Biochemical analyzer with intelligent quality control and calibration management function

Abstract

The application discloses a biochemical analyzer with intelligent quality control and calibration management function, which obtains the absorbance values of each item of the quality control sample through detection, and respectively calculates the correction coefficients of each item by taking the target values of each item of the quality control sample as parameters, and reserves the correction coefficients as the calculation parameters of the detection results of the corresponding items of the subsequent samples and quality control samples. When the instrument detects the quality control sample again, the correction coefficients of the corresponding items are modified or not modified according to the deviation degree of the detection results of the corresponding items of the subsequent quality control sample and the target values of the corresponding items. The instrument directly calculates the detection results of the corresponding items by taking the latest correction coefficients of each item as the absorbance values of the corresponding items of the subsequent samples and quality control samples, so that the intelligent quality control and calibration management are realized. The instrument also limits the correction coefficient modification conditions after the calibration sample is detected, so that the quality control management of the instrument is more convenient and effective.

Description

Technical Field

[0001] This invention relates to commonly used equipment in fields such as biology, agriculture, basic scientific research, medicine, and environmental protection, and specifically to a biochemical analyzer with intelligent quality control and calibration management functions. Background Technology

[0002] Biochemical analyzers are widely used and have significant practical value in basic scientific research, biology, biochemistry, environmental protection, agricultural products, animal husbandry, food industry, medical services, and chemical engineering. Using quality control materials and calibrators to test and evaluate biochemical analyzers is a crucial measure to ensure the accuracy of their test results. While the methods of using quality control materials and calibrators for testing and evaluating biochemical analyzers have different focuses, their purpose is the same: to ensure the accuracy of the biochemical analyzer system's test results.

[0003] In practice, the test results of biochemical analyzers often deviate due to differences or changes in various factors such as environmental temperature and humidity, reagent quality, the condition of the biochemical analyzer itself, parameter settings, and the quality of quality control materials and calibrators. Therefore, the quality control management of biochemical analyzers is the core content of instrument quality management.

[0004] The process of using quality control samples in existing biochemical analyzers is as follows: First, the target values ​​of each component, or the content of each component, of the selected quality control sample are manually input into the instrument. Based on the target values ​​and the range provided by the quality control sample, the difference range of each component around the target value is manually calculated (commonly expressed as ±1SD-3SD) and input into the instrument. The instrument uses the corresponding reagents for each item to detect the components of the quality control sample to obtain the detection results of the content of each corresponding component. The accuracy level of the biochemical analyzer system (including instruments, reagents, quality control, etc.) is evaluated by manually observing the degree of difference between the actual detection results obtained by the biochemical analyzer for each component of the quality control sample and the target values ​​of each corresponding item. That is, the detection results of the instrument system meet the standards of the specified accuracy or quality control requirements.

[0005] Current biochemical analyzers rely on manual inspection and evaluation to determine whether the test results of each component content of a quality control sample meet the expected quality control range for that specific item. If the accuracy of the test result for any component content of a quality control sample fails to meet requirements (i.e., the test result for that component content exceeds the allowable target value range), the operator of the biochemical analyzer needs to modify the correction coefficient value for that component content stored in the instrument (including modification after testing with calibrators) to ensure that the test results for the content of each component content of the quality control sample all meet the allowable deviation range for that specific component content.

[0006] If the detection results of the biochemical analyzer system are close to the target value, it indicates that the instrument's detection results are accurate. Otherwise, the instrument's calibration coefficients need to be modified and confirmed. The process of modifying and confirming the instrument's calibration coefficients includes re-testing the quality control samples with the instrument after ruling out abnormalities in instrument condition, reagent status, and quality control materials, in order to confirm whether the instrument's accuracy meets the accuracy requirements. This process is quite cumbersome, especially when dealing with numerous testing items. To ensure the quality of each item's test results, operators often need to spend a significant amount of time and effort each day checking the instrument's quality control testing quality to avoid producing unqualified test results with large errors. Currently, the processes of quality control material testing, quality evaluation, and deviation correction rely heavily on manual operation, which has the disadvantages of being cumbersome and time-consuming.

[0007] On the other hand, currently, laboratories generally rely on operators to perform tests on biochemical analyzers using calibrators and appropriate reagents to correct deviations in the instrument's test results. Based on the calibrator test results, deviations in the instrument's test results are corrected, or the accuracy of the instrument's test results is evaluated and judged. This is also the material and method used for quality management of biochemical analyzer test results.

[0008] Currently, the calibration method is as follows: before testing, the operator inputs the target values ​​of each component content of the calibrator into the instrument. The biochemical analyzer then detects each component of the calibrator. The instrument calculates the correction coefficient for each detected component based on the relationship between the absorbance values ​​of each component obtained after testing and the target values ​​of the corresponding components. This correction coefficient is then used to calculate the test results for subsequent samples and quality control materials. However, because the components in the calibrator differ from those in the tested samples, the test results obtained by using an instrument calibrated with a pure glucose solution often show discrepancies when detecting glucose in urine, dairy products, and blood. Furthermore, in situations where the instrument is in poor condition or the reagents are of poor quality, drastically modifying the correction coefficients for corresponding test items solely based on the calibrator's test results may mask abnormalities in the biochemical analyzer system. One of the main reasons that the calibration coefficients need to be significantly modified is that there is an abnormality in the biochemical analyzer's detection system (including instruments, reagents, quality control, calibrators, etc.). If the behavior of significantly modifying the calibration coefficients is not controlled and corrected at all, it will cause the operator to overlook important abnormal factors or the risks that abnormalities bring to the instrument's detection quality.

[0009] Quality control and calibrators often have discrepancies in their stated target values, especially since products from different manufacturers may contain systematic or unsystematic errors. Therefore, relying solely on quality control and calibrators to evaluate or calibrate the results of a biochemical analyzer may not always yield satisfactory results. Operators often need to use their experience or other methods to adjust the calibration coefficients for each test item to achieve a reasonable accuracy range for all components of the sample (including quality control and calibrators).

[0010] Currently, biochemical testing can include more than 20 items, generally requiring biochemical analyzers to test quality control samples daily. During quality control testing, if any item deviates, the operator must use calibrators to test and verify each item individually to confirm that the calibrator's results meet the ideal quality control target range. This process is time-consuming and extremely cumbersome, often delaying normal work and preventing timely testing of biochemical samples. Furthermore, maintaining a consistently qualified or good quality control status for all biochemical analyzer tests using existing methods often requires a significant investment of the operator's time and energy. Some users even abandon quality control management altogether, leading to a substantial risk of errors in the accuracy of actual biochemical analyzer tests. Therefore, it is clear that the existing quality control methods used in biochemical analyzers are no longer adequate for practical work needs.

[0011] Currently, after quality control testing of biochemical analyzers, manual verification is required to ensure that all test results are within acceptable deviation ranges. If the test results deviate from the allowable quality control range, the biochemical analyzer needs to be tested with calibrators, the correction coefficients modified, and then the analyzer re-verified using quality control samples to confirm that it has been calibrated to the acceptable deviation range. These processes are currently performed manually, with operators manually judging the deviations of the quality control and calibration results. If deviations are found, the operator manually modifies the correction coefficients based on the degree of deviation. This can be done by using calibrators for testing and then modifying the correction coefficients based on the calibrator test results, or by evaluating based on the calibrator test results, or by the operator comprehensively considering the quality control and calibrator test results to determine the modification and its extent.

[0012] Therefore, existing quality control management for biochemical analyzers has the following drawbacks:

[0013] 1. The method of using calibrators for calibration and quality control verification is cumbersome, time-consuming, and inefficient, resulting in the inability to test samples in a timely manner;

[0014] 2. The quality control verification process relies heavily on human judgment and the skills and qualifications of the operators. There is a risk that the biochemical analyzer may be out of control due to unfamiliarity with the operation or human oversight of quality control management. Summary of the Invention

[0015] Purpose of the invention: The technical problem to be solved by the present invention is the prominent problem of low automation, low intelligence, cumbersome operation and time consumption in the quality control and testing process of existing biochemical analyzers. The present invention discloses a biochemical analyzer with intelligent quality control and calibration management functions, which enables the biochemical analyzer to achieve efficient and rapid quality control and calibration management on the basis of intelligence, and ensures that the quality of the biochemical analyzer's test results is in a good and controllable state.

[0016] To address the aforementioned technical problems, this invention discloses a biochemical analyzer with intelligent quality control and calibration management functions. This biochemical analyzer performs the following steps on each batch of quality control samples:

[0017] Step 1: Obtain information about the batch of quality control products, including the unique code of the batch of quality control products, the target values ​​of the content of each component in the quality control products, and the range of the content of each component in the batch of quality control products; The biochemical analyzer calculates three or more deviation level standards for the correction coefficient of each component in the quality control products based on the target values ​​of the content of each component and the corresponding content range of the component.

[0018] Step 2: The quality control sample is tested to obtain the absorbance values ​​of each component. Based on the relationship between the absorbance values ​​obtained from the tests of each component and the target values ​​of the corresponding components, the correction coefficients for the biochemical analyzer's detection of the corresponding component content of the quality control sample are automatically calculated. This results in the correction coefficients for the correlation between the absorbance values ​​obtained from the tests of each component and the target values ​​of the corresponding components. The biochemical analyzer saves these correction coefficients, and subsequently, when testing any sample, it automatically uses these correction coefficients to directly calculate the absorbance values ​​of the corresponding components for each sample to obtain the test results for each sample.

