YY/T 1791-2021Hepatitis B virus e antibody (HBeAb) detection reagent kit (luminescent immunoassay) (English PDF)
乙型肝炎病毒e抗体检测试剂盒（发光免疫分析法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 6, 2021
Implementation date
May 1, 2023
Scope
YY/T 1791-2021 is the English-translated version of 乙型肝炎病毒e抗体检测试剂盒（发光免疫分析法）.
YY/T 1791-2021 is the Chinese pharmaceutical industry standard for kits that detect hepatitis B virus e antibody by a competitive luminescence immunoassay.
It sets the technical requirements, the test methods, the labels and marks, the instruction leaflet and the rules for packaging, transport and storage, covering the appearance, the agreement with national reference materials, the detection limit, precision and stability.
It applies to kits for the quantitative or qualitative detection of HBeAb in human serum and plasma, whatever the luminescent format: chemiluminescence, microparticle chemiluminescence, electrochemiluminescence or light-initiated chemiluminescence. Issued on 6 December 2021, it has applied since 1 May 2023.
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Document preview — YY/T 1791-2021
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Requirements
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the technical requirements, test methods, labeling, labeling of hepatitis B virus e antibody detection kit (luminescence immunoassay) label, instruction manual, packaging, transportation and storage, etc.
This standard is applicable to the quantitative or qualitative detection of hepatitis B disease in human serum and plasma using the principle of competition method and luminescence analysis technology.
Kit for HBeAb (hereinafter referred to as "HBeAb"). Including chemiluminescence, microparticle chemiluminescence, electrochemiluminescence, photoexcited chemiluminescence and time-resolved fluorescence. This standard does not apply to.
a) HBV e-antibody calibrators and HBV e-antibody quality control products intended to be sold separately;
b) Biochip based on the principle of luminescence immunoassay.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 21415 Metrological traceability of measurement calibrators and control substance assignments in biological samples of in vitro diagnostic medical devices origin
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostic reagents for professional use
3 Requirements
3.1 Quantitative detection kit
3.1.1 Appearance
The following requirements should be met.
a) The components of the kit should be complete and complete, and the liquid should not leak;
b) Chinese packaging labels should be clear and not damaged.
3.1.2 Traceability
The manufacturer should provide the source, assignment method and uncertainty of the calibrator used in accordance with GB/T 21415 and related regulations.
3.1.3 Accuracy
For testing with HBeAb national standard or enterprise standard standardized by national standard, the relative deviation of the measurement results should not be greater than ±20%.
3.1.4 Conformance rate of positive reference products
Use the HBeAb national reference product or the enterprise positive reference product standardized by the national reference product for testing, if the test result is false negative, it will not be detected.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 21415In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- GB/T 29791.2In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
GB/T 21415-2008 — In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
GB/T 21415-2025 — In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
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