YY/T 1515-2017 English PDF (YYT1515-2017)

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YY/T 1515-2017: HIV-1 RNA quantitative assay
YY/T 1515-2017
HIV-1 RNA quantitative assay
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Human immunodeficiency virus (type I) nucleic acid
Quantitative detection reagent (box)
Published by.2017-05-02
2018-04-01 implementation
State Food and Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Requirements 1
4 Test method 2
5 Logo, label and instruction manual 3
6 Packaging, transportation and storage 3
Reference 4
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. The issuing organization of this document 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, Roche Diagnostics Products (Shanghai) Co., Ltd., Mérieux Diagnostic Products (on
Hai) Co., Ltd. Beijing company.
The main drafters of this standard. Xu Sihong, Cai Xiaorong, Bai Dan.
Human immunodeficiency virus (type I) nucleic acid
Quantitative detection reagent (box)
1 Scope
This standard specifies the requirements, test methods, identification, labeling and use of human immunodeficiency virus (I type) nucleic acid quantitative detection reagents.
Express, packaging, transportation and storage.
This standard applies to the application of nucleic acid amplification methods (including real-time fluorescent PCR, nucleotide-based amplification, ie NASBA method and branches)
DNA is bDNA) is a basic principle for the quantitative detection of human immunodeficiency virus (type I) in human serum and/or plasma (HIV-
1) RNA reagent, abbreviated as. human immunodeficiency virus (type I) nucleic acid quantitative detection reagent (box).
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 191-2008 packaging storage and transportation icon
GB/T 29791.2-2013 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostics
Reagent
3 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 HIV-1 RNA positive reference product compliance rate
Testing with a national HIV-1 RNA positive reference or a standardized HIV-1 RNA positive reference, the results should be consistent with the corresponding
Reference product requirements.
3.3 HIV-1 RNA negative reference product compliance rate
Testing with a national HIV-1 RNA negative reference or a standardized HIV-1 RNA negative reference, the results should be consistent with the corresponding
Reference product requirements.
3.4 HIV-1 RNA Quantitative Reference
Use national HIV-1 RNA quantitative reference products or standardized HIV-1 RNA quantitative reference products for testing, the results should be consistent with the corresponding
Reference product requirements.
3.5 HIV-1 RNA Sensitivity Reference
Testing with national HIV-1 RNA sensitivity reference or standardized HIV-1 RNA sensitivity reference, the results should be consistent
The requirements of the corresponding reference products.
3.6 HIV-1 RNA linear reference
Testing with national HIV-1 RNA linear reference or standardized HIV-1 RNA linear reference, the results should be consistent with the corresponding
Reference product requirements.
3.7 Stability
3.7.1 General. Verification of shelf life stability and thermal stability.
3.7.2 Stability of validity. The manufacturer shall specify the period of validity of the product. Reagent (box) for a certain period of time after the expiration date is detected
Sexual reference product conformity rate, negative reference product compliance rate, quantitative reference product, sensitivity reference product and linear reference product, etc., the results should be consistent with
3.1~3.6 corresponding requirements.
3.7.3 Thermal stability test. The reagent (box) is treated under the specified heating conditions (37 ° C), and the appearance, positive reference conformity, and negative are detected.
Reference product conformity rate, quantitative reference product, sensitivity reference product and linear reference product, etc., the results should meet the corresponding requirements of 3.1~3.6.
Note 1. 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 2. Generally, a product with a validity period of 1 year and no more than 1 month is selected, and the validity period is half a year.
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 HIV-1 RNA positive reference product compliance rate
Use the national HIV-1 RNA positive reference or the standardized HIV-1 RNA positive reference to test, according to the product manual
Operation, the results should meet the requirements of 3.2.
4.3 HIV-1 RNA negative reference product compliance rate
Use the national HIV-1 RNA negative reference or the standardized HIV-1 RNA negative reference to test, according to the product manual
Operation, the results should meet the requirements of 3.3.
4.4 HIV-1 RNA Quantitative Reference
Use national HIV-1 RNA quantitative reference products or standardized HIV-1 RNA quantitative reference products for testing, according to product specifications
Operation, the results should meet the requirements of 3.4.
4.5 HIV-1 RNA Sensitivity Reference
Test with national HIV-1 RNA sensitivity reference or standardized HIV-1 RNA sensitivity reference, according to product description
The book is operated and the results should meet the requirements of 3.5.
4.6 HIV-1 RNA Linear Reference
Use the national HIV-1 RNA linear reference or the standardized HIV-1 RNA linear reference to test, according to the product manual
The operation shall be in accordance with the requirements of 3.6.
4.7 Stability
The following methods are available.
a) Stability of the validity period. the reagent (box) within a certain period of time after the expiration date is taken, and the operation is carried out according to the product manual. The result should be in accordance with 3.7.2.
Requirements.
b) Thermal stability. Place the reagent (box) at a certain temperature for a certain period of time (usually 37 ° C), according to the product manual
The results should be in accordance with 3.7.3.
5 logo, label and instruction manual
Should comply with the provisions of GB/T 29791.2-2013.
6 Packaging, transportation, storage
6.1 Packaging
The packaging and transportation pictorial signs shall comply with the provisions of GB/T 191-2008. The packaging container should ensure good sealing, completeness and 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 29791.2-2013 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional use
In vitro diagnostic reagent
[2] Pharmacopoeia of the People's Republic of China (2010 edition) three IV in vitro diagnostics