In vitro diagnostic equipment, testing lines, and abnormality detection methods

Abstract

An in vitro diagnostic device (06), an inspection line, and an abnormality detection method, comprising: a sample conveying device (01) transporting a sample rack carrying a sample and delivering the sample to a sample aspiration position for a sample aspiration test; a sample identification device (02) detecting identification information of the sample and sending the identification information to a control device (03); the control device (03) obtaining the test result of the sample, determining whether there are at least two test results that meet a set condition within a preset range, and if so, sending abnormality prompt information to an output device (04), which outputs the abnormality prompt information; wherein the set condition includes that the test results are consistent and the corresponding identification information is different. Abnormality detection is achieved, and a user can be promptly alerted when an abnormality occurs, thereby avoiding clinical risks caused by mismatch between identification information and test results.

Description

Technical Field

[0001] The present invention relates to the technical field of in vitro diagnosis, and in particular to an in vitro diagnostic device, a test line and an abnormality detection method. Background Art

[0002] In vitro diagnostic equipment such as hematology analyzers, biochemistry analyzers and immunoassay analyzers are a type of analytical instrument with high sensitivity and specificity. They are often used in clinical laboratories to detect various analytical indicators of blood, urine or other body fluids.

[0003] During clinical testing, in vitro diagnostic equipment can match samples with corresponding test results based on the identification information on the test tube. However, during actual testing, errors in tube identification reading or other reasons may occur, resulting in mismatches between the tube identification information and the test results, which can pose significant clinical risks. SUMMARY OF THE INVENTION

[0005] Technical issues

[0006] The present invention mainly provides an in vitro diagnostic device, an inspection pipeline and an abnormality detection method to solve the clinical risk problem caused by the mismatch between test tube identification information and test results.

[0007] Solution to the problem

[0008] Technical Solutions

[0009] According to a first aspect, one embodiment provides an in vitro diagnostic apparatus comprising a sample transport device, a sample identification device, a control device, and an output device;

[0010] The sample transport device is used to transport the sample rack carrying the sample and deliver the sample to the sample suction position for sample suction testing;

[0011] The sample identification device is connected to the control device and is used to detect identification information of the sample and send the identification information to the control device;

[0012] The control device is used to obtain the test results of the sample, determine whether there are at least two test results that meet the set conditions within a preset range, and if so, send an abnormal prompt information to the output device, wherein the set conditions include that the test results are consistent and the corresponding identification information is different;

[0013] The output device is used to output the abnormal prompt information.

[0014] According to a second aspect, an embodiment provides a testing pipeline, characterized in that it includes a sample transport device, a sample identification device, a control device, an output device, and at least one in vitro diagnostic device;

[0015] The sample transport device is used to transport the sample rack carrying the sample to the in vitro diagnostic device;

[0016] The sample identification device is connected to the control device and is used to detect identification information of the sample and send the identification information to the control device;

[0017] The in vitro diagnostic device is signal-connected to the control device for testing the sample and outputting the test results to the control device;

[0018] The control device is used to determine whether there are at least two test results that meet the set conditions within a preset range, and if so, send an abnormal prompt information to the output device, wherein the set conditions include that the test results are consistent and the corresponding identification information is different;

[0019] The output device is used to output the abnormal prompt information.

[0020] According to the third aspect, an embodiment provides an anomaly detection method, including:

[0021] Obtain sample identification information and test results;

[0022] Determine whether there are at least two test results within a preset range that meet a set condition, wherein the set condition includes that the test results are consistent and the corresponding identification information is different;

[0023] If it exists, an exception prompt message will be output.

[0024] According to a fourth aspect, an embodiment provides a computer-readable storage medium, comprising a program, wherein the program can be executed by a processor to implement the method described above.

[0025] Advantageous Effects of the Invention

[0026] Beneficial effects

[0027] According to the in vitro diagnostic equipment, inspection pipeline and abnormality detection method of the above-mentioned embodiments, since abnormal prompt information can be output when it is determined that there are at least two test results that are consistent and have different corresponding identification information within a preset range, abnormality detection is achieved, and the user can be reminded in time when an abnormality occurs, thereby avoiding the clinical risks brought about by the mismatch between identification information and test results.

