Field evaluation of Abbott Real Time HIV-1 Qualitative test for early infant diagnosis using dried blood spots samples in comparison to Roche COBAS Ampliprep/COBAS TaqMan HIV-1 Qual Test in Kenya

•The Abbott HIV Qualitative was evaluated using 200 DBS from infants with HIV exposure in Kenya.•The Abbott HIV Qualitative and COBAS Ampliprep/Taqman HIV Qual tests were compared.•The study demonstrated that the Abbott Qualitative can be used for timely HIV diagnosis in infants. Timely diagnosis an...

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Bibliographic Details
Published in:Journal of virological methods 2014-08, Vol.204, p.25-30
Main Authors: Chang, Joy, Omuomo, Kenneth, Anyango, Emily, Kingwara, Leonard, Basiye, Frank, Morwabe, Alex, Shanmugam, Vedapuri, Nguyen, Shon, Sabatier, Jennifer, Zeh, Clement, Ellenberger, Dennis
Format: Article
Language:English
Subjects:
Automation, Laboratory
Blood - virology
Desiccation
Dried blood spots
Early Diagnosis
Early infant diagnosis
HIV
HIV Infections - diagnosis
HIV Infections - virology
HIV-1 - isolation & purification
Humans
Infant
Kenya
Reagent Kits, Diagnostic
Sensitivity and Specificity
Specimen Handling - methods
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Summary:•The Abbott HIV Qualitative was evaluated using 200 DBS from infants with HIV exposure in Kenya.•The Abbott HIV Qualitative and COBAS Ampliprep/Taqman HIV Qual tests were compared.•The study demonstrated that the Abbott Qualitative can be used for timely HIV diagnosis in infants. Timely diagnosis and treatment of infants infected with HIV are critical for reducing infant mortality. High-throughput automated diagnostic tests like Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Qual Test (Roche CAPCTM Qual) and the Abbott Real Time HIV-1 Qualitative (Abbott Qualitative) can be used to rapidly expand early infant diagnosis testing services. In this study, the performance characteristics of the Abbott Qualitative were evaluated using two hundred dried blood spots (DBS) samples (100 HIV-1 positive and 100 HIV-1 negative) collected from infants attending the antenatal facilities in Kisumu, Kenya. The Abbott Qualitative results were compared to the diagnostic testing completed using the Roche CAPCTM Qual in Kenya. The sensitivity and specificity of the Abbott Qualitative were 99.0% (95% CI: 95.0–100.0) and 100.0% (95% CI: 96.0–100.0), respectively, and the overall reproducibility was 98.0% (95% CI: 86.0–100.0). The limits of detection for the Abbott Qualitative and Roche CAPCTM Qual were 56.5 and 6.9copies/mL at 95% CIs (p=0.005), respectively. The study findings demonstrate that the Abbott Qualitative test is a practical option for timely diagnosis of HIV in infants.
ISSN:0166-0934
1879-0984
DOI:10.1016/j.jviromet.2014.03.010