[0019] Step 3: The biochemical analyzer analyzes, judges, and processes the correction coefficients for the content of each component based on the quality control sample, including: re-testing the quality control sample to obtain new absorbance values ​​for each component; directly calculating the re-test results for each corresponding component based on the new absorbance values ​​obtained from the re-test and the original correction coefficients stored in the biochemical analyzer; comparing the re-test results with the target values ​​for each corresponding component to obtain the deviation degree; and for any component, matching the deviation degree with a preset deviation level standard for further analysis. The deviation level corresponding to the degree of deviation is determined; based on the deviation level corresponding to the degree of deviation, the correction coefficients of each corresponding item of the quality control product are differentiated, the differentiation process including not modifying the correction coefficients of each corresponding item of the quality control product and modifying them; when the correction coefficient of any item is modified, the biochemical analyzer automatically uses the modified correction coefficient of the corresponding item to directly calculate the new absorbance value of the corresponding item component obtained from the retest of the quality control product to obtain the detection result of the content of the corresponding item component of the quality control product; the instrument saves the modified correction coefficient of the corresponding item and uses it to detect the results of the retest of the corresponding items of subsequent samples, calibrators and the quality control product.

[0020] Optionally, the biochemical analyzer performs the following steps on the calibrators to be tested:

[0021] Obtain the information of the calibrator to be tested, which includes the target values ​​of the content of each component in the calibrator; set the deviation level standard of the correction coefficient of each component content of the calibrator, which includes the acceptable deviation standard, the standard for deviation that should be modified, and the alarm prompt standard.

[0022] The analysis, determination, and processing of correction coefficients obtained from the detection of each component using the calibrator include: the biochemical analyzer detecting the calibrator to obtain absorbance values ​​for each component contained in the calibrator; the biochemical analyzer automatically calculating new correction coefficient values ​​for each component detection based on the absorbance values ​​obtained from the detection of each component and the target values ​​of the corresponding component content, and comparing these new correction coefficient values ​​with the original correction coefficients for each corresponding component; if the relationship between the new correction coefficient value and the original correction coefficient of any component of the calibrator meets the acceptable deviation standard, then the correction coefficient for that component is not modified, and the detection result of the content of that component in the calibrator is calculated based on the absorbance values ​​obtained from the detection of that component and the original correction coefficient of the component content; if the relationship between the new correction coefficient and the original correction coefficient of any component of the calibrator meets the standard for deviation modification, then the biochemical analyzer, based on the new correction coefficient and the original correction coefficient of the component, calculates the detection result of the content of that component in the calibrator; if the relationship between the new correction coefficient and the original correction coefficient of any component of the calibrator meets the standard for deviation modification, then the biochemical analyzer... The biochemical analyzer recalculates the relationship between the absorbance value obtained from the detection of the component in the calibrator and the target value of the corresponding component, obtaining a new correction coefficient for that component. This new correction coefficient automatically replaces the original correction coefficient for that component in the calibrator. When the relationship between the new correction coefficient and the original correction coefficient of any component in the calibrator meets a preset alarm standard, the biochemical analyzer issues an alarm for the component content. The operator then confirms whether the correction coefficient needs to be modified based on the absorbance value of that component detected in the calibrator. After any correction coefficient is modified, the biochemical analyzer automatically uses the modified correction coefficient to directly calculate the new detection result for the component content of the corresponding component in the quality control sample. The modified correction coefficient is saved and used to obtain the detection results for subsequent re-detection of the corresponding components in various samples, calibrators, and quality control samples.

[0023] Specifically, the three or more deviation level standards for each component of the batch of quality control products include the acceptable standard for the target value deviation of the quality control products, the standard for the target value deviation of the quality control products that should be corrected, and the standard for quality control alarm prompts;

[0024] The degree of deviation is characterized by the deviation between the test results of the corresponding components of the quality control product and the target value of the corresponding items of the quality control product.

[0025] Step three involves matching the degree of deviation with a preset deviation level standard to determine the deviation level corresponding to the degree of deviation; and then differentiating the correction coefficients for each corresponding item of the quality control product based on the deviation level corresponding to the degree of deviation, including:

[0026] If the deviation value meets the acceptable standard for the target deviation of the quality control product, the correction coefficient of the corresponding item of the quality control product will not be modified.

[0027] If the deviation value meets the correction standard for the target value deviation of the quality control product, the biochemical analyzer automatically recalculates the new correction coefficient for the corresponding item of the quality control product based on the relationship between the new absorbance value obtained from the re-detection of each component of the quality control product and the target value of the corresponding item of the quality control product, and automatically replaces the original correction coefficient of the corresponding item of the quality control product with the new correction coefficient. Alternatively, the biochemical analyzer automatically modifies the correction coefficient of the corresponding item of the quality control product so that the deviation value of the new detection result calculated based on the modified correction coefficient of the corresponding item and the absorbance value of the corresponding item of the quality control product meets the acceptable standard for the target value deviation of the quality control product. The new detection result of the corresponding item of the quality control product is then recalculated using the new absorbance value of the corresponding component obtained from the re-detection of the quality control product.

[0028] If the deviation value meets the quality control alarm standard, the biochemical analyzer will issue an alarm for the test result of that item, and the operator of the biochemical analyzer will confirm whether the correction coefficient for that item needs to be automatically modified based on the quality control test result. If so, the biochemical analyzer will automatically recalculate the new correction coefficient for the corresponding item of the quality control product based on the relationship between the new absorbance values ​​obtained from the retesting of each component of the quality control product and the target value of the corresponding item. The new correction coefficient will then automatically replace the original correction coefficient for the corresponding item of the quality control product, and the newly obtained correction coefficient will be used to adjust the calibration. The new absorbance values ​​of the corresponding components obtained from the retesting of the quality control sample are used to recalculate the new test results for the corresponding items of the quality control sample. If not, a correction factor is determined. If the instrument is repaired or adjusted, or the reagents or quality control are replaced, and another quality control or calibrator test is performed, the correction factor for the item is determined based on the other test results. Subsequently, the biochemical analyzer uses the correction factor confirmed by the operator of the biochemical analyzer to calculate the absorbance values ​​of the corresponding items of each subsequent sample, calibrator, and quality control sample to obtain the test results for the corresponding items, and forms a new correction factor for each corresponding component.

[0029] Specifically, the preset acceptable standard for the target deviation of the quality control product is [-mSD, +mSD], where m ranges from 1 to 7; the preset modifiable standard for the target deviation is [-nSD, -mSD)∪(mSD, nSD], where n ranges from 2 to 8 and satisfies n>m; the preset standard for the quality control alarm is (-∞, -nSD)∪(nSD, +∞), where SD is the standard deviation of the corresponding item of the quality control product.

[0030] Specifically, the three or more deviation level standards for each component of the batch of quality control products include the acceptable standard for the target value deviation of the quality control products, the first standard for the correctable target value deviation of the quality control products, the second standard for the correctable target value deviation of the quality control products, and the quality control alarm prompt standard.

[0031] The degree of deviation is characterized by the deviation between the test results of the corresponding components of the quality control product and the target value of the corresponding items of the quality control product.

[0032] Step three involves matching the degree of deviation with a preset deviation level standard to determine the deviation level corresponding to the degree of deviation; and then differentiating the correction coefficients for each corresponding item of the quality control product based on the deviation level corresponding to the degree of deviation, including:

[0033] When the deviation value meets the acceptable standard for the deviation of the target value of the component content of the quality control product, the original correction coefficient of the corresponding item remains unchanged;

[0034] When the deviation value meets the first standard for correctable deviation of the target value of the quality control product component content, the biochemical analyzer automatically modifies the correction coefficient of the corresponding item. The new test result calculated based on the modified correction coefficient of the corresponding item and the absorbance value of the corresponding item of the quality control product meets the acceptable standard for deviation of the target value of the quality control product component content of each corresponding item of the quality control product.

[0035] When the deviation value meets the second standard for correctable deviation of the target value component content of the quality control product, the biochemical analyzer automatically modifies the correction coefficient of the corresponding item. The new detection result calculated based on the modified correction coefficient of the corresponding item and the absorbance value of the corresponding item of the quality control product meets the first standard for correctable deviation of the target value of the quality control product.

[0036] When the deviation value meets the quality control alarm standard, the biochemical analyzer will issue an alarm for the test result of that item. The operator of the biochemical analyzer will then confirm whether the correction coefficient for that item needs to be automatically modified based on the quality control test result. If so, the biochemical analyzer will automatically recalculate the new correction coefficient for the corresponding item of the quality control product based on the relationship between the new absorbance value obtained from the retest of the component content of each item of the quality control product and the target component content of the corresponding item. The new correction coefficient will then automatically replace the original correction coefficient for the corresponding item of the quality control product, and the newly obtained correction coefficient for the corresponding item will be adopted. The new absorbance values ​​of the corresponding components obtained from the retesting of the quality control product are used to recalculate the new component content test results for the corresponding items of the quality control product. If not, a correction factor is determined. If the instrument is repaired or adjusted, or the reagents or quality control are replaced, and another quality control or calibrator test is performed, the correction factor for the item is determined based on the other test results. Subsequently, the biochemical analyzer uses the correction factor confirmed by the operator of the biochemical analyzer to calculate the absorbance values ​​of the corresponding items obtained from the subsequent tests of each sample, calibrator, and quality control product to obtain the test content results for the corresponding items, and forms a corresponding new correction factor.

