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Evaluation method for ELISA (enzyme-linked immunosorbent assay) detection kit of small molecule compound in food

A technology for small molecule compounds and detection kits, applied in biological testing, measurement devices, analytical materials, etc., can solve the problems of technical difficulties, considerable problems in the evaluation of ELISA detection kits, interference, etc.

Inactive Publication Date: 2014-02-12
CHINESE ACAD OF INSPECTION & QUARANTINE
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  • Summary
  • Abstract
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Problems solved by technology

[0007] In view of the fact that there are not many mature evaluation system schemes available for reference at home and abroad, and the nature of the kit itself makes it impossible to directly copy the evaluation schemes and technologies of other products. At the same time, various complex food matrices will cause many interference factors , so how to accurately evaluate the evaluation of ELISA detection kits for small molecular compounds in food is quite technically difficult

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  • Evaluation method for ELISA (enzyme-linked immunosorbent assay) detection kit of small molecule compound in food

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Embodiment Construction

[0020] Evaluation steps of the present invention are as follows:

[0021] (1) Indoor verification unit

[0022] 1. Linear verification

[0023] Prepare standard solutions at 6 concentration levels including 0 μg / L with the sample diluent provided in the kit. The concentration levels cover the linear range provided by the kit instructions. Each concentration level is divided into 3 days and 2 parallels per day for a total of 6 tests. In parallel, the response signal is plotted against the concentration, the regression equation is presented, and the regression analysis is performed. Calculate the difference (the difference between the actual signal response value and the value shown on the curve) and plot the difference (Y-axis) against the concentration (X-axis) to find a non-random model; if a potential key variation is found, need Model to reduce or eliminate until only random noise values ​​remain. Among them, the number of tests:

[0024] 6 concentration levels × 2 para...

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Abstract

The invention discloses an evaluation method for an ELISA (enzyme-linked immunosorbent assay) detection kit of a small molecule compound, such as residue of a pesticide and veterinary drug, an additive and the like in food. The evaluation method is characterized by comprising the following steps: carrying out laboratory experiments through linear verification, selectivity verification, matrix suitability experiment, change resistance evaluation, inter-batch variation and stability evaluation; and carrying out laboratory collaborative experiment through accuracy verification. The core matrix suitability experiment comprises the steps: determining an appropriate matrix scope, verifying accuracy, calculating deviation, evaluating repeatability and confirming detection limit and quantitation limit. According to the evaluation method, laboratory verification and laboratory collaborative experiment are combined, and the commercialized ELISA detection kit can be accurately evaluated.

Description

technical field [0001] The invention relates to an evaluation technology of an ELISA detection kit, in particular to a quality evaluation method of an ELISA detection kit for small molecular compounds such as agricultural and veterinary drug residues and additives in food. Background technique [0002] The kit mainly exists as a rapid screening method in the analysis and detection work. At the beginning, it appeared as an alternative to the traditional classic method. Almost all kit methods need to use the traditional detection method when problems are found. The method is used as the basis for final confirmation (especially in food physicochemical and microbiological testing), so most people agree with some methodological instability of the kit method, such as false positive rate, false negative rate, quantitative precision, etc. poor degree etc., and accept this possible result error. It is precisely this kind of recognition that makes people ignore the more scientific an...

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Application Information

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IPC IPC(8): G01N33/53
CPCG01N33/53G01N2430/00
Inventor 邹明强王燕飞薛强
Owner CHINESE ACAD OF INSPECTION & QUARANTINE