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- Title
Analytical characteristics and comparative evaluation of Aptima HIV-1 Quant Dx assay with Ampliprep/COBAS TaqMan HIV-1 test v2.0.
- Authors
Hatzakis, Angelos; Papachristou, Helen; Nair, Sangeetha J.; Fortunko, Jacqueline; Foote, Tracy; HeeCheol Kim; Peling, Tashi L.; Worlock, Andrew J.
- Abstract
Background: Quantitation of HIV-RNA is critically important for diagnosis, prognosis, treatment, monitoring and assessment of infectivity in HIV-1 infection. The objective of this study was to assess performance characteristics of the Aptima HIV-1 Quant Dx assay (Aptima), a new transcription mediated amplification (TMA), fully integrated and automated assay from Hologic Inc., San Diego, CA, USA. The analytical sensitivity, analytical specificity, precision and detection of HIV-1 subtypes were tested based on commercially available international standards or panels. A selected group of 244 anti-HIV-1 (+) plasma samples was used for comparison with Roche COBAS Ampliprep/COBAS TaqMan HIV- 1 test v2.0 (Roche CAP/CTM), (Roche Molecular Systems, Pleasanton, CA). Results: The 50 and 95% limit of detection were estimated at 4.9 (95% CI 3.9-5.7) and 17.6 (15.2-21.2) IU/mL respectively. The specificity was found 99.83 (99.06-99.97)%. The standard deviations and coefficient of variations for panels with 50 and 100 copies/mL (1.7 and 2 log copies/mL) were 0.14 log copies/mL (8.67%CV) and 0.18 log copies/mL (9.91%CV) respectively. The detection rate for Aptima and Roche assays was 220/244 (90.2%) and 217/ 244 (88.9%) respectively. Conclusion: The Aptima assay is a sensitive, specific, precise and accurate test for measuring HIV-1 viral loads and for the detection of HIV-1 infections.
- Subjects
HIV infections; BIOLOGICAL assay; RNA analysis; GENETIC transcription; BLOOD plasma; BLOOD testing
- Publication
Virology Journal, 2016, Vol 13, Issue 1, p1
- ISSN
1743-422X
- Publication type
Article
- DOI
10.1186/s12985-016-0627-y