[0037] Optionally, the biochemical analyzer also has the function of automatically correcting continuous unidirectional deviations in the test results of quality control samples. This function includes:

[0038] If any item of the quality control product deviates from the target value of the corresponding item in only one direction in multiple consecutive tests, where "one-way deviation from the target value" means that the multiple consecutive test results of the quality control product item form a positive deviation in one direction relative to the target value of the corresponding item, or that the multiple consecutive test results of the quality control product item form a negative deviation in one direction relative to the target value of the corresponding item, once the number of times the multiple consecutive test results of any item of the quality control product deviate from the target value of the corresponding item reaches the maximum number of consecutive one-way deviations set for the corresponding item, the biochemical analyzer automatically corrects the last test result of that item. The correction includes: when the multiple consecutive test results of the quality control product item form a positive deviation in one direction relative to the target value of the corresponding item, the biochemical analyzer modifies the test result of the last test of that item of the quality control product that has reached the allowed number of one-way deviations. The modified test result of that item of the quality control product, which is the last test result of the last test within the instrument's set allowable consecutive deviation, has a deviation of zero or negative from the target value of the corresponding item, and the negative deviation meets the preset... The quality control sample target value deviation is acceptable according to the following standard: When the results of multiple consecutive tests of a quality control sample item show a unidirectional negative deviation relative to the target value of the corresponding item, the biochemical analyzer modifies the test result of the last test of that item to reach the number of times the instrument is allowed to have a unidirectional deviation. The new test result of the last test of the corrected quality control sample item with a continuous deviation has a deviation of zero or a positive deviation from the target value of the corresponding item, and the positive deviation meets the preset acceptable standard for the quality control sample target value deviation. The instrument recalculates the new correction coefficient for the corresponding item based on the relationship between the absorbance value obtained from the current test of the component of the quality control sample item and the new test result of the last test of the modified quality control sample item. The new correction coefficient replaces the original correction coefficient for the item. From then on, the instrument uses the newly obtained correction coefficient for the item to calculate the test result for the corresponding item for the corresponding item of each subsequent sample, calibrator, and quality control sample. The instrument maintains this rule and automatically corrects the continuous deviation of the quality control test results according to this rule.

[0039] Furthermore, the biochemical analyzer records and reports the most recent test result of the component of the quality control sample according to the revised test result of the last test of the component of the quality control sample, or marks the test result of the component of the quality control sample before modification and the test result after modification separately, or records and reports them simultaneously.

[0040] Optionally, the relationship between the new correction factor for the content of any component of the calibrator and the original correction factor for the corresponding component is characterized by the following formula:

[0041]

[0042] The newly obtained correction coefficient for the content of the component in this calibrator is calculated directly based on the absorbance value obtained from the detection of the component in this calibrator and the target value of the corresponding component content in this calibrator.

[0043] Optionally, the biochemical analyzer uses correction coefficients obtained from quality control sample testing to calculate test results and modify correction coefficients for subsequent samples, quality control samples, and calibrators. The instrument also accepts modifications to correction coefficients based on calibrator test results. Whether for quality control testing or calibrator testing, if the post-test result evaluation confirms that the correction coefficient for the item needs to be modified, the instrument automatically modifies the correction coefficient for the corresponding item and saves the modified correction coefficient for subsequent test result calculations for samples, quality control samples, and calibrators.

[0044] Optionally, the biochemical analyzer uses more than one level of quality control material for more than one test item during the quality control material testing process; based on the quality control material, the correction coefficients of more than one level for each item are analyzed, determined, and processed; the processed correction coefficients of more than one level for each item are used to calculate the test results of the corresponding component content when testing samples, quality control materials, and calibrators; the correction coefficients obtained from different levels of quality control testing are applicable to the specified concentration range of the test components.

[0045] Beneficial effects:

[0046] (1) The biochemical analyzer of the present invention obtains the correction coefficients of each corresponding item by the initial detection of the content of each item component in the batch of quality control products, and analyzes, judges and processes the correction coefficients of each item based on the quality control products. That is, for any item component, the degree of deviation is determined by the detection results of the subsequent detection of each corresponding item component in the quality control products and the target value of each corresponding item in the quality control products; the degree of deviation is matched with a preset deviation level standard to determine the deviation level corresponding to the degree of deviation; the correction coefficients of each corresponding item in the quality control products are differentiated based on the deviation level corresponding to the degree of deviation, the differentiation processing includes not modifying the correction coefficients of each corresponding item in the quality control products and modifying them. This system enables automated, intelligent, and continuous effective control of the biochemical analyzer without human intervention. It provides the analyzer with intelligent evaluation of quality control sample test results within a reasonable range and allows for timely and efficient correction of deviations exceeding controllable limits. This significantly reduces operator workload and the difficulty of quality control management, improving the quality and efficiency of biochemical testing. By pre-setting deviation level standards corresponding to the degree of deviation, the analyzer automatically analyzes, judges, and processes the correction coefficients for each item based on the quality control sample, reducing reliance on manual calibration and avoiding the risk of the analyzer being out of control due to overlooked quality control management.

[0047] (2) The biochemical analyzer provided by the present invention sets a quality control alarm prompt standard. When the deviation is too large, the biochemical analyzer operator is prompted by an alarm. The biochemical analyzer operator can then confirm whether the correction coefficient of the item needs to be automatically modified based on the quality control test results. This avoids blind correction and improves the reliability and accuracy of quality control and calibration management.

[0048] (3) The biochemical analyzer provided by the present invention also analyzes, judges and processes the correction coefficients of each item based on the calibrator. When the relationship between the new correction coefficient of any item of the calibrator and the original correction coefficient of the corresponding item meets the preset alarm prompt standard, the biochemical analyzer will make an alarm prompt on the detection result of the component content of the item. The operator of the biochemical analyzer can confirm whether it is necessary to automatically modify the correction coefficient of the item based on the absorbance value obtained by detecting the component content of the item of the calibrator. This can effectively help the operator to detect the abnormality of the instrument system in time and avoid simply accepting the modification of the correction coefficient by the calibrator detection.

[0049] (4) The biochemical analyzer provided by this invention also has the function of automatically correcting continuous unidirectional deviations in the test results of quality control products. This function can correct long-term unidirectional system deviations of the instrument system, making the overall test results of the instrument system more consistent with the actual situation, that is, making the test results of the detection system (including the combined effects of instruments, reagents and other factors) more consistent with reality and more accurate.

[0050] (5) The method and biochemical analyzer can automatically scan the input quality control information and automatically calculate and establish deviation rating standards for the test results of quality control products for any item, without the need for manual calculation of the deviation rating standards for the input quality control product target value. Attached Figure Description

[0051] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments, and the advantages of the present invention in the above and / or other aspects will become clearer.

[0052] Figure 1 This is a quality control record chart of 30 times / day provided by the biochemical analyzer in Embodiment 3 of the present invention; the biochemical analyzer is set to accept the target value deviation of the quality control product for this item as [-1SD, +1SD], and the maximum number of consecutive unidirectional deviations of the quality control product is 3 times / day.

[0053] Figure 2 This is a chart showing an additional 30 quality control records per day for the biochemical analyzer provided in Embodiment 3 of the present invention. Figure 2 In this biochemical analyzer, the acceptable standard for the target value deviation of the quality control material for this project is set to [-2SD, +2SD], and the maximum number of consecutive unidirectional deviations of the quality control material is set to 3 times / day.

[0054] Figure 3 The following is a chart showing 19 additional quality control records per day for the biochemical analyzer provided in Embodiment 3 of the present invention; Figure 3 In this biochemical analyzer, the acceptable standard for the target value deviation of the quality control sample is set to [-2SD, +2SD], the modifiable standard for the target value deviation of the quality control sample is [-3SD, -2SD)∪(2SD, 3SD], and the standard for quality control alarm prompts is (-∞, ...).

[0055] -3SD)∪(3SD,+∞], and the maximum number of consecutive unidirectional deviations of the quality control product is 4 times / day.

[0056] Figure 4 This is a graph showing the quality control record of a biochemical analyzer that does not have intelligent quality control and calibration management functions, with 14 records per day. Detailed Implementation

[0057] The technical solution of the present invention will now be described in detail with reference to the accompanying drawings.

[0058] This application provides a biochemical analyzer with intelligent quality control and calibration management functions. The analyzer has automatic analysis and correction functions for the test results of quality control samples. The analyzer performs the following steps for each batch of quality control samples:

[0059] Step 1: Obtain information about the batch of quality control products, including the unique code of the batch of quality control products, the target values ​​of the content of each component in the quality control products, and the range of the content of each component in the batch of quality control products; The biochemical analyzer calculates three or more deviation level standards for each component in the quality control products based on the target values ​​of the content of each component and the corresponding content range of the component.

[0060] When a new batch of quality control samples is used, the operator provides the analyzer with the information of the quality control samples through scanning, electronic file import, or keyboard input. In some embodiments, the content range of each component in the batch of quality control samples is +3SD to -3SD. The analyzer automatically calculates three deviation level standards for the content of each component in the batch of quality control samples. The boundary values ​​of each deviation level standard are multiples of the SD of the content of the corresponding component in the batch of quality control samples, and the boundary values ​​of each deviation level standard are all within the range of the content of the corresponding component in the batch of quality control samples.

[0061] As an example, the specific operation is as follows: After the operator inputs the quality control item, target value, and reference range of the quality control item to be tested into the instrument (or the instrument can scan and input this information), the instrument automatically sets the upper limit of the reference range to +2SD of that quality control item. The formula for calculating 1SD is: (target value of the item + upper limit of the quality control reference range) / 2 + target value. The value obtained by this formula is the target value of the item +1SD. The +3SD value of this quality control item is then the sum of +1SD and 2SD.

[0062] The lower limit of the reference range for this quality control item is taken as -2SD. The formula for -1SD is: (target value of this quality control item - lower limit of the reference range of the quality control item) / 2; the formula for -3SD is: target value – (3×1SD).

