol / L bilirubin for jaundice), and one with a high concentration of interfering substances (e.g., about 1.0 g / L to 2.0 g / L hemoglobin for hemolysis or at least about 300 μmol / L bilirubin for jaundice). In some cases, biological samples can be analyzed in duplicate, twice daily for 5 days, for a total of about 20 measurements per sample. The results can be compared with known guidelines, such as the Clinical and Laboratory Standards Institute (CLSI) EP5-A2 guideline or the National Committee for Clinical Laboratory Standards (NCCLS) EP5-A guideline.

[0049] Precision can be expressed as the coefficient of variation (CV) and can indicate the variability between repeatable laboratory results. A lower CV can indicate higher precision and / or higher reliability. In other words, CV can be inversely proportional to precision and / or reliability. For example, a CV of less than 3% can be considered acceptable for first, second, and / or third laboratory instruments.

[0050] Accuracy refers to the difference between laboratory results provided by laboratory instruments and reference (i.e., known or true) values. Accuracy can be assessed by comparing laboratory results from laboratory instruments to known standards. Accuracy can be reported as a percentage of deviation or the percentage of laboratory results falling within a specified range of reference values.

[0051] Specificity measures the ability of a laboratory instrument to accurately identify and / or measure a desired analyte in the absence of interference from other substances. Specificity can indicate the degree to which laboratory results produced by a laboratory instrument are affected by cross-reactivity or interference from other analytes or substances present in the biological sample.

[0052] Sensitivity refers to the ability of a laboratory instrument to detect low concentrations of an analyte. Sensitivity can be assessed by determining the lowest concentration of an analyte that can be reliably detected and / or distinguished from 0 (e.g., with at least about 95% probability) and quantified by the laboratory instrument. For example, sensitivity limits can be determined according to guidelines such as CLSI EP17-A2.

[0053] The reliability range can vary depending on the biological sample being tested. For example, laboratory tests for analyte concentrations in serum may have different reliability ranges than laboratory tests for analyte concentrations in urine or cerebrospinal fluid (CSF).

[0054] Potassium (K) measurements can be used to diagnose hypokalemia (metabolic alkalosis, metabolic acidosis, or the absence of an acid-base imbalance), hyperkalemia (potassium overdose, acidosis, or crush injury), renal failure, Addison's disease, or other conditions involving electrolyte imbalance. For example, the reliability range of a potassium (K) test performed by the first exemplary chemical analyzer can be (mmol / L = millimoles per liter):

[0055] When the biological sample is serum or plasma, the concentration is 1.0 mmol / L to 15.0 mmol / L; and

[0056] When the biological sample is urine, the concentration is 2 mmol / L to 300 mmol / L.

[0057] Specifically, values ​​included in the reliability range defined above have a sensitivity greater than 95%. Therefore, a given sensitivity range is (95%, 100%). For example, values ​​included in the reliability range defined above have in-run precision, where the relative CV is less than 2.0% when the biological sample is serum or plasma, and less than 4.0% when the biological sample is urine. Therefore, in this case, a given in-run precision range when the biological sample is serum or plasma can be represented by a given relative CV range of (0, 2.0%). When the biological sample is urine, a given in-run precision range can be represented by a given relative CV range of (0, 4.0%).

[0058] For example, the reliability range of a glucose test performed by a second exemplary chemical analyzer could be (mg / dL = milligrams per deciliter):

[0059] When the biological sample is serum, plasma, or CSF, the concentration is 10 mg / dL to 810 mg / dL; and

[0060] When the biological sample is urine, the concentration ranges from 3.6 mg / dL to 810 mg / dL.

[0061] Specifically, values ​​included in the reliability range defined above have a sensitivity greater than 95%. Therefore, the given sensitivity range is (95%, 100%). For example, regardless of whether the biological sample is serum, plasma, CSF, or urine, values ​​included in the reliability range defined above have in-operation precision with a relative CV ≤ 3.0%. Therefore, in this case, the given in-operation precision range can be represented by a given relative CV range (0, 3.0%). Regardless of whether the biological sample is serum, plasma, CSF, or urine, values ​​included in the reliability range defined above have a relative CV ≤ 3.0% in-laboratory precision. Therefore, in this case, the given in-laboratory precision range can be represented by a given relative CV range (0, 3.0%).

[0062] Therefore, accurate laboratory results for glucose tests performed on serum, plasma, or cerebrospinal fluid by the second exemplary laboratory instrument fall within the range of 10 mg / dL to 810 mg / dL. Similarly, accurate laboratory results for glucose tests performed on urine by the second exemplary laboratory instrument fall within the range of 3.6 mg / dL to 810 mg / dL. Laboratory results with analyte concentrations <10 mg / dL or >819 mg / dL in serum / plasma / CSF biosamples will be outside the reliability range of the laboratory instrument. Similarly, laboratory results with analyte concentrations <3.6 mg / dL or >810 mg / dL in urine biosamples will be outside the reliability range of the laboratory instrument.

[0063] In the context of the reliability range of a glucose test performed by a second exemplary laboratory instrument, if the laboratory result is below 10 mg / dL (e.g., a laboratory result of 5 mg / dL), the relational result can be <, 10 mg / dL. Continuing the example, if the conditions of the following laboratory rules are evaluated, the computing device will cause an action to be taken:

[0064] IF (result of CSF glucose concentrations <= 18 mg / dL) THEN (flag the result as “High risk of bacterial meningitis”)

[0065] This is because the relationship of <, 10 mg / dL implies that the conditions of the above laboratory rule are determinable and true.

[0066] For example, the reliability range of the immunoglobulin M test performed on serum or plasma by the third exemplary chemical analyzer is 0.2 g / L to 5.0 g / L (g / L = grams per liter). For example, the reliability range of the prealbumin test performed on serum by the third exemplary chemical analyzer is 0.03 g / L to 0.8 g / L.

