YY/T 1200-2013 English PDF (YY/T1200-2013)

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YY/T 1200-2013: Glucose assay kit (Enzymic method)
YY/T 1200-2013
Glucose assay kit (Enzymic method)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Glucose assay kit (enzymatic)
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, publication of this standard
Institutions do 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, Liu Yan, the first noble.
Glucose assay kit (enzymatic)
1 Scope
This standard specifies the measurement principle glucose assay kit (enzymatic), requirements, test methods, marking, labeling and instructions for use, package
Loading, transportation and storage.
This standard applies to hexokinase and glucose oxidase assay kit, the kit for the quantitative analysis of blood in the clinical laboratory
Clear, plasma, urine, cerebrospinal fluid glucose concentration in body fluids.
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
3.1 hexokinase method
Glucose ATP
Hexokinase
------------ → glucose-6-phosphate ADP
Glucose-6-phosphate NAD
G6PDH
----------- → 6- phosphorylation of glucose aldehyde acid NADPH H
Measuring method. end-point method.
Detection wavelength. Manufacturer given wavelength.
3.2 glucose oxidase
Glucose O2 H2O
GOD
-------- → gluconate H2O2
2H2O2 4- amino antipyrine phenol
POD
-------- → quinone imine 4H2O
Measuring method. end-point method.
Detection wavelength. Manufacturer given wavelength.
Under certain wavelength detection generated quinone imine color control standard to calculate the glucose content.
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.