[0063] Step 2: The quality control sample is tested to obtain the absorbance values ​​of each component. Based on the relationship between the absorbance values ​​obtained from the tests of each component and the target values ​​of the corresponding components, the correction coefficients for the biochemical analyzer's detection of the corresponding component content of the quality control sample are automatically calculated. This results in the correction coefficients for the correlation between the absorbance values ​​obtained from the tests of each component and the target values ​​of the corresponding components. The biochemical analyzer saves these correction coefficients, and subsequently, when testing any sample, it automatically uses these correction coefficients to directly calculate the absorbance values ​​of the corresponding components for each sample to obtain the test results for each sample.

[0064] In step two, the operator loads the quality control sample to be tested into the sample port or dedicated quality control port of the biochemical analyzer for testing. During testing, the biochemical analyzer performs tests on different items of the quality control sample according to the normal testing procedure. The analyzer records the absorbance values ​​at each stage of the reaction between the quality control sample and the reagents for each different item. Based on the selected detection method for each item, the analyzer automatically calculates the correction coefficient for detecting the content of each corresponding item component of the quality control sample by relating the absorbance values ​​obtained for each item to the target value of the corresponding item of the quality control sample.

[0065] As an example, the biochemical analyzer in this example uses the endpoint method for detection. The detection result of the endpoint method is calculated using the following formula: Detection result = (Absolute value of absorbance at the end of the detection reaction - ...)

[0066] (The absorbance value obtained when the test cup contains only reagent before the sample is added) × correction factor

[0067] Step 3: The biochemical analyzer analyzes, judges, and processes the correction coefficients for the content of each component based on the quality control sample, including: re-testing the quality control sample to obtain new absorbance values ​​for each component; directly calculating the re-test results of each corresponding component based on the new absorbance values ​​obtained from the re-test and the original correction coefficients stored in the biochemical analyzer; comparing the re-test results of each corresponding component with the target values ​​of each corresponding item to obtain the deviation degree of each item; for any component, matching the deviation degree with a preset deviation level standard to determine its content relative to the target value of each item. The deviation level corresponds to the degree of deviation; based on the deviation level corresponding to the degree of deviation, the correction coefficients of each corresponding item of the quality control product are differentiated, the differentiation process includes not modifying the correction coefficients of the component content of each corresponding item of the quality control product and modifying them; when the correction coefficient of any item is modified, the biochemical analyzer automatically uses the modified correction coefficient of the corresponding item to directly calculate the detection result of the component content of the corresponding item of the quality control product by using the new absorbance value of the corresponding item obtained by the re-detection of the quality control product; the modified correction coefficient of the corresponding item is saved so that it can be used to obtain the detection results of the re-detection of the corresponding items of subsequent samples, calibrators and the quality control product.

[0068] When replacing a new batch of quality control materials, the operator needs to input the information of the new batch into the biochemical analyzer, including the unique code of the new batch, the target values ​​of the content of each component in the new batch, and the deviation level standards for the content of each component. Subsequently, when testing the new batch of quality control materials, the biochemical analyzer establishes new correction coefficients for the content of each component according to the above steps, and analyzes, judges, and processes the correction coefficients for the content of each component based on the new batch of quality control materials.

[0069] The biochemical analyzer provided in this application has an automatic start-up function for modifying calibration coefficients. By analyzing, judging, and processing the calibration coefficients of the corresponding items based on the current quality control sample, the test results of the corresponding items of the current quality control sample meet the preset quality control accuracy. This allows the quality control sample to automatically obtain test results that meet the expected requirements. In other words, the biochemical analyzer monitors and automatically and intelligently corrects the quality control deviations of the biochemical analyzer according to the prescribed principles. This ensures that the biochemical analyzer system is in good condition without much operator intervention, and that the quality of the test results performed by the biochemical analyzer is consistently good and acceptable.

[0070] In some embodiments, the biochemical analyzer performs the following steps on the calibrator to be tested: obtaining information about the calibrator to be tested, the calibrator information including target values ​​for the content of each component contained in the calibrator; setting a deviation level standard for the correction coefficients of the content of each component of the calibrator, the deviation level standard for the correction coefficients of the content of each component of the calibrator including an acceptable deviation standard, a deviation that should be modified standard, and an alarm prompt standard.

[0071] The three deviation level standards for the content of each component in the calibrator include the acceptable deviation standard, the deviation that should be corrected standard, and the alarm indication standard.

[0072] This embodiment compares the difference between the original correction coefficient and the newly obtained correction coefficient, and establishes a standard based on the degree of difference: a small difference is considered an acceptable deviation standard; a large difference is considered a standard that should be modified; and when the difference exceeds the standard that should be modified, it serves as an alarm for the calibrator.

[0073] The analysis, determination, and processing of correction coefficients for the content of each component in the calibrator are performed, including: the biochemical analyzer detects the calibrator and obtains the absorbance values ​​of each component contained in the calibrator; the biochemical analyzer automatically calculates new correction coefficient values ​​for each component based on the absorbance values ​​obtained from the detection of each component in the calibrator and the target values ​​of the corresponding component content, and compares them with the original correction coefficients of the corresponding component content; when the relationship between the new correction coefficient value and the original correction coefficient of any component content in the calibrator meets the acceptable deviation standard, the correction coefficient of that component content is not modified, and the detection result of that component content in the calibrator is calculated based on the absorbance values ​​obtained from the detection of that component in the calibrator and the original correction coefficient of that component content; when the relationship between the new correction coefficient and the original correction coefficient of any component content in the calibrator meets the preset standard for deviation modification, the biochemical analyzer... The relationship between the absorbance value obtained from the detection of the corresponding component of the calibrator and the target value of the corresponding component content is recalculated to obtain a new correction coefficient for the component content. This new correction coefficient automatically replaces the original correction coefficient for that component content. When the relationship between the new correction coefficient and the original correction coefficient of any component content meets a preset alarm standard, the biochemical analyzer will issue an alarm for that component content. The operator must then confirm whether the correction coefficient needs to be automatically modified based on the absorbance value of that component content. After any correction coefficient is modified, the biochemical analyzer automatically uses the modified correction coefficient to directly calculate the new detection result for the corresponding component content of the quality control sample. The modified correction coefficient is saved for use in obtaining subsequent detection results for the corresponding components of various samples, calibrators, and quality control samples.

[0074] In this embodiment, the biochemical analyzer not only uses the correction coefficients obtained from quality control sample testing to calculate the test results and modify the correction coefficients for subsequent samples, quality control samples, and calibrators; the instrument also accepts modifications to the correction coefficients obtained from calibrator testing. Whether it is quality control testing or calibrator testing, when the evaluation of the test results confirms that the correction coefficient modification for the item is satisfactory, the instrument automatically modifies the correction coefficient for the corresponding item and saves it for subsequent test result calculations when testing samples, quality control samples, and calibrators.

[0075] Optionally, the relationship between the new correction factor for the content of any component of the calibrator and the original correction factor for the corresponding component can be characterized by the following formula:

[0076]

[0077] The newly obtained correction coefficient for the content of the component in this calibrator is calculated directly based on the absorbance value obtained from the detection of the component in this calibrator and the target value of the corresponding component content in this calibrator.

[0078] In some embodiments, the number of deviation level standards for each component of the batch of quality control products is three, including an acceptable deviation standard for the target value of the quality control product, a standard for correcting the target value deviation of the quality control product, and a quality control alarm prompt standard. The degree of deviation is characterized by the deviation value between the detection result of the re-detection of each corresponding component of the quality control product and the target value of each corresponding item of the quality control product. The step three, which involves matching the degree of deviation with the preset deviation level standards, is used to determine the deviation level corresponding to the degree of deviation; and the process of differentiating the correction coefficients of each corresponding item of the quality control product based on the deviation level corresponding to the degree of deviation includes:

[0079] If the deviation value meets the acceptable standard for the target deviation of the quality control product, the correction coefficient of the corresponding item of the quality control product will not be modified.

[0080] If the deviation value meets the correction standard for the target value deviation of the quality control product, the biochemical analyzer automatically recalculates the new correction coefficient for the corresponding item of the quality control product based on the relationship between the new absorbance value obtained from the re-detection of each component of the quality control product and the target value of the corresponding item of the quality control product, and automatically replaces the original correction coefficient of the corresponding item of the quality control product with the new correction coefficient. Alternatively, the biochemical analyzer automatically modifies the correction coefficient of the corresponding item of the quality control product so that the deviation value of the new detection result calculated based on the modified correction coefficient of the corresponding item and the absorbance value of the corresponding item of the quality control product meets the acceptable standard for the target value deviation of the quality control product. The new detection result of the corresponding item of the quality control product is recalculated using the new absorbance value of the corresponding component obtained from the re-detection of the quality control product. Thereafter, the biochemical analyzer uses the modified correction coefficient of the corresponding item when performing the detection of this item on each sample, calibrator, and quality control product.

