Journal
JOURNAL OF VIROLOGICAL METHODS
Volume 191, Issue 2, Pages 122-127Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jviromet.2013.04.002
Keywords
Standard; Nucleic acid amplification techniques (NAT); Human immunodeficiency virus type 1 (HIV-1)
Funding
- Taiwan FDA
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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 degrees 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. (C) 2013 Elsevier B.V. All rights reserved.
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