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Calibration method

A technology of calibration points and calibrators, which is applied in the direction of material inspection products, instruments, and analytical materials, can solve the problems of time and cost increase, frequency, and requirements for different calibration procedures, and achieve the effect of preventing waste and saving costs

Active Publication Date: 2019-04-02
F HOFFMANN LA ROCHE & CO AG
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  • Claims
  • Application Information

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Problems solved by technology

[0007] Effective throughput and availability as well as the cost of running IVD analytes can be impacted by the fact that significant time may have to be dedicated to performing and repeating calibration procedures
This applies even more to those in vitro diagnostic analyzers that are configured to process different samples and test for different analytes in a random sequence and according to the type of sample and / or according to the assay being used analytes to test different reagents, meaning that different sample / analyte / reagent combinations may require different calibration procedures and be on a more frequent basis
Additionally, the time and cost to perform a calibration procedure increases with the number of calibrator levels required for the same calibration procedure

Method used

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Embodiment Construction

[0070] figure 1 A method for calibrating an in vitro diagnostic analyzer is demonstrated. The method comprises performing a multi-point calibration procedure 100 comprising measuring a plurality of calibrator levels 10, 11, 12, thereby obtaining a plurality of corresponding calibration points 1-n, calculating a result 20 of the multi-point calibration procedure 100 and based on the calculation The results 20 are used to determine whether the multi-point calibration procedure 100 fails or passes 30 . In the event of a failure of the multi-point calibration procedure 100, the method comprises determining 40 whether the failure is associated with one or more individual failed calibration points 1-n, and in the affirmative 50, triggering a repetition 60 only with respect to the failed calibration point 1 The calibrator level 10 is measured and the result 20' of the multi-point calibration procedure 100 is recalculated after replacing only the faulty calibration point 1 with the n...

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Abstract

A computer-implemented method of calibrating an in-vitro diagnostic analyzer is disclosed. The method comprises executing a multi-point calibration procedure comprising measuring a plurality of calibrator levels and thereby obtaining a plurality of respective calibration points. The method further comprises calculating a result of the multi-point calibration procedure and determining failure or passing of the multi-point calibration procedure based on the calculated result. In case of failure of the multi-point calibration procedure, the method comprises determining if failure is related to one or more individual failed calibration point(s), and in the affirmative, triggering a repetition of measuring the calibrator level(s) only with respect to the failed calibration point(s) and re-calculating the result of the multi-point calibration procedure after replacing only the failed calibration point(s) with the newly obtained calibration point(s).

Description

technical field [0001] The present disclosure relates to a computer-implemented method of calibrating an in vitro diagnostic analyzer. Background technique [0002] In medicine, physicians' diagnosis and patient treatment often rely on the measurement of analyte concentrations or other parameters of patient samples. Such measurements are typically performed by in vitro diagnostic analyzers, which can be configured to analyze specific types of samples and use various detection techniques to detect specific types of analytes. Since the life of a patient may depend on the accuracy and reliability of such measurements, it is important that the instrument works correctly. [0003] In vitro diagnostic analyzers are generally required to implement a set of quality control (QC) procedures in order to check that they are working correctly. [0004] One of these procedures is to perform a calibration. In most cases, calibration is performed using standard solutions, whose concentra...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/48
CPCG01N33/48G01N35/00693G01N35/00623G01N2035/00653G01N2035/00702
Inventor M·克林贡夫
Owner F HOFFMANN LA ROCHE & CO AG