YY/T 1182-2020 in English

VALID

Nucleic acids amplification test reagents(kits)

Issued on:2020-02-21
Implemented on:2021-01-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	YY/T 1182-2020
Document status:	VALID
Title in English:	Nucleic acids amplification test reagents(kits)
Title in Chinese:	核酸扩增检测用试剂(盒)
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-02-21
Implemented on:	2021-01-01
Superseding:	YY/T 1182-2010 Nucleic acids amplification test reagents(kits)
Professional Classification:	YY-Pharmaceutics
Related Topics:	Reagent test kit amplify u6 kit For detection Reagents for detection Reagents for testing Kidney function test kit pre-amplification v6 kit q5 kit How to detect nuclides Automatic Nucleic Acid Detection pcr amplification amplification Instant Kit Kit Consumables Uric acid assay kit double amplification Water quality testing box Nucleic Acid Amplification Detection Nucleic acid detection box Test box specification Gold kit reagents Molecular detection Nucleic acid detection Test box specification Reagents for Nucleic Acid Amplification Detection Molecular nucleic acid detection in the kit Uric acid kit egfr detection kit gold kit membrane kit For pcr amplification nucleic acid amplification Micro nucleic acid detection Plasticizer detection multiparameter kit Water quality testing box plant kit plant kit Nucleic Acid Amplification Reagents For amplicon Plasticizer detection Shihe Kit Shihe, kit Standard Box Reagent Nucleic acid detection window period Amplification detection Pulse element kit About nucleic acid testing abroad Domestic kit Micro nucleic acid detection Nucleic acid detection window period Nucleic acid detection pcr kit How to detect nucleic acid non-amplified detection egfr kit Forensic Test Kit Nucleic acid detection without amplification Underwater Nuclear Detection Benzene test kit Nucleic acid detection pcr kit t4 kit Amplification Kit Nucleic acid system Lithium Detection Kit Lithium Detection Kit Kit detection system q7 kit What to detect with pcr amplification pcr rapid detection kit Amplicon Reagents Principle of water quality testing kit ATP kit usage Ki67 detection kit How to use the influenza test kit Glycolysis/OXPHOS Assay Kit Detection method of brucellosis detection kit How to detect amplification detection atp detection kit Covid test kit results hiv nucleic acid detection method HIV testing kit sales cod detection premade reagents Kit S/N Premade reagents for detecting COD Urine RNA nucleic acid detection NanoTemPer his kit Aquatic products special testing kit Abscisic acid elisa detection kit Total chlorine determination kit detection Nuclear phase detector detection Principle and method of urine testing kit Test kit testing standards disclosed Cadmium kit detection method principle test detection amplification new Testing kit International nucleic acid testing Nucleic acid detector industry Carburizing agent testing quality yy/t1182-2020 kit bridge accepted yy/t1182-2010 Test kit industry Test kit group Tuberculosis nucleic acid detection method

本标准规定了核酸扩增检测用试剂（盒）的术语和定义、分类技术要求、试验方法、标签和使用说明、包装、运输和贮存等。
本标准适用于核酸扩增检测用试剂（盒）的质量控制。核酸扩增方法包含聚合酶链反应（PCR）技术与等温核酸扩增技术等。
本标准不适用于下列产品：
用于血源筛查的试剂（盒）；
用于基因测序的试剂（盒）。
本标准为核酸扩增检测用试剂（盒）通用标准，已有专项标准的产品或试剂（盒），宜依据产品特性及专项标准要求，制定相应的产品标准或技术要求。

Introduction

Background of Standard Revision

YY/T 1182-2020 replaces the 2010 version of the standard, mainly responding to the following technical development needs:

The evolution of molecular diagnostic technology from conventional PCR to digital PCR, isothermal amplification and other technologies
Increase in clinical requirements for sensitivity and specificity of nucleic acid detection kits
Harmonization and unification with the GB/T 29791.2 "Performance Evaluation of In Vitro Diagnostic Medical Devices" series of standards

Main Technical Changes

Technical Indicators	Requirements of the 2010 version	Requirements of the 2020 version	Clinical significance
Linear range	Correlation coefficient ≥0.980	Expanded to 3-15 cycle thresholds	Adapt to low viral load detection needs
Precision	CV≤10%	Quantitative detection CV≤5%	Improve result comparability
Detection limit verification	Sample size not specified	≥20 replicates required	Ensure low concentration detection stability

Details of core performance indicators

3.4 Cycle Threshold (Ct)

Define the cycle number corresponding to the intersection of the amplification curve and the threshold line. The standard requires:

The coefficient of variation of the Ct value within the linear range is CV≤5%
The linear relationship of the 10-fold gradient dilution sample needs to be verified

5.2.4 Accuracy Verification

When using certified reference materials (CRM) for verification:

The deviation between the measured value and the nominal value should be ≤0.5 logarithmic level
Non-CRM verification requires methodological comparison

Implementation Recommendations

Laboratory Validation Plan

Precision Verification: Select 3 concentration levels (high, medium, and low) and repeat the test 10 times for each concentration
Detection limit determination: Use the concentration corresponding to 95% positive detection rate
Cross-reaction: Need to test the interference of common homologous sequences

Key points of quality control

Regularly check the temperature consistency between wells of PCR instrument (temperature difference ≤0.5℃)
Establish Levey-Jennings control chart for indoor quality control products
Participate in inter-laboratory quality assessment organized by CAP or CNAS

More samples: JJG 21-2008 DL/T 368-2010 GB 50021-2001(2009)

Sample only — not a preview of YY/T 1182-2020

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