[0081] If the deviation value meets the quality control alarm standard, the biochemical analyzer will issue an alarm for the test result of that item, and the operator of the biochemical analyzer will confirm whether the correction coefficient for that item needs to be automatically modified based on the quality control test result. If the operator confirms that the correction coefficient for that item needs to be automatically modified based on the quality control test result, the biochemical analyzer will automatically recalculate the new correction coefficient for the corresponding item of the quality control product based on the relationship between the new absorbance values ​​obtained from the retesting of each component of the quality control product and the target value of the corresponding item. The analyzer will then automatically replace the original correction coefficient for the corresponding item with the new correction coefficient and use this newly obtained correction coefficient to recalculate the new test result for the corresponding item based on the new absorbance values ​​obtained from the retesting of the quality control product. If the operator of the biochemical analyzer confirms that the correction factor for this item cannot be automatically modified based on the current quality control test results, other methods will be used to determine the correction factor. For example, if the instrument is repaired and adjusted, or reagents or quality control are replaced, alternative quality control or calibrator tests will be performed, and the correction factor for this item will be determined based on the results of these alternative tests. Subsequently, the biochemical analyzer will use the correction factor confirmed by the operator to calculate the absorbance values ​​obtained from the corresponding items of subsequent samples, calibrators, and quality control samples to obtain the test results for that item, thus forming new correction factors for each corresponding component.

[0082] In this embodiment, before confirming whether to automatically modify the correction factor for this item based on the current quality control test results, the operator of the biochemical analyzer should confirm or perform necessary maintenance on the instrument status, parameter settings, reagents, and quality control materials. After confirming that the above factors of the biochemical analyzer are normal, or after necessary testing and verification, the operator of the biochemical analyzer should then confirm whether to automatically modify the correction factor for this item based on the current quality control test results. The necessary testing and verification may be done by replacing different bottles of quality control materials or using calibrators for testing.

[0083] Optionally, the preset acceptable standard for the target deviation of the quality control product is [-mSD, +mSD], where m ranges from 1 to 7. The preset corrected standard for the target deviation of the quality control product is [-nSD, -mSD)∪(mSD, nSD], where n ranges from 2 to 8 and satisfies n>m. The preset quality control alarm prompt standard is (-∞, -nSD)∪(nSD, +∞), where SD is the standard deviation of the corresponding item for the quality control product.

[0084] In some embodiments, the biochemical analyzer automatically specifies the deviation level standard for the content of each component in the batch of quality control products. Specifically, the instrument automatically sets the standard for correcting the deviation of the quality control product target value to [-2SD, -1SD)∪(1SD, 2SD], and sets the acceptable standard for the deviation of the quality control product target value to [-1SD, +1SD].

[0085] In other embodiments, the number of deviation level standards for the content of each component in the batch of quality control products is four, including an acceptable deviation standard for the quality control product target value, a first correctable deviation standard for the quality control product target value, a second correctable deviation standard for the quality control product target value, and a quality control alarm prompt standard. In this embodiment, the degree of deviation is characterized by the deviation value between the detection result of the re-detection of each corresponding component of the quality control product and the target value of each corresponding item of the quality control product. In this embodiment, step three, matching the deviation degree with a preset deviation level standard, is used to determine the deviation level corresponding to the deviation degree. The process of differentiating the correction coefficients of each corresponding item of the quality control product based on the deviation level corresponding to the deviation degree includes: when the deviation value meets the acceptable standard for the deviation of the quality control product target value, the original correction coefficient of the corresponding item remains unchanged; when the deviation value meets the first standard for correctable deviation of the quality control product target value, the biochemical analyzer automatically modifies the correction coefficient of the corresponding item, and the new detection result calculated based on the modified correction coefficient of the corresponding item and the absorbance value of the corresponding item of the current quality control product meets the acceptable standard for the deviation of the target value of each corresponding item of the quality control product; when the deviation value meets the second standard for correctable deviation of the quality control product target value, the biochemical analyzer automatically modifies the correction coefficient of the corresponding item, and the new detection result calculated based on the modified correction coefficient of the corresponding item and the absorbance value of the corresponding item of the current quality control product meets the first standard for correctable deviation of the quality control product target value; when the deviation value meets the quality control alarm indication standard... On time, the biochemical analyzer will issue an alarm for the test results of this item, and the operator will need to confirm whether the correction factor for this item needs to be automatically modified based on the quality control test results. If so, the biochemical analyzer will automatically recalculate the new correction factor for the corresponding item of the quality control sample based on the relationship between the new absorbance values ​​obtained from the retesting of each component of the quality control sample and the target value of the corresponding item. The new correction factor will then automatically replace the original correction factor for the corresponding item of the quality control sample, and the newly obtained correction factor will be used to apply the results of this quality control test. The new absorbance value of the corresponding component obtained from the retesting of the quality control sample is used to recalculate the new test result for the corresponding item of the quality control sample. If not, other methods are used to determine the correction factor, such as repairing and adjusting the instrument, replacing reagents or quality control, and performing quality control or calibrator tests again, and determining the correction factor for the item based on the alternative test results. Thereafter, the biochemical analyzer uses the correction factor confirmed by the operator of the biochemical analyzer to calculate the test result for the corresponding item by using the absorbance values ​​obtained from the tests of the corresponding items of subsequent samples, calibrators, and quality control samples.

[0086] In this embodiment, the correction standard for the target value deviation of the quality control product has been further refined. The refined correction standard for the target value deviation of the quality control product includes a first correctable standard for the target value deviation and a second correctable standard for the target value deviation of the quality control product. This further refinement of the correction standard for the target value deviation of the quality control product is intended to reduce the calibration range of the test results, ensuring that the biochemical analyzer can meet the quality control management requirements.

[0087] Although in this embodiment, the standard for correcting the deviation of the quality control product target value has been further refined, it is not limited to only refining it into a first standard for correcting the deviation of the quality control product target value and a second standard for correcting the deviation of the quality control product target value, but can also be refined into more standards.

[0088] In some embodiments, the biochemical analyzer also has a function of automatically correcting continuous unidirectional deviations of quality control sample test results. This function includes: if multiple consecutive test results of any item of the quality control sample deviate only unidirectionally from the target value of the corresponding item, where unidirectional deviation from the target value refers to multiple consecutive test results of the quality control sample item forming a positive deviation in one direction relative to the target value of the corresponding item, or multiple consecutive test results of the quality control sample item forming a negative deviation in one direction relative to the target value of the corresponding item, once the number of times the continuous test results of any item of the quality control sample deviate unidirectionally from the target value of the corresponding item reaches the maximum allowed number of continuous unidirectional deviations for the corresponding item, the biochemical analyzer automatically corrects the most recent test result for that item. This correction includes: when multiple consecutive test results of the quality control sample item form a positive deviation in one direction relative to the target value of the corresponding item, the biochemical analyzer modifies the test result of the last test of that item that reached the allowed number of unidirectional deviations. The modified result for that item is the one for which the instrument sets the allowed continuous deviation. The last test result of the quality control product has a zero or negative deviation from the target value of the corresponding item, and the negative deviation meets the preset acceptable standard for the deviation of the quality control product target value. When the test results of the quality control product item form a unidirectional negative deviation relative to the target value of the corresponding item in multiple consecutive tests, the biochemical analyzer modifies the test result of the last test of the quality control product item to reach the number of unidirectional deviations allowed by the instrument. The new test result of the last test of the quality control product item with continuous deviations has a zero or positive deviation from the target value of the corresponding item, and the positive deviation meets the preset acceptable standard for the deviation of the quality control product target value. The instrument recalculates the new correction coefficient of the corresponding item based on the relationship between the absorbance value obtained from the current test of the component of the quality control product item and the new test result of the most recent test of the modified quality control product item. The new correction coefficient of the item replaces the original correction coefficient of the item. From then on, the instrument uses the newly obtained correction coefficient of the item to calculate the test result of the corresponding item for the corresponding items of subsequent samples, calibrators and quality control products. Furthermore, the instrument continues to monitor and automatically correct continuous deviations of the quality control products according to this rule.

[0089] In some embodiments, the biochemical analyzer records and reports the most recent test result of the component of the quality control sample according to the new test result of the most recent test of the component of the quality control sample after modification, or marks the test result of the component of the quality control sample before modification and the test result after modification respectively, or records and reports them simultaneously.

[0090] In some embodiments, the biochemical analyzer uses more than one level of quality control materials for more than one test item during the quality control material testing process; based on the quality control materials, it analyzes, determines, and processes the correction coefficients of more than one level for the content of each item's components; the processed correction coefficients of more than one level for the content of each item's components are applied to the calculation of the test results of the corresponding item's component content when subsequently testing samples, quality control materials, and calibrators.

[0091] Example 1,

[0092] Taking protein content as an example, the specific workflow of this biochemical analyzer in this embodiment for automatically detecting quality control samples and automatically correcting the quality control test results is as follows:

[0093] 1) Each time a specific batch of quality control samples is tested, the operator inputs the batch's information into the biochemical analyzer via scanning, electronic file import, or keyboard input. This information includes the batch number or other unique identifier of the control sample, the target values ​​for each component content, and the range of each component content. The biochemical analyzer calculates three deviation level standards for the protein content of this component based on the target value and corresponding range.

[0094] Specifically, the target value for the protein content of this batch of quality control samples is 23.13 mg / ml. The three preset deviation levels for this component are: acceptable deviation standard for the quality control sample target value, standard requiring correction for the quality control sample target value deviation, and quality control alarm prompt standard. Specifically, the acceptable deviation standard for the quality control sample target value is as follows:

[0095] The deviation of the target value of the quality control product should be corrected according to the standard of [-0.3mg / ml, +0.3mg / ml], which is [-1.8mg / ml, -0.3mg / ml)∪(0.3mg / ml, 1.8mg / ml], and the standard of quality control alarm is (-∞, -1.8mg / ml)∪(1.8mg / ml, +∞).

[0096] In this embodiment, the deviation between the detection results of the re-detection of each corresponding component of the quality control product and the target value of each corresponding item of the quality control product is characterized by the deviation value between the detection results of the re-detection of each corresponding component of the quality control product and the target value of each corresponding item of the quality control product.

