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1.
Int J STD AIDS ; 22(7): 373-5, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21729954

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.


Subject(s)
HIV Infections/virology , HIV-1/isolation & purification , Molecular Diagnostic Techniques/methods , Plasma/virology , Viral Load/methods , Anti-HIV Agents/administration & dosage , Drug Monitoring/methods , HIV Infections/diagnosis , HIV Infections/drug therapy , Humans , Predictive Value of Tests , RNA, Viral/blood , Sensitivity and Specificity , Uganda
2.
Int J STD AIDS ; 22(6): 308-9, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21680664

ABSTRACT

The performance characteristics of HIV rapid diagnostic tests (RDTs) vary by test and by population. We assessed five commercial RDTs in Uganda where all but one RDT (Determine; Abbott Laboratories, Germany) performed close to manufacturer's expectations. Determine had low specificity (85.2%, positive predictive value 67.3%) due to false-positive results with weak-positive bands. Properly trained staff, good quality control programmes and validation of RDTs with laboratories having confirmatory testing capacity may be warranted to assure accuracy in each setting.


Subject(s)
HIV Infections/diagnosis , HIV-1/isolation & purification , Reagent Kits, Diagnostic , Blotting, Western , Cohort Studies , Enzyme-Linked Immunosorbent Assay , False Positive Reactions , HIV Infections/virology , Humans , Point-of-Care Systems , Reproducibility of Results , Rural Population , Sensitivity and Specificity , Uganda
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