[0067] Making one or more other actions may include causing a second laboratory instrument to perform a second clinical test. Alternatively or additionally, making one or more actions may include causing a third laboratory instrument to perform a third clinical test.

[0068] The second and / or third laboratory instruments can be configured to measure the first parameter with higher sensitivity, precision, specificity, linearity, and accuracy than the first laboratory instrument. Specifically, the second and / or third laboratory instruments can have a reliability range for the first parameter that encompasses the reliability range of the first parameter of the first laboratory instrument, or the second and / or third laboratory instruments can have a reliability range for the first parameter that includes the laboratory results. Thus, the laboratory instruments can have a reliability range for the first parameter such that the laboratory results are outside the reliability range of the first laboratory instrument but within the reliability range of the second and / or third laboratory instruments. Additionally or alternatively, the laboratory results may be indeterminate for the first laboratory instrument but determinizable for the second and / or third laboratory instruments, for example, because the first parameter can be measured by the second and / or third laboratory instruments with higher sensitivity than the first laboratory instrument.

[0069] Laboratory instruments (e.g., a first laboratory instrument, a second laboratory instrument, and / or a third laboratory instrument) can be laboratory analyzers, such as those included in an ALS. In particular, the first laboratory instrument and one or more of the second and third laboratory instruments are included in an ALS.

[0070] Laboratory instruments can be medical or clinical analyzers. Laboratory instruments may also include one or more pre-analysis components, analysis components, and post-analysis components.

[0071] An analyzer is specifically an instrument configured to perform one or more analytical steps, such as measuring one or more properties of a sample (e.g., the concentration of a given analyte). Analytical laboratory instruments can be or include immunoassay analyzers, chemical analyzers, identification and antibiotic susceptibility analyzers, bacteriological analyzers, molecular analyzers, hematological analyzers, or urine analyzers.

[0072] Automated components can be used to move containers from one laboratory instrument to another, or to move containers from one component of a laboratory instrument to another component of the same laboratory instrument or to another component of another laboratory instrument. Automated components may include tracks, belts, and / or tubular carriers configured to move biological samples.

[0073] Typically, an automated laboratory system (also referred to herein as an "ALS") is a combination of multiple components and computing devices, wherein the computing devices are operatively connected to and configured to control each component. Components may be analyzers, pre-analytical laboratory instruments, post-analytical laboratory instruments, input / output modules, and automated components configured to move samples (e.g., tracks, belts, tube carriers). In particular, an ALS may include one or more subsystems, wherein each subsystem comprises one or more components of the ALS.

[0074] Pre-analytical laboratory instruments are instruments configured to perform one or more pre-analytical steps on biological samples to prepare the samples for use in analytical instruments. Pre-analytical laboratory instruments may include centrifuges, decappers, recappers, and / or aliquoters.

[0075] Post-analytical instruments are instruments configured to perform one or more post-analytical steps on biological samples after the samples have been processed by one or more analytical instruments. Post-analytical laboratory instruments may include (for example, resealing devices, storage devices, refrigerators, or input / output devices) resealers. Both pre-analytical and post-analytical laboratory instruments can be referred to as peri-analytical laboratory instruments.

[0076] In one example, hematological and urinalytic tests can be performed on a female patient based on symptoms including right-sided pain, a temperature of 37.5°C, a pulse of 103, a blood pressure of 150 / 80, and a respiratory rate of 19. The laboratory workflow may include a first laboratory rule that specifies the actions to be taken when conditions dependent on the results of the hematological and urinalytic tests are met. For example, the first laboratory rule might be as follows:

[0077] IF (WBC1 > T WBC1 AND MDW > T MDW AND (WBC2> T) WBC2 AND BC > T BC THEN (Perform chemical & immunoassay) (IF (WBC1 > T) WBC1 AND MDW > T MDW AND (WBC2> T) WBC2 AND BC > T BC )THEN (carry out a chemistry & immunoassay test)),

[0078] WBC1 refers to the white blood cell count from a hematological test, and MDW refers to the monocyte distribution width from a hematological test. Urine analysis tests can measure new values ​​for bacterial count (BC) and white blood cell count (WBC2). T... WBC1 T WBC2 and T MDW These are two thresholds used for white blood cell counting and one threshold used for monocyte distribution width. T BC This is the threshold for bacterial counting. If the condition (WBC1 > T) is met... WBC1 AND MDW > T MDW AND (WBC2 > T) WBC2 AND BC > T BC If the aforementioned white blood cell count, monocyte distribution width, and bacterial count fall outside their respective reliability ranges, then action is taken, for example, to perform chemical and immunoassay tests.

[0079] - The correlation result with white blood cell count from hematological tests is >, U WBC1 Type, where U WBC1 It is greater than T WBC1 The value; and

[0080] - The correlation result with monocyte distribution width from hematological tests is >, U MDW Type, where U MDW It is greater than T MDW The value; and

[0081] - The correlation result with white blood cell count from urine analysis tests is >, U WBC2 Type, where U WBC2 It is greater than T WBC2 The value; and

[0082] - The correlation result with bacterial counts from urine analysis tests is >, U BC Type, where U BC It is greater than T BC The value.

[0083] In this scenario, chemical and immunoassay tests performed on third-party laboratory instruments might indicate elevated lactate, elevated C-reactive protein (CRP), elevated procalcitonin (PCT), and elevated interleukin (IL-6). These elevated values ​​may satisfy the conditions of laboratory rules, and therefore, warrant one or more actions specified by the third-party laboratory rules. For example, one or more actions might include (i) displaying the meaning of laboratory results obtained through the performance of hematological tests, urinalysis tests, and chemical and immunoassay tests, and / or (ii) sending an alert. In this example, one or more actions could lead to a diagnosis of E. coli, for which a female patient could be treated.

