YY/T 1223-2014Total T4 quantitative labelling immunoassay kit (English PDF)
总甲状腺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
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1223-2014 is the English-translated version of 总甲状腺素定量标记免疫分析试剂盒.
YY/T 1223-2014 is the Chinese pharmaceutical industry standard for the kit that measures total thyroxine 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 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 1223-2014
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
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the total thyroxine labeled immunosorbent assay kit for quantitative classification, requirements, test methods, marking, labeling, instructions for use Books, packaging, transportation and storage.
This standard applies to the principles of competition law for the quantitative determination of total thyroxine (TT4) kit (hereinafter referred to as. TT4 kit). package Including enzyme markers (electric) chemiluminescent labels, (time-resolved) fluorescence labeling and other labeling methods, microplates, tubes, magnetic particles, beads and plastic beads As a quantitative determination of TT4 carrier immunoassay kits. This standard does not apply to.
a) colloidal gold-labeled TT4 test strip;
b) all kinds of TT4 with 125I-labeled and other radioisotope RIA or IRMA kit.
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 191 Packaging - Pictorial signs Category 3 TT4 immunoassay kit according to labeling methods can be divided into enzyme-labeled TT4 kit (electric) chemiluminescent labels TT4 test Kit, (time-resolved) fluorescence labeling kits TT4 etc; according to the solid support can be divided into microtiter plate, pipe, magnetic particle, microsphere beads And plastic beads as the carrier of TT4 kit; according to the procedure of the operation can be divided into manual method and automated method TT4 test instrument Cartridge.
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 component was loose body, adding purified After re-solvent such as water should be within 10min to dissolve, no sediment or floc.
4.2 Linear
In 20.0ng/mL ~ 240.0ng/mL range, with lg-logit mathematical model fitting or other appropriate mathematical model fitting, agent Amount - response curve linear correlation coefficient absolute value (| r |) shall not be less than 0.9900.
Note 1. The lower limit of the linear range of not more than 20.0ng/mL, the upper limit of the linear range of not less than 240.0ng/mL.
Note 2. The conversion between common units as follows. 1nmol/L × 0.0777 = 1µg/dL, 1µg/dL × 12.8720 = 1nmol/L, 1nmol/L × 0.7769 = 1µg/L, 1ng/mL × 1.0000 = 1µg/L.
4.3 The minimum detection limit
Should not be higher than 10.0ng/mL.
......
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
Normative references
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