[0028] Brief description of the accompanying drawings BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 A schematic structural diagram of an in vitro diagnostic device provided by an embodiment of the present invention;

[0030] Figure 2A flowchart of an anomaly detection method provided by an embodiment of the present invention;

[0031] Figure 3 A flowchart of a specific anomaly detection method provided by an embodiment of the present invention;

[0032] Figure 4 A schematic diagram of a preset range customization interface according to an embodiment of the present invention;

[0033] Figure 5 A schematic diagram of a similarity customization interface according to an embodiment of the present invention;

[0034] Figure 6 A schematic diagram of the structure of an inspection pipeline provided by an embodiment of the present invention.

[0035] Invention Embodiments

[0036] Modes for Carrying Out the Invention

[0037] The present invention will be further described in detail below by means of specific embodiments in conjunction with the accompanying drawings. Similar elements in different embodiments are numbered with associated similar elements. In the following embodiments, many detailed descriptions are provided to enable the present application to be better understood. However, those skilled in the art will readily appreciate that some of the features may be omitted in different circumstances, or may be replaced by other elements, materials, or methods. In some cases, some operations related to the present application are not shown or described in the specification. This is to avoid the core portion of the present application being overwhelmed by excessive descriptions, and for those skilled in the art, it is not necessary to describe these related operations in detail. They will fully understand the related operations based on the description in the specification and the general technical knowledge in the art.

[0038] In addition, the features, operations, or characteristics described in the specification may be combined in any appropriate manner to form various embodiments. Furthermore, the steps or actions in the method description may be reordered or adjusted in a manner readily apparent to those skilled in the art. Therefore, the various sequences in the specification and drawings are provided solely for the purpose of clearly describing a particular embodiment and are not intended to be mandatory, unless otherwise specified.

[0039] Unless otherwise specified, the terms “connection” and “coupling” mentioned in this application include direct and indirect connections (couplings).

[0040] In clinical testing, in vitro diagnostic equipment is often used to detect various analytical indicators in blood, urine, or other body fluids. Taking a blood analyzer as an example, in order to distinguish blood samples, the test tubes containing blood are often affixed with barcodes. When a blood sample is tested, the test tube rack holding the blood tubes passes through a barcode scanner equipped on the sampling device. The barcode scanner scans the barcodes on the test tube rack one by one and provides the obtained barcode information to the system. The system then matches the test results of the blood sample with the corresponding barcode information one by one. Only when the sample and the test result are correctly matched can the correct report be issued to the patient.

[0041] In actual sample testing, for a blood analyzer or an inspection pipeline that includes at least one blood analyzer, repeated testing of the same test tube may occur in some cases. For example, a user may question the test result of a sample and proactively find the relevant test tube for repeated testing. Another example is when a blood analyzer malfunctions due to an abnormality in the sample injection device or a stuck test tube rack, and the blood analyzer repeatedly measures the same test tube. Another example is when a user adjusts the position of the test tube during the sample test, which may result in repeated testing of the same test tube. When repeatedly testing the same test tube, if the barcode is blurred or the barcode scanner reads an error code, it is very likely that multiple barcodes will actually match the same test result, resulting in a mismatch between the test tube barcode and the test result, which will bring huge clinical risks.

[0042] In view of the above problems, the solution of the present invention is proposed. In an embodiment of the present invention, if at least two test results are found to be consistent but with different corresponding identification information within a preset range, an abnormal prompt message is output to the user.

[0043] Please refer to Figure 1, is a schematic structural diagram of an in vitro diagnostic device provided by an embodiment of the present invention, the in vitro diagnostic device includes a sample conveying device 01, a sample identification device 02, a control device 03 and an output device 04. The sample conveying device 01 includes a sample feeding mechanism 11 and a sample recovery mechanism 12, etc., which can transport the sample rack carrying the sample and deliver the sample to the sample aspiration position for sample aspiration testing. The sample feeding mechanism 11 of the sample conveying device 01 is equipped with a sample identification device 02, and the sample identification device 02 is connected to the control device 03. When the sample conveying device 01 transports the sample rack carrying the sample through the sample identification device 02 via the sample feeding mechanism 11, the sample identification device 02 detects the identification information of the sample and sends the obtained identification information to the control device 03. The sample identification device 02 can be, for example, a scanner, a camera, a card reader or a radio frequency identification device, etc., and the identification information of the sample can be, for example, a barcode, a QR code or an electronic tag. The control device 03 controls the sample feeding mechanism 11 of the sample conveying device 01 to transfer the sample rack to deliver the sample to the sample suction position, and then performs a sample suction test on the sample at the sample suction position. After completing the sample test, the sample recovery mechanism 12 of the sample conveying device 01 is controlled to transfer the tested sample to the recovery area for recovery.

