Objectives Detection of acute HIV infection is vital in preventing onward transmission. HIV point-of-care testing (POCT) has improved uptake of HIV testing but has been limited to third-generation assays, which only detect chronic HIV infection. Previous evaluation of the fourth-generation Alere Determine HIV-1/2 Ag/Ab Combo POCT showed only 50% sensitivity for HIV core protein p24 (p24 antigen) detection, which is suboptimal for diagnosis of acute HIV infection with limited advantage over third-generation POCT. We aimed to assess the sensitivity of the new Alere HIV Combo POCT to detect acute HIV infection.
Methods Stored samples in samples already identified as p24-positive using standard-of-care fourth-generation assays were randomly selected alongside groups of antibody-positive samples and HIV-negative samples. Each sample was tested using the new Alere POCT according to manufacturer's instructions. Sensitivity and specificity were then calculated.
Results The Alere HIV Combo POCT test demonstrated 88% sensitivity 95% CI (78% to 98%) and 100% specificity 95% CI (99.7% to 100%) for detection of p24 antigen.
Conclusions This new POCT shows improved sensitivity for detection of p24 antigen and may be of value for clinical use in detecting acute HIV infection. Further evaluation of its use in a clinical setting is still required.
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This information has previously been presented at the British HIV Association Spring Conference, 21–24 April 2015, Brighton, UK and at the European AIDS Clinical Society Conference, 21–24 October, Barcelona, Spain in poster format.
Handling editor Jackie A Cassell
Contributors We confirm that all authors have seen and approved the content and have contributed significantly to this work. MC was responsible for locating and storing all samples used in this study. SO was responsible for overseeing the correct identification of samples and for teaching laboratory based testing techniques and safety. She also provided information about the standard laboratory based assays currently used and assisted with manuscript editing. JF oversaw the study and assisted with manuscript editing.
Funding The point-of-care tests were provided by the manufacturer, Alere.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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