YY/T 1259-2015Diagnostic kit for IgG antibody to hepatitis E virus(ELISA) (English PDF)
戊型肝炎病毒IgG抗体检测试剂盒（酶联免疫吸附法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 1259-2015 is the English-translated version of 戊型肝炎病毒IgG抗体检测试剂盒（酶联免疫吸附法）.
YY/T 1259-2015 is the Chinese pharmaceutical industry standard for the diagnostic kit that detects IgG antibody to hepatitis E virus by enzyme-linked immunosorbent assay.
It specifies the terms and definitions, the classification, the requirements, the test methods, the marking, the labelling, the instructions and the rules for packaging, transport and storage, covering the agreement with the national reference materials for positive and negative sera, the detection limit, the specificity, the repeatability and the stability of the kit. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 1259-2015
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 HEV IgG antibody test kit (ELISA) terms and definitions, classification, requirements, test Test methods, marking, labeling, instructions, packaging, transportation and storage.
This standard applies to the principle of indirect ELISA using the hepatitis E virus (HEV) antigen-coated microplate and enzyme-labeled And other anti-human IgG reagent composition kit for the detection of human serum or plasma samples HEV IgG antibodies.
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 Physical examination
3.1.1 Appearance. liquid component should be clear and transparent.
3.1.2 Kit components should be complete, complete, no liquid leakage.
3.2 Traceability
The manufacturer shall provide a source of calibrators used according to GB/T 21415 and the relevant regulations, traceability assignment method and corresponding indicators, as well as Uncertainty and so on.
3.3 Reference product meets the positive rate
For examination by national reference or standardized by the National Reference reference product, 10 parts by detecting anti -HEVIgG positive reference material, false negative Of no more than 1 part.
3.4 Reference product meets the negative rate
For examination by national reference or standardized by the National Reference Reference products, in 30 parts of anti -HEVIgG negative reference materials, false positive Of no more than 1 part.
3.5 The minimum detection limit
For examination by national reference or standardized by the National Reference Reference products, reference material verification of serial dilutions of positive end should be consistent Reference materials detection requirements.
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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 1259-2015
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