[0084] One or more actions may include rerunning (i.e., repeating or performing) the first clinical test. In other words, one or more actions may include performing the first clinical test a second time. Additionally or alternatively, the rerun of the first clinical test may be performed after diluting or otherwise modifying the biological sample.

[0085] For example, laboratory rules could be as follows:

[0086] IF (result > upper limit of reliability range) THEN rerun with dilution

[0087] In the example above, the condition is "result > upper limit of reliability range", and the action to be taken is "rerun with dilution".

[0088] Another example of laboratory rules is as follows:

[0089] IF (result of CSF glucose concentrations <= 18 mg / dL) THEN (flag the result as “High risk of bacterial meningitis”)

[0090] Therefore, if the correlation result indicates that the glucose concentration in the biological sample containing CSF is less than or equal to 18 mg / dL (1.0 mmol / L), actions can be taken, such as marking the laboratory result corresponding to the correlation result (e.g., specified by the correlation result) as indicating bacterial meningitis, displaying a corresponding alarm, storing first and / or second information by a computer, or sending the first and / or second information to a computer, rerunning the first clinical test, or performing a second or third clinical test to confirm the result.

[0091] Reagents can be substances or compounds that can promote chemical reactions. Reagents may include one or more of the following: solvents (e.g., water), enzymes, catalysts. Reagents may be of a variety of types known for analyzing biological samples. Some examples of reagents include liquid reagents containing labeled, specifically binding reagents (e.g., antibodies or nucleic acid probes), liquid reagents containing reactive and / or non-reactive substances, red blood cell suspensions, and particle suspensions. In other examples, reagents may be chemiluminescent substrates. Reagents may be assay reagents. Assay reagents may include substances in a reacted or unreacted state such as: wash buffers, rinse solutions, sample pretreatments, diluents, staining agents, dyes, substrates, antibody conjugates, enzymes or enzyme conjugates, nucleic acid conjugates, cell lysis reagents, etc. Components of assay reagents typically include substances in a reacted or unreacted state such as: water, buffers, chemicals, particles, substrates, enzymes, fixatives, preservatives, nucleic acids, antibodies, acids, bases, and mixtures thereof.

[0092] One or more actions may include diluting the biological sample. Diluting the biological sample may be performed before rerunning the first clinical test. Diluting the biological sample can be performed by adding one or more diluents to the biological sample. Diluents may include water and / or saline.

[0093] One or more actions may include displaying first information and / or second information.

[0094] One or more actions may include displaying third information. This third information may, based on the first and second information, specify whether a laboratory result falls within one or more of a borderline range, a warning range, and a normal range. The borderline, normal, and warning ranges may be associated with a patient's underlying condition. Specifically, a borderline range is a range of laboratory result values ​​that indicate a life-threatening condition for individuals, for example, belonging to a given population. A normal range is, in particular, a range of laboratory result values ​​that are considered normal, for example, among members of a given population. A warning range is, in particular, a range of laboratory result values ​​that are neither normal nor life-threatening for individuals in a given population. Specifically, a population is a group of individuals grouped by one or more of age, sex, race, geographic origin, etc.

[0095] Displaying the first, second, and / or third information can have one or more of the following effects:

[0096] - Enables the use of laboratory results that would otherwise be unavailable;

[0097] - Enables faster diagnostics;

[0098] - Reduce the number of clinical tests required.

[0099] These effects are achieved by displaying relational results and / or third-party information when the primary laboratory result is outside the reliable range. Such laboratory results are typically discarded or displayed without context. Through this displayed relational result or third-party information, even unreliable laboratory results can be used at least to some extent, enabling a faster diagnosis of the patient. In some cases, further clinical testing using more reliable laboratory instruments can be omitted.

[0100] In some cases, the second information specifies one or more of the measurement units for the upper bound of the reliability range (hereinafter also referred to as the "first measurement unit") and the measurement units for the lower bound of the reliability range (hereinafter also referred to as the "second measurement unit"). Including information specifying the first and / or second measurement units allows for the reduction of errors that may arise when determining the conditions of laboratory rules by comparing values ​​expressed in different measurement units.

[0101] For example, as described above, assessing whether the conditions for a laboratory rule can be determined involves comparing the relationship outcome (e.g., the upper and / or lower bounds specified in the second information) with a reference value. In particular, the reference value may be expressed in a third unit of measurement.

[0102] If the second information specifies a first unit of measurement, assessing whether the conditions of the laboratory rule can be determined may include evaluating whether the first unit of measurement is equal to a third unit of measurement. If the first and third units of measurement are different from each other, assessing whether the conditions of the laboratory rule can be determined may include representing the relational result and / or the reference value in a first common unit of measurement before comparing the relational result with a reference value. More specifically, if the first common unit of measurement is a third unit of measurement, the relational result is represented only in the first common unit of measurement. Conversely, if the first common unit of measurement is a first unit of measurement, only the reference value is represented in the first common unit of measurement. Generally, if the first common unit of measurement is different from both the first and third units of measurement, both the relational result and the reference value are represented in the first common unit of measurement.

[0103] If the second information specifies a second unit of measurement, assessing whether the conditions of the laboratory rule can be determined may include evaluating whether the second unit of measurement is equal to a third unit of measurement. If the second and third units of measurement are different from each other, assessing whether the conditions of the laboratory rule can be determined may include representing the relationship result and / or the reference value in a second common unit of measurement before comparing the relationship result with a reference value. More specifically, if the second common unit of measurement is a third unit of measurement, the relationship result is represented only in the second common unit of measurement. Conversely, if the second common unit of measurement is a second unit of measurement, the reference value is represented only in the second common unit of measurement. Typically, if the first common unit of measurement differs from both the second and third units of measurement, both the relationship result and the reference value are represented in the second common unit of measurement.

