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JJF 2089-2023 English PDF

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JJF 2089-2023: Calibration Specification for Fully Automated ELISA Analyzers
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
JJF 2089-2023	English	449	Add to Cart	4 days [Need to translate]	Calibration Specification for Fully Automated ELISA Analyzers	Valid	JJF 2089-2023

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Basic data

Standard ID	JJF 2089-2023 (JJF2089-2023)
Description (Translated English)	Calibration Specification for Fully Automated ELISA Analyzers
Sector / Industry	Metrology & Measurement Industry Standard
Word Count Estimation	22,258
Date of Issue	2023-10-12
Date of Implementation	2024-04-12
Issuing agency(ies)	State Administration for Market Regulation

JJF 2089-2023: Calibration Specification for Fully Automated ELISA Analyzers

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
National Metrology Technical Specifications of the People's Republic of China Calibration specifications for fully automatic enzyme-linked immunoassay analyzer Released on 2023-10-12 Implemented on 2024-04-12 Released by the State Administration for Market Regulation Fully automatic enzyme-linked immunoassay analyzer Calibration specifications Focal point: National Biometrics Technical Committee Main drafting unit: China Institute of Metrology Unit participating in the drafting: CCIC (Henan) Metrology and Inspection Co:, Ltd: Henan Institute of Metrology Heilongjiang Institute of Metrology, Verification and Testing The National Biometrics Technical Committee is entrusted with the interpretation of this specification: The main drafters of this specification: Sheng Linghui (China Institute of Metrology) Wu Liqing (China Institute of Metrology) Participating drafters: Ding Fengyuan [CCIC (Henan) Metrology and Inspection Co:, Ltd:] Zhao Yingchen [CCIC (Henan) Metrology and Inspection Co:, Ltd:] Jia Hui (Henan Institute of Metrology) Ding Haiming (Heilongjiang Institute of Metrology, Verification and Testing) Zhou Tong (Heilongjiang Institute of Metrology, Verification and Testing)

Introduction(Ⅱ) 1 Scope(1) 2 Cited documents(1) 3 Terminology and units of measurement(1) 4 Overview(1) 5 Measuring characteristics(2) 6 Calibration conditions(2) 6:1 Environmental conditions(2) 6:2 Measurement standards and other equipment(2) 7 Calibration items and calibration methods (2) 7:1 Adding liquid volume indication error and adding liquid repeatability (3) 7:2 Incubation temperature indication error (3) 7:3 Washing residue(4) 7:4 Stability of absorbance indication (4) 7:5 Absorbance indication error (4) 7:6 Absorbance Repeatability(5) 7:7 Absorbance channel differences(5) 7:8 Absorbance linearity(5) 8 Calibration result expression(6) 8:1 Calibration result processing(6) 8:2 Measurement uncertainty of calibration results(6) 9 Re-schooling time interval(6) Appendix A:1990 International Temperature Scale Pure Water Density Table (7) Appendix B Calibration original record format (8) Appendix C Calibration certificate inner page format (12) Appendix D Example of uncertainty assessment of measurement results of absorbance indication error (13)

Introduction

JJF 1071 "Rules for Writing National Measurement Calibration Specifications", JJF 1001 "General Measurement Terms and Definitions" and JJF 1059:1 "Evaluation and Expression of Measurement Uncertainty" together constitute the basic series supporting the formulation of this specification: specification: The measurement characteristics and calibration methods of the detector part of the fully automatic enzyme-linked immunoassay analyzer in this specification mainly refer to JJG861-2007 "Enzyme Label Analyzer": This specification is released for the first time: Calibration specifications for fully automatic enzyme-linked immunoassay analyzer

1 Scope

This specification applies to the calibration of fully automatic enzyme-linked immunoassay analyzers based on the principle of absorbance measurement:

2 cited documents

This specification references the following documents: JJG861-2007 enzyme label analyzer JJF 1059:1-2012 Evaluation and expression of measurement uncertainty JJF 1071-2010 Rules for Writing National Measurement Calibration Specifications YY/T 1529-2017 Enzyme-linked immunoassay analyzer For dated references, only the dated version applies to this specification; for undated references, only the dated edition applies: The latest version (including all modification orders) shall apply to this specification:

3 Terminology and units of measurement

The following terms and definitions defined in JJG861-2007 and YY/T 1529-2017 apply to this specification: The known antigen or antibody is adsorbed on the surface of the solid phase carrier, and the antigen or antibody is enzyme-labeled with the surface of the solid phase carrier: It is a method of carrying out immune reaction with antibodies or antigens to achieve qualitative or quantitative detection of target objects: Note: Enzyme-linked immunoassay usually adsorbs the antigen or antibody on a solid-phase carrier (coating), and the tested sample (containing the antigen or antibody to be tested) (body) and enzyme-labeled antibodies or antigens, which react with the antigens or antibodies bound to the solid-phase carrier according to a certain procedure to form antigens and antibodies: The amount of enzyme label bound to the complex and the solid-phase carrier is proportional to the amount of the analyte in the sample: After adding the enzyme reaction substrate, The substrate is catalyzed by the enzyme to generate a colored product, and the color reaction of the substrate is used to determine whether there is a corresponding immune reaction: The depth of color reaction and Proportional to the amount of corresponding antibody or antigen in the sample: An instrument that uses the principle of enzyme-linked immunoassay to conduct qualitative and quantitative analysis of samples: All analysis processes include sample The filling of products and reagents, incubation and plate washing, data measurement, result calculation and output are all automated:

4 Overview

Fully automatic enzyme-linked immunoassay analyzer (hereinafter referred to as "analyzer") usually consists of a liquid distribution unit, an incubation unit, It is composed of core modules such as plate washing unit, detection unit and computer system: During measurement, the instrument first passes through the liquid distribution unit The test specimen and enzyme-labeled antigen or antibody are added to the solid-phase carrier (such as 96) coated with antibody or antigen in different steps: well microplate); then transfer the solid phase carrier to the incubation unit and incubate at a constant temperature for a certain period of time; after the incubation is completed, The solid phase carrier is transferred to the washing unit for washing to remove unbound antigens or antibodies; then the chromogenic substrate is added and Incubate and develop color, and finally use a detection unit to measure the absorbance of the reaction solution at a specific wavelength: Qualitative or quantitative analysis is carried out based on the principle that the amount of the test substance is proportional to a certain ratio:

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