[0044] In an embodiment of the present invention, control device 03 is configured to obtain the test results of a sample and determine whether there are at least two test results that meet set conditions within a preset range. If so, control device 03 sends an abnormality prompt message to output device 04, which then outputs the abnormality prompt message. The set conditions include that the test results are consistent and the corresponding identification information is different. The preset range includes a preset time range or a preset number of samples. If control device 03 determines that there are no test results that meet the set conditions within the preset range, it saves the test results of the sample.

[0045] In actual application, the in vitro diagnostic device further includes an input device 05, which is connected to the control device 03 and is used to obtain user input operations. The input device 05 may include, for example, a keyboard, a mouse and / or a touch screen.

[0046] In one embodiment, the preset range can be set by the user. Specifically, the user can send an instruction to define the preset range to the control device 03 through the input device 05. When the control device 03 receives the instruction to define the preset range, it controls the display unit of the output device 04 to display the preset range customization interface. The preset range customization interface includes a setting menu for customizing the preset range, such as a menu for setting a preset time range or a menu for setting a preset number of samples. The input device 05 obtains the user's custom operation in the preset range customization interface and generates a corresponding operation instruction, and then sends the operation instruction to the control device 03. The control device 03 determines the preset range according to the operation instruction, that is, determines the preset range according to the user's custom operation in the preset range customization interface.

[0047] Based on the above-mentioned in vitro diagnostic device, the embodiment of the present invention also provides an abnormality detection method, the flow chart of which is shown in FIG. Figure 2 , the method may include the following steps:

[0048] Step 101: Obtain sample identification information and test results.

[0049] During the sample testing process, the sample transport device 01 transports the sample rack carrying the sample through the sample identification device 02 via the sample introduction mechanism 11. At this point, the sample identification device 02 detects the sample's identification information and transmits it to the control device 03. After the sample introduction mechanism 11 transports the sample to the sample aspiration position, the control device 03 controls the test unit of the in vitro diagnostic device to aspirate and test the sample at the sample aspiration position, obtaining the sample's test results.

[0050] Step 102: Determine whether there are at least two test results within a preset range that meet the test result consistency requirements and have different corresponding identification information.

[0051] After obtaining the sample identification information and the corresponding test results, the control device 03 determines whether there are at least two test results within a preset range that meet a set condition, wherein the set condition includes that the test results are consistent and the corresponding identification information is different. If so, step 103 is executed; otherwise, step 104 is executed. The preset range includes a preset time range or a preset number of samples. This preset range can be pre-set or customized by the user based on actual application conditions.

[0052] In a specific embodiment, the control device 03 can obtain all test results within a preset time range or all test results in a preset number of samples every preset time range or a preset number of samples, and determine whether there are at least two test results among these test results that meet the set conditions.

[0053] In another specific embodiment, each time a current test result is obtained, the control device 03 may obtain other test results within a preset time range or other test results from a preset number of samples, and determine whether there is at least one test result among the test results of the other tested samples that is consistent with the current test result and has different corresponding identification information. The time when the current test result is obtained is within the preset time range, and the preset number of samples includes the sample corresponding to the current test result.

[0054] Step 103: Output abnormal prompt information.

[0055] If the control device 03 determines that there are at least two test results within the preset range that meet the requirements of the test results consistency and have different corresponding identification information, it sends an abnormal prompt information to the output device 04, and the abnormal prompt information is output through the output device 04. For example, the abnormal prompt information can be output in the form of an interface information prompt, an alarm sound, and / or an alarm indicator light, so as to prompt the user that an abnormality has occurred in the test. When the abnormal prompt information is output in the form of an interface information prompt, for example, the test results and / or identification information that are consistent but have different corresponding identification information can be highlighted in the interface. The cause of the abnormality may be, for example, an abnormality in the sample injection mechanism, a barcode printing error, a barcode reading error, a sample swap in the middle, a sample placement error, etc. After viewing the abnormal prompt information, the user can take abnormal handling measures in a timely manner to eliminate possible abnormal causes, eliminate the risk of mismatch between identification information and test results, and avoid issuing an erroneous test report.

[0056] Step 104: Save the test results of the sample.

[0057] If the control device 03 determines that there is no test result that meets the set conditions within the preset range, it saves the test result of the sample.