[0104] Obtaining a relational result may involve constructing the relational result using laboratory results and one or more of an upper and lower bound. In particular, the step of constructing the relational result is performed only if the laboratory result is outside the reliability range, such as being greater than the upper bound or less than the lower bound.

[0105] For example, constructing the relationship result may include comparing the laboratory result to an upper bound and a lower bound. If the laboratory result is greater than the upper bound or less than the lower bound, the method includes generating first information and second information. This is if the laboratory result falls within the reliability range.

[0106] For example, if the laboratory result is greater than the upper bound, the first information specifies that the laboratory result is greater than the upper bound and therefore outside the reliability range. In this case, the first information can be specified using the character ">", the string "greater than", the string "above", etc. Specifically, if the laboratory result is greater than the upper bound, the second information includes the numerical value of the upper bound and / or the string specifying the upper bound.

[0107] For example, if the laboratory result is less than the lower bound, the first information specifies that the laboratory result is less than the lower bound and therefore outside the reliability range. In this case, the first information can be specified using the character "<", the string "less than", the string "below", etc. Specifically, if the laboratory result is less than the lower bound, the second information includes the numerical value of the lower bound and / or the string specifying the lower bound.

[0108] Obtaining relational results may include, for example, receiving relational results from a first laboratory instrument.

[0109] Assessing whether the conditions for laboratory rules are determinable can include determining the range to which laboratory results belong by using relational results. The range to which laboratory results belong can be a first range or a second range. A first range can consist of values ​​above the upper limit of the reliability range. A second range can consist of values ​​below the lower limit of the reliability range.

[0110] Assessing whether the conditions for a laboratory rule can be determined may also include determining whether one of a first requirement and a second requirement is met. The first requirement may be a requirement that the condition is met for each value within the range to which the laboratory result belongs, and the second requirement may be a requirement that the condition is not met for each value within the range to which the laboratory result belongs. If either the second requirement or the first requirement is met, then the condition is determined. Specifically, the first range is an interval (upper bound, lower bound). The upper bound is considered part of the first range only if it does not fall within the reliability range. For example, the second range is an interval (...). (lower bound), where the lower bound is only considered part of the second range if the lower bound is not within the reliability range.

[0111] Specifically, the first requirement is met if the range to which the laboratory results belong is included within the validity range of the condition. For example, the second requirement is met if the validity range of the condition and the range to which the laboratory results belong do not intersect. The validity range of the condition is specifically the range of values ​​for which the condition is satisfied when corresponding to a range of values.

[0112] In some cases, relational results may include one or more of the following: numerical values, relational operators (e.g., =, >, <), and units of measurement (e.g., units of concentration, such as milliliters per liter, or ml / L)). Examples of relational results include the following:

[0113] 1. >, 8000, μL / L (First relational result);

[0114] 2. >, 12000, μL / L (Second relationship result);

[0115] 3. <, 8000, μL / L (Third relation result); and

[0116] 4. <, 12000, μL / L (Fourth relation result).

[0117] The numbered examples above represent relational results, which include a relational operator followed by a numerical value and then a unit of measurement; the relational operator and the numerical value are separated by a comma, and the numerical value and the unit of measurement are separated by a comma. In the first example, the ">" relational operator is followed by the numerical value "8000" and the unit of measurement microliters / liter (i.e., "μL / L").

[0118] The first exemplary laboratory rule corresponding to the example numbered above can be as follows:

[0119] IF (result > 10 ml / l) THEN (flag a specified pathology)

[0120] A first exemplary laboratory rule can be used to test for the presence of a specified pathology based on a condition that the result is greater than 10 ml / l. In the above laboratory rule, the condition is "result > 10 ml / l", and the action is "mark specified pathology". This condition includes a reference value, i.e., 10 ml / l. The first exemplary laboratory rule can correspond to the first requirement because the action is performed when the condition is met (i.e., the evaluation is true) for each value within the range to which the laboratory result belongs.

[0121] The assessment of whether the conditions of the first exemplary laboratory rule can be determined by using the first relational result, including converting the first relational result to a reference value, involves identifying the unit of measurement. After conversion, the first relational result is >, 8, ml / L. Therefore, in this case, the range to which the laboratory result belongs is R1 = (8 ml / L, The validity range of the conditions for the first exemplary rule is R² = (10 ml / L, The range R1 is not included in the range R2, and R1 and R2 are not disjoint. Therefore, the conditions are undeterminable in this case. In particular, the actions specified in the main laboratory rules are not taken in this case.

[0122] The assessment of whether the conditions of the first exemplary laboratory rule can be determined by using the second relational result, including converting the second relational result to a reference value, involves identifying the unit of measurement. After conversion, the aforementioned relational result is >, 12, ml / L. Therefore, in this case, the range to which the laboratory result belongs is R3 = (12 ml / L, Range R3 is included in range R2. Therefore, in this case, the condition can be determined. In particular, this condition corresponds to a laboratory result being true, and therefore, action should be taken based on the first exemplary result.

[0123] The assessment of whether the conditions of the first exemplary laboratory rule can be determined by using the third relation result, including converting the third relation result to a reference value, involves identifying the unit of measurement. After conversion, the aforementioned relation result is <, 8, ml / L. Therefore, in this case, the range to which the laboratory result belongs is R4=( (8 ml / L). Ranges R4 and R2 do not intersect. Therefore, the condition can be determined in this case. In particular, this condition corresponds to a false laboratory result, and according to the first exemplary rule, no action should be taken.

