YY/T 1526-2017Detection kit for HIV-1 p24 antigen and antibodies to human immunodeficiency virus (chemiluminescence immunoassay) (English PDF)
人类免疫缺陷病毒抗原抗体联合检测试剂盒（发光类）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 2, 2017
Implementation date
April 1, 2018
Scope
YY/T 1526-2017 is the English-translated version of 人类免疫缺陷病毒抗原抗体联合检测试剂盒（发光类）.
YY/T 1526-2017 is the Chinese pharmaceutical industry standard for the kit that detects HIV-1 p24 antigen together with antibodies to HIV-1 and HIV-2 by chemiluminescence immunoassay, the fourth generation combined screening test.
It sets the requirements, the test methods, the marks, labels and instructions for use and the rules for packaging, transport and storage, covering the agreement with national reference panels, the detection limit for the antigen and for the antibodies, the specificity, the precision and the stability. Issued on 2 May 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1526-2017
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative References4
- 3 Requirements4
- 4 Test Methods6
- 5 Mark, Label and Use Instructions8
- 6 Package, Transportation and Storage8
- Bibliography9
1 Scope
This Standard specifies the requirements, test methods, mark, label and use instructions, package, transportation and storage of detection kit for antigen and antibodies to human immunodeficiency virus (chemiluminescence immuno-assay).
This Standard is applicable to the kit perform qualitative detection of human immunodeficiency virus 1 (HIV-1), p24 antigen and (HIV-1 p24) and HIV (including HIV- 1 and HIV-2) antibodies in the human serum and/or plasma through the light source (including chemiluminescence analysis, immunofluorescence analysis, time-resolved immunofluorescence analysis) excited by special substance based on the sandwich method; namely, detection kit for antigen and antibodies to human immunodeficiency virus.
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 191-2008 Packaging - Pictorial Marking for Handling of Goods
GB/T 29791.2-2013 In Vitro Diagnostic Medical Devices - Information Supplied by the Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional
3 Requirements
3.1 Appearance
reference product of minimum detection limit; the requirements for minimum detection quantity is no higher than 2.5IU/mL (<=2.5IU/mL); and its matrix serum is negative.
3.3.4 Precision
Test with a national precision reference product or a standardized precision reference product; the results are both positive, the coefficient of variation of CV<=15% (n=10).
3.4 Stability
Verification of shelf life stability and thermal stability.
a) Shelf life stability. the period of shelf life for the products specified by the manufacturer. Take the reagent (kit) for a certain period of time before the expiration of valid date; detect the appearance, positive reference product compliance rate, negative reference product compliance rate, minimum detection limit, and precision, and the like items; the results shall meet the requirements of 3.2 and 3.3.
b) handle the reagent (kit) under the specified heating conditions (37°C); detect the appearance, positive reference product compliance rate, negative reference product compliance rate, minimum detection limit, precision, and the like items; the results shall meet the requirements of 3.2 and 3.3.
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.
4 Test Methods
4.4.1 Shelf life stability. take the reagent (kit) for a certain period of time before the expiration of valid date; operate as per the product instructions; the results shall meet the requirements of 3.4 a).
4.4.2 Thermal stability. place the reagent (kit) for certain time under certain temperature conditions (generally 37°C); operate as per the product instructions; the results shall meet the requirements of 3.4 b).
4.1 Appearance
Take visual examination with normal or corrected visual acuity under natural light, the results shall meet the requirements of 3.1.
4.2 HIV antibody detection
4.2.1 Negative reference product compliance rate
Test with a national negative reference product or a standardized negative reference product; operate as per the product instructions; the results shall meet the requirements of 3.2.1.
5 Mark, Label and Use Instructions
It shall conform to the provisions of GB/T 29791.2-2013.
6 Package, Transportation and Storage
6.1 Package
The packaging and transporting pictorial signs shall conform to the provisions of GB/T 191-2008. The packaging container shall ensure the good sealing, completeness, and no leakage, no damage.
6.2 Transportation
The kit shall be transported as required by the manufacturer. During the transportation, it shall be protected from moisture; prevent heavy loads from piling up; avoid direct sunlight, rain and snow; prevent contact with acid and alkali substances; prevent the damage to the inner and outer package.
6.3 Storage
The kit shall be stored under the conditions specified by the manufacturer.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
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Related Standards
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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