T/ZJATA 0006-2021 Active Group standards

T/ZJATA 0006-2021 Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-Chemiluminescence Method)

Publish Date: 2021-12-20 Implement Date: 2022-01-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/ZJATA 0006-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine, health, and labor protection

ICS Name: Laboratory medicine

Publish Date: 2021-12-20

Implement Date: 2022-01-20

Scope

Scope: This document specifies the technical requirements, testing methods, inspection rules, marking, labeling, user manuals, packaging, transportation, storage, and quality commitments for human papillomavirus (HPV) nucleic acid detection kits (hereinafter referred to as "kits"). This document applies to human papillomavirus (HPV) nucleic acid detection kits using the hybrid capture–chemiluminescence method. Main technical content: The HPV nucleic acid detection kit is an essential companion product for HPV nucleic acid detection using the hybrid capture–chemiluminescence method. It is used for DNA detection of high-risk HPV infections and can serve as one of the main means of qualitative monitoring after cervical disease diagnosis and treatment. Currently, the use of the hybrid capture–chemiluminescence method for HPV nucleic acid detection has gradually become mature in China. However, no corresponding ISO or IEC standards have been found for HPV nucleic acid detection kits produced using this method. Internationally, most HPV nucleic acid detection kits adhere to enterprise standards. Currently, the domestic industry standard YY/T 1226–2014, "HPV Nucleic Acid (Typing) Detection Kit," sets general standards for methods such as real-time fluorescent PCR, PCR hybridization principles, and enzyme signal amplification. However, it lacks quantitative and detailed specifications for the technical requirements and testing methods of HPV nucleic acid (typing) detection kits using the hybrid capture–chemiluminescence method. For example, the detection limit indicators are not advanced enough, there are no requirements for the cross-reaction rate of negative reference samples, and there are no requirements for the relative photon number variation coefficient in repeatability. The quality of detection kits directly determines the accuracy of test results, making it essential to establish a standard for HPV nucleic acid detection kits (hybrid capture–chemiluminescence m