Sensitivity of the STAT-VIEW rapid self-test and implications for use during acute HIV infection

ObjectivesHIV testing is an important step towards diminishing incident infections. Rapid self-tests whose use is becoming more common in France could help increase access to testing, yet could fail to diagnose HIV during acute HIV infection (AHI). The aim of the present study was to evaluate HIV-detection sensitivity of a commonly used rapid self-test (STAT-VIEW HIV1/2), compared with another point-of-care rapid test (INSTI), among patients presenting with AHI.MethodsIndividuals tested at Saint-Antoine Hospital (Paris, France) with negative or indeterminate western blot (WB) results and detectable HIV-RNA were included. Rapid tests were performed retrospectively on stored serum. Patients with and without reactive rapid tests were compared, while probability of having a reactive test was modelled across infection duration using logistic regression.ResultsOf the 40 patients with AHI, 23 (57.5%) had a reactive STAT-VIEW rapid test. Patients with non-reactive versus reactive tests had a significantly shorter median time since infection (p=0.01), time since onset of symptoms (p=0.009), higher proportion with Fiebig stage III versus IV (p=0.003), negative WB results (p=0.007), higher HIV-RNA levels (p=0.001) and lower CD4+ and CD8+ cell count (p=0.03, p<0.001, respectively). When examining sensitivity over the course of AHI duration, the probability of HIV detection was 75.5% at 5 weeks from HIV transmission. The INSTI provided similar results with respect to proportion of reactive tests (62.5%), determinants for non-reactive test and probability of HIV detection at 5 weeks of infection (85.0%).ConclusionsOver half of AHI patients had reactive serology using the STAT-VIEW rapid self-test when performed on serum samples. Considering that detection sensitivity increased substantially over infection time, individuals should not rely on a negative result to accurately exclude HIV infection within at least 5 weeks of potential HIV exposure. Notwithstanding strong recommendations against rapid test use during AHI, some utility in detecting HIV is observed 5–12 weeks after transmission.

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Point-of-Care Diagnostics for Acute HIV Infection: An Important Public Health Priority

The Journal of Infectious Diseases ◽

10.1093/infdis/jis618 ◽

2012 ◽

Vol 206 (12) ◽

pp. 1949-1950 ◽

Cited By ~ 1

Author(s):

N. E. Rosenberg ◽

G. Kamanga ◽

S. Phiri ◽

D. Nsona ◽

A. Pettifor ◽

...

Keyword(s):

Public Health ◽

Hiv Infection ◽

Point Of Care ◽

Acute Hiv Infection ◽

Important Public Health ◽

Public Health Priority ◽

Health Priority ◽

Point Of Care Diagnostics ◽

Acute Hiv

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Acute HIV Infection in Pregnancy: The Case for Third Trimester Rescreening

Case Reports in Infectious Diseases ◽

10.1155/2011/340817 ◽

2011 ◽

Vol 2011 ◽

pp. 1-5

Author(s):

Jocelyn Wertz ◽

Jason Cesario ◽

Jennifer Sackrison ◽

Sean Kim ◽

Chi Dola

Keyword(s):

Viral Load ◽

Hiv Infection ◽

Late Pregnancy ◽

First Trimester ◽

Acute Hiv Infection ◽

Hiv Rna ◽

Increased Risk ◽

Acute Hiv ◽

Anti Hiv ◽

In Pregnancy

Combination testing with anti-HIV Elisa and Western blot is both sensitive and specific for diagnosis of established HIV-1 infection but could not detect acute HIV infection (AHI). AHI is a time of extremely high viral load, which may correlate to increased risk of horizontal or vertical transmission. Thus, early identification of AHI could allow for interventions to decrease transmission. However, recognition of AHI can be challenging as symptoms could be absent or nonspecific, therefore, AHI is often not detected, particularly in pregnancy. We present a case report of AHI in a pregnant woman who presented with headache and fever. She tested negative for HIV in the first trimester and at time of AHI at 26 3/7 weeks by anti-HIV Elisa, but was diagnosed with AHI based on an HIV RNA viral load of 434,000 copies/mL. This report presents a case for improved awareness of AHI in pregnancy, and the need for repeat HIV testing in late pregnancy, and highlighted that early detection of AHI might be possible with adding HIV RNA testing at time of standard anti-HIV Elisa screening test in pregnancy. Novel laboratory approaches including pooling of sera for HIV RNA could reduce the cost of HIV RNA testing.

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P95 The ability of the alere™ hivcombo point-of care test to detect acute HIV infection

Sexually Transmitted Infections ◽

10.1136/sextrans-2015-052126.138 ◽

2015 ◽

Vol 91 (Suppl 1) ◽

pp. A47.2-A47

Author(s):

Naomi Fitzgerald ◽

Maria Cross ◽

Siobhan O’Shea ◽

Julie Fox

Keyword(s):

Hiv Infection ◽

Point Of Care ◽

Acute Hiv Infection ◽

Point Of Care Test ◽

Acute Hiv

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Rapid HIV RNA rebound after antiretroviral treatment interruption in persons durably suppressed in Fiebig I acute HIV infection

Nature Medicine ◽

10.1038/s41591-018-0026-6 ◽

2018 ◽

Vol 24 (7) ◽

pp. 923-926 ◽

Cited By ~ 110

Author(s):

Donn J. Colby ◽

◽

Lydie Trautmann ◽

Suteeraporn Pinyakorn ◽

Louise Leyre ◽

...

