YY/T 1580-2018Creatine kinase MB isoenzyme (CK-MB) testing kit (immunoinhibition method) (English PDF)
肌酸激酶MB同工酶测定试剂盒（免疫抑制法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
February 24, 2018
Implementation date
March 1, 2019
Scope
YY/T 1580-2018 is the English-translated version of 肌酸激酶MB同工酶测定试剂盒（免疫抑制法）.
YY/T 1580-2018 is the Chinese pharmaceutical industry standard for the creatine kinase MB isoenzyme assay kit based on the immunoinhibition method.
It sets the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the appearance, the blank absorbance, analytical sensitivity, linearity, precision, accuracy and stability.
It applies to kits used manually or on semi-automatic and automatic biochemical analysers. Issued on 24 February 2018, it has applied since 1 March 2019.
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Document preview — YY/T 1580-2018
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 the requirements, test methods, labels and instructions for use of the creatine kinase MB isoenzyme assay kit, packaging, transportation and Storage.
This standard applies to the creatine kinase MB isoenzyme assay kit (immunosuppression method) (hereinafter referred to as the kit), including manual and semi-self Reagents used on dynamic and fully automated biochemical analyzers.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 Requirements
3.1 Appearance
The components of the kit should be complete and complete, and the liquid should be free of leakage.
3.2 Loading
It should be no less than the value indicated.
3.3 Reagent blank
3.3.1 Reagent blank absorbance
When using a blank sample to add a reagent test, the reagent blank absorbance should be small at the measurement wavelength (1 cm diameter) specified in the kit instructions. At 0.5.
3.3.2 Reagent blank absorbance change rate
When a blank sample is added to the reagent test, the reagent blank absorbance change rate (deltaA/min) should be no more than 0.002.
3.4 Analytical sensitivity
When measuring a 100 U/L sample, the rate of change in absorbance (deltaA/min) should be not less than 0.008.
3.5 Linear
The linear range of the kit should cover [10,200] U/L, which should be consistent in this interval.
a) the linear correlation coefficient (r) should be not less than 0.990;
b) In the [10,50] U/L interval, the linear deviation should not exceed ±2.5 U/L; in the (50,200) U/L interval, the linear deviation should not exceed ±5%.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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