YY/T 1248-2014Hepatitis B virus surface antibody(HBsAb) detection reagent(kit)(Chemiluminescent immunoassay) (English PDF)
乙型肝炎病毒表面抗体测定试剂（盒）（化学发光免疫分析法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1248-2014 is the English-translated version of 乙型肝炎病毒表面抗体测定试剂（盒）（化学发光免疫分析法）.
YY/T 1248-2014 is the Chinese pharmaceutical industry standard for the reagent kit that detects the surface antibody of hepatitis B virus by chemiluminescent immunoassay.
It specifies the technical requirements, the test methods, the logos, the labels, the instruction manual and the rules for packaging, transport and storage, covering the detection limit, the agreement with the national reference materials, the linear range, the precision, the hook effect and the stability of the reagent. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 1248-2014
National Standard of the People's Republic of China
- ICS
- 11.100
- 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 GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the hepatitis B surface antibody assay reagent (kit) (chemiluminescent immunoassay) technical requirements, test methods, Logos, labels, brochures, packaging, transportation and storage.
This standard applies to the use of chemiluminescence analysis, using the principle of double antigen sandwich method qualitative or quantitative determination of human serum, plasma beta Hepatitis virus surface antibody (hereinafter referred to as "HBsAb") reagent (box). Including chemiluminescence, ECL, and time-resolved fluorescence method. This standard does not apply to.
a) intended for sale separate hepatitis B surface antibody calibrators and control materials hepatitis B surface antibody;
b) by CLIA for the principle of biochips.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 21415 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrological traceability Derived
3 Requirements
3.1 Quantitative assay reagent (kit)
3.1.1 Appearance
Shall meet the following requirements.
a) a liquid component should be clear and transparent;
b) reagent (box) of each component should be complete, complete, no liquid leakage; Chinese packaging labels should be clear, no damage.
3.1.2 Traceability
Manufacturers should provide a source of calibrators used according to GB/T 21415 and the relevant provisions, assignment methods, and uncertainty and so on.
3.1.3 Accuracy
With HBsAb national reference or standardized by the National Reference Reference products as samples for testing, the relative deviation of measurement results It should be within ± 20% range.
3.1.4 Reference material negative coincidence rate
With the national reference or standardized by the National Reference negative reference materials were determined not appear positive.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
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
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1248-2014
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