Method for assigning antibody standard substance and determining antigen neutralization equivalent

一种标准品、抗体的技术，应用在医学检测领域，能够解决抗体检测试剂最低检出限无从精准确定等问题，达到提高检测准确性、提高临床效率、试剂质量稳定的效果

Active Publication Date: 2021-07-16
NANJING LANSION BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the lack of antibody standards, the minimum detection limit of antibody detection reagents cannot be accurately determined

Method used

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  • Method for assigning antibody standard substance and determining antigen neutralization equivalent

Examples

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Comparison scheme
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Embodiment 1

[0027] Embodiment 1: The assignment method of antibody standard substance, specifically comprises the following steps:

[0028] 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.

[0029] This embodiment is to prepare the antibody standard substance (standard substance) of novel coronavirus (COVID-19), and its assigning method is:

[0030] Collect high-titer antibody serum from conva...

Embodiment 2

[0034] Embodiment 2: The method for determining the minimum detection limit of antibody detection reagents specifically includes the following steps:

[0035] 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 detected 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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Abstract

The invention relates to a method for assigning an antibody standard substance and determining an antigen neutralization equivalent, which specifically comprises the following steps: S1, determining the antigen neutralization equivalent of the antibody standard substance or a sample: carrying out gradient dilution on a matrix for an antigen with known purity and concentration, respectively adding the same amount of antibody standard substances or samples containing antibodies into the gradient diluents with different concentrations, and after reaction, carrying out 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 the samples; wherein the measurement unit of the antigen neutralization equivalents of the antibodies in the antibody standard substances or samples in a certain volume is represented by the mass-volume concentration of neutralizable antigens in antibodies; in order to particularly clarify that the mass number in the mass-volume unit is the corresponding amount of the neutralization antigens, NAE such as 1 ng NAE / mL, 1 [mu]g NAE / mL, 1 mg NAE / mL and the like is added after the mass unit.

Description

[0001] This application is a divisional application of the Chinese invention patent application with the application number "202010679432.5", the application date is "July 15, 2020", and the title of the invention is "A method for assigning values ​​to antibody standard products and determining the minimum detection limit of antibody detection reagents". . technical field [0002] The invention relates to the technical field of medical detection, in particular to a method for assigning an antibody standard and determining the neutralization equivalent of an antigen. Background technique [0003] 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 directl...

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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