YY/T 1458-2016Antibodies to thyroid peroxidase quantitative test reagent(chemiluminescent immunoassay) (English PDF)
抗甲状腺过氧化物酶抗体定量检测试剂（盒）（化学发光免疫分析法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1458-2016 is the English-translated version of 抗甲状腺过氧化物酶抗体定量检测试剂（盒）（化学发光免疫分析法）.
YY/T 1458-2016 is the Chinese pharmaceutical industry standard for the reagent that measures antibodies to thyroid peroxidase quantitatively by chemiluminescent immunoassay.
It specifies the requirements, the test methods, the identification, the labelling, the instruction manual and the rules for packaging, transport and storage, covering the appearance, the traceability of the calibrator, the accuracy, the linear range, the detection limit, the precision, the hook effect and the stability of the reagent. Issued on 26 January 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1458-2016
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 reference documents
- 3 Request
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the anti-thyroid peroxidase antibody quantitative detection reagent (box) (chemiluminescence immunoassay method) requirements, test methods, Identification, labeling, instruction manual, packaging, shipping and storage.
This standard is suitable for quantitative determination of human anti-thyroid peroxidase antibody reagent (box) by chemiluminescence immunoassay [ Referred to as "Anti-TPO reagent (box)"]. Anti-TPO reagent (box) according to the different principles of chemiluminescence can be divided into enzymatic and non-enzymatic Optical immunoassay reagent (box), according to the different operating procedures can be divided into manual operation and instrument automatic operation method.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 21415-2008 In Vitro Diagnostic Medical Devices Quantitative Measurement of Biological Samples Metering of Calibration and Control Substance The origin of traceability
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 Request
3.1 Appearance
Should be based on the characteristics of the product packaging requirements of the appropriate appearance requirements, the general composition of the components of the kit should be, traits, inner and outer packaging, labels And so on.
a) kit components should be complete, both inside and outside the packaging should be complete, clear label;
b) liquid reagents no leakage, freeze-dried components were loose body, after the liquid solution evenly (no visible particles, no precipitation).
3.2 Traceability
Should be based on GB/T 21415-2008 and the relevant provisions of the TPO calibrator used to provide the source, the assignment process and measurement uncertainty And so on.
3.3 Accuracy
Accuracy should meet one of the following requirements. a) Relative deviation.
With a reference material (CRM) or other recognized reference material that can be used to evaluate conventional methods as a sample, The relative deviation of the measurement results should not exceed ± 10%. b) Comparison test.
Anti-TPO reagent (box) and the specified analysis system for comparison test.
1) The correlation coefficient (r) should be not less than 0.950 and the slope should be within [0.9,1.1].
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 21415-2008In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
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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
YY/T 0466.1-2009 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2016 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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YY/T 1458-2016
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