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YY/T 1198-2013 English PDF (YYT1198-2013)

YY/T 1198-2013 English PDF (YYT1198-2013)

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YY/T 1198-2013: Aspartate aminotransferase diagnostic kit (IFCC method)

This standard specifies the determination principle, requirements, test method, marks, signs, instructions, packaging, transport and storage of aspartate aminotransferase diagnostic kit (lFCC method). This standard applies to the quality control of aspartate aminotransferase diagnostic kit (lFCC method) This product is used for in-vitro quantitative determination of the aspartate aminotransferase activity in human serum or plasma.
YY/T 1198-2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
Aspartate aminotransferase diagnostic kit
(IFCC method)
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. State Food and Drug Administration
Table Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Determination Principle ... 4
4 Requirements ... 4
5 Test Method ... 6
6 Mark, Label and Instructions ... 9
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. Aspartate aminotransferase diagnostic kit (lFCC method)
1??Scope
This standard specifies the determination principle, requirements, test method, marks, signs, instructions, packaging, transport and storage of aspartate aminotransferase diagnostic kit (lFCC method).
This standard applies to the quality control of aspartate aminotransferase diagnostic kit (lFCC method) This product is used for in-vitro quantitative determination of the aspartate aminotransferase activity in human serum or plasma.
2??Normative??References
The following documents are 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.
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1. General requirements
GB/T 191 Packaging - Pictorial Marking for Handling of Goods
3??Determination??Principle
This method is the method recommended by IFCC. The reaction equation of method principle is as follows.
L-aspartic acid + ??-ketoglutaric acid ??? oxaloacetic acid + L-glutamic acid Oxaloacetic acid + NADH + H+ ??? L-malic acid + NAD+
In the above coupled reaction, the oxidation rate of NADH is proportional to the enzymatic activity of the specimen. NADH has characteristic absorption peak at the wavelength of 340 nm. Therefore, the activity of ALT can be calculated through measuring the decline rate of NADH absorbance.
The amino of L-aspartic acid will be transferred to malic dehydrogenase (MDH) under the catalysis of AST. Then carry out coupled reaction; oxidize the NADH to NAD+. NADH has characteristic absorption peak at the wavelength of 340 nm. Its oxidation rate is proportional to the activity of AST in serum. Therefore, the activity of ALT (U/L) can be calculated through measuring the decline rate of NADH absorbance at 340 nm.
4??Requirements
4.1 Appearance
It shall meet the appearance requirements specified by the manufacturer. AST
MDH
5.8 Stability
Take the reagent (kit), which is stored to the expiry of validity period under the specified storage conditions OR under the accelerated test conditions specified by the manufacturer, for test. It shall meet the requirements of 4.8.
6??Mark,??Label??and??Instructions
6.1 Mark and label of kit packaging box
The packaging-pictorial marking for handling of goods shall meet the requirements of GB/T 191, and shall include at least the following contents.
a) Product name and specification;
b) Production batch number;
c) Expiry date;
d) Storage conditions.
6.2 Mark and label of single kit packaging bottle
The single kit packaging bottle shall include the following contents.
a) Product name and specification;
b) Trademark;
c) Net content of product;
d) Production batch number;
e) Expiry date;
f) Storage conditions.
6.3 Instructions
The instructions shall include the following contents.
a) Product name;
b) Packaging specification;
c) Intended use;
d) Test principle;
e) Main components;
f) Storage conditions and expiry date;
g) Applicable instruments;
h) Sample requirements;
i) Test method;
j) Reference value (reference interval);
k) Explanation of test results;
l) Limitation of the test method;
m) Product performance index;
n) Precautions;
o) References;
p) Manufacturing enterprise;
q) Production enterprise license number of medical device;
r) Registration certificate number of medical device;
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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