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YY/T 1197-2013 PDF English

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YY/T 1197-2013: Alanine aminotransferase diagnostic kit (IFCC method)
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YY/T 1197-2013: Alanine aminotransferase diagnostic kit (IFCC method)

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YY ICS 11.100 C 44 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA Alanine Aminotransferase Diagnostic Kit (IFCC Method) Issued on: OCTOBER 21, 2013 Implemented on: OCTOBER 1, 2014 Issued by. State Food and Drug Administration

Table of Contents

Foreword ... 3 1 Scope ... 4 2 Normative References ... 4 3 Determination Principle ... 4 4 Requirements ... 4 5 Test Method ... 5 6 Mark, Label and Instructions ... 8 7 Packaging, Transport and Storage ... 10

Foreword

This Standard was drafted in accordance with the rules specified in GB/T 1.1-2009. Please note that some contents in this Document may involve patents. The issuing organization of this Document does not undertake the responsibility to identify these patents. This Standard was proposed by State Food and Drug Administration. This Standard shall be under the jurisdiction of the China Clinical Laboratory Testing and In vitro Diagnostic Test System of Standardization Administration of China (SAC/TC 136). Drafting organization of this Standard. National Institute for Food and Drug Control. The main drafters of this Standard. Wang Yumei, Huang Jie, Liu Yan, and Gao Shangxian. Alanine Aminotransferase Diagnostic Kit (IFCC Method)

1 Scope

This standard specifies the determination principle, requirements, test method, signs, instructions, packaging, transport and storage, etc. of alanine aminotransferase diagnostic kit (IFCC method). This standard applies to the quality control of alanine aminotransferase diagnostic kit (IFCC method). This product is used for in-vitro quantitative determination of the alanine aminotransferase activity in human serum or plasma.

2 Normative References

The following document is indispensable for the application of this Document. For dated references, only dated edition applies to this document. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 Packaging - Pictorial Marking for Handling of Goods

3 Determination Principle

The alanine aminotransferase diagnostic kit (IFCC method) is the modified methods recommended by the International Federation of Clinical Chemistry (IFCC). The principle of this method is that the alanine amino will be transferred to α-ketoglutaric acid to generate pyruvic acid and glutamic acid, under the catalysis of ALT. Then the pyruvic acid will react with NADH to generate lactic acid and NAD- under the catalysis of LDH. NADH has characteristic absorption peak at the wavelength of 340 nm; and its oxidation rate is proportional to the activity of ALT in serum. Therefore, the activity of ALT can be calculated through determining the decline rate of NADH absorbance at 340 nm.

4 Requirements

4.1 Appearance It shall meet the appearance requirements specified by the manufacturer. 4.2 Load The load of liquid reagent shall not be less than the labelled amount. 4.3 Reagent blank 4.3.1 Absorbance of reagent blank It shall not be less than 1.0 (wavelength of 340 nm, light path of 1 cm). 4.3.2 Rate of change for the absorbance of reagent blank It shall not be greater than 0.004/min (end-point method is not applicable). 4.4 Linear interval s) Product standard number; t) Approval and modification date of the instructions.

7 Packaging, Transport and Storage

7.1 Packaging 7 1.1 Packaging for storage and transport The packaging for storage and transport AND marking of the kit shall meet the requirements of GB/T 191. 7.1.2 Unit packaging 7.1.2.1 The kit shall be complete, labeled clearly, sealed tightly, and free of leakage. 7.1.2.2 The instructions shall be enclosed within the kit. 7.2 Transport Product transport shall be carried out according to the provisions of contract. 7.3 Storage Kit shall be stored under the conditions specified by the manufacturer. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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