T/ZJATA 0005-2021 Active Group standards

T/ZJATA 0005-2021 Human Papillomavirus (HPV) Nucleic Acid Detection Hybrid Capture-Chemiluminescence Assay

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 0005-2021

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 abbreviations, methodological principles, instruments and equipment, reagents or materials, samples, detection steps, and detection reports for the nucleic acid detection method of human papillomavirus (HPV) based on hybrid capture and chemiluminescence. This document is applicable to the nucleic acid detection of human papillomavirus (HPV) using the hybrid capture-chemiluminescence principle; Main technical content: The existing cervical cancer screening mainly relies on cytological methods, and the detection results are influenced by many subjective factors. The hybrid capture-chemiluminescence method for HPV nucleic acid detection is a molecular-level detection method based on etiology. It is a rapid and effective detection method that has been invented and implemented in the medical field in recent years, which can detect all 14 high-risk HPV types that cause cervical cancer at one time, with a cervical cancer detection rate of over 99%. This method is currently recognized as the "gold standard" HPV detection technology at home and abroad, with advantages such as high sensitivity, good reproducibility, low risk of misdiagnosis, simplicity, non-invasiveness, and painlessness. It can be carried out in ordinary laboratories and can more objectively evaluate whether the examined women already have cervical cancer precursors or are at high risk of developing cervical cancer precursors. At present, the use of the hybrid capture-chemiluminescence method for HPV nucleic acid detection has gradually matured in China, but there are currently no mature detection standards at home or abroad. Therefore, this document proposes to establish a group standard for the hybrid capture-chemiluminescence method for HPV nucleic acid detection, aiming to fill the domestic gap and provide accurate detection basis for detection institutions to determine the HPV nucleic acid detection, ensuring the reliability of the detection.