YY/T 1523-2017 English PDF (YYT1523-2017)

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YY/T 1523-2017: Bicarbonate assay kit(PEPC enzymatic method)
YY/T 1523-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Bicarbonate Assay Kit
(PEPC Enzymatic Method)
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Requirements ... 4
4 Test Methods ... 6
5 Label and Use Instructions ... 9
6 Package, Transportation and Storage ... 10
Bibliography ... 11
Bicarbonate Assay Kit
(PEPC Enzymatic Method)
1 Scope
This Standard specifies the requirements, test methods, label and use instructions,
package, transportation and storage of bicarbonate assay kit.
This Standard is applicable to the reagent kit performing quantitative detection
(hereinafter referred to as kit) against the carbon dioxide in the human serum or plasma
by phosphoenolpyruvate carboxylase (PEPC) enzymatic method, including the
reagent used by manual, semi-automatic, fully automatic biochemistry analyzer.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 29791.2 In Vitro Diagnostic Medical Devices - Information Supplied by the
Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional
Use
3 Requirements
3.1 Appearance
The appearance of kit shall meet the following requirements.
a) The components of kit shall be complete and intact; there is no liquid leakage;
b) The text and symbols of package label shall be clear.
3.2 Loading amount
It shall be no less than the marked value.
3.3 Reagent blank absorbance
certain period of time after the expiration date; test the reagent blank absorbance,
analytical sensitivity, linear, repeatability, accuracy, which shall meet the requirements
of 3.3, 3.4, 3.5, 3.6.1, 3.7.
3.8.3 Thermal stability test
Test the reagent blank absorbance, analytical sensitivity, linear, repeatability, accuracy,
which shall meet the requirements of 3.3, 3.4, 3.5, 3.6.1, 3.7.
NOTE 1. Thermal stability cannot be used to derive the valid date of the product; unless it is
from a derivation formula based on a large number of stability studies.
NOTE 2. Generally, a product with a valid period of 1 year and no more than 1 month is selected;
the valid period shall be half a year; and so on. However, if it exceeds the specified time, when
the product meets the requirements, it is also acceptable.
NOTE 3. According to the product characteristics, any combination of the methods specified in
3.8.2, 3.8.3 can be selected; but the selected method shall be able to verify the stability of the
product to ensure that the product performance meets the standard requirements with the shelf
life period.
4 Test Methods
4.1 Basic requirements of instrument
Spectrophotometer or biochemical analyzer, the wavelength range shall meet the
requirements for reagent use; biochemical analyzer shall be equipped with thermostat
(temperature value shall be within ±0.3°C of the setting value; fluctuation shall be no
greater than ±0.2°C); the absorbance measurement resolution shall be 0.001 above.
4.2 Appearance
Take visual examination with normal or corrected visual acuity under natural light, the
results shall meet the requirements of 3.1.
4.3 Loading amount
Use general measuring gauge to measure; it shall meet the requirements of 3.2.
4.4 Reagent blank absorbance
Use reagent kit to test the blank sample; record the absorbance value at the dominant
wavelength of the reading point specified in the reagent kit parameters; which shall
meet the requirements of 3.3.
NOTE. The blank sample can be pure water sample, saline, zero calibration solution, and the
Xi – measurement concentration;
T – calibrated concentration of reference material.
4.8.3 Recovery test
Add certain volume of standard solution or pure product to human sample (the volume
ratio between standard solution and human sample shall not generate matrix change;
after adding the standard solution, the total concentration of the sample shall be within
the linear range of the kit); each concentration shall be test for 3 times; calculate the
average value; calculate the recovery rate as per the Formula (5), which shall meet
the requirements of 3.7b).
Where.
R – recovery rate;
V – volume of the added standard solution;
V0 – volume of human sample;
C – mean concentration of detection after human sample is added standard solution;
C0 – mean concentration of detection of human sample;
Cs – concentration of standard solution.
4.9 Stability
4.9.1 Shelf life stability
Take the sample after the expiration date, test as per the method specified in 4.4, 4.5,
4.6, 4.7.1, 4.8, which shall meet the requirements of 3.8.2.
4.9.2 Thermal stability test
Take the sample within the shelf life of product, according to the manufacturer claimed
thermal stability conditions, test as per the methods specified in 4.4, 4.5, 4.6, 4.7.1,
4.8, which shall meet the requirements of 3.8.3.
5 Label and Use Instructions
It shall meet the requirements of GB/T 29791.2.