Chronic and early antiretroviral therapy impact human immunodeficiency virus (HIV) serological assay sensitivity, leading to more false-negative test results in HIV diagnosis

Karolien Stoffels, Fien Vanroye, Virginie Mortier, Laurent Debaisieux, Marie-Luce Delforge, Melissa Depypere, Géraldine Dessilly, Dolores Vaira, Ellen Vancutsem, Sigi Van den Wijngaert, Kristel Van Laethem, Koen O A Vercauteren, Chris Verhofstede, Katrien Fransen

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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.

Original languageEnglish
JournalJournal of Infectious Diseases
Volume222
Issue number10
Pages (from-to)1660-1669
Number of pages10
ISSN0022-1899
DOIs
Publication statusPublished - 2020

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