Regulation and quality evaluation system for HIV diagnostics in China. Issue 2 (March 2016)

• Record Type: Journal Article
• Authors: Xu, Sihong; Huang, Weijin; Zhang, Li; An, Juanjuan; Li, Xiuhua; Song, Aijing; Nie, Jianhui; Zhang, Chuntao; Wang, Youchun
• Is Part Of: Biologicals. Volume 44:Issue 2(2016:Mar.)
• Page Start: 111
• Page End: 116
• Publication Date: 2016-03
• Subjects: Regulatory framework -- Quality evaluation system -- National reference panel -- HIV diagnostics -- China; HIV Human immunodeficiency virus -- AIDS Acquired Immuno-Deficiency Syndrome -- NAT nucleic acid tests -- ELISA enzyme-linked immunosorbent assay -- NIFDC National Institutes for Food and Drug Control -- CFDA China Food and Drug Administration -- GMP good manufacturing practice -- gp41 glycoprotein 41 of HIV -- gp160 glycoprotein 160 of HIV -- p24 core antigen of HIV -- IVD In Vitro Diagnostic -- CTSs Common Technical Specifications -- FDA Food and Drug Administration -- CBER Center for Biologics Evaluation and Research -- PMA premarket approval; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2015.12.004
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: A sophisticated regulatory framework has been constructed for Human immunodeficiency virus (HIV) diagnostics in China, which have developed over the past 30 years. China National Institutes for Food and Drug Control acts as the legal institution in this regulatory framework, launching important activities to ensure the quality of HIV diagnostics. These include the analysis of the main problems faced in developing domestic HIV diagnostics, by investigating the quality of HIV diagnostics and their development; exploring the key factors affecting the quality of HIV diagnostics, to determine the criteria for screening national reference samples; the development of new technologies and methods for preparing reference samples; and the establishment of nine types of national reference panels and nine national standards to evaluate the quality of HIV diagnostics. Based on these researches, a quality evaluation system was established, including nine types of national reference panels, nine national standards for HIV diagnostics, and five sample banks (HIV-positive sample bank, HIV-negative sample bank, common international genotype sample bank, seroconversion series sample bank, HIV virus bank) to evaluate the quality of HIV diagnostics in China. The regulatory framework and the quality evaluation system are pivotal in ensuring the quality of the HIV diagnostics licensed in China.