[0097] When the deviation value meets the acceptable standard for the target value deviation of the quality control material [-0.3 mg / ml, +0.3 mg / ml], the biochemical analyzer will not modify the correction coefficient for this item.

[0098] When the deviation value meets the correction standard for the target value deviation of the quality control product [-1.8mg / ml, -0.3mg / ml)∪(0.3mg / ml, 1.8mg / ml], the biochemical analyzer automatically modifies the correction coefficient of the corresponding item. The new test result obtained by calculating the corresponding item based on the modified correction coefficient and the absorbance value of the corresponding item of the quality control product is equal to the target value of each corresponding item of the quality control product, or the deviation value of the new test result obtained from the target value of each corresponding item of the quality control product meets the acceptable standard for the target value deviation of the quality control product, that is, it meets the standard [-0.3mg / ml, +0.3mg / ml].

[0099] When the deviation value meets the quality control alarm prompt standard (-∞, -1.8 mg / ml) ∪ (1.8 mg / ml, +∞), the biochemical analyzer will issue an alarm prompt for the test result of that item, and the operator of the biochemical analyzer will confirm whether the correction coefficient of that item needs to be automatically modified based on the quality control test result. If so, the biochemical analyzer will automatically recalculate the new correction coefficient of the corresponding item of the quality control item based on the relationship between the new absorbance value obtained from the retest of each component of the quality control item and the target value of the corresponding item of the quality control item, and automatically replace the original correction coefficient of the corresponding item of the quality control item with the new correction coefficient, and adopt the newly obtained correction coefficient. The correction factor for the item is recalculated based on the new absorbance value of the corresponding component obtained from the retest of the quality control sample to obtain a new test result for the item corresponding to the quality control sample. This new test result for the item corresponding to the quality control sample should be equal to the target value. Alternatively, the biochemical analyzer can be configured to automatically calculate a new correction factor for the item corresponding to the quality control sample by setting the quality control test result to a value that meets a preset acceptable deviation standard for the quality control sample target value. If not, other methods are used to determine the correction factor, such as performing separate quality control or calibrator tests after instrument maintenance and adjustment, reagent or quality control sample replacement, and determining the correction factor for the item based on the separate test results.

[0100] Subsequently, the biochemical analyzer uses the correction coefficient confirmed by the operator to calculate the absorbance values ​​of the corresponding items for each sample, calibrator, and quality control sample to obtain the test results for that item.

[0101] 2) Load the quality control sample to be tested into the sample position or dedicated quality control position of the biochemical analyzer of this embodiment for testing. During testing, the biochemical analyzer of this embodiment tests the different components of the quality control sample according to the normal testing procedure. The biochemical analyzer of this embodiment records the absorbance values ​​at each stage of the reaction between the quality control sample and the reagents for each different item.

[0102] Specifically, when detecting protein content, the protein content detection reagent is first added to the test cup. The instrument detects the test cup containing the reagent and obtains the absorbance value of the test cup and the reagent at this time, which is 0.0030. After the sample is added and fully reacted with the reagent, the absorbance value is 0.2600 when detected again. The net absorbance value obtained after the reagent reacts with the sample is: 0.2600 - 0.0030 = 0.257, in OD.

[0103] 3) In this embodiment, the biochemical analyzer selects the corresponding detection method according to the protein content item and calculates the relationship between the absorbance value of the obtained item component content and the target value of the corresponding item of the quality control product. The corresponding relationship value between the target value of the quality control product and the measured absorbance value is the correction coefficient of the protein content item component content.

[0104] Specifically, the correction factor for the protein content component is 23.13 mg / ml / (0.2600 - 0.0030 OD) = 90.

[0105] 4) The biochemical analyzer in this embodiment automatically retains the correction coefficient of the protein content obtained in step 3, and uses it as the correction coefficient value for the corresponding item's test results when the biochemical analyzer tests the sample, quality control material, and calibrator thereafter.

[0106] 5) The biochemical analyzer analyzes, determines, and processes the correction coefficient for the protein content of the quality control sample, including: re-testing the quality control sample to obtain a new absorbance value for the protein content; directly calculating the re-test result of the corresponding component based on the new absorbance value and the original correction coefficient of the biochemical analyzer; determining the degree of deviation based on the re-test result and the target value of the corresponding component; matching the degree of deviation with a preset deviation level standard to determine the deviation level; and differentiating the correction coefficients for each corresponding component based on the deviation level, including either leaving the correction coefficient unchanged or modifying it. When the correction factor for this item is modified, the biochemical analyzer automatically uses the modified correction factor to calculate the new absorbance value of the component obtained from the retest of the quality control sample, thus obtaining the detection result of the component content of that item in the quality control sample. The modified correction factor is saved for use in obtaining the detection results of subsequent retests of this item on various samples, calibrators, and the quality control sample.

[0107] Under the guidance of the aforementioned methods, procedures, and principles, the biochemical analyzer intelligently monitors, automatically corrects, and manages the quality of its test results.

[0108] Example 2

[0109] In Example 1, when the deviation value meets the correction standard for the target value deviation of the quality control sample, the biochemical analyzer automatically modifies the correction coefficient for the corresponding item. The new test result calculated based on the modified correction coefficient and the absorbance value of the corresponding item of the quality control sample is equal to the target value of each corresponding item of the quality control sample, or the deviation of the new test result from the target value of each corresponding item of the quality control sample meets the acceptable standard for the target value deviation of the quality control sample. The above modification process has the problem of a large calibration range in the test results. Generally speaking, the test results of the quality control sample are acceptable within their allowable reference range. A large calibration range may lead to excessively large deviations in the instrument's test results, especially for items with a large reference range for the quality control sample.

[0110] To address the above issues, in this embodiment, the four preset deviation levels for the project components are divided into an acceptable standard for the target value deviation of the quality control product, a first standard for the target value deviation of the quality control product that can be modified, a second standard for the target value deviation of the quality control product that can be corrected, and a quality control alarm prompt standard. Specifically, the acceptable standard for the target value deviation of the quality control product is [-0.3 mg / ml, +0.3 mg / ml], the first standard for the target value deviation of the quality control product that can be modified is [-0.9 mg / ml, -0.3 mg / ml)∪(0.3 mg / ml, 0.9 mg / ml], the second standard for the target value deviation of the quality control product that can be modified is [-1.8 mg / ml, -0.9 mg / ml)∪(0.9 mg / ml, 1.8 mg / ml], and the quality control alarm prompt standard is (-∞, -1.8 mg / ml)∪(1.8 mg / ml, +∞).

[0111] When the deviation value meets the target deviation of the quality control material, the first standard can be modified [-0.9 mg / ml, -0.3 mg / ml] ∪

[0112] When the concentrations are (0.3 mg / ml, 0.9 mg / ml), the biochemical analyzer automatically adjusts the correction factor for the corresponding item. The new test result, calculated based on the adjusted correction factor and the absorbance value of the corresponding item in the quality control sample, deviates from the target value of each corresponding item in the quality control sample. This deviation meets the acceptable standard for the target value deviation of the quality control sample, i.e., it complies with the requirements.

[0113] [-0.3 mg / ml, +0.3 mg / ml].

[0114] When the deviation value meets the second standard for correction of the quality control target value deviation [-1.8 mg / ml, -0.9 mg / ml], it is acceptable.

[0115] When the concentrations are (0.9 mg / ml, 1.8 mg / ml), the biochemical analyzer automatically modifies the correction factor for the corresponding item. The new detection result, calculated based on the modified correction factor and the absorbance value of the corresponding item in the quality control sample, deviates from the target value of each corresponding item in the quality control sample. This deviation meets the first standard for correctable deviation of the quality control sample target value.

[0116] [-0.9mg / ml, -0.3mg / ml)∪(0.3mg / ml, 0.9mg / ml].

[0117] When the deviation value meets the acceptable standard for the target value deviation of the quality control product and the standard for quality control alarm prompts, the processing method adopted by the biochemical analyzer is the same as that in Example 1, and therefore will not be repeated.

[0118] In this embodiment, the correction standard for the target value deviation of the quality control material is further refined. The refined correction standard for the target value deviation of the quality control material includes a first correctable standard and a second correctable standard. This further refinement of the correction standard for the target value deviation of the quality control material is to reduce the calibration range of the test results, ensuring that the test results of the biochemical analyzer not only comply with quality control management specifications but also have better stability, thus better meeting quality control management requirements.

[0119] Example 3

[0120] In this embodiment, the biochemical analyzer also has the function of automatically correcting continuous unidirectional deviations in the test results of quality control products. This function includes: if the test results of any item of the quality control product deviate only unidirectionally from the target value of the corresponding item in multiple consecutive tests, where unidirectional deviation from the target value means that the test results of any item of the quality control product form a positive deviation in one direction relative to the target value of the corresponding item, or a negative deviation in one direction relative to the target value of the corresponding item, once the test results of any item of the quality control product show continuous deviations in the target value, the function will automatically correct the continuous unidirectional deviations in the test results of the quality control product. When the number of times the unidirectional deviation from the target value of the corresponding item of the quality control product reaches the maximum allowed number of consecutive unidirectional deviations of the quality control product, the biochemical analyzer automatically corrects the most recent test result of that item. The correction includes: when multiple consecutive test results of the quality control product show a unidirectional positive deviation from the target value of the corresponding item, the biochemical analyzer modifies the most recent test result of that item on the quality control product. The modified most recent test result of that item on the quality control product has a zero or negative deviation from the target value of the corresponding item, and the absolute value of the negative deviation meets the following requirements. The preset acceptable standard for target value deviation of the quality control sample is defined. When multiple consecutive test results of a quality control sample item show a unidirectional negative deviation relative to the target value of the corresponding item, the biochemical analyzer modifies the most recent test result of that item for the quality control sample. The new, corrected test result of the most recent test result of that item for the quality control sample has a deviation of zero or a positive deviation from the target value of the corresponding item, and this positive deviation meets the preset acceptable standard for target value deviation of the quality control sample. The instrument uses the absorbance value obtained from the current component detection of that item for the quality control sample and the new, corrected test result of the most recent test result for that item for the quality control sample. The instrument recalculates the interrelationships to obtain new correction coefficients for the corresponding items, and replaces the original correction coefficients for the items with the new correction coefficients. From then on, the instrument uses the newly obtained correction coefficients for the items to calculate the absorbance values ​​of the corresponding items for each subsequent sample, calibrator, and quality control to obtain the test results for the corresponding items. The biochemical analyzer records and reports the most recent test result for the item for the quality control according to the new test result for the most recent test of the item for the quality control according to the revised result, or marks and records and reports the test results before and after the modification respectively.

