YY/T 1517-2017 English PDF (YYT1517-2017)

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YY/T 1517-2017: Detection kit for IgA antibody to epstein-barr viral capsid antigens
YY/T 1517-2017
Detection kit for IgA antibody to epstein-barr viral capsid antigens
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
EB virus capsid antigen (VCA) IgA antibody
Detection kit
Published by.2017-05-02
2018-04-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The organization is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. China Food and Drug Control Research Institute, Zhongshan Bioengineering Co., Ltd.
The main drafters of this standard. Zhou Haiwei, Shi Dawei, Shen Shu, Wang Shengyu, Song Xiaodong, Li Feng, Fan Jieyun, Zhang Chuntao.
EB virus capsid antigen (VCA) IgA antibody
Detection kit
1 Scope
This standard specifies the technical requirements and test of the EB virus capsid antigen (VCA) IgA antibody detection kit (hereinafter referred to as "kit").
Test methods, labels and instructions, packaging, transportation and storage.
This standard is applicable to the qualitative detection of human serum/plasma by the principle of enzyme-linked immunosorbent assay, chemiluminescence assay, time-resolved fluorescence assay, etc.
Kit for EB virus capsid antigen IgA antibody.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 Technical requirements
3.1 Appearance
The appearance should meet the following requirements.
a) The components of the kit should be complete and complete, and the liquid should be free of leakage;
b) Chinese packaging labels should be clear and free of wear.
3.2 Positive reference product compliance rate
Test with a national positive reference or a standardized positive reference, the results should meet the corresponding requirements.
3.3 Negative reference product compliance rate
Test with a national negative reference or a standardized negative reference, the results should meet the corresponding requirements.
3.4 Minimum detection limit
Test with the national minimum detection limit reference or the standard minimum detection limit reference, the results should meet the corresponding requirements.
3.5 repeatability
Test with national repetitive reference products or standardized repetitive reference products, the results should be EB virus capsid antigen IgA antibody
Positive and coefficient of variation (CV,%) should be no more than 15.0%.
3.6 Inter-batch difference
National repetitive reference or standardized repetitive reference was tested with 3 batch kits, inter-assay coefficient of variation (CV, %)
Should not be greater than 20.0%.
3.7 Stability
Verification of shelf life stability and thermal stability.
a) Stability of the validity period. The company shall specify the validity period of the kit. Take the kit within a certain period of time after the expiration date, and check the appearance and positive.
Reference product compliance rate, negative reference product compliance rate, minimum detection limit and repeatability, the results should be consistent with 3.1, 3.2, 3.3, 3.4, 3.5
Corresponding requirements;
b) Thermal stability. The kit is processed under the specified heating conditions (37 ° C) to detect the appearance, positive reference conformity, and negative reference.
Product compliance rate, minimum detection limit and repeatability, the results should meet the corresponding requirements of 3.1, 3.2, 3.3, 3.4, 3.5.
Note 1. Generally, products with a validity period of 1 year are selected for products not exceeding 1 month, products with a validity period of not more than half a month are selected for half a year, and so on. But as super
After the specified time, the product is also acceptable when it meets the requirements.
Note 2. Thermal stability cannot be used to derive the expiration date of a product unless it is based on a derivation formula based on a large number of stability studies.
Note 3. According to the product characteristics, any combination of methods a) and b) can be selected, but the selected method should be able to verify the stability of the product to ensure the performance of the product during the effective period.
meet the standards.
4 Test methods
4.1 Appearance
Visual inspection with normal or corrected visual acuity under natural light shall be in accordance with 3.1.
4.2 Positive reference product compliance rate
Use national positive reference products or standardized positive reference products for testing, according to the product manual, the results should be consistent with 3.2
Claim.
4.3 Negative reference product compliance rate
Use national negative reference or standardized negative reference for testing, according to the product manual, the results should be consistent with 3.3
Claim.
4.4 Minimum detection limit
Use the national minimum detection limit reference product or the standardized minimum detection limit reference product for testing, according to the product manual, the result should be
Meet the requirements of 3.4.
4.5 Repeatability
Take the same batch of kits and repeat the test 10 times with the national repetitive reference or the standardized repetitive reference, and calculate 10 tests.
The average value x- of the result and the standard deviation s, the coefficient of variation CV is calculated according to the formula (1), and the result should meet the requirements of 3.5.
CV=s/x-×100% (1)
In the formula.
CV --- coefficient of variation;
s --- standard deviation;
X- --- The average of the test results.
4.6 Inter-batch difference
Use the three batches of kits to detect the same national repetitive reference or standardized repetitive reference, according to the product specification.
Perform the operation, repeat 10 times each time, calculate the average value x- and standard deviation s of 30 test results, and calculate the coefficient of variation CV according to formula (2).
Meet the requirements of 3.6.
CV=s/x-×100% (2)
In the formula.
CV --- coefficient of variation;
s --- standard deviation;
X- --- The average of the test results.
4.7 Stability
The following methods can be used for verification.
a) Stability of the validity period. the kit will be taken within a certain period of time after the expiration date, and the operation shall be carried out according to the product manual. The result should be in accordance with 3.7a).
Claim.
b) Thermal stability. Place the kit at a certain temperature for a certain period of time (usually 37 ° C), according to the product manual,
The results should meet the requirements of 3.7b).
5 labels and instructions
Should meet the requirements of GB/T 29791.2.
6 Packaging, transportation and storage
6.1 Packaging
The packaging and transportation pictorial signs shall comply with the requirements of GB/T 191. The packaging container should ensure good sealing, completeness, no leakage, no damage.
6.2 Transportation
The kit should be shipped as required by the manufacturer. During transportation, it should be protected from moisture, prevent heavy loads from being piled up, and avoid direct sunlight and rain and snow.
Leach, prevent contact with acid and alkali substances, and prevent damage to the inner and outer packaging.
6.3 Storage
The kit should be stored under the conditions specified by the manufacturer.
references
[1] GB/T 21415-2008 In vitro diagnostic medical devices biological samples of the amount of measurement of calibrators and control substances assigned
Metrology traceability (ISO 17511.2003, IDT)
[2] Pharmacopoeia of the People's Republic of China (2010 Edition)
[3] YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971.2007, IDT)
[4] YY/T 1183-2010 Enzyme-linked immunosorbent assay reagent (box)
7102-
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