1. Short Communication: Validation of the Asante HIV-1 Rapid Recency Assay for Detection of Recent HIV-1 Infections in Uganda
- Author
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Freddie Kibengo, Thomas C. Quinn, Charles Ssuuna, Julia Ejang, Deogratius Ssemwanga, Sarah Kalibbala, Ronald M. Galiwango, Joseph Kagaayi, Aminah Kigozi, Maria J. Wawer, Tom Lutalo, Gertrude Nakigozi, Anthony Ndyanabo, John Bosco Wasswa, Steven J. Reynolds, Christine Watera, Ronald H. Gray, David Serwadda, Larry W. Chang, Edward Nelson Kankaka, Mary K. Grabowski, Godfrey Kigozi, Oliver Laeyendecker, Pontiano Kaleebu, and Aggrey Anok
- Subjects
Pediatrics ,medicine.medical_specialty ,Epidemiology ,business.industry ,Immunology ,Hiv incidence ,Human immunodeficiency virus (HIV) ,MEDLINE ,virus diseases ,HIV Infections ,Viral Load ,medicine.disease_cause ,Incidence estimation ,Infectious Diseases ,Virology ,HIV Seropositivity ,HIV-1 ,medicine ,Humans ,Uganda ,Hiv transmission ,business ,Point of care - Abstract
Point of care rapid recency testing for HIV-1 may be a cost-effective tool to identify recently infected individuals for incidence estimation, and focused HIV prevention through intensified contact tracing. We validated the Asante™ HIV-1 rapid recency(®) assay for use in Uganda. Archived specimens (serum/plasma), collected from longitudinally observed HIV-1 recently and long-term infected participants, were tested with the Asante HIV-1 rapid recency assay per manufacturer's instructions. Previously identified antiretroviral therapy (ART)-naive samples with known seroconversions within 6 months of follow-up were tested in independent laboratories: the Rakai Health Sciences Program (RHSP) and the Uganda Virus Research Institute HIV Reference Laboratory (UVRI-HRL). In addition, samples from participants who seroconverted within 6–18 months and samples from individuals with chronic HIV-1 infection of at least 18 months duration were classified into three categories: ART naive, ART exposed with suppressed viral loads, and ART exposed with detectable viremia. Of the 85 samples seroconverting in ≤6 months, 27 and 42 samples were identified as “recent” by the Asante HIV-1 rapid recency test at the RHSP laboratory and UVRI-HRL, corresponding to sensitivities of 32% and 49%, respectively. There was 72% agreement between the laboratories (Cohen's kappa = 0.481, 95% CI = 0.317–0.646, p
- Published
- 2021
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