[0058] The abnormality detection method provided in this embodiment can output abnormal prompt information when there are at least two test results that meet the consistency of test results and have different corresponding identification information in samples within a preset time range or a preset number of samples, thereby realizing abnormality detection in sample testing and being able to promptly prompt the user when an abnormality occurs, so that the user can take abnormality handling measures in time after viewing the abnormal prompt information, thereby eliminating the clinical risks brought about by the mismatch between identification information and test results.

[0059] In order to more clearly reflect the purpose of the present invention, further examples are given based on the above embodiments. Figure 3 , which is a flowchart of a specific anomaly detection method provided by an embodiment of the present invention, is described by taking the preset range being a preset time range as an example. The method may include the following steps:

[0060] Step 201: Customize the preset time range.

[0061] The in vitro diagnostic device provides the user with the function of customizing a preset range. Before testing a sample, the user can customize the preset range. Specifically, the user sends an instruction to define the preset range to the control device 03 through the input device 05. When the control device 03 receives the instruction to define the preset range, it controls the display unit of the output device 04 to display a preset range customization interface. The preset range customization interface includes a setting menu for customizing the preset range. The user can perform a custom operation in the preset range customization interface through the input device 05, and the control device 03 determines the preset range based on the custom operation. In this embodiment, the preset range is a preset time range, and a setting menu for customizing the preset time range is provided in the preset range customization interface.

[0062] In this application, the preset range may include a preset time range or a preset number of samples. Preferably, a setting menu for customizing the preset time range and the preset number of samples may be provided in the preset range customization interface, and the user may select one of them for setting. For example, Figure 4 A schematic diagram of a preset range customization interface is shown. This interface provides a menu for setting a preset time range and a menu for setting a preset number of samples. Selecting either menu item makes it editable, allowing the user to perform related customization operations. In this embodiment, the user can customize the preset time range by selecting the "Preset Time Range" checkbox. This allows customization, such as setting the preset time range to 2 hours.

[0063] Step 202: Obtain identification information and test results of the sample.

[0064] During the process of testing the sample, the control device 03 obtains the identification information and test results of the sample. The specific process can be found in the above step 101.

[0065] Step 203: Obtain other test results within a preset time range.

[0066] After each current test result is obtained, control device 03 obtains other test results within a preset time range, where the time when the current test result was obtained is within the preset time range. For example, control device 03 obtains a current test result, such as the test result for sample 40, at 10:00 AM in step 202. Assuming the user-defined preset time range of 2 hours in step 201 is 2 hours, control device 03 obtains other test results within a 2-hour period before (including) 10:00 AM, i.e., it obtains all test results between 8:00 AM and 10:00 AM, excluding the current test result for sample 40.

[0067] Step 204: Determine whether there is at least one test result among other test results that is consistent with the current test result and has different corresponding identification information.

[0068] After acquiring other test results within the preset time range, the control device 03 determines whether there is at least one test result among the other test results that is consistent with the current test result and has different corresponding identification information. If so, step 205 is executed; otherwise, step 206 is executed.

[0069] Specifically, after the control device 03 obtains other test results within the preset time range, it can calculate the similarity between the current test result and each other test result, and then determine whether the similarity is greater than or equal to the similarity threshold. If the similarity is greater than or equal to the similarity threshold, it is determined that the current test result is consistent with the other test results, so that it can be determined whether the current test result is consistent with the other test results.

[0070] When the control device 03 calculates the similarity between two test results, the following method may be used: calculating the deviation rate of the same test item in the two test results, and then calculating the percentage of the number of deviation rates that meet a preset threshold condition to the total number of deviation rates, to obtain the similarity between the two test results. The deviation rate includes the absolute value of the deviation, the percentage of the deviation, and / or the percentage of the test item results. The corresponding preset threshold conditions may be, for example, the absolute value of the deviation is less than or equal to a preset first threshold, the percentage of the deviation is less than or equal to a preset second threshold, and / or the percentage of the test item results is greater than or equal to a preset third threshold.

[0071] Take a blood analyzer, for example, which can be used to perform routine blood tests. For example, a routine blood test result (test result) for a sample includes 16 test items (or test parameters), such as white blood cell count, red blood cell count, neutrophil percentage, and hemoglobin. Each test item has a corresponding measurement value. Assuming another test result also includes these 16 test items, the measurement values of the same test item in the two test results are compared, and their deviation rate is calculated, such as the absolute value of the deviation. If the absolute value of the deviation is less than or equal to a preset threshold (for example, the absolute value of the deviation is less than or equal to 5%), the measurement values of the test item in the two test results are considered consistent. Assuming the similarity threshold is 14 / 16 = 87.5%, if the measurement values of at least 14 of the 16 test items in the two test results are exactly the same or consistent (in this case, the similarity between the two test results is greater than or equal to 87.5%), the two test results are considered consistent.

