A collaborative study to establish the first National Standard for HIV-1 RNA nucleic acid amplification techniques (NAT) in Taiwan

Yang, Y.-C.Y.-C.YangYang-Chih Shih, D.D.Yang-Chih ShihMONG-HSUN TSAICheng, C.-H.C.-H.ChengCheng, H.-F.H.-F.ChengLo, C.-F.C.-F.LoWang, D.-Y.D.-Y.Wang2018-09-102018-09-102013http://www.scopus.com/inward/record.url?eid=2-s2.0-84878237417&partnerID=MN8TOARShttp://scholars.lib.ntu.edu.tw/handle/123456789/380685The 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. ? 2013 Elsevier B.V.Human immunodeficiency virus type 1 (HIV-1); Nucleic acid amplification techniques (NAT); Standard[SDGs]SDG3article; bioassay; clinical laboratory; clinical study; controlled study; genotype; health care quality; human; Human immunodeficiency virus 1; nonhuman; nucleic acid amplification; priority journal; quality control; quantitative analysis; reference value; standard; Taiwan; HIV Infections; HIV-1; Humans; International Cooperation; Nucleic Acid Amplification Techniques; Reference Standards; RNA, Viral; Taiwan; Viral LoadA collaborative study to establish the first National Standard for HIV-1 RNA nucleic acid amplification techniques (NAT) in Taiwanjournal article10.1016/j.jviromet.2013.04.002