[0121] The operator uses the biochemical analyzer of this embodiment to perform quality control management on the alkaline phosphatase component of the quality control sample. The target value for the corresponding item of this quality control sample is 40 U / ml, and one standard deviation (1 SD) is 3 U / ml.

[0122] Figure 1This is a chart showing the 30-times / day quality control record of the biochemical analyzer in this embodiment. The biochemical analyzer is set to accept a target deviation standard of [-1SD, +1SD] for the quality control samples, and the maximum number of consecutive unidirectional deviations of the quality control samples is 3 times / day. From... Figure 1 It can be seen that the quality control record charts obtained by the biochemical analyzer fully meet the operator's expected requirements, and the entire process is automatically judged and corrected.

[0123] Figure 2 This is a chart showing another 30 quality control records per day for the biochemical analyzer in this embodiment. The biochemical analyzer is configured with an acceptable standard for target value deviation of the quality control samples for this item as [-2SD, +2SD], and the maximum number of consecutive unidirectional deviations of the quality control samples is set to 3 times per day. Figure 2 As shown, the quality control record charts obtained by this biochemical analyzer fully meet the operator's requirements, and the entire process is automatically judged and corrected.

[0124] Figure 3 This is a chart showing 19 additional quality control records per day for the biochemical analyzer in this embodiment. The biochemical analyzer is configured with the acceptable standard for the target value deviation of the quality control sample for this item as [-2SD, +2SD], the required correction standard for the target value deviation of the quality control sample as [-3SD, -2SD)∪(2SD, 3SD], the quality control alarm indication standard as (-∞, -3SD)∪(3SD, +∞), and the maximum number of consecutive unidirectional deviations of the quality control sample is 4 times per day. Figure 3 It can be seen that the quality control record charts obtained by the biochemical analyzer fully met the specified requirements from the 1st to the 18th day, with automatic judgment and correction. However, on the 19th day, the absolute value of the deviation between the quality control test result and the target value of the quality control sample exceeded 3 SD. Therefore, the quality control test result on the 19th day exceeded the quality control alarm standard. Thus, the biochemical analyzer has an automatic alarm function for quality control test results that exceed the specified deviation. In this case, the operator can check the cause of the deviation and intervene to correct it.

[0125] Figure 4 This is a quality control record chart (14 times / day) for a biochemical analyzer that lacks intelligent quality control and calibration management functions. The operator requires that the deviation between the retest results of this component and the target values ​​of the corresponding items on this quality control sample conforms to [-2SD, +2SD]. For example... Figure 4As shown, the absolute value of the deviation of the biochemical analyzer without intelligent quality control and calibration management functions was less than 2 SD from the 1st to the 5th test per day, and the quality control results met the specifications. However, starting from the 6th test per day, the absolute value of the deviation of the biochemical analyzer without intelligent quality control and calibration management functions exceeded 2 SD for 9 consecutive tests per day, and the absolute value of the deviation of 4 of these tests reached or exceeded 3 SD. That is, the test results of this item by the biochemical analyzer without intelligent quality control and calibration management functions were seriously unqualified in the last 9 tests per day. Under the previous quality control management, the operator of the biochemical analyzer without intelligent quality control and calibration management functions should have corrected the deviation when the quality control test results deviated from the operator's expected acceptable deviation standard. The quality control test results recorded in the figure have exceeded the expected range 9 times per day. In order to maintain the instrument test results in accordance with the expected requirements, a lot of manual intervention and correction are required, which is a lot of work. If no correction is made, it is obvious that the quality of the instrument test results has deviated from the expected acceptable quality control range, which will inevitably lead to poor test result quality.

[0126] The biochemical analyzer provided by this invention can automatically, quickly, and in accordance with regulations complete its own quality control management and effective and safe calibration. While effectively reducing the workload of operators, it provides an intelligent way to ensure that the biochemical analyzer's daily test results meet quality control requirements in a basically automatic manner.

[0127] This invention provides a concept and method for a biochemical analyzer with intelligent quality control and calibration management functions. Many methods and approaches exist for implementing this technical solution; the above description is merely a preferred embodiment of the invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of this invention, and these improvements and modifications should also be considered within the scope of protection of this invention. All components not explicitly stated in this embodiment can be implemented using existing technologies.

Claims

1. A biochemical analyzer with intelligent quality control and calibration management functions, characterized in that, The biochemical analyzer performs the following steps on each batch of quality control samples: Step one, obtaining the information of the batch of quality control samples, including the unique code of the batch of quality control samples, the target value of the content of each item component contained in the quality control samples, and the range of the content of each item component of the batch of quality control samples; the biochemical analyzer calculates three or more deviation level standards of the correction coefficient of each item component of the quality control samples according to the target value of the content of each item component of the quality control samples and the range of the corresponding component content; Step two, detecting the quality control samples to obtain the absorbance value of each item component of the quality control samples; automatically calculating the correction coefficient of the biochemical analyzer for detecting the content of each corresponding item component of the quality control samples according to the relationship between the absorbance value obtained by detecting each item component of the quality control samples and the target value of the content of each corresponding item component of the quality control samples, that is, obtaining the correction coefficient of the correlation between the absorbance value obtained by detecting each item component of the quality control samples by the biochemical analyzer and the target value of the content of each corresponding item component of the quality control samples; The biochemical analyzer saves each item correction coefficient, and thereafter, the biochemical analyzer automatically adopts the correction coefficient of the corresponding item obtained by detecting the quality control samples to directly calculate the absorbance value of each sample corresponding to the item component to obtain the detection result of each sample corresponding to the item component; Step three, the biochemical analyzer analyzes, judges and processes the correction coefficient of each item component of the quality control samples, including: detecting the quality control samples again to obtain the new absorbance value of each item component of the quality control samples; directly calculating the detection result of the re-detection of each corresponding item component of the quality control samples according to the new absorbance value obtained by re-detecting each item component of the quality control samples and the original correction coefficient of each corresponding item component stored in the biochemical analyzer; comparing the detection result of the re-detection of each corresponding item component of the quality control samples with the target value of each corresponding item to obtain the deviation degree of each corresponding item; for any item component, matching the deviation degree with the preset deviation level standard to determine the deviation level corresponding to the deviation degree; based on the deviation level corresponding to the deviation degree, the correction coefficient of each corresponding item of the quality control samples is processed differently, and the different processing includes no modification and modification of the correction coefficient of each corresponding item of the quality control samples; after the correction coefficient of any item is modified, the biochemical analyzer automatically adopts the modified correction coefficient of the corresponding item to directly calculate the detection result of the content of the corresponding item component of the quality control samples from the new absorbance value of the corresponding item component obtained by re-detecting the quality control samples this time; the biochemical analyzer saves the modified correction coefficient of the corresponding item, which is used for the detection result of the re-detection of the corresponding item of each subsequent sample, calibrator and quality control sample; The biochemical analyzer also has the function of automatically correcting the continuous one-way deviation of the detection result of the quality control samples, which includes: If the quality control product of any item continuously detects results deviating from the target value of the corresponding item of the quality control product in one direction, the one-way deviation from the target value of the corresponding item of the quality control product means that the continuous detection results of the quality control product of any item form a positive deviation in one direction with respect to the target value of the corresponding item of the quality control product, or the continuous detection results of the quality control product of any item form a negative deviation in one direction with respect to the target value of the corresponding item of the quality control product. Once the number of continuous detection results of the quality control product of any item deviating from the target value of the corresponding item of the quality control product in one direction reaches the maximum number of allowed continuous one-way deviations of the corresponding item, the biochemical analyzer automatically corrects the last detection result of the item, and the correction includes: when the continuous detection results of the quality control product of any item form a positive deviation in one direction with respect to the target value of the corresponding item of the quality control product, the biochemical analyzer modifies the last detection result of the quality control product of any item to the last detection result of the quality control product of any item reaching the maximum number of allowed one-way deviations, and the modified last detection result of the quality control product of any item has a new detection result of the last detection of the continuous deviation, which has a zero or negative deviation from the target value of the corresponding item of the quality control product, and the negative deviation meets the preset acceptable standard of the target value deviation of the quality control product; when the continuous detection results of the quality control product of any item form a negative deviation in one direction with respect to the target value of the corresponding item of the quality control product, the biochemical analyzer modifies the last detection result of the quality control product of any item to the last detection result of the quality control product of any item reaching the maximum number of allowed one-way deviations, and the modified last detection result of the quality control product of any item has a new detection result of the last detection of the continuous deviation, which has a zero or positive deviation from the target value of the corresponding item of the quality control product, and the positive deviation meets the preset acceptable standard of the target value deviation of the quality control product; the instrument recalculates a new correction coefficient of the corresponding item according to the relationship between the absorbance value obtained by detecting the component of the quality control product of any item and the new detection result of the last detection of the quality control product of any item after modification, and replaces the original correction coefficient of the item with the new correction coefficient of the item, and the instrument uses the new correction coefficient of the item to calculate the detection result of the corresponding item of the subsequent samples, calibrators and quality control products based on the absorbance value obtained by detecting the corresponding item of the subsequent samples, calibrators and quality control products, and the instrument automatically corrects the continuous deviation of the quality control detection result.