[0124] The assessment of whether the conditions of the first exemplary laboratory rule can be determined by using the fourth relation result, including converting the fourth relation result to a reference value, involves identifying the unit of measurement. After conversion, the above relation result is <, 12, ml / L. Therefore, in this case, the range to which the laboratory result belongs is R5=( (12 ml / L). Range R5 is not included in range R2, and R5 and R2 are not mutually exclusive. Therefore, the conditions are undetermined in this case. In particular, the actions specified in the main laboratory rules are not taken in this case.

[0125] The second exemplary laboratory rules are as follows:

[0126] (Mark a certain pathology) EXCEPT IF (result < 10 ml / l)

[0127] The second exemplary laboratory rule includes the action of "labeling a certain pathological condition" and the condition of "result <10 ml / l". Given the "EXCEPT IF" expression, the condition of "result <10 ml / l" in the above second exemplary laboratory rule can be referred to as an "exception condition".

[0128] For the first relational outcome, the exception condition for the second exemplary laboratory rule is undetermined. Therefore, the action of marking a specific pathological suspicion (i.e., the marking action) will not occur. For the second relational outcome, the exception condition is not met, and the marking action is taken. For the third relational outcome, the exception condition is met, and no marking action is taken. For the fourth relational outcome, the exception condition for the second exemplary laboratory rule is undetermined, and the marking action will not occur.

[0129] The third exemplary laboratory rules are as follows:

[0130] IF (result < 100 ml / l) THEN (result is automatically accepted)

[0131] Therefore, if the condition “result < 100 ml / l” is determined and the determined result of the condition is true (e.g., 1 instead of 0), the computing device can cause one or more actions to be taken, one or more of which include automatically accepting the laboratory result.

[0132] For example, if the conditions are not determined, the method further includes one or more of the following:

[0133] -The conditions for notifying users are uncertain.

[0134] - To store information in a computer-readable medium under specified conditions that cannot be determined.

[0135] If the conditions are uncertain, it may be because laboratory rules were not applied.

[0136] Alternatively, if conditions are uncertain, the first clinical test may be performed on a second laboratory instrument using a different methodology.

[0137] In some examples, causing one or more actions to be taken includes initiating the taking of one or more actions. Initiating the taking of one or more actions may include sending an instruction to laboratory instrument specifying that one or more actions should be taken. In particular, the laboratory instrument is configured to receive the instruction, access the information included in the instruction, and follow the instruction to take one or more actions.

[0138] For example, causing one or more actions to be performed includes providing instructions to laboratory instruments to perform one or more actions. Exemplarily, a computer device may generate instructions for one or more instrument components of a laboratory instrument. For example, the instructions specify that one or more actions should be performed, and one or more instrument components are configured to receive the instructions, access information included in the instructions, and follow the instructions to perform one or more actions.

[0139] In particular, making one or more actions include, for example, taking one or more actions by laboratory instruments.

[0140] The method may further include receiving biological samples.

[0141] This method may further include performing a first clinical test.

[0142] According to a second aspect, a data processing system is provided. The data processing system includes means for performing the methods described above. The data processing system can be included in a laboratory analyzer or an automated laboratory system.

[0143] According to a third aspect, a laboratory instrument including a data processing system is provided. The laboratory instrument can be configured to receive biological samples and / or perform a first clinical test.

[0144] According to the fourth aspect, a computer program is provided. The computer program can be implemented as part of a computer program product. The computer program includes instructions that, when executed by a computer, cause the computer to perform the methods described above.

[0145] According to a fifth aspect, a computer-readable medium is provided. The computer-readable medium includes instructions that, when executed by a computer, cause the computer to perform the methods described above.

[0146] The subject matter described in this disclosure can be implemented as a method or on a device, and may be implemented as one or more computer programs (e.g., computer program products).

[0147] Such a computer program can cause a data processing device to perform one or more operations described in this disclosure.

[0148] The subject matter described in this disclosure can be implemented in data signals or on a machine-readable medium, wherein the medium is embodied in one or more information carriers such as CD-ROM, DVD-ROM, semiconductor memory, or hard disk. In particular, the disclosed subject matter can be tangibly embodied in a non-transitory machine (i.e., computer) readable medium.

[0149] Furthermore, the subjects described in this disclosure can be implemented as a system including a processor and memory coupled to the processor. The memory can encode one or more programs to cause the processor to execute one or more methods described in this application. Other subjects described in this disclosure can be implemented using various machines.

[0150] Details of one or more implementations are set forth in the exemplary drawings and description below. Other features will be apparent from the specification, drawings, and claims. Attached Figure Description

[0151] Figure 1 A computer 100 and an automated laboratory system (ALS) 200 that can be used in some implementations are shown.

[0152] Figure 2 A flowchart is shown, illustrating the steps of a method according to some embodiments.

[0153] Figure 3 An example is shown illustrating the range of reliability of laboratory results based on a first clinical test and the first clinical test performed by laboratory instruments.

[0154] Figure 4 Another example is shown.

[0155] Figure 5 Another example is shown.

[0156] Figure 6 Another example is shown.

[0157] Figure 7 Another example is shown.

[0158] Figure 8 Another example is shown.

[0159] Figure 9 Another example is shown.

[0160] Figure 10 Another example is shown. Detailed Implementation

[0161] The examples will be described in detail below with reference to the accompanying drawings. Various modifications can be made to the examples. In particular, one or more elements of one example can be combined and used in other examples to form new examples.