Keyword(s):

Hiv Infection ◽

Antiretroviral Treatment ◽

Treatment Interruption ◽

Acute Hiv Infection ◽

Hiv Rna ◽

Acute Hiv

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Higher HIV RNA Viral Load in Recent Patients with Symptomatic Acute HIV Infection in Lyon University Hospitals

PLoS ONE ◽

10.1371/journal.pone.0146978 ◽

2016 ◽

Vol 11 (1) ◽

pp. e0146978 ◽

Cited By ~ 1

Author(s):

Isabelle Girerd-Genessay ◽

Dominique Baratin ◽

Tristan Ferry ◽

Christian Chidiac ◽

Vincent Ronin ◽

...

Keyword(s):

Viral Load ◽

Hiv Infection ◽

University Hospitals ◽

Acute Hiv Infection ◽

Hiv Rna ◽

Acute Hiv

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Screening Yield of HIV Antigen/Antibody Combination and Pooled HIV RNA Testing for Acute HIV Infection in a High-Prevalence Population

JAMA ◽

10.1001/jama.2016.0286 ◽

2016 ◽

Vol 315 (7) ◽

pp. 682 ◽

Cited By ~ 34

Author(s):

Philip J. Peters ◽

Emily Westheimer ◽

Stephanie Cohen ◽

Lisa B. Hightow-Weidman ◽

Nicholas Moss ◽

...

Keyword(s):

Hiv Infection ◽

Acute Hiv Infection ◽

Hiv Rna ◽

High Prevalence ◽

Hiv Antigen ◽

Acute Hiv ◽

Antigen Antibody

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Undiagnosed acute HIV infection identified through RNA testing of pooled serum samples obtained during a dengue outbreak in São Paulo, Brazil

Revista da Sociedade Brasileira de Medicina Tropical ◽

10.1590/0037-8682-0370-2016 ◽

2017 ◽

Vol 50 (1) ◽

pp. 110-112 ◽

Cited By ~ 2

Author(s):

Elaine Monteiro Matsuda ◽

Daniela Rodrigues Colpas ◽

Norberto Camilo Campos ◽

Luana Portes Ozorio Coelho ◽

Andreia Moreira dos Santos Carmo ◽

...

Keyword(s):

Hiv Infection ◽

Sao Paulo ◽

São Paulo ◽

Serum Samples ◽

Acute Hiv Infection ◽

Dengue Outbreak ◽

Acute Hiv

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Anogenital HIV RNA in Thai men who have sex with men in Bangkok during acute HIV infection and after randomization to standard vs. intensified antiretroviral regimens

Journal of the International AIDS Society ◽

10.7448/ias.18.1.19470 ◽

2015 ◽

Vol 18 (1) ◽

pp. 19470 ◽

Cited By ~ 12

Author(s):

Nittaya Phanuphak ◽

Nipat Teeratakulpisarn ◽

Frits van Griensven ◽

Nitiya Chomchey ◽

Suteeraporn Pinyakorn ◽

...

Keyword(s):

Hiv Infection ◽

Acute Hiv Infection ◽

Hiv Rna ◽

Acute Hiv ◽

Sex With Men

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The performance of the Alere HIV combo point-of-care test on stored serum samples; useful for detection of early HIV-1 infections?

Sexually Transmitted Infections ◽

10.1136/sextrans-2016-052818 ◽

2017 ◽

Vol 94 (5) ◽

pp. 331-333 ◽

Cited By ~ 6

Author(s):

Carla van Tienen ◽

Sharona Rugebregt ◽

Sandra Scherbeijn ◽

Hannelore Götz ◽

Corine Geurts van Kessel

Keyword(s):

Hiv Infection ◽

Point Of Care ◽

Acute Infection ◽

Rapid Test ◽

Public Health Department ◽

Laboratory Setting ◽

Serum Samples ◽

Point Of Care Test ◽

P24 Antigen ◽

Hiv 1

IntroductionThe Alere HIV-1/2 Antigen/Antibody Combo point-of-care test is a commercially available 4th-generation rapid test for the diagnosis of HIV infection, including acute infection. We evaluated the sensitivity of this test in samples from patients with acute, recent or chronic HIV-1 infection.MethodsA validation of the test was performed using 89 HIV-positive serum samples collected in 2008–2016, that were stored at −20°C. Twenty-three samples were only p24-positive (acute infection); 49 samples were antibody-positive and p24-positive (recent infection); 17 samples were only antibody-positive (chronic infection). HIV infection was confirmed by standard-of-care assays and PCR. Samples came from patients attending an outpatient clinic for STDs at the Public Health Department and from patients within the Erasmus Medical Center, Rotterdam, the Netherlands.ResultsThe overall sensitivity of the test for diagnosing HIV infection based on detection of p24 antigen and/or antibodies was 92% (95% CI 86% to 98%) (82/89). In acute sera with only p24 antigen positivity, the sensitivity of the test decreased to 65% (95% CI 46% to 85%) (15/23). When both antibody and antigen testing were positive, the p24 sensitivity was only 24% (95% CI 12% to 36%) (12/49), but in these sera the final test result was positive in all sera (49/49) due to the positive antibody component.ConclusionsIn a laboratory setting, this test has an overall sensitivity of 92% to detect any stage of HIV-1 infection using sera specimens. It performs relatively well in detecting early HIV and may be beneficial as an initial screening in patients with a recent exposure to HIV. Additional testing in a laboratory setting remains mandatory as a proportion of acute HIV-1 infections are missed with this test.

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