[0072] For example, if the result values of the 16 test items or detection parameters of a test result are different from the corresponding result values of another test result, but the deviation rate of the corresponding result values is less than or equal to the preset threshold (for example, the deviation rate is less than 5%), the two test results can also be considered consistent.

[0073] In actual applications, the similarity threshold and / or preset threshold condition described above can be a pre-set default value or can be set by the user. Specifically, the user can send a similarity customization instruction to the control device 03 via the input device 05. Upon receiving the instruction, the control device 03 controls the display unit of the output device 04 to display a similarity customization interface, which includes a setting menu for customizing the similarity threshold and / or preset threshold condition. The input device 04 obtains the user's customized operations in the similarity customization interface and determines the similarity threshold and / or preset threshold condition based on the user's customized operations in the similarity customization interface via the input device.

[0074] For example, Figure 5A schematic diagram of a similarity customization interface is shown. This interface can include a setting menu for similarity thresholds and preset threshold conditions. When the corresponding checkbox is selected, the corresponding content can be set. After confirmation, the control device 03 will operate according to the set content. If not all are selected, for example, only "Similarity Threshold" is selected and "Set Preset Threshold Condition" is not selected, the control device 03 will determine the similarity threshold based on the user's customized operation, and the preset threshold condition will use the default value. In the "Set Preset Threshold Condition" menu, the user can select the deviation rate type to be used through the "Deviation Rate Type" drop-down menu. For example, it can be an absolute deviation value, a deviation percentage, and / or a percentage of the test item result, and then set the corresponding preset threshold condition in the "Preset Threshold Condition". For example, the user selects "Similarity Threshold" and "Set Preset Threshold Condition" in the interface, sets the similarity threshold to "90%", selects the deviation rate type as "Absolute Value of Deviation", and sets the corresponding preset threshold condition to "≤5%". After confirmation, during the sample test process, the control device 03 obtains a current test result, obtains other test results within the preset time range, and compares the current test result with other test results. When the absolute value of the deviation of the result value of the same test item in the two test results is less than or equal to 5%, it is considered that the result value of the test item is consistent. If the result values of at least 90% of the test items in the test results of the two test results are consistent, it is judged that the two test results are consistent.

[0075] The above method can be used to determine whether the current test result is consistent with other test results. It should be noted that this is only an example and is not intended to limit the present invention. In actual applications, other algorithms can also be used to determine whether two test results are consistent.

[0076] Step 205: Output abnormal prompt information.

[0077] When the control device 03 determines whether there is at least one test result among the other test results that is consistent with the current test result and has different corresponding identification information, it sends an abnormal prompt information to the output device 04 and controls the output device 04 to output the abnormal prompt information. The specific output method and effect can be seen in step 103.

[0078] In actual applications, the control device 03 can automatically execute exception handling strategies while sending exception prompt information to the output device 04, such as automatically stopping sampling, automatically stopping the current sample test, terminating sample analysis, etc., so as to timely avoid the misalignment of the test results of subsequent samples and the identification information of the samples due to the current test abnormality.

[0079] The exception handling strategy can be configured in advance by the user. For example, before testing the sample, the user can send an operation instruction for configuring the exception handling strategy to the control device 03 through the input device 05. When the control device 03 receives the instruction, it controls the display unit of the output device 04 to display a configuration menu for configuring the exception handling strategy, and determines the exception handling strategy according to the configuration operation of the user in the configuration menu. When the control device 03 outputs the exception prompt information, it also performs exception handling according to the determined exception handling strategy. The exception handling strategy can include, for example, stopping the injection and / or terminating the sample analysis. For example, the output device 04 can display the options of these exception handling strategies on its display interface. When at least one exception handling strategy is selected, the selected exception handling strategy is the determined exception handling strategy.

[0080] In actual applications, when the control device 03 sends the abnormality prompt information to the output device 04, the user may also confirm whether to stop the current sample test. Specifically, when the control device 03 sends the abnormality prompt information to the output device 04, it can simultaneously control the display unit of the output device 04 to display a prompt box to stop the sample test. When the user confirms the operation of stopping the sample test in the prompt box through the input device 05, the current sample test is stopped.

[0081] Step 206: Save the current test result.