[0162] Figure 1 A computer 100 and an automated laboratory system (ALS) 200, which may be used in some embodiments, are illustrated. The computer 100 and the automated laboratory system 200 may be part of a laboratory. The computer 100 may include an input / output (I / O) interface 111, a processor 112, memory 113, and a network interface controller 114. One or more peripheral (input or output) devices may be able to connect to the input / output interface 111. Peripheral input devices may include one or more of the following: a computer keyboard and / or a pointing device such as a mouse. Peripheral output devices may include one or more of the following: a terminal, a printer, a disk drive or other storage device, and a video monitor. The processor 112 may include a central processing unit (CPU) and / or a graphics processing unit (GPU), each having one or more processing cores. The memory 113 may include main memory (e.g., random access memory (RAM), read-only memory (ROM), or flash memory) and / or secondary memory (e.g., a solid-state drive or a hard disk drive).

[0163] Network interface controller 114 may be connected to computer network 12. ALS 200 may also be connected to computer network 12. In some cases, computer 100 may be included in ALS 200 (i.e., may be part of ALS 200). ALS 200 may also be referred to as laboratory instrument or automated laboratory instrument. ALS 200 may include immunoassay laboratory instruments 210a, 210b, and 220a and 220b. For example, immunoassay laboratory instruments 210a and 210b are first-type immunoassay instruments, and immunoassay laboratory instruments 210a and 210b are second-type immunoassay instruments. Exemplarily, immunoassay laboratory instruments 210a and 210b may have a smaller footprint and lower throughput capacity compared to immunoassay laboratory instruments 220a and 220b.

[0164] The automated laboratory system 200 may include first-type chemical analyzer laboratory instruments 230a and 230b, and second-type chemical analyzer laboratory instruments 240a, 240b, and 240c. The automated laboratory system 200 may also include one or more post-analysis laboratory instruments 250, automation components 260, and one or more pre-analysis laboratory instruments 270. The pre-analysis laboratory instrument 270 may include a loading area (not shown) for loading and identifying sample containers in the ALS 200, a centrifuge (not shown) for centrifuging the sample containers, and / or a cap remover (not shown) for removing the caps from the sample containers.

[0165] Specifically, the automation component 260 includes tracks, belts, and / or tubes configured to move biological samples within the ALS 200. The automation component 260 is capable of transporting containers containing biological samples from one of components 270, 210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250 of the ALS 200 to another component 270, 210a, 210b, 220a, 220b, 230a, 230b, 240a, 240b, 240c, 250 of the ALS 200. For example, the automation component 260 is capable of transporting containers containing biological samples from a pre-analysis laboratory instrument 270 to one of an immunoassay laboratory instrument 210a, 210b, 220a, 220b.

[0166] Figure 2 A flowchart illustrating steps of a method according to some embodiments is shown. This method can be used to control and / or operate a first laboratory instrument. This method can be used to improve the extraction of laboratory, clinical, or diagnostic information from clinical tests.

[0167] In step 310, the method includes obtaining the relational results of a first clinical test via a computing device (e.g., computer 100). The first clinical test is performed on a biological sample in a sample container using a first laboratory instrument. For example, the first clinical test may be used for a quantitative enzymatic ultraviolet (UV) measurement of glucose. The first clinical test may be performed on a 40 μL cerebrospinal fluid (CSF) biological sample combined with approximately 4.5 mL of reagents. The reagents may include an ISE electrolyte buffer (approximately 1.27 mL) and / or an ISE electrolyte reference (approximately 3.23 mL). Furthermore, the biological sample may include a dipotassium or tripotassium (K2 / K3) salt of ethylenediaminetetraacetic acid (EDTA). The measurement of glucose may be used to diagnose and treat a patient's disease or condition, such as diabetes, neonatal hypoglycemia, or insulinoma. The first laboratory instrument may be a chemical analyzer (e.g., one of chemical analyzer laboratory instruments 230a, 230b, 240a, 240b, and 240c). Biological samples are in sample containers (e.g., 10 ml to 15 mL test tubes). These biological samples may be associated with patients receiving treatment at medical facilities (e.g., hospitals).

[0168] In some cases, in step 310, the computing device receives a relational result from a first laboratory instrument configured to assess whether the laboratory result of the first clinical test falls within the reliability range of the first clinical test performed by the first laboratory instrument. If the laboratory result is outside the reliability range, the first laboratory instrument can be configured to construct a relational result. If the laboratory result is greater than the upper bound U... B Then the computing device constructs the following relation result >, U B Conversely, if the laboratory results are below the lower bound L B The computing device then constructs the following relation result: <, L B .

[0169] In some cases, at step 310, the computing device constructs a relational result by receiving a result from the first laboratory instrument and comparing the laboratory result with the upper and lower bounds of the reliability range of the first clinical test. Specifically, the comparison aims to determine whether the result provided by the first laboratory instrument is within the reliability range. If the laboratory result is greater than the upper bound U... B Then the computing device constructs the following relation result >, U B Conversely, if the laboratory results are below the lower bound L B The computing device then constructs the following relation result: <, L B .

[0170] The relational result includes first and second information. The first information is included in the relational operator ">" or "<" and specifies that the laboratory result of the first clinical test is outside the reliability range of the first clinical test performed by laboratory instruments. Furthermore, the relational operator ">" specifies that the laboratory result is greater than the upper bound U. B Furthermore, the relational operator "<" specifies that the laboratory result is less than the lower bound L. B Specifically, the second information in the relational result specifies the value of the upper or lower bound of the reliability range.

[0171] In the first example, the reliability range (e.g., analytical measurement range) of a clinical test measuring the concentration of a substance in CSF using a chemical analyzer can be 10 mg / dL to 810 mg / dL. Specifically, the laboratory result of this test can be less than 10 mg / dL. Therefore, the laboratory instrument may indicate that the laboratory result is too low to be measured. Thus, the first information can specify that the laboratory result is outside the reliability range, for example, via the "<" relational operator. In the first example, 10 mg / dL is the lower bound of the reliability range, and 810 mg / dL is the upper bound of the reliability range. Since the laboratory instrument indicates that the glucose concentration in CSF is too low to be measured and the reliability range is 10 mg / dL to 810 mg / dL, the second information can specify "10," i.e., the lower bound of the reliability range. In the first example, the second information also includes the unit "mg / dL". Therefore, according to the example, the relational result including the first and second information includes "<", 10, and "mg / dL".

