title: Regulation and quality evaluation system for HIV diagnostics in China.
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.
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Division of HIV/AIDS and Sexually-Transmitted Virus Vaccines, National Institutes for Food and Drug Control, No. 2, Tiantan Xi Li, Beijing 100050, China.
authors.forename: Sihong
authors.initials: S
authors.lastname: Xu
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Division of HIV/AIDS and Sexually-Transmitted Virus Vaccines, National Institutes for Food and Drug Control, No. 2, Tiantan Xi Li, Beijing 100050, China.
authors.forename: Weijin
authors.initials: W
authors.lastname: Huang
authors.affiliation: Center for Drug Evaluation, China Food and Drug Administration, Jia-1, Fuxing Road, Haidian District, Beijing 100038, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Center for Medical Device Evaluation, China Food and Drug Administration, 3-5/F, Tower B3, Five Buildings, No. 9, Chegongzhuang Street, Xicheng District, Beijing 100044, China.
authors.forename: Juanjuan
authors.initials: J
authors.lastname: An
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Division of HIV/AIDS and Sexually-Transmitted Virus Vaccines, National Institutes for Food and Drug Control, No. 2, Tiantan Xi Li, Beijing 100050, China.
authors.forename: Xiuhua
authors.initials: X
authors.lastname: Li
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Division of HIV/AIDS and Sexually-Transmitted Virus Vaccines, National Institutes for Food and Drug Control, No. 2, Tiantan Xi Li, Beijing 100050, China.
authors.forename: Aijing
authors.initials: A
authors.lastname: Song
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Division of HIV/AIDS and Sexually-Transmitted Virus Vaccines, National Institutes for Food and Drug Control, No. 2, Tiantan Xi Li, Beijing 100050, China.
authors.forename: Jianhui
authors.initials: J
authors.lastname: Nie
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Division of HIV/AIDS and Sexually-Transmitted Virus Vaccines, National Institutes for Food and Drug Control, No. 2, Tiantan Xi Li, Beijing 100050, China.
authors.forename: Chuntao
authors.initials: C
authors.lastname: Zhang
authors.affiliation: Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Division of HIV/AIDS and Sexually-Transmitted Virus Vaccines, National Institutes for Food and Drug Control, No. 2, Tiantan Xi Li, Beijing 100050, China. Electronic address: wangyc@nifdc.org.cn.
authors.forename: Youchun
authors.initials: Y
authors.lastname: Wang
mesh_terms: D002681:China; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000379:methods* / Q000592:standards*; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans
keywords: China; HIV diagnostics; National reference panel; Quality evaluation system; Regulatory framework