YY/T 1197-2013 English PDF (YYT1197-2013)

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YY/T 1197-2013: Alanine aminotransferase diagnostic kit (IFCC method)
YY/T 1197-2013
Alanine aminotransferase diagnostic kit (IFCC method)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Alanine aminotransferase assay kit
(IFCC method)
(IFCCmethod)
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 mechanism does 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 drafting unit. China Academy of Food and Drug test.
The main drafters of this standard. Wang Yumei, Huang Jie, Liu Yan, the first noble.
Alanine aminotransferase assay kit
(IFCC method)
1 Scope
This standard specifies alanine aminotransferase assay kit (IFCC method) measurement principle, requirements, test methods, and the use of labels
Instructions, packaging, transportation and storage.
This standard applies to the quality of alanine aminotransferase assay kit (IFCC method) control, the product is used for quantitative in vitro determination of human
Autologous serum or plasma alanine aminotransferase 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.
GB/T 191 Packaging - Pictorial signs
3 Principle of Measurement
Alanine aminotransferase assay kit (IFCC method) is part of the International Federation of Clinical Chemistry (IFCC) recommended improved methods. this
Law principle is used in the catalytic ALT, alanine aminotransferase to α- ketoglutarate to produce pyruvate and glutamate. Pyruvate and
NADH reaction of lactic acid and NAD in the catalytic LDH. NADH at a wavelength of 340nm has a specific absorption peak speed of oxidation
Rate proportional to the activity of serum ALT, and measured the rate of decline in NADH absorbance at 340nm can be calculated ALT activity.
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
It should not be less than 1.0 (wavelength 340nm, optical path 1cm).
4.3.2 Reagent blank absorbance change rate
It should be less than 0.004/min (end-point method is not applicable).
4.4 Linear Interval
Linear range ceiling at least 500U/L, the linear range, linear theory and measured concentrations concentration correlation coefficient r should not be less than 0.9900.