YY/T 1217-2013Luteinizing hormone quantitative labelling immunoassay kit (English PDF)
促黄体生成素定量标记免疫分析试剂盒
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 1217-2013 is the English-translated version of 促黄体生成素定量标记免疫分析试剂盒.
YY/T 1217-2013 is the Chinese pharmaceutical industry standard for the kit that measures luteinizing hormone quantitatively by a labelled immunoassay.
It specifies the classification, the requirements, the test methods, the marking, the labelling, the instructions for use 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. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 1217-2013
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
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the luteinizing hormone labeled immunosorbent assay kit for quantitative classification, requirements, test methods, marking, labeling and use of said Specification, packaging, transportation and storage.
This standard applies to the double antibody sandwich method for the quantitative determination of the principles of luteinizing hormone (LH) kit (hereinafter referred to as. LH Reagents box). Including enzyme-labeled, (electro) chemiluminescent labels, (time-resolved) fluorescent labels as capture antibody labeling method, in microplates, tubes, magnetic Granules, beads and plastic beads as the carrier coating antibody, quantitative measurement of LH immunoassay kit. This standard does not apply to.
a) various types of colloidal gold-labeled LH test strips;
b) all kinds of LH RIA or IRMA kit and other radiolabelled with 125I.
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.
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements Category 3 LH kit according to different labeling methods can be classified into the enzyme-labeled LH kit (electro) chemiluminescent labels LH kit (time Resolved) fluorescence labeled LH kits etc; according to the solid support can be divided into microtiter plate, pipe, magnetic particle, microsphere beads and plastic beads As the carrier of the LH kits; it can be divided according to the different operating procedures manual method and apparatus for automatic operation of law LH kits.
4 Requirements
4.1 Appearance and physical examination
The kit components should be complete, and outside packaging should be complete, clear labels, no leakage of liquid reagent, lyophilized loose body component was added deionized Once the sub-water complex solvent should be completely dissolved within 20min.
4.2 The minimum detection limit
Should not be higher than 1.0IU/L.
4.3 Accuracy
Kit calibrator with the corresponding concentration of national measurement standards were analyzed simultaneously, double logarithmic or other appropriate mathematical model proposed Together, it requires two dose - response curve does not deviate significantly from the parallel; LH to national standards as reference, the measured value with the kit calibrator Flag titer values should be between 0.900 to 1.100.
4.4 Dose - response curve is linear
In [2.0,100] IU/L range, double logarithmic or other appropriate mathematical model fitting, the dose - response curve linear correlation coefficient (r)
......
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
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
YY/T 0466.1-2023 — Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
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YY/T 1217-2013
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