[0172] In step 320, the computing device assesses whether the conditions of the laboratory rules can be determined using the first information and the second information. Specifically, in step 320, the computing device assesses whether the first information and the second information allow for determining whether the condition is true or false.

[0173] For example, in the first example, the laboratory rules could be as follows:

[0174] IF (result of assessing glucose concentration < 18 mg / dL) THEN (indicates "high risk of bacterial meningitis")

[0175] According to laboratory rules, if the result of assessing the glucose concentration in a biological sample for CSF is less than 18 mg / dL, then the condition "assessment of glucose concentration <18 mg / dL" is met.

[0176] In the first example, the first piece of information (enclosed in the relational operator "<") and the second piece of information (i.e., the upper bound value of 10 and the string "mg / dL" specifying the unit of measurement) indicate that the laboratory result is less than 10 mg / dL. If the result is less than 10 mg / dL, then the result must also be less than 18 mg / dL. Because it can be determined that the condition is met, the condition is deterministic.

[0177] Laboratory rules specify one or more actions to be taken depending on the determined outcome of a condition. In this example, the action includes indicating a high risk of bacterial meningitis. In this case, the action may include one or more of the following: displaying an alert, sending an urgent message from the laboratory to a facility treating a patient associated with the biosample, and marking the relationship outcome as associated with a high risk of bacterial meningitis. Alerts and messages can indicate that a patient is at high risk of bacterial meningitis.

[0178] If the conditions are determined, and based on the determined results, one or more actions are to be taken, the computing device causes one or more actions to be taken (step 330). Specifically, in step 330, the computing device provides the laboratory instrument with an instruction to take at least one of the one or more actions, and / or to take at least one of the one or more actions.

[0179] If the conditions are uncertain, and based on the determined result, do not take one or more actions, or do not take one or more actions specified in the rules.

[0180] In the first example, the conditions are identified and met, and the computing device takes the action specified by the rules. Specifically, the computing device displays an alarm on its video monitor, sends an emergency message to the facility where the patient associated with the biological sample is being treated, and marks the relationship result as a result highly correlated with bacterial meningitis.

[0181] Optionally, if the condition is undetermined, the computing device causes one or more additional actions to be taken (step 340). Specifically, one or more additional actions may include instructing a second laboratory instrument to perform a second clinical test. The second laboratory instrument may be configured to measure the parameters measured by the first laboratory instrument with higher sensitivity, precision, specificity, linearity, and / or accuracy than the first laboratory instrument. In some cases, one or more additional actions may include storing information specifying the undetermined condition in a log file stored in its memory or in a database.

[0182] Figure 3Shows an example of the display of laboratory results based on a first clinical test and the reliability range of the first clinical test performed by a laboratory instrument. In some cases, one or more actions include displaying third information that specifies whether the laboratory result can belong to one or more of a critical range, a warning range, and a normal range based on the first information and the second information. In the example, the relationship result obtained by the computing device is >, 2.5. Additionally, in the example, the laboratory result R of the first clinical test belongs to:

[0183] If R < 1 or R > 4, then it is the critical (red) range;

[0184] If 1 ≤ R > 2 or 3 < R ≤ 4, then it is the warning (yellow) range; and

[0185] If 2 ≤ R ≤ 3, then it is the normal (green) range.

[0186] Specifically, the above critical, warning, and normal ranges can be specified by one or more laboratory rules and the conditions "R < 1 or R > 4", "1 ≤ R > 2 or 3 < R ≤ 4", and "2 ≤ R ≤ 3" can be the conditions of one or more laboratory rules.

[0187] In this example, the first information and the second information indicate that the laboratory result can be within the critical range, the warning range, or the normal range. Therefore, in this example, the third information is included in the black arrow 501 shown, which indicates that it cannot be determined (i.e., at least one condition of one or more laboratory rules cannot be determined) whether the laboratory result is within the normal range, the warning range, or the critical range. The black arrow points to the right (towards 4), indicating that the relationship result includes the ">" relational operator.

[0188] Figure 4 Shows another example of the display of laboratory results based on a first clinical test and the reliability range of the first clinical test performed by a laboratory instrument. This example is different from the previous example in that the relationship result is <, 2.5. In this example, the first information and the second information indicate that the laboratory result can be within the critical range, the warning range, or the normal range. Therefore, in this example, the third information is included in Figure 4 the black arrow 502 shown, which indicates that it cannot be determined (i.e., at least one condition of one or more laboratory rules cannot be determined) whether the laboratory result is within the normal range, the warning range, or the critical range. The black arrow points to the left (towards 1), indicating that the relationship result includes the "<" relational operator.

[0189] Figure 5Another example is shown illustrating the display of the reliability range of the laboratory results based on the first clinical test and the first clinical test performed by the laboratory instrument. This example differs from the previous one in that the relationship result is <, 0.5. Therefore, in this example, the first and second information indicate that the laboratory result is within the critical range, because the second information includes values ​​less than the upper boundary of the critical range (i.e., less than 1), and the first information indicates that the laboratory result is less than the value of the second information. Therefore, the third information specifies that the laboratory result belongs to the critical range and is included in red arrow 701.

[0190] Figure 6 Another example is shown displaying the reliability range of the laboratory results based on the first clinical test and the first clinical test performed by the laboratory instrument. This example differs from the previous one in that the relationship result is >4.5. In this example, the first and second information indicate that the laboratory result is within the critical range because the second information includes a value greater than the lower boundary of the critical range (i.e., greater than 4), and the first information indicates that the laboratory result is greater than the value of the second information. Therefore, the laboratory result is within the critical range, and the red arrow 702 pointing to the right (i.e., away from the lower boundary of the critical range) is shown as its indication.

