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Identification of Acute HIV-1 Infection by Hologic Aptima HIV-1 RNA Qualitative Assay.

Identification of Acute HIV-1 Infection by Hologic Aptima HIV-1 RNA Qualitative Assay.
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Manak MM, Eller LA, Malia J, Jagodzinski LL, Trichavaroj R, Oundo J, Lueer C, Cham F, de Souza M, Michael NL, Robb ML, Peel SA,


Manak MM, Eller LA, Malia J, Jagodzinski LL, Trichavaroj R, Oundo J, Lueer C, Cham F, de Souza M, Michael NL, Robb ML, Peel SA, (click to view)

Manak MM, Eller LA, Malia J, Jagodzinski LL, Trichavaroj R, Oundo J, Lueer C, Cham F, de Souza M, Michael NL, Robb ML, Peel SA,

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Journal of clinical microbiology 2017 04 1955(7) 2064-2073 doi 10.1128/JCM.00431-17

Abstract

The Hologic Aptima HIV-1 Qualitative RNA assay was used in a rigorous screening approach designed to identify individuals at the earliest stage of HIV-1 infection for enrollment into subsequent studies of cellular and viral events in early infection (RV 217/Early Capture HIV Cohort [ECHO] study). Volunteers at high risk for HIV-1 infection were recruited from study sites in Thailand, Tanzania, Uganda, and Kenya with high HIV-1 prevalence rates among the populations examined. Small-volume blood samples were collected by finger stick at twice-weekly intervals and tested with the Aptima assay. Participants with reactive Aptima test results were contacted immediately for entry into a more comprehensive follow-up schedule with frequent blood draws. Evaluation of the Aptima test prior to use in this study showed a detection sensitivity of 5.5 copies/ml (50%), with all major HIV-1 subtypes detected. A total of 54,306 specimens from 1,112 volunteers were examined during the initial study period (August 2009 to November 2010); 27 individuals were identified as converting from uninfected to infected status. A sporadic reactive Aptima signal was observed in HIV-1-infected individuals under antiretroviral therapy. Occasional false-reactive Aptima results in uninfected individuals, or nonreactive results in HIV-1-infected individuals not on therapy, were observed and used to calculate assay sensitivity and specificity. The sensitivity and specificity of the Aptima assay were 99.03% and 99.23%, respectively; positive and negative predictive values were 92.01% and 99.91%, respectively. Conversion from HIV-1-uninfected to -infected status was rapid, with no evidence of a prolonged period of intermittent low-level viremia.

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