TY - JOUR
T1 - Short Communication
T2 - Validation of the Asante HIV-1 Rapid Recency Assay for Detection of Recent HIV-1 Infections in Uganda
AU - Galiwango, Ronald Moses
AU - Ssuuna, Charles
AU - Kaleebu, Pontiano
AU - Kigozi, Godfrey
AU - Kagaayi, Joseph
AU - Nakigozi, Gertrude
AU - Reynolds, Steven James
AU - Lutalo, Tom
AU - Kankaka, Edward Nelson
AU - Wasswa, John Bosco
AU - Kalibbala, Sarah N.
AU - Kigozi, Aminah N.
AU - Watera, Christine
AU - Ejang, Julia
AU - Ndyanabo, Anthony
AU - Anok, Aggrey J.
AU - Ssemwanga, Deogratius
AU - Kibengo, Freddie M.
AU - Quinn, Thomas C
AU - Grabowski, Mary
AU - Chang, Larry W.
AU - Wawer, Maria
AU - Gray, Ronald H
AU - Laeyendecker, Oliver B.
AU - Serwadda, David
N1 - Publisher Copyright:
© Copyright 2021, Mary Ann Liebert, Inc., publishers 2021.
PY - 2021/12
Y1 - 2021/12
N2 - 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 < .0001). Specificity was 100% (200/200) among chronically infected ART-naive samples. The Asante HIV-1 rapid recency assay had low sensitivity for detection of recent HIV-1 infections in Uganda, with substantial interlaboratory variability due to differential interpretation of the test strip bands. Specificity was excellent. Assessment of assay performance in other settings is needed to guide decisions on test utility.
AB - 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 < .0001). Specificity was 100% (200/200) among chronically infected ART-naive samples. The Asante HIV-1 rapid recency assay had low sensitivity for detection of recent HIV-1 infections in Uganda, with substantial interlaboratory variability due to differential interpretation of the test strip bands. Specificity was excellent. Assessment of assay performance in other settings is needed to guide decisions on test utility.
KW - AsanteHIV rapid recency assay
KW - HIV
KW - HIV incidence
KW - HIV prevention
KW - HIV transmission
KW - recent HIV infection
UR - http://www.scopus.com/inward/record.url?scp=85119439309&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85119439309&partnerID=8YFLogxK
U2 - 10.1089/aid.2020.0279
DO - 10.1089/aid.2020.0279
M3 - Article
C2 - 33499732
AN - SCOPUS:85119439309
SN - 0889-2229
VL - 37
SP - 893
EP - 896
JO - AIDS research and human retroviruses
JF - AIDS research and human retroviruses
IS - 12
ER -