title: Comparison of the Abbott m2000 HIV-1 Real-Time and Roche AMPLICOR Monitor v1.5 HIV-1 assays on plasma specimens from Rakai, Uganda.
abstract: The need for viral load (VL) monitoring of HIV patients receiving antiretroviral therapy (ART) in resource-limited settings (RLS) has become apparent with studies showing the limitations of immunological monitoring. We compared the Abbott m2000 Real-Time (Abbott) HIV-1 assay with the Roche AMPLICOR Monitor v1.5 (Roche) HIV-1 assay over a range of VL concentrations. Three hundred and eleven plasma samples were tested, including 164 samples from patients on ART ≥ six months and 147 from ART-naïve patients. The Roche assay detected ≥400 copies/mL in 158 (50.8%) samples. Of these, Abbott produced 145 (91.8%) detectable results ≥400 copies/mL; 13 (8.2%) samples produced discrepant results. Concordance between the assays for detecting HIV-1 RNA ≥400 copies/mL was 95.8% (298/311). The sensitivity, specificity, positive predictive value and negative predictive value of Abbott to detect HIV-1 RNA ≥400 copies/mL were 91.8%, 100%, 100% and 92.2%, respectively. For the 151 samples with HIV-1 RNA ≥400 copies/mL for both assays, a good linear correlation was found (r = 0.81, P < 0.0001; mean difference, 0.05). The limits of agreement were -0.97 and 1.07 log(10) copies/mL (mean ± 2 SD). The Abbott assay performed well in our setting, offering an alternative methodology for HIV-1 VL for laboratories with realtime polymerase chain reaction (PCR) capacity.
authors: Rakai Health Sciences Program, Kalisizo, Rakai, Uganda.
authors: I
authors: I
authors: Ssebugenyi
authors: A
authors: A
authors: Kizza
authors: B
authors: B
authors: Mpoza
authors: G
authors: G
authors: Aluma
authors: I
authors: I
authors: Boaz
authors: K
authors: K
authors: Newell
authors: O
authors: O
authors: Laeyendecker
authors: J P
authors: JP
authors: Shott
authors: D
authors: D
authors: Serwadda
authors: S J
authors: SJ
authors: Reynolds
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage; D016903:Drug Monitoring / Q000379:methods; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy / Q000821:virology*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D010949:Plasma / Q000821:virology*; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood; D012680:Sensitivity and Specificity; D014454:Uganda; D019562:Viral Load / Q000379:methods*
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral