title: Evaluation of Performance of Two Rapid Tests for Detection of HIV-1 and -2 in High- and Low-Prevalence Populations in Nigeria.
abstract: The availability of reliable human immunodeficiency virus types 1 and 2 (HIV-1/2) rapid tests in resource-limited settings represents an important advancement in the accurate diagnosis of HIV infection and presents opportunities for implementation of effective prevention and treatment interventions among vulnerable populations. A study of the potential target populations for future HIV vaccine studies examined the prevalence of HIV infections at six selected sites in Nigeria and evaluated the use of two rapid diagnostic tests (RDTs) for HIV. The populations included market workers at sites adjacent to military installations and workers at highway settlements (truck stops) who may have a heightened risk of HIV exposure. Samples from 3,187 individuals who provided informed consent were tested in parallel using the Determine (DT) and Stat-Pak (SP) RDTs; discordant results were subjected to the Uni-Gold (UG) RDT as a tiebreaker. The results were compared to those of a third-generation enzyme immunoassay screen with confirmation of repeat reactive samples by HIV-1 Western blotting. One participant was HIV-2 infected, yielding positive results on both RDTs. Using the laboratory algorithm as a gold standard, we calculated sensitivities of 98.5% (confidence interval [CI], 97.1 to 99.8%) for DT and 98.1% (CI, 96.7 to 99.6%) for SP and specificities of 98.7% (CI, 98.3 -99.1%) for DT and 99.8% (CI, 99.6 to 100%) for SP. Similar results were obtained when the sites were stratified into those of higher HIV prevalence (9.4% to 22.8%) versus those of lower prevalence (3.2% to 7.3%). A parallel two-test algorithm requiring both DT and SP to be positive resulted in the highest sensitivity (98.1%; CI, 96.7 to 99.6%) and specificity (99.97%; CI, 99.9 to 100%) relative to those for the reference laboratory algorithm.
authors: Henry Jackson Foundation, MHRP-HJF, Silver Spring, Maryland, USA mmanak@hivresearch.org.
authors: Mark M
authors: http://orcid.org/0000-0002-9217-9129
authors: MM
authors: Manak
authors: U.S. Military HIV Research Program (HJF-MRI), Abuja, Nigeria.
authors: Ogbonnaya S
authors: OS
authors: Njoku
authors: Henry Jackson Foundation, MHRP-HJF, Silver Spring, Maryland, USA.
authors: Ashley
authors: A
authors: Shutt
authors: Walter Reed Army Institute of Research, MHRP-WRAIR, Silver Spring, Maryland, USA.
authors: Jennifer
authors: J
authors: Malia
authors: Walter Reed Army Institute of Research, MHRP-WRAIR, Silver Spring, Maryland, USA.
authors: Linda L
authors: LL
authors: Jagodzinski
authors: Henry Jackson Foundation, MHRP-HJF, Silver Spring, Maryland, USA.
authors: Mark
authors: M
authors: Milazzo
authors: U.S. Military HIV Research Program (HJF-MRI), Abuja, Nigeria.
authors: Aminu
authors: A
authors: Suleiman
authors: U.S. Military HIV Research Program (HJF-MRI), Abuja, Nigeria.
authors: Amos A
authors: AA
authors: Ogundeji
authors: U.S. Military HIV Research Program (HJF-MRI), Abuja, Nigeria.
authors: Robert
authors: R
authors: Nelson
authors: U.S. Military HIV Research Program (HJF-MRI), Abuja, Nigeria.
authors: Ojor R
authors: OR
authors: Ayemoba
authors: Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, Thailand.
authors: Robert J
authors: RJ
authors: O'Connell
authors: Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
authors: Darrell E
authors: DE
authors: Singer
authors: Walter Reed Army Institute of Research, MHRP-WRAIR, Silver Spring, Maryland, USA.
authors: Nelson L
authors: NL
authors: Michael
authors: Walter Reed Army Institute of Research, MHRP-WRAIR, Silver Spring, Maryland, USA.
authors: Sheila A
authors: SA
authors: Peel
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D015483:HIV Antibodies; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology*; D015497:HIV-1 / Q000235:genetics / Q000276:immunology*; D015498:HIV-2 / Q000235:genetics / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D009549:Nigeria / Q000453:epidemiology; D012367:RNA, Viral / Q000032:analysis / Q000235:genetics; D012680:Sensitivity and Specificity
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies; D012367:RNA, Viral