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AmpliSens DNA-HIV-FRT PCR kit has successfully passed the study and shown excellent results in comparison with Abbott and Roche manufactured real-time PCR kits

Performance of an Early Infant Diagnostic Test, AmpliSens DNA-HIV-FRT, Using Dried Blood Spots (DBS) Collected from Children Born to Human Immunodeficiency Virus (HIV)-Infected Mothers in Ukraine.

Joy Chang,a Tetyana Tarasova,b Vedapuri Shanmugam,a Marianna Azarskova,c Shon Nguyen,a Mackenzie Hurlstona, Jennifer Sabatier,a Guoqing Zhang,a Saladin Osmanov,a Dennis Ellenberger,a Chunfu Yang,a Charles Vitek,c Maria Liulchuk,d Natalya Nizovad

Centers for Disease Control and Prevention (CDC), Atlanta, GA, USAa; UNICEF, Kyiv, Ukraineb; Centers for Disease Control and Prevention (CDC/Ukraine), Kyiv, Ukrainec; Ukrainian Center for Disease Control, Ministry of Health of Ukraine, Kyiv, Ukrained

J. Clin. Microbiol. doi:10.1128/JCM.02392-15

Copyright 2015, American Society for Microbiology.


An accurate and accessible early infant diagnosis (EID) test is crucial for identifying HIV infected infants and linking them to treatment.

To improve EID services in Ukraine, Dried Blood Spots (DBS) from 237 HIV-exposed children (≤18 months) from six regions in Ukraine during 2012 to 2013 were tested by AmpliSens DNA-HIV-FRT (AmpliSens), Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Qual Test (Roche CAP/CTM Qual), and Abbott Real Time HIV-1 Qualitative (Abbott Qualitative).

By comparing the paired whole-blood results generated from AmpliSens at the oblast HIV reference laboratories in Ukraine, the sensitivity was 99% (95% confidence interval [CI], 95 to 100) for AmpliSens and Roche CAP/CTM Qual, and 96% (95% CI, 90 to 98) for Abbott Qualitative. The specificity was 100% (95% CI, 97 to 100) for AmpliSens and Abbott Qualitative, and 99% (95% CI, 96 to 100) for Roche CAP/CTM Qual.

The sensitivity and specificity of each DBS test were calculated with the AmpliSens whole-blood test as the reference group.

Performance of AmpliSens DBS test, compared with AmpliSens whole-blood test.

The results of our study demonstrate that the performance of the AmpliSens using DBS was as good as the AmpliSens using whole blood and comparable with the performance of the Roche CAP/CTM Qual and the Abbott Qualitative EID tests. The sensitivity of 0.99 (95% CI, 0.95 to 1.00) and specificity of 1.00 (95% CI, 0.97 to 1.00) of the AmpliSens DBS test exceeded WHOs 2010 recommendations for virologic tests, which were ≥95% for sensitivity and 98% for specificity at different HIV prevalence levels.


These results indicated that AmpliSens DBS and whole-blood tests performed equally well and were comparable with the two commercial EID tests. More importantly, the performance characteristics of AmpliSens DBS test meets the World Health Organization EID test requirements; implementing AmpliSens DBS test might improve EID services in resource-limited settings.

The study has been performed in the Centers for Disease Control and PreventionDisease Control and Prevention (CDC), Atlanta, Georgia, USA, for testing. All DBS were tested blindly on the AmpliSens, Roche CAP/CTM Qual, and Abbott Qualitative.

DBS were delinked from patient identifier information before sending to CDC for testing. The anonymous testing at CDC was determined as nonhuman subjects research by the Associate Director for Science at the Center for Global Health, CDC, Atlanta, Georgia, USA.

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