GB/T 40982-2021 in English

VALID

Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) nucleic acid detection kit

Issued on:2021-11-26
Implemented on:2022-03-01
File Format:PDF
Delivery:Within 1 day

Price(USD)： $144.00
$140.00

Standard No:	GB/T 40982-2021
Document status:	VALID
Title in English:	Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) nucleic acid detection kit
Title in Chinese:	新型冠状病毒核酸检测试剂盒质量评价要求
Language:	English
File Format:	Electronic (PDF)
Delivery:	Within 1 day
Issued on:	2021-11-26
Implemented on:	2022-03-01
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	GB-National Standard
Related Keywords:	detection limit verification quality assessment requirements standard evaluation dimensions technical requirements verification methods sensitivity s1-s3 acid detection kit introduction analysis detection limit ≤1:59049 dilution national sensitivity reference
Related Topics:	Detection kit Detection Reagent nucleic acid Quality Evaluation Reagent test kit new gene Nucleic acid kit box price Detection Reagent Detection kit Nucleic acid amplification testing test dose Kidney function test kit Reagent Quality Check Reagent Quality Check Nucleic acid probe primer quality requirements Absolute quantification of virus detection Nucleic acid amplification testing Central Evaluation Quality Inspection Coronavirus Water quality testing box Nucleic acid detection kit Virus Detection Kit Nucleic acid detection box Virus Detection Kit New Test Solution nucleic acid agent Molecular detection Nucleic acid detection new ice box New Analytical Reagents Prion Detection Kit Water quality virus detection egfr detection kit Domestic water quality virus detection A new type of water quality testing Quality Evaluation Nucleic acid detection kit New Mass Spectrometer Detector Kit quality Kit quality new drugs Nucleic acid quantitative machine Micro nucleic acid detection The quality of the kit Water quality testing box About nucleic acid testing abroad novel coronavirus Micro nucleic acid detection How to detect nucleic acid coronavirus first Nucleic acid reagent Kawa, new drug Lithium Detection Kit Lithium Detection Kit pcr nucleic acid technology Novel Rhinovirus Viral RNA Kit GBT40982 GB/T 40982-2021 Lentivirus quality Principle of water quality testing kit COVID-19 nucleic acid standards Ki67 detection kit seahorse kit price Detection method of brucellosis detection kit atp detection kit HIV testing kit sales Structural diagram of the new coronavirusnature Zhang Gaiping's new crown Evaluation of nursing quality for single disease Test quality evaluation Phase nuclear device detection specification requirements Test kit testing standards disclosed Quality requirements for agricultural genetically modified detection kits Respiratory virus multiplex nucleic acid detection kit industry Acid value test Testing kit Viral nucleic acid extraction kit quality Execution of Influenza Virus Nucleic Acid Kit Detection methods for new coronavirus Carburizing agent testing quality COVID-19 detection methods and their advantages and disadvantages COVID-19 sequencing Test kit industry Novel coronavirus testing method steps The most accurate method for detecting the new coronavirus

《GB/T 40982-2021新型冠状病毒核酸检测试剂盒质量评价要求》由TC136（全国医用临床检验实验室和体外诊断系统标准化技术委员会）归口，主管部门为国家药品监督管理局。

Introduction

Analysis of core requirements of the standard

Evaluation dimensions	Technical requirements	Verification methods
Sensitivity	S1-S3 positive, detection limit ≤1:59049 dilution	National sensitivity reference gradient test
Specificity	22 respiratory pathogens negative compliance rate 100%	National negative reference verification
Repeatability	Ct value CV≤5.0% (report Ct value reagent)	Repeat the critical positive sample 10 times

Detailed explanation of key technical indicators

4.4 Detection limit verification

It is required to use the national reference material with a fixed value of digital PCR (3×10⁵ copies/mL) for 1:177147 gradient dilution verification to ensure the detection capability of the kit under extremely low viral loads. The actual validation should include:

S1-S3 must be detected positive
At least 3 independent batches should be validated
Repeat the test 5 times for each dilution

4.6 Cross-reaction control

The standard clearly requires specific validation of 4 human coronaviruses (HKU1/OC43/NL63/229E) and SARS/MERS pseudoviruses, and recommends:

Implementation case: When a company used magnetic bead-based nucleic acid extraction reagents in conjunction with fluorescent PCR detection, it was found that there was a 0.3% cross-reaction rate to OC43 coronavirus. The standard requirements were met after optimizing the probe Tm value.

Standard evolution and industry impact

Compared with the emergency approval requirements in 2020, this standard mainly strengthens:

Add the applicability description of isothermal amplification technology
Clarify the evaluation framework of new methodologies such as CRISPR
Refine the statistical requirements for stability verification

Implementation suggestions

Key points for manufacturers

Establish indoor working standards equivalent to national reference materials
Improve the verification documentation of nucleic acid extraction efficiency (it is recommended to provide ≥95% recovery rate data)
Thermal stability test must include simulation of extreme transportation conditions

Key points of quality control

Quality control links	Frequency	Acceptance criteria
Batch difference	Each production batch	Ct value difference ≤1.5
Transportation verification	Annual verification	Performance degradation ≤5%

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

Sample only — not a preview of GB/T 40982-2021

Loading PDF document...

Error loading PDF. Please make sure the file is valid and try again.

We also recommend

GB/T 40966-2021 in English

Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) antigen detection kit
2021-11-26