Objectives HIV 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.
Methods Individuals 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.
Results Of 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%).
Conclusions Over 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.
- HIV primary infection
- HIV testing
- Point-of-care testing
- HIV home test.
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Handling editor Jackie A Cassell
Contributors We confirm that all authors have seen and approved the content and have contributed significantly to this work. NW was responsible for locating stored samples, performing rapid tests and gathering biological data. NB was responsible for overseeing interpretation of data and drafting and revising the article. JB was responsible for gathering clinical data and gave critical revisions to the manuscript. AB performed statistical analysis and drafted parts of the manuscript. LM-J designed and oversaw the study and critically revised the article. P-MG oversaw the study and gave critical revisions of the manuscript.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The authors confirm that, for approved reasons, some access restrictions apply to the data underlying the findings. The data cannot be publicly available due to legal and ethical restrictions from the French Authority (Commission nationale de l’informatique et des libertés). Requests for data use can be made to the corresponding author of the study (Narjis Boukli at firstname.lastname@example.org).