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YY/T 1528-2017 English PDF (YYT1528-2017)

YY/T 1528-2017 English PDF (YYT1528-2017)

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YY/T 1528-2017: Myoglobin assay kit(immunoturbidimetric method)

This Standard specifies the requirements, test methods, label and operating manual, package, transportation and storage of myoglobin assay kit (immunoturbidimetric method). This Standard is applicable to the assay kit for the quantitative detection of myoglobin in human serum or plasma by the immunoturbidimetric method (transmission method); it includes reagents used on the manual, semi-automatic, fully automatic biochemical analyzers.
YY/T 1528-2017
YY
NATIONAL PHARMACEUTICAL INDUSTRY
STANDARD OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.100
C 44
Myoglobin Assay Kit
(Immunoturbidimetric Method)
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your EMAIL address in 0~60 minutes.
Table of Contents
Foreword ... 3
1 Scope .. 4
2 Normative References ... 4
3 Requirements ... 4
4 Test Methods .. 6
5 Label and Operating Manual .. 10
6 Package, Transportation and Storage .. 10
Myoglobin Assay Kit
(Immunoturbidimetric Method)
1 Scope
This Standard specifies the requirements, test methods, label and operating manual, package, transportation and storage of myoglobin assay kit (immunoturbidimetric method).
This Standard is applicable to the assay kit for the quantitative detection (hereinafter referred to as assay kit) of myoglobin in human serum or plasma by the
immunoturbidimetric method (transmission method); it includes reagents used on the manual, semi-automatic, fully automatic biochemical analyzers.
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 assay kit shall satisfy.
a) Each component of the assay kit shall be complete, intact, without leakage of the liquid;
b) Letter symbols on the package label shall be clear.
3.2 Content
It shall be no less than the nominal value.
shall be no greater than 10ng/mL; when sample concentration is >100ng/mL, the relative deviation shall be no greater than 10%; 95% test sample shall meet the above requirements.
3.8 Stability
3.8.1 General
Verify the stability of the valid period and thermal stability.
3.8.2 Stability of the valid period
The manufacturer shall specify the valid period of the product. The blank absorbance, analysis sensitivity, linearity, repeatability, accuracy of the product test reagent within certain time after the valid period shall meet the requirements in 3.3, 3.4, 3.5, 3.6.1, 3.7.
3.8.3 Thermal stability test
The blank absorbance, analysis sensitivity, linearity, repeatability, accuracy of the test reagent shall meet the requirements of 3.3, 3.4, 3.5, 3.6.1, 3.7.
NOTE 1. thermal stability can?€?t be used to derive the product valid period, unless it is the derivation formula based on a large amount of stability study data.
NOTE 2. generally, if the valid period is 1 year, select the product not exceeding 1 month, if the valid period is half a year, select the product not exceeding half a month, derive similarly. If the specified time is exceeded, the product still meets the requirements, it is also acceptable. NOTE 3. any combination methods of 3.8.2, 3.8.3 can be selected according to the product characteristics; however, the selected method is suitable for verifying the stability of the product; so that ensure the product properties within the valid period shall meet the standard requirements.
4 Test Methods
4.1 Basic requirements of instrument
For the spectrophotometer or biochemical analyzer, the wavelength range shall meet the requirements of the reagent use; biochemical analyzer with constant temperature device (the temperature value shall be within ??0.3??C of the specified setting value, the fluctuation is no great than ??0.2??C); the absorbance measurement resolution shall be 0.001 above.
4.2 Appearance
reference material (CRM) or other recognized reference materials for 3 times; the test results can be recorded as (Xi); respectively calculate the relative deviation B as per Formula (4); if the 3 results all meet the requirements of 3.7a), then it is judged qualified. If the results greater than or equal to 2 times are nonconforming, then it is judged disqualified. If 1 result doesn?€?t meet the requirements, then re-test continuously for 20 times; respectively calculate the relative deviation as per Formula (4); if the test results greater than or equal to 19 times meet the requirements of 3.7a), then the accuracy shall meet the requirements of 3.7a).
Where.
Bi ?€? relative deviation;
Xi ?€? measurement concentration;
T ?€? calibration concentration of reference material.
4.8.3 Enterprise reference product test
The manufacturer provides the enterprise reference product, which shall be tested as per the routine sample; each sample shall be tested for 3 times; calculate the average value of the test results, which shall meet the requirements of 3.7b).
4.8.4 Comparing test
Use no less than 40 human samples with different concentrations that cover the test concentration range to perform the comparing test by the analysis system with traceability and designed by the manufacturer. Respectively test each sample as per the to-be-tested assay kit and selected analysis system; each sample shall be tested once; use the linear regression method to perform the linear fitting against the two groups of results; then obtain the correlation coefficient (r) and slope of the linear regression equation; calculate the absolute and relative deviation between determination value of each sample?€?s to-be-tested assay kit and the determination value of control system, which shall meet the requirements of 3.7c).
4.9 Stability
4.9.1 Stability of valid period
Take the sample beyond the valid period to test as per the methods stipulated 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

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