GB/T 40999-2021 in English
VALIDQuality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) total antibody detection kit
- Issued on:2021-11-26
- Implemented on:2022-03-01
- File Format:PDF
- Delivery:Within 1 day
$140.00
《GB/T 40999-2021新型冠状病毒抗体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
Standard Framework and Technology Evolution
GB/T40999-2021 is my country's first national standard for quality evaluation of new coronavirus antibody detection kits, marking the improvement of the emergency standard system in the field of in vitro diagnostics. The standard was quickly formulated and issued within 18 months after the outbreak of SARS-CoV-2, reflecting the technical evolution path from emergency use authorization (EUA) to standardized management.
Analysis of core quality requirements
| Evaluation dimensions | Immunochromatography | Enzyme-linked immunosorbent assay | Chemiluminescence |
|---|---|---|---|
| Physical properties | Membrane strip ≥2.5mm, migration speed ≥10mm/min | No special requirements | |
| Positive compliance rate | Must include 5 IgM + 5 IgG positive samples | ||
| Precision requirements | Color uniformity | CV≤15% | |
Detailed explanation of key technical indicators
Cross-reaction verification requirements
Clause 4.2.2 of the standard clearly requires that negative reference materials must contain 4 human coronaviruses (HKU1/OC43/NL63/229E) and other respiratory pathogen positive samples. This regulation is based on the epidemiological survey data of the Chinese Center for Disease Control and Prevention in 2020, which can effectively avoid false positives caused by seasonal coronaviruses.
Stability verification plan
The standard innovatively adopts a dual-track verification: it requires both shelf life stability (real-time aging) and thermal stability (accelerated aging) as auxiliary evidence. However, it is specially noted that thermal stability data cannot directly deduce the shelf life, and a mathematical model conversion needs to be established.
Implementation suggestions
- Reference material selection: The national reference materials listed in Appendix A (No. 370093-370097) are preferred. Self-built reference materials must contain all components specified in the standard.
- Verification sample size: The precision test requires 10 repetitions (within batch) and 30 repetitions (between batches), in line with CLSI EP05-A3 requirements.
- Data recording: The original light value data must be saved for ELISA/chemiluminescence method, and the coefficient of variation calculation must include the measured value and the cutoff ratio.
Comparison with similar standards
| Standard number | Scope of application | Precision requirements | Reference material type |
|---|---|---|---|
| GB/T40999-2021 | Antibody Test (Total Antibody) | CV≤15% | National Reference Product |
| YY/T 1579-2018 | General Antibody Test for Infectious Diseases | CV≤20% | Enterprise Reference Product |
| FDA EUA (2020) | Emergency Use Authorization | No unified requirements | Commercial Quality Control Product |
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