[0082] If the control device 03 determines that there is no test result among other test results that is consistent with the current test result and has different corresponding identification information, the current test result is saved.

[0083] The anomaly detection method provided in this embodiment compares the current test result with other test results within a preset time range after each current test result is obtained. When it is determined that there is at least one test result among the other test results that is consistent with the current test result and has different corresponding identification information, an abnormal prompt message is output to the user to prompt the user that an abnormality has occurred in the test. After viewing the abnormal prompt message, the user can take abnormal handling measures in a timely manner to eliminate possible abnormal causes, eliminate the risk of mismatch between identification information and test results, and avoid issuing erroneous detection reports. The preset time range can be customized by the user. Furthermore, when using the method of this embodiment to determine whether the test results are consistent, the user can customize the similarity threshold and / or preset threshold conditions to meet the needs of different application scenarios. The operation is flexible and practical.

[0084] The above embodiment method is described by taking the preset range as a preset time range as an example. In another embodiment, the preset range can also be a preset number of samples. In this case, the preset range customization interface provides the user with a setting menu for customizing the preset number of samples, or can be as follows Figure 4 As shown, a setting menu for a preset time range and a setting menu for a preset number of samples are provided, allowing the user to select a setting menu for customization. After each current test result is obtained, the control device 03 obtains other test results from the preset number of samples and then executes steps 204 to 206. The preset number of samples includes the sample corresponding to the current test result.

[0085] For example, the user Figure 4 In the preset range customization interface shown, the "Preset Sample Number" checkbox is selected and the number is set to 10. Then, after the control device 03 obtains each current test result, it obtains the 9 test results before the current test result, and then determines whether there is at least one test result among these 9 test results that is consistent with the current test result and has different corresponding identification information. If so, an abnormal prompt information is sent to the output device 04.

[0086] In the above embodiment, after the control device 03 obtains a current test result, it compares the current test result with other test results within a preset time range, or compares the current test result with other test results in a preset number of samples. In actual application, the control device 03 can also perform a comparison and judgment every preset time range or every preset number of samples. For example, the user Figure 4 In the preset range customization interface shown, the checkbox of "Preset Time Range" is selected and its range is set to 2 hours. During the sample test process, the control device 03 obtains all the test results obtained within these 2 hours every 2 hours, and then determines whether there are at least two test results that are consistent but have different corresponding identification information. If so, an abnormal prompt message is sent to the output device 04. For example, the user Figure 4 In the preset range customization interface shown, the "Preset Sample Number" checkbox is selected and the number is set to 10. During the sample testing process, the control device 03 tests 10 samples each time, obtains all the test results of these 10 samples, and then determines whether there are at least two test results among these test results that are consistent and have different corresponding identification information. If so, an abnormal prompt message is sent to the output device 04.

[0087] Based on the same inventive concept, the methods of the above embodiments can also be applied to a test line containing at least one in vitro diagnostic device. Figure 6, is a schematic diagram of the structure of a testing pipeline provided by an embodiment of the present invention. The testing pipeline includes a sample conveyor 01, a sample identification device 02, a control device 03, an output device 04, and at least one in vitro diagnostic device 06. Sample conveyor 01 transfers a sample rack carrying a sample to in vitro diagnostic device 06 according to a transfer path. In vitro diagnostic device 06 is signal-connected to control device 03 and is configured to test the sample and output the test results to control device 03. While transporting the sample, sample conveyor 01 passes through sample identification device 02, which is connected to control device 03. As the sample passes through sample identification device 02, sample identification device 02 detects the sample's identification information and transmits it to control device 03. Control device 03 then determines whether there are at least two test results within a preset range that meet set conditions. If so, it transmits an abnormality notification message to output device 04, instructing output device 04 to output the abnormality notification message. The set conditions include consistent test results and different corresponding identification information. The preset range may include a preset time range or a preset number of samples.

[0088] Based on the inventive concept of this application, for the same batch of samples, if the sample changes position midway, a prompt can be given. For example, the user needs to repeat the measurement of the sample on sample rack No. 1, such as based on the need for re-examination. Assuming that the in vitro diagnostic device scans the sample at the first hole position (which can be recorded as position 1-1) of sample rack No. 1 for the first time, the sample identification information is "123", and when the sample at position 1-1 is scanned for the second time, the identification information obtained becomes "234", then the user can be reminded that the sample may have changed position midway, and the sample test results and the sample identification information may be misplaced. Because, for the same batch of samples tested, the sample position should always remain unchanged, unless the next batch of samples reuses the original sample rack, the samples at the same position may be different.

