Abstract
BackgroundQuantitation 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).ResultsThe 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.ConclusionThe Aptima assay is a sensitive, specific, precise and accurate test for measuring HIV-1 viral loads and for the detection of HIV-1 infections.
Highlights
Quantitation of Human immunodeficiency virus (HIV)-Ribonucleic acid (RNA) is critically important for diagnosis, prognosis, treatment, monitoring and assessment of infectivity in HIV-1 infection
They are subdivided into nine subtypes (A-D, F-H, J, K) and numerous circulating recombinant forms (CRFs)
There are a number of commercially available viral load assays which are mainly based on real-time Polymerase chain reaction (PCR) [6,7,8,9,10,11]
Summary
Quantitation of HIV-RNA is critically important for diagnosis, prognosis, treatment, monitoring and assessment of infectivity in HIV-1 infection. Quantitation of HIV-RNA (viral load) has proven clinical utility in the diagnosis, prognosis, treatment, monitoring and the assessment of infectivity in HIV-1 infected patients [1,2,3,4]. Due. There are a number of commercially available viral load assays which are mainly based on real-time PCR [6,7,8,9,10,11]. The test is not approved for use in the US but is CE-IVD certified for the detection and quantitation of HIV-1 It utilizes transcription mediated amplification (TMA) involving target capture, target amplification by TMA and realtime detection of amplicons by fluorescent probes in a Hatzakis et al Virology Journal (2016) 13:176 single tube. The Aptima HIV-1 Quant Dx assay requires only 0.5mL of sample per reaction with a dead volume as little as 0.2 mL
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