Field accuracy of fourth-generation rapid diagnostic tests for acute HIV-1: a systematic review.
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ABSTRACT:
SUBMITTER: Lewis JM
PROVIDER: S-EPMC4645957 | biostudies-literature | 2015 Nov
REPOSITORIES: biostudies-literature
Publications
Field accuracy of fourth-generation rapid diagnostic tests for acute HIV-1: a systematic review.
Lewis Joseph M JM Macpherson Peter P Adams Emily R ER Ochodo Eleanor E Sands Anita A Taegtmeyer Miriam M
AIDS (London, England) 20151101 18
<h4>Introduction</h4>Fourth-generation HIV-1 rapid diagnostic tests (RDTs) detect HIV-1 p24 antigen to screen for acute HIV-1. However, diagnostic accuracy during clinical use may be suboptimal.<h4>Methods</h4>Clinical sensitivity and specificity of fourth-generation RDTs for acute HIV-1 were collated from field evaluation studies in adults identified by a systematic literature search.<h4>Results</h4>Four studies with 17 381 participants from Australia, Swaziland, the United Kingdom and Malawi w ...[more]
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Project description:ObjectiveTo evaluate the limitations of rapid tests for HIV-1.DesignDiagnostic test accuracy study.SettingRural Rakai, Uganda.Participants1517 males aged 15-49 screened for trials of circumcision for HIV prevention.Main outcome measuresSensitivity, specificity, negative predictive values, and positive predictive values of an algorithm using three rapid tests for HIV, compared with the results of enzyme immunoassay and western blotting as the optimal methods.ResultsRapid test results were evaluated by enzyme immunoassay and western blotting. Sensitivity was 97.7%. Among 639 samples where the strength of positive bands was coded if the sample showed positivity for HIV, the algorithm had low specificity (94.1%) and a low positive predictive value (74.0%). Exclusion of 37 samples (5.8%) with a weak positive band improved the specificity (99.6%) and positive predictive value (97.7%).ConclusionWeak positive bands on rapid tests for HIV should be confirmed by enzyme immunoassay and western blotting before disclosing the diagnosis. Programmes using rapid tests routinely should use standard serological assays for quality control. Trial registration Clinical Trials NCT00425984.
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Project description:ObjectiveTo assess the use of fourth-generation rapid diagnostic tests in identifying acute infection of Human Immunodeficiency Virus (HIV).MethodsBCN Checkpoint promotes sexual health among men who have sex with men (MSM), with a focus on diagnosing HIV early, initiating combined antiretroviral treatment (cART) promptly, and recommending regular repeat testing for those who have tested negative. This cross-sectional study included all test results obtained at the centre between 25 March 2016 and 24 March 2019. The Alere™ HIV Combo (now rebranded to Determine™ HIV Ultra, from Abbott) was used to detect p24 antigen (p24 Ag) and/or immunoglobulin M (IgM) and G (IgG) antibodies to HIV-1/HIV-2 (HIV Ab). Rapid polymerase chain reaction (PCR) confirmatory testing and Western blot (WB) were performed for clients with a positive rapid test result. Confirmed HIV cases were promptly referred to the HIV unit for care and cART prescription.ResultsA total of 12,961 clients attended BCN Checkpoint during the study and 27,298 rapid tests were performed. 450 tests were found to be reactive, of which 430 confirmed as HIV-positive, representing a prevalence of 3.32%. Four confirmed cases (0.93%) were detected as "p24 Ag only", nine (2.09%) as "both p24 and HIV Ab" and 417 (96.98%) as "HIV Ab only". The "p24 Ag only" group had a 1-log higher viral load than the other groups and initiated treatment on the following working day. Overall, there were 20 false-positive results (0.07% and 4.44% of total and reactive tests, respectively), of which 10 positive for "p24 Ag only" and 10 for "HIV Ab only".ConclusionsFour Acute HIV Infections (AHI), with very high viral loads, have been detected with the "p24 Ag only" while the HIV Ab were still absent. Referral to the HIV unit and initiation of cART on the following working day contributed to improving persons' health and to reduce HIV transmission chain.
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Project description:Early and accurate detection of HIV is crucial when using pre-exposure prophylaxis (PrEP) for HIV prevention to avoid PrEP initiation in acutely infected individuals and to minimize the risk of drug resistance in individuals with breakthrough infection.To determine if fourth-generation antigen/antibody (Ag/Ab) rapid diagnostic tests (RDT) would have detected HIV infection earlier than the third-generation RDT used in MTN-003 (VOICE).5029 VOICE participants were evaluated with third-generation Alere Determine™ HIV-1/2, OraQuick ADVANCE® Rapid HIV-1/2, Uni-Gold™ Recombigen® HIV-1/2 and Bio-Rad GS HIV-1/2+O EIA; and fourth-generation Alere Determine™ HIV-1/2 Ag/Ab Combo, Conformité Européene (CE)-Marked Alere™ HIV Combo and Bio-Rad HIV Combo Ag/Ab EIA. Multispot®, GS HIV-1 Western Blot (WB) and Geenius™ (Bio-Rad) were also evaluated.Of 57 antibody-negative pre-seroconversion plasma samples with HIV RNA >20 copies/mL identified, 16 (28%) were reactive by CE-Marked Alere™ HIV Combo (1 Ab; 9 Ag; 6 Ag/Ab reactive) and 4 (7%) by Alere Determine™ HIV-1/2 Ag/Ab Combo (2 Ab; 2 Ag; 0 Ag/Ab reactive) (p=0.0005). Multispot® confirmed only 1 of 16 acute infections while WB and Geenius™ confirmed none. GS HIV Combo Ag/Ab EIA identified 27 of 57 (47%) pre-seroconversion RNA-positive samples.In VOICE, 28% of infections missed by current third-generation RDT would have been identified with the use of CE-Marked Alere™ HIV Combo. Geenius™, Multispot® and WB were all insensitive (<10%) in confirming infections detected by fourth-generation assays. An improved diagnostic algorithm that includes a fourth-generation RDT with HIV RNA testing will be essential for efficiently identifying seroconverters on PrEP.
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