[0089] This document is described with reference to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope of this document. For example, the various operational steps and components used to perform the operational steps may be implemented in different ways (e.g., one or more steps may be deleted, modified, or incorporated into other steps) depending on the specific application or any number of cost functions associated with the operation of the system.

[0090] Furthermore, as will be appreciated by those skilled in the art, the principles herein may be embodied in a computer program product on a computer-readable storage medium pre-installed with computer-readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu-ray discs, etc.), flash memory, and / or the like. These computer program instructions may be loaded onto a general-purpose computer, a special-purpose computer, or other programmable data processing device to form a machine, such that the instructions, when executed on the computer or other programmable data processing device, generate a device that implements a specified function. These computer program instructions may also be stored in a computer-readable memory, which may instruct the computer or other programmable data processing device to operate in a specific manner, such that the instructions stored in the computer-readable memory may form an article of manufacture, including a device that implements a specified function. The computer program instructions may also be loaded onto a computer or other programmable data processing device, causing the computer or other programmable device to execute a series of operational steps to produce a computer-implemented process, such that the instructions, when executed on the computer or other programmable device, provide the steps for implementing the specified function.

[0091] Although the principles of this invention have been shown in various embodiments, many modifications of structure, arrangement, proportion, elements, materials and components that are particularly suitable for specific environments and operational requirements can be used without departing from the principles and scope of this invention. The above modifications and other changes or amendments are intended to be included within the scope of this invention.

[0092] The foregoing detailed description has been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, the present disclosure will be considered in an illustrative rather than a restrictive sense, and all such modifications will be included within its scope. Similarly, the advantages, other advantages and solutions to the problems of the various embodiments have been described above. However, the benefits, advantages, solutions to the problems and any elements that can produce these, or make them more specific, should not be interpreted as critical, required or necessary. The term "comprising" and any other variants used in this article are all non-exclusive inclusions, so that a process, method, article or device that includes a list of elements includes not only these elements, but also other elements that are not explicitly listed or do not belong to the process, method, system, article or device. In addition, the term "coupled" and any other variants used in this article refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections and / or any other connections.

[0093] Those skilled in the art will recognize that many changes can be made to the details of the above embodiments without departing from the basic principles of the invention. Therefore, the scope of the invention should be determined from the following claims.

Claims

1. An in vitro diagnostic device, characterized in that It includes a sample conveying device, a sample identifying device, a control device and an output device; The sample transport device is used to transport the sample rack carrying the sample and deliver the sample to the sample suction position for sample suction testing; The sample identification device is connected to the control device and is used to detect identification information of the sample and send the identification information to the control device; The control device is used to obtain the test results of the sample, determine whether there are at least two test results that meet the set conditions within a preset range, and if so, send an abnormal prompt information to the output device, wherein the set conditions include that the test results are consistent and the corresponding identification information is different; The output device is used to output the abnormal prompt information.

2. The in vitro diagnostic device according to claim 1, wherein Also included is an input device; The output device includes a display unit, the display unit is used to display a preset range customization interface, the preset range customization interface includes a setting menu for customizing the preset range; The input device is used to obtain the user's customized operation in the preset range customized interface; The control device is further configured to control the display unit to display a preset range customization interface upon receiving an instruction for defining a preset range sent via the input device, and to determine the preset range based on a user's customization operation in the preset range customization interface via the input device.

3. The in vitro diagnostic device according to claim 1 or 2, characterized in that The preset range includes a preset time range or a preset number of samples.

4. The in vitro diagnostic device according to claim 3, wherein The control device is specifically used to obtain all test results of samples within the preset time range or the preset number of samples, and determine whether there are at least two test results among these test results that meet the set conditions. If so, an abnormal prompt information is sent to the output device.

5. The in vitro diagnostic device according to claim 3, wherein The control device is specifically used to obtain other test results from the samples within the preset time range or the preset number of samples after each current test result is obtained, and determine whether there is at least one test result among the other test results that is consistent with the current test result and has different corresponding identification information; if so, send an abnormal prompt information to the output device; wherein, the time when the current test result is obtained is included in the preset time range, and the samples of the preset number of samples include the sample corresponding to the current test result.

6. The in vitro diagnostic device according to claim 1, wherein The control device is specifically used to determine whether two test results are consistent: Calculate the similarity between two test results; Determining whether the similarity is greater than or equal to a similarity threshold; If the similarity is greater than or equal to the similarity threshold, it is determined that the two test results are consistent.

