Second generation HIV-1 NAT subtype international reference reagent

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NIBSC 12/224 is designated by the World Health Organization (WHO)Second generation HIV-1 NAT subtype international reference reagentMainly used for performance validation and quality control of nucleic acid testing reagents (NAT), ensuring consistency and comparability of testing capabilities for multiple HIV-1 subtypes in different laboratories worldwide.

Overview of Core Information:

‌产品名称‌： HIV-1 NAT subtypes (Main) (2nd International Reference Panel Preparation)

Item number/code: NIBSC 12/224

International standard type: WHO Reference Reagent

Sample size included: 10 freeze-dried samples

Representative HIV-1 subtypes: A, B, C, D, AE, F, G, AG-GH, N group, O group

Virus status: Heat inactivated treatment, no longer infectious activity

Matrix: Negative human plasma

Storage conditions: Upon receipt, it should be stored at -20 ° C or lower temperature

Usage: Only used for the development and quality control of in vitro diagnostic reagents, not suitable for human or animal use

Design background and application value:

Early HIV nucleic acid testing mainly targeted the B subtype virus prevalent in the West, but in most parts of the world, non-B subtypes were predominant. To enhance the broad-spectrum detection, WHO promotes the establishment of a reference panel covering multiple subtypes. NIBSC 12/224 is designed specifically for this purpose, helping laboratories evaluate whether reagents can effectively identify HIV-1 strains with different genetic backgrounds and avoid missed detections.

This panel has been widely used for:

Development and Validation of New HIV Testing Reagents

Inter laboratory comparison and capability assessment

Registration and approval support for diagnostic reagent kits

Instructions for Use:

Each ampoule should be reconstituted in 1ml of nuclease free water.

Gently mix and let it stand for at least 20 minutes.

It is recommended to use it once to avoid repeated freeze-thaw cycles that may affect stability.

Wear protective gloves during operation to prevent the generation of aerosols or cuts.

Safety Tip:

Although the virus contained in the preparation has been inactivated and the source material has been tested negative for HBsAg, anti HIV, and HCV RNA, it is still a biological source substance and should be considered a potential biological hazard. It must be operated in a BSL-2 or higher level laboratory according to regulations.