2. The biochemical analyzer with intelligent quality control and calibration management function according to claim 1, characterized in that, The biochemical analyzer performs the following steps on the calibrator to be detected: obtaining the information of the calibrator to be detected, the information of the calibrator including the target value of the content of each component of the calibrator; setting the deviation level standard of the correction coefficient of each component of the calibrator, the deviation level standard of the correction coefficient of each component of the calibrator including the acceptable standard of deviation, the standard of deviation to be modified and the alarm prompt standard; analyzing, judging and processing the correction coefficient obtained by detecting each component of the calibrator based on the calibrator, including: the biochemical analyzer detects the calibrator to obtain the absorbance value of each component of the calibrator; The biochemical analyzer automatically calculates new correction coefficient values of each item component detection this time according to the absorbance values obtained by detecting each item component of the calibrator and the target values of the corresponding item component content of the calibrator, and compares them with the original correction coefficients of each corresponding item; when the relationship between the new correction coefficient value of any item of the calibrator this time and the original correction coefficient of the corresponding item meets the acceptable deviation standard, the correction coefficient of the item is not modified, and the detection result of the item component content of the calibrator this time is calculated according to the absorbance value obtained by detecting the item component of the calibrator and the original correction coefficient of the item component content; when the relationship between the new correction coefficient of any item of the calibrator this time and the original correction coefficient of the corresponding item meets the standard that the deviation should be modified, the biochemical analyzer re-calculates the new correction coefficient of the item component based on the relationship between the absorbance value obtained by detecting the item component of the calibrator this time and the target value of the corresponding item of the calibrator, and automatically replaces the original correction coefficient of the item of the calibrator with the new correction coefficient of the item of the calibrator; when the relationship between the new correction coefficient of any item of the calibrator this time and the original correction coefficient of the corresponding item meets the preset alarm prompt standard, the biochemical analyzer alarms the detection result of the item component content, and the operator of the biochemical analyzer confirms whether the correction coefficient of the item needs to be modified according to the absorbance value of the item detection of the calibrator this time; after the correction coefficient of any item is modified, the biochemical analyzer automatically uses the modified correction coefficient of the corresponding item to directly calculate the new detection result of the corresponding item component content of the quality control product this time from the absorbance value obtained by detecting the corresponding item component of the quality control product this time; and saves the modified correction coefficient of the corresponding item, which is used to obtain the detection results of the corresponding item detection of subsequent samples, calibrators and quality control products.

3. The biochemical analyzer with intelligent quality control and calibration management function according to claim 1, characterized in that, the three or more deviation level standards of the correction coefficient of each item component of the quality control product include a quality control target value deviation acceptable standard, a quality control target value deviation should be modified standard and a quality control alarm prompt standard; the deviation degree is represented by the deviation value of the detection result of the re-detection of each corresponding item component of the quality control product and the target value of each corresponding item of the quality control product; the matching based on the deviation degree and the preset deviation level standard in step three is used to determine the deviation level corresponding to the deviation degree; the differentiated processing of the correction coefficient of each corresponding item of the quality control product based on the deviation level corresponding to the deviation degree includes: if the deviation value meets the quality control target value deviation acceptable standard, the correction coefficient of the corresponding item of the quality control product is not modified; If the deviation value meets the quality control target value deviation correction standard, the biochemical analyzer automatically recalculates a new correction coefficient of the corresponding item of the quality control sample according to the relationship between the new absorbance value obtained by re-detecting each item component of the quality control sample and the target value of the corresponding item of the quality control sample, and automatically replaces the original correction coefficient of the corresponding item of the quality control sample with the new correction coefficient of the corresponding item of the quality control sample, or the biochemical analyzer automatically modifies the correction coefficient of the corresponding item of the quality control sample, so that the deviation value between the new detection result calculated according to the modified correction coefficient of the corresponding item and the absorbance value of the corresponding item of the quality control sample and the target value of each corresponding item of the quality control sample meets the quality control target value deviation acceptable standard; and the new absorbance value obtained by re-detecting the corresponding item component of the quality control sample is recalculated to obtain a new detection result of the corresponding item of the quality control sample by using the new correction coefficient of the corresponding item; If the deviation value meets the quality control alarm prompt standard, the biochemical analyzer alarms and prompts the detection result of the item, and the biochemical analyzer operator confirms whether the correction coefficient of the item needs to be automatically modified according to the quality control detection result; if yes, the biochemical analyzer automatically recalculates a new correction coefficient of the corresponding item of the quality control sample according to the relationship between the new absorbance value obtained by re-detecting each item component of the quality control sample and the target value of the corresponding item of the quality control sample, and automatically replaces the original correction coefficient of the corresponding item of the quality control sample with the new correction coefficient of the corresponding item of the quality control sample, and recalculates a new detection result of the corresponding item of the quality control sample by using the new correction coefficient of the corresponding item; if no, other methods are used to determine the correction coefficient, such as instrument maintenance and adjustment, reagent or quality control replacement, re-detection of the calibration sample, determination of the correction coefficient of the item according to the re-detection result, and calculation of the detection result of the corresponding item by using the correction coefficient confirmed by the biochemical analyzer operator for the absorbance value obtained by detecting the corresponding item of each subsequent sample, calibration sample and quality control sample, and formation of a new correction coefficient for each corresponding component.

4. The biochemical analyzer with intelligent quality control and calibration management function according to claim 3, characterized in that, The preset quality control target value deviation acceptable standard is [-mSD, +mSD], and the value range of m is 1 to 7; the preset quality control target value deviation correction standard is [-nSD, -mSD)∪(mSD, nSD], and the value range of n is 2 to 8 and n>m is satisfied; and the preset quality control alarm prompt standard is (-∞, -nSD)∪(nSD, +∞), wherein SD is the standard deviation of the corresponding item of the quality control sample.

5. The biochemical analyzer with intelligent quality control and calibration management function according to claim 1, characterized in that, The three or more deviation level standards of the correction coefficients of each item component of the quality control sample include the quality control target value deviation acceptable standard, the quality control target value deviation correctable first standard, the quality control target value deviation correctable second standard and the quality control alarm prompt standard. The three or more deviation level standards of the correction coefficients of each item component of the quality control sample include the quality control target value deviation acceptable standard, the quality control target value deviation correctable first standard, the quality control target value deviation correctable second standard and the quality control alarm prompt standard. The deviation degree is characterized by a deviation value of a detection result of each corresponding item component of the quality control sample re-detection and a target value of each corresponding item of the quality control sample; The deviation degree is characterized by a deviation value of a detection result of each corresponding item component of the quality control sample re-detection and a target value of each corresponding item of the quality control sample; The deviation degree is characterized by a deviation value of a detection result of each corresponding item component of the quality control sample re-detection and a target value of each corresponding item of the quality control sample; When the deviation value meets the acceptable deviation standard of the target value of the quality control sample, the original correction coefficient of the corresponding item remains unchanged. When the deviation value meets the acceptable deviation standard of the target value of the quality control sample, the original correction coefficient of the corresponding item remains unchanged. When the deviation value meets the acceptable deviation standard of the target value of the quality control sample, the original correction coefficient of the corresponding item remains unchanged. When the deviation value meets the acceptable deviation standard of the target value of the quality control sample, the original correction coefficient of the corresponding item remains unchanged.

6. The biochemical analyzer with intelligent quality control and calibration management function according to claim 1, characterized in that, When the deviation value meets the acceptable deviation standard of the target value of the quality control sample, the original correction coefficient of the corresponding item remains unchanged. When the deviation value meets the acceptable deviation standard of the target value of the quality control sample, the original correction coefficient of the corresponding item remains unchanged. When the deviation value meets the acceptable deviation standard of the target value of the quality control sample, the original correction coefficient of the corresponding item remains unchanged. When the deviation value meets the acceptable deviation standard of the target value of the quality control sample, the original correction coefficient of the corresponding item remains unchanged. 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8. The biochemical analyzer with intelligent quality control and calibration management function according to any one of claims 1 to 7, characterized in that, The correction coefficient obtained by detecting the quality control sample is used for calculating and correcting the detection results of subsequent samples, quality control samples and calibration samples. The instrument also accepts the modification of the correction coefficient based on the detection results of the calibration sample. When the evaluation of the detection results confirms that the correction coefficient of the corresponding item meets the modification requirements, the instrument automatically modifies the correction coefficient of the corresponding item and saves the modified correction coefficient of the corresponding item for subsequent detection of samples, quality control samples and calibration samples.

9. The biochemical analyzer with intelligent quality control and calibration management function according to any one of claims 1 to 7, characterized in that, The biochemical analyzer uses more than one level of quality control sample for more than one detection item during the quality control sample detection process. The correction coefficients of more than one level of each item are analyzed, judged and processed based on the quality control sample. The processed correction coefficients of more than one level of each item are applied to the calculation of the detection results of the corresponding item component content during the subsequent detection of samples, quality control samples and calibration samples. The correction coefficients obtained by detecting different levels of quality control are suitable for the specified detection component concentration range.

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