Identification of Acute HIV-1 Infection by Hologic Aptima HIV-1 RNA Qualitative Assay
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.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Jul 01, 2017
- Source ID
- 10.1128/jcm.00431-17
Entities
People
- Cornelia Lueer
- Fatim Cham
- Jennifer Malia
- Joseph Oundo
- Leigh Anne Eller
- Linda L. Jagodzinski
- Mark M. Manak
- Mark de Souza
- Merlin L Robb
- Nelson Michael
- Rapee Trichavaroj
- Sheila A. Peel
Organizations
- Armed Forces Research Institute of Medical Sciences
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Makerere University
- United States Department of Defense
- Walter Reed Army Institute of Research