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Evaluation method of commoditized quantitative detection kit

A quantitative detection and evaluation method technology, applied in the biological field, can solve problems such as inaccurate evaluation results, inability to judge the interoperability between standard products or standard solutions and kits, and inability to trace upwards in measurement results, etc.

Active Publication Date: 2015-04-29
NAT INST OF METROLOGY CHINA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, due to the lack of national certified reference materials in the evaluation method currently proposed, the accuracy of the standard value of the standard product and standard solution itself cannot be guaranteed, nor can it be judged whether the standard product or standard solution is compatible with the kit. It is impossible to judge whether there is a matrix effect between the standard product and the sample, and the measurement results cannot be traced upwards, which may easily cause inconsistencies in the evaluation results of the same kit in different laboratories; at the same time, in terms of data processing methods, most current statistical methods only calculate Reflecting the discrete nature of the data, the systematic errors of many instruments and experimental conditions in the experimental process were not calculated, resulting in inaccurate evaluation results

Method used

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  • Evaluation method of commoditized quantitative detection kit
  • Evaluation method of commoditized quantitative detection kit
  • Evaluation method of commoditized quantitative detection kit

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Experimental program
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Effect test

Embodiment 1

[0196] An evaluation method for a commercialized quantitative detection kit, which uses national certified reference materials to perform kit performance indicators, including accuracy, precision, detection limit, quantitation limit, linearity, specificity, matrix effect and interoperability. Evaluation and calculation; during the calculation process, the uncertainty evaluation of the evaluation results of accuracy, detection limit, quantification limit, specificity, and matrix effect is carried out; according to the size of the uncertainty, the conformity of the index measurement results and the claimed results is judged ;

[0197] Described accuracy evaluation method comprises the steps:

[0198] (1) Comparison with standard materials or reference methods

[0199] Compared with the standard substance:

[0200] Use the kit to test the same sample at least 6 times, and evaluate the expanded uncertainty of the kit’s measurement results in accordance with the requirements of t...

Embodiment 2

[0270] The commercialized quantitative detection kit evaluation method of the present invention, said kit includes but not limited to insulin chemiluminescent immunoassay kit,

[0271] The method for evaluating using the insulin chemiluminescence immunoassay kit comprises the following steps:

[0272] (1) Dilute insulin standard substances to the following concentration levels with blank serum without insulin, or with BSA solution that has been verified by matrix effect and has interoperability on the Beckman DxI 800 immunoassay system: 143.4pmol / , 15.1pmol / , 44.7 pmol / , 75.2pmol / , 105.0pmol / , 134.5pmol / L, according to formula (1) for accuracy verification. Use the standard substance in the Beckman DxI 800 insulin chemiluminescence immunoassay kit to calibrate the Beckman DxI 800 immunoassay system, then use this system to repeat the measurement of the 143.4pmol / L insulin standard substance solution 6 times, and the average value of the measurement results is 150.1pmol / L L, a...

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Abstract

The invention discloses an evaluation method of a commoditized quantitative detection kit. The method is used for evaluating a sample by evaluation indexes, wherein the evaluation indexes comprise accuracy evaluation, precision evaluation, repeatability evaluation, detection limit evaluation, quantitation limit evaluation, lineation or range evaluation, specificity evaluation, matrix effect and intercommunity evaluation. The evaluation method of the commoditized quantitative detection kit is accurate and reliable and can be accepted by general production enterprises and science researchers.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to an evaluation method for commercialized quantitative detection kits based on standard substances and uncertainty calculations. Background technique [0002] A kit refers to a collection of necessary reagents / equipment to complete a specific experiment. The kit is simple, fast, convenient, suitable for on-site operation, etc. It has lower requirements for matrix analysis and operation skills, and it is easier to realize streamlined and standardized management. It effectively eliminates the influence of subjective factors of experimenters and reduces accidental errors during the experiment. It is widely used in the detection field. [0003] In recent years, the R&D and sales of kits in the global market have shown a rapid upward trend. In 2005, the global market sales exceeded 20 billion US dollars, and the annual growth rate was about 15%. On the one hand, the rapid development of k...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/00
Inventor 武利庆金有训杨彬李佳乐李奥欣
Owner NAT INST OF METROLOGY CHINA