Chronic and Early Antiretroviral Therapy Impact Human Immunodeficiency Virus (HIV) Serological Assay Sensitivity, Leading to More False-Negative Test Results in HIV Diagnosis. (20th May 2020)

• Record Type: Journal Article
• Authors: Stoffels, Karolien; Vanroye, Fien; Mortier, Virginie; Debaisieux, Laurent; Delforge, Marie-Luce; Depypere, Melissa; Dessilly, Géraldine; Vaira, Dolores; Vancutsem, Ellen; Van den Wijngaert, Sigi; Van Laethem, Kristel; Vercauteren, Koen O A; Verhofstede, Chris; Fransen, Katrien
• Is Part Of: Journal of infectious diseases. Volume 222:Number 10(2020)
• Page Start: 1660
• Page End: 1669
• Publication Date: 2020-05-20
• Subjects: HIV -- HIV diagnosis -- HIV confirmatory assays -- HIV rapid tests; Communicable diseases -- Periodicals; Diseases -- Causes and theories of causation -- Periodicals; Medicine -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.9
• DOI: 10.1093/infdis/jiaa271
• Languages: English
• ISSNs: 0022-1899

Abstract

Abstract: This retrospective study evaluated the reactivity of 3 human immunodeficiency virus (HIV) confirmatory assays (INNO-LIA, Geenius, and MP) and 7 HIV rapid tests on samples from 2 different study populations in Belgium. For the early-treated cohort (83 HIV-1 adult patients treated within 3 months after infection), HIV-1 diagnosis was not obtained in at least 1 confirmatory assay in 12.0% (10/83) and in an HIV rapid test in 31.3% (26/83). Confirmation assay sensitivities ranged from 87.5% to 95.2%, whereas rapid test assay sensitivities ranged from 75.9% to 100%. The time to treatment initiation or the length of time on treatment did not have a statistical influence on the probability to obtain a false-negative test result. The fastest reversion was demonstrated after 4 months of treatment. Among the long-term treated cohort (390 HIV-1 patients with ≥ 9 years of undetectable viral load), false-negative test results were found in at least 1 HIV confirmatory assay for 2.1% (8/390) of the patients and in a HIV rapid test for 4.9% (19/390). Confirmation assay sensitivities ranged from 98.1% to 99.5%, whereas rapid test sensitivities ranged from 96.2% to 100%. Longer treatment increased nonreactivity of the HIV rapid tests ( P = .033). Undetectable viral load decreases the sensitivities of HIV diagnostic tests, and further monitoring of the performance of serological assays is advised. Abstract : Antiretroviral treatment may cause false-negative results in HIV diagnostic assays: false negativity was demonstrated for seroconverters with early treatment initiation in 12.0%–31.3%, and for patients on suppressive treatment for ≥ 9 years in 2.1%–4.9%.