title: A collaborative study to establish the first National Standard for HIV-1 RNA nucleic acid amplification techniques (NAT) in Taiwan.
abstract: The World Health Organization (WHO) International Standard (IS) for human immunodeficiency virus type 1 (HIV-1) RNA is only available in limited amounts. It is critical to use the most common HIV-1 genotype as source for secondary standards, e.g. a National Standard for Taiwan. The objective of this study was to establish the first National Standard for HIV-1 RNA NAT assays in Taiwan. A collaborative study, including eleven laboratories from five different countries, was carried out to establish the HIV-1 RNA National Standard by calibration, in International Units (IU), against the WHO HIV-1 RNA IS. The HIV-1 RNA content for the candidate was quantitated by each laboratory in three independent assays and the results were collected and analyzed statistically. Overall, a high level of agreement among results was achieved from different laboratories. In addition, the stability study indicated that the candidate was stable for 24 months at -80±5°C. In conclusion, the candidate standard was established as the first National Standard for HIV-1 RNA for use in NAT assays in Taiwan. The standard is intended to be used for the quality control of HIV-1 NAT assays and as a quantitative reference material for HIV-1 NAT assays.
authors.affiliation: Food and Drug Administration, Department of Health, Executive Yuan, Taipei 11561, Taiwan. ycyang@fda.gov.tw
authors.forename: Yi-Chen
authors.initials: YC
authors.lastname: Yang
authors.forename: Daniel
authors.initials: D
authors.lastname: Yang-Chih Shih
authors.forename: Mong-Hsun
authors.initials: MH
authors.lastname: Tsai
authors.forename: Chia-Hung
authors.initials: CH
authors.lastname: Cheng
authors.forename: Hwei-Fang
authors.initials: HF
authors.lastname: Cheng
authors.forename: Chi-Fang
authors.initials: CF
authors.lastname: Lo
authors.forename: Der-Yuan
authors.initials: DY
authors.lastname: Wang
mesh_terms: D015658:HIV Infections / Q000821:virology*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007391:International Cooperation; D021141:Nucleic Acid Amplification Techniques / Q000379:methods / Q000592:standards*; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D012015:Reference Standards; D013624:Taiwan; D019562:Viral Load / Q000379:methods / Q000592:standards*
chemical_list: D012367:RNA, Viral