7. The in vitro diagnostic device according to claim 6, wherein When calculating the similarity between two test results, the control device is specifically used to: Calculate the deviation rate of the same test item in two test results; The percentage of the number of deviation rates that meet the preset threshold condition to the total number of deviation rates is calculated to obtain the similarity between the two test results.

8. The in vitro diagnostic device according to claim 7, wherein The deviation rate includes an absolute value of the deviation, a percentage of the deviation and / or a percentage of the test item results.

9. The in vitro diagnostic device according to claim 7, wherein: Also included is an input device; The output device includes a display unit, the display unit is used to display a similarity customization interface, the similarity customization interface includes a setting menu for customizing the similarity threshold and / or the preset threshold condition; The input device is used to obtain the user's customized operation in the similarity customization interface; The control device is further configured to control the display unit to display a similarity customization interface upon receiving a similarity customization instruction sent via the input device, and determine a similarity threshold and / or preset threshold condition based on a user's customization operation via the input device in the similarity customization interface.

10. The in vitro diagnostic device according to claim 1, wherein The control device is further configured to save the test result of the sample when it is determined that no test result meeting the set condition exists within the preset range.

11. An inspection line, characterized in that: Includes a sample transport device, a sample identification device, a control device, an output device and at least one in vitro diagnostic device; The sample transport device is used to transport the sample rack carrying the sample to the in vitro diagnostic device; The sample identification device is connected to the control device and is used to detect identification information of the sample and send the identification information to the control device; The in vitro diagnostic device is signal-connected to the control device for testing the sample and outputting the test results to the control device; The control device is used to determine whether there are at least two test results that meet the set conditions within a preset range, and if so, send an abnormal prompt information to the output device, wherein the set conditions include that the test results are consistent and the corresponding identification information is different; The output device is used to output the abnormal prompt information.

12. A method for detecting anomalies, characterized in that: include: Obtain sample identification information and test results; Determine whether there are at least two test results within a preset range that meet a set condition, wherein the set condition includes that the test results are consistent and the corresponding identification information is different; If it exists, an exception prompt message will be output.

13. The method according to claim 12, wherein: Also includes: Upon receiving an instruction to define a preset range, displaying a preset range customization interface, wherein the preset range customization interface includes a setting menu for customizing the preset range; The preset range is determined according to a custom operation in the preset range custom interface.

14. The method according to claim 12 or 13, wherein: The preset range includes a preset time range or a preset number of samples.

15. The method according to claim 14, wherein The determining whether there are at least two test results that meet the set conditions within the preset range includes: Obtain all test results of samples within the preset time range or the preset number of samples; It is determined whether there are at least two test results that meet the set condition among the test results.

16. The method according to claim 14, wherein The determining whether there are at least two test results that meet the set conditions within the preset range includes: After obtaining each current test result, obtaining other test results of samples within the preset time range or the preset number of samples; Determine whether there is at least one test result among the other test results that is consistent with the current test result and has different corresponding identification information; The time when the current test result is obtained is included in the preset time range, and the preset number of samples includes the sample corresponding to the current test result.

17. The method according to claim 12, wherein Determining whether two test results are consistent includes: Calculate the similarity between two test results; Determining whether the similarity is greater than or equal to a similarity threshold; If the similarity is greater than or equal to the similarity threshold, it is determined that the two test results are consistent.

18. The method according to claim 17, wherein Calculating the similarity between two test results includes: Calculate the deviation rate of the same test item in two test results; The percentage of the number of deviation rates that meet the preset threshold condition to the total number of deviation rates is calculated to obtain the similarity between the two test results.

19. The method according to claim 18, wherein The deviation rate includes an absolute value of the deviation, a percentage of the deviation and / or a percentage of the test item results.

20. The method of claim 18, wherein Also includes: Upon receiving the similarity customization instruction, displaying a similarity customization interface, wherein the similarity customization interface includes a setting menu for customizing the similarity threshold and / or the preset threshold condition; The similarity threshold and / or preset threshold condition is determined according to the custom operation in the similarity custom interface.

21. The method according to claim 12, wherein After determining whether there are at least two test results that meet the set conditions within the preset range, the method further includes: If there is no test result that meets the set conditions within the preset range, the test result of the sample is saved.

22. A computer-readable storage medium, characterized in that The method comprises a program which can be executed by a processor to implement the method according to any one of claims 12 to 21.

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