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YY/T 1200-2013 English PDF (YYT1200-2013)

YY/T 1200-2013 English PDF (YYT1200-2013)

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YY/T 1200-2013: Glucose assay kit (Enzymic method)

This Standard specifies the determination principle, requirements, test method, mark, label, instructions, packaging, transport and storage, etc. of glucose assay kit (enzymic method). This Standard uses glucose hexokinase and oxidase method to measure the kit which is used for the quantitative analysis of glucose concentration for serum, plasma, urine, cerebrospinal fluid and other body fluids in clinical examination.
YY/T 1200-2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
Glucose assay kit (Enzymic 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 ... 5
5 Test Method ... 6
6 Mark, Label and Instructions ... 9
7 Packaging, Transport and Storage ... 11
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, Liu Yan, and Gao Shangxian. Glucose assay kit (Enzymic method)
1 Scope
This Standard specifies the determination principle, requirements, test method, mark, label, instructions, packaging, transport and storage, etc. of glucose assay kit (enzymic method). This Standard uses glucose hexokinase and oxidase method to measure the kit which is used for the quantitative analysis of glucose concentration for serum, plasma, urine, cerebrospinal fluid and other body fluids in clinical examination.
2 Normative??References
The articles contained in the following document have become part of this Document when they are quoted herein. For the dated documents so quoted, all the modifications (including all corrections) or revisions made thereafter shall be applicable to this document. GB/T 191 Packaging - Pictorial Marking for Handling of Goods
3 Determination??Principle
3.1 Hexokinase method
Glucose + ATP ----------??? glucose-6-phosphoric acid + ADP
Glucose-6-phosphoric acid + NAD+ ------??? 6-phosphate acid glucose aldehyde acid + NADPH + H+
Assay method. end-point method
Detection wavelength. the wavelength given by the manufacturer.
3.2 Glucose oxidase method
Glucose + O2 + H2O -----??? gluconic acid + H2O2
2H2O2 + 4-amino antipyrine + phenol ------??? quinone-imine + 4H2O
Assay method. end-point method
hexokinase
G6PDH
GOD
POD
Where.
R - recovery rate;
V - volume of standard solution added;
Vo - volume of human serum sample;
C - measured concentration of human serum sample after adding standard solution; co - measured concentration of human serum sample;
cs - concentration of standard solution.
5.6 Analysis sensitivity
Dilute the sample with certain concentration (n units of material to be tested). Measure the absorbance. Calculate the concentration of sample whose light absorption value and blank absorption value are different. The results shall meet the requirements of 4.6. 5.7 Precision
5.7.1 Within-batch precision
Test the reagent (kit) with high and low-value quality control materials (divided into normal interval and pathological interval). Repeat the test for 10 times. Calculate the mean value (????) and standard deviation (SD) of measured values respectively. Calculate the coefficient of variation (CV) of within-batch precision according to Formula (4).
Use high and low-value quality control materials to respectively determine the same-batch of 20 kits to be tested. Calculate the mean value (????1) and standard deviation (SD1) of the 20 measured results.
Use the same quality control material to repeatedly determine the same-batch of 1 kit to be tested for 20 times. Calculate the mean value (????2) and standard deviation (SD2) of the measured results. Calculate the coefficient of variation (CV) of the deviation between the bottles (lyophilized powder) according to Formula (5) and (6).
When SD1< SD2, take CV=0.
The results shall meet the requirements of 4.7.1.
SDbetween-bottles
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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