YY/T 1198-2013 English PDF (YY/T1198-2013)

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YY/T 1198-2013: Aspartate aminotransferase diagnostic kit (IFCC method)
YY/T 1198-2013
Aspartate aminotransferase diagnostic kit (IFCC method)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Aspartate aminotransferase assay kit
(IFCC method)
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this standard may involve patents. The standard release
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Chinese Academy of Food and Drug test.
The main drafters of this standard. Wang Yumei, Huang Jie, Liu Yan, the first noble.
Aspartate aminotransferase assay kit
(IFCC method)
1 Scope
This standard specifies the aspartate aminotransferase assay kit (IFCC method) measurement principle, requirements, test methods, marking, marking
Sign and instructions for use, packaging, transport and storage.
This standard applies to aspartate aminotransferase assay kit (IFCC method) quality control, the product is for in vitro quantitative measurement
Given human serum or plasma aspartate aminotransferase (AST) activity.
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
GB/T 191 Packaging - Pictorial signs
3 Principle of Measurement
Law for the IFCC recommended method. Its principle of the method reaction equation is as follows.
L- aspartic acid α- ketoglutarate →
AST L- glutamate oxaloacetate
Oxaloacetate NADH H →
MDH
NAD-malic acid L-
In the coupling reaction with the oxidation rate of NADH activity was directly proportional specimens, NADH at 340nm wavelength has a specific absorption
Income can be monitored NADH absorbance to calculate the rate of decline of vitality AST.
AST catalytic L- aspartate aminotransferase and malate dehydrogenase (MDH) catalyzed coupling reactions, so that the oxidation of NADH
NAD. NADH has a specific absorption peak at 340nm at a rate proportional to the activity which is oxidized and serum AST in 340nm
NADH absorbance was measured at the rate of descent can be measured AST activity (U/L).
4 Requirements
4.1 Appearance
Compatible with the manufacturer's normal appearance requirements.
4.2 PACKING
Loading amount of the liquid reagent to be less than the labeled amount.
4.3 reagent blank
4.3.1 Reagent blank absorbance
Reagent blank absorbance of not less than 1.0 (wavelength 340nm, optical path 1cm).