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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Validation for clinical use of a novel HIV-2 plasma RNA viral load assay using the Abbott m2000 platform
Journal of Clinical Virology, Volume 55, No. 2, Year 2012
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Description
Background: Optimal care of persons infected with human immunodeficiency virus type 2 (HIV-2) requires an accurate assessment of HIV-2 plasma viral load (VL), but no clinically approved quantitative HIV-2 RNA VL assay exists. Objectives: To validate a novel quantitative HIV-2 RNA assay for clinical and research use. Study design: The Abbott m2000sp/rt platform was adapted for quantification of HIV-2 RNA in plasma. Amplification targeted a region of the long terminal repeat conserved in Group A and B HIV-2. Electron microscopy-counted-HIV-2 standards, the WHO/NIBSC HIV-2 International Standard and clinical specimens (N= 162) were used to determine the precision, sensitivity, specificity, linear range, accuracy, and clinical performance of the assay. Results: The quantitative linear range of the HIV-2 RNA assay was 10-1,000,000copies/mL (R2>0.99), with a limit of detection of 8copies/mL (95% CI, 5-18copies/mL). The assay did not cross-react with HIV-1, and quantification of HIV-2 RNA was not affected by the presence of >5log10HIV-1RNAcopies/mL. The total standard deviation (SD) and intra- and inter-run SD were 0.095, 0.093 and 0.162, respectively, at nominal inputs of 3.7, 1.7 and 1.0log10HIV-2RNAcopies/mL. The HIV-2 WHO/NIBSC International Standard (1000IU) was shown to contain 152RNAcopies/mL (95% CI 141-163). Overall, HIV-2 RNA was quantified at ≥10copies/mL from 86 (53%) clinical specimens (median, 2.24log10copies/mL; range 10-16,870), and nine specimens (6%) had HIV-2 RNA detected at <10copies/mL. Conclusions: We developed and validated a highly sensitive HIV-2 VL assay that is suitable for clinical and research use. © 2012 Elsevier B.V.
Authors & Co-Authors
Chang, Ming
United States, Seattle
University of Washington
Gottlieb., Geoffrey S.
United States, Seattle
University of Washington
Dragavon, Joan A.
United States, Seattle
University of Washington
Cherne, Stephen L.
United States, Seattle
University of Washington
Kenney, Donna L.
United States, Seattle
University of Washington
Hawes, Stephen Edward
United States, Seattle
University of Washington
Smith, Robert Alexander
United States, Seattle
University of Washington
Kiviat, Nancy B.
United States, Seattle
University of Washington
Sow, Papa Salif
Senegal, Dakar
Université Cheikh Anta Diop de Dakar
Coombs, Robert W.
United States, Seattle
University of Washington
Statistics
Citations: 42
Authors: 10
Affiliations: 2
Identifiers
Doi:
10.1016/j.jcv.2012.06.024
ISSN:
13866532
e-ISSN:
18735967
Research Areas
Infectious Diseases
Study Approach
Quantitative