[0191] Figure 7 Another example is shown displaying the reliability range of a laboratory result based on a first clinical test and the first clinical test performed by a laboratory instrument. This example differs from the previous one in that the relationship result is >, 3.5. The first and second information indicate that the laboratory result falls within the warning or critical range because the second information includes a value greater than the lower boundary of the warning range (i.e., a value greater than 3), and the first information indicates that the laboratory result is greater than the value of the second information. In this example, the third information specifies that the laboratory result may fall within the critical or warning range and is included in the yellow arrow 703 pointing to the right (away from the lower boundary of the warning range).

[0192] Figure 8 Another example is shown displaying the reliability range of the laboratory results based on the first clinical test and the first clinical test performed by the laboratory instrument. This example differs from the previous one in that the relationship result is >, 1.5. The first and second information indicate that the laboratory result falls within the warning or critical range because the second information includes values ​​less than the upper boundary of the warning range (i.e., values ​​less than 2), and the first information indicates that the laboratory result is less than the value of the second information. Therefore, the third information specifies that the laboratory result may fall within the critical or warning range and is included in the yellow arrow 704 pointing to the left (i.e., away from the upper boundary of the warning range).

[0193] Figure 9This is another example of displaying the reliability range of a laboratory result based on a first clinical test and performed by laboratory instruments. In some cases, one or more actions include displaying third information that, based on the first and second information, specifies whether the laboratory result falls within one or more of the warning and normal ranges. In the example, the relational result obtained by the computing device is >, 4.5. Furthermore, in the example, the laboratory result R of the first clinical test belongs to:

[0194] If R < 2, then it is a warning (yellow) range; and

[0195] If R ≥ 2, then it is within the normal (green) range.

[0196] In this example, the first and second information indicate that the laboratory result is within the normal range because the second information includes a value greater than the lower boundary of the normal range (i.e., greater than 2), and the first information indicates that the laboratory result is greater than the value of the second information. Therefore, in this example, the third information specifies that the laboratory result is within the normal range and is included in the green arrow 705 pointing to the right (i.e., away from the lower boundary of the normal range).

[0197] Figure 10 This is yet another example showing the display of the reliability range of the laboratory results based on the first clinical test and the first clinical test performed by the laboratory instrument. This example differs from the previous one in that the relationship result is <, 1.5. Therefore, in this example, the first and second information indicate that the laboratory result is within the warning range, because the second information includes a value less than the upper boundary of the warning range (i.e., less than 2), and the first information indicates that the laboratory result is less than the value of the second information. Therefore, the third information specifies that the laboratory result belongs to the warning range and is included in the yellow arrow 706 pointing to the left.

Claims

1. A method comprising: • The relationship results of the first clinical trial were obtained by computing devices, wherein: - The first clinical test is performed on a biological sample in a sample container using a first laboratory instrument; - The relationship result includes first information and second information, the first information indicating that the laboratory result of the first clinical test is outside the reliability range of the first clinical test performed by the laboratory instrument, and the second information indicating one or more of the upper and lower bounds of the reliability range. • Whether the conditions of the laboratory rules can be determined by the computing device using the first information and the second information, wherein - The laboratory rules specify one or more actions to be taken depending on the determined outcome of the conditions; - To take at least one of the one or more actions on one or more of the biological sample, the sample container, and the relationship outcome, and / or the one or more actions include displaying information about one or more of the biological sample, the sample container, the relationship outcome, and the patient; And, if the conditions can be determined, and one or more actions are to be taken based on the determination of the conditions, then: • The computing device enables the taking of one or more actions.

2. The method according to claim 1, wherein, If the conditions cannot be determined, the method further includes causing one or more other actions to be taken.

3. The method according to claim 2, wherein, The one or more other actions include performing a second clinical test.

4. The method according to claim 3, wherein, The first clinical test includes measuring a first clinical parameter using a first methodology, and the second clinical test includes measuring the first clinical parameter using a second methodology.

5. The method according to any one of claims 2 to 4, wherein, Making the one or more other actions include making the second laboratory instrument perform the second clinical test.

6. The method according to any one of claims 2 to 5, wherein, The one or more other actions include notifying the user that the condition cannot be determined and / or storing information specifying that the condition cannot be determined in a computer-readable medium.

7. The method according to any one of the preceding claims, wherein, The one or more actions include rerunning the first clinical test and / or performing a third clinical test.

8. The method according to any one of the preceding claims, wherein, The one or more actions include displaying third information, which, based on the first and second information, specifies whether the laboratory result falls within one or more of a critical range, a warning range, or a normal range, wherein the critical range, the warning range, and the normal range are associated with the patient's underlying condition.

9. The method according to any one of the preceding claims, wherein, The second information specifies one or more of the measurement units of the upper bound of the reliability range and the measurement units of the lower bound of the reliability range.

10. The method according to any one of the preceding claims, wherein, Making the one or more actions take include providing instructions to the laboratory instrument to take the one or more actions.

11. The method according to any one of the preceding claims, wherein, Making taking the one or more actions include taking the one or more actions.

12. A data processing system comprising means for performing the method according to any one of claims 1 to 11.

13. A laboratory instrument comprising the data processing system according to claim 12, wherein, The laboratory instrument is configured to receive the biological sample and / or perform the first clinical test.

14. A computer program comprising instructions that, when executed by a computer, cause the computer to perform the method according to any one of claims 1 to 11.

15. A computer-readable medium comprising instructions that, when executed by a computer, cause the computer to perform the method according to any one of claims 1 to 11.

Images