YY/T 1197-2013 (YY/T1197-2013, YYT 1197-2013, YYT1197-2013)
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| YY/T 1197-2013 | English | 150 |
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Alanine aminotransferase diagnostic kit (IFCC method)
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YY/T 1197-2013
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| Standard ID | YY/T 1197-2013 (YY/T1197-2013) | | Description (Translated English) | Alanine aminotransferase diagnostic kit (IFCC method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 10,181 | | Quoted Standard | GB/T 191 | | Drafting Organization | Chinese Institute of Food and Drug test | | Administrative Organization | National medical clinical laboratory testing and in vitro diagnostic systems Standardization Technical Committee | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the measurement principle enzyme alanine aminotransferase assay kit (IFCC method), requirements, test methods, labeling and instructions for use, packaging, transportation and storage. This standard applies to alanine aminotransfer |
YY/T 1197-2013
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.
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