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Method for assigning antibody standard substance and determining minimum detection limit of an antibody detection reagent

An antibody detection and detection limit technology, applied in the field of medical detection, can solve the problems of inability to determine the minimum detection limit of antibody detection reagents, inaccurate determinations, etc., to improve detection accuracy, stable reagent quality, and improve clinical efficiency. Effect

Active Publication Date: 2021-01-08
NANJING LANSION BIOTECH CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is to provide a method for assigning values ​​to antibody standard products and determining the minimum detection limit of antibody detection reagents. It can also be used as an assignment method for the activity of antibody standards

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: The assignment method of antibody standard substance, specifically comprises the following steps:

[0026] Determination of antigen neutralization equivalent of S1 antibody standard: Dilute the antigen of known purity and concentration with matrix to obtain a series of gradient dilutions of different concentrations; add an equal amount of Antibody standard, after the reaction, use the first antibody detection reagent to detect the antibody of each mixed solution, so as to determine the antigen neutralization equivalent of the antibody standard, so as to assign a value to the antibody standard; among them, the amount of antibody in the antibody standard Values ​​are expressed in mass-volume concentration units of their antigen neutralizing equivalents.

[0027] This example is to prepare the antibody standard (standard substance) of the new coronavirus (COVID-19), and its value assignment method is:

[0028] Collect high-titer antibody serum from convalesc...

Embodiment 2

[0032] Embodiment 2: The method for determining the minimum detection limit of antibody detection reagents specifically includes the following steps:

[0033] Determination of antigen neutralization equivalent of S1 sample: The antigen with known purity and concentration is serially diluted with matrix, and the dilution ratios of the serial dilution are 1:2, 1:4, 1:8, 1:16, 1:32 respectively , 1:64, 1:128, and 1:256 to obtain multiple gradient dilutions with different concentrations; add an equal amount of samples containing specific antibodies to each gradient dilution, react at 37 °C for 30 minutes, and then test each Each mixed solution is tested with a specific antibody detection reagent (primary antibody detection reagent). When a positive reaction occurs in a certain dilution of the mixed solution in the test result, the antigen of the previous higher concentration mixed solution of the mixed solution is determined. The amount is the antigen neutralization equivalent of ...

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PUM

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Abstract

The invention relates to a method for assigning an antibody standard substance and determining the minimum detection limit of an antibody detection reagent. The method specifically comprises the following steps: S1, determining the antigen neutralization equivalent of an antibody standard substance or a sample: carrying out gradient dilution on an antigen with known purity and concentration by using a matrix, respectively adding an equal amount of antibody standard substances or samples containing antibodies into each gradient diluent with different concentrations, and after reaction, carryingout antibody detection on each mixed solution by using a first antibody detection reagent to determine the antigen neutralization equivalent of the antibody standard substances or samples; S2, determining the antibody titer of the samples: carrying out gradient dilution on the samples containing the antibody in the S1 by using a matrix, and carrying out antibody detection on the gradient diluentof each dilution by using a second antibody detection reagent to determine the antibody titer; and S3, obtaining the lowest detection limit of the antibody detection reagent: multiplying the determined antigen neutralization equivalent of the sample by the determined antibody titer of the sample to obtain the lowest detection limit of the second antibody detection reagent.

Description

technical field [0001] The invention relates to the technical field of medical detection, in particular to a method for assigning values ​​of antibody standard products and determining the minimum detection limit of antibody detection reagents. Background technique [0002] In Vitro Diagnostic (In Vitro Diagnosis, IVD) medical devices are products that obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.), including reagents, calibrators, control substances, equipment or systems. Diagnostic reagents are one of the basic tools to detect whether a patient is sick or not, and the accuracy of the results directly affects the doctor's diagnosis and the patient's health and life safety. With the advancement of modern medical technology, more precise requirements are put forward for the results of medical tests, and thus the quality requirements for in vitro diagnostic products are also getting higher and higher. [0003] The preparati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/53
CPCG01N33/6854G01N33/53G01N33/96G01N33/56983G01N2333/165G01N2469/20G01N33/543
Inventor 许行尚杰弗瑞·陈王鹏
Owner NANJING LANSION BIOTECH CO LTD
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