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.