YY/T 1677-2019Vitamin B12 testing kit ( labelling immunoassay ) (English PDF)
维生素B12测定试剂盒（标记免疫分析法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 23, 2019
Implementation date
October 1, 2020
Scope
YY/T 1677-2019 is the English-translated version of 维生素B12测定试剂盒（标记免疫分析法）.
YY/T 1677-2019 is the Chinese pharmaceutical industry standard for the vitamin B12 assay kit based on a labelled immunoassay.
It sets the requirements, the test methods, the identification, labels and instructions for use and the rules for packaging, transport and storage, covering the appearance, the traceability of the calibrator, accuracy, linearity, the detection limit, precision, interference and stability.
It applies to kits for the quantitative determination of vitamin B12 in human serum or plasma. Issued on 23 October 2019, it has applied since 1 October 2020.
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Document preview — YY/T 1677-2019
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 the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies requirements for human vitamin B12 quantitative labeling immunoassay kits, test methods, identification, labels, instructions for use, Packaging, transportation and storage.
This standard is applicable to immunoassay kits for the quantitative determination of vitamin B12 in human serum or plasma in vitro. This standard does not apply to.
a) Qualitative or semi-quantitative reagents (such as test strips, biochips, etc.) for human vitamin B12 labeled with colloidal gold or other methods;
b) Vitamin B12 calibrators and vitamin B12 quality controls intended for sale separately.
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 version (including all amendments) applies to this document.
GB/T 191 Packaging, storage and transportation icon
GB/T 21415 Metrological tracing of measurement of calibrators and control substances in biological samples of in vitro diagnostic medical devices Source
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 Appearance
The appearance should meet the following requirements.
a) The components of the kit should be complete and complete, and the liquid should not leak;
b) The marking shall be clear and easy to identify.
3.2 Traceability
The manufacturer should provide the source, assignment process and uncertainty of the calibrator used according to GB/T 21415 and related regulations.
3.3 Accuracy
You can choose one of the following methods for verification (if applicable, the relative deviation method is preferred).
a) Relative deviation. measured using a certified reference material (CRM) or other recognized reference material that can be used to evaluate conventional methods The relative deviation between the measured value and the marked value should be within ± 15%;
b) Recovery test. The recovery rate should be in the range of 85% to 115%.
3.4 Detection limit
The detection limit should be <=145pg/mL.
3.5 Linear
The linear range should cover 150pg/mL ~ 1000pg/mL. Within the linear range specified by the manufacturer, the correlation coefficient r should be >=0.990.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 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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