Diagnosing acute HIV infection at point of care: a retrospective analysis of the sensitivity and specificity of a fourth-generation point-of-care test for detection of HIV core protein p24.
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.



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.



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.



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.
Department of Genito-Urinary Medicine, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Naomi
N
Fitzgerald
Infection Sciences, Virology Section, Viapath, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Maria
M
Cross
Infection Sciences, Virology Section, Viapath, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Siobhan
S
O'Shea
Department of Genito-Urinary Medicine, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Julie
J
Fox
D015483:HIV Antibodies / Q000032:analysis / Q000097:blood*; D016655:HIV Core Protein p24 / Q000032:analysis / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D008403:Mass Screening; D000067716:Point-of-Care Testing; D011933:Reagent Kits, Diagnostic; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D006113:United Kingdom
D015483:HIV Antibodies; D016655:HIV Core Protein p24; D011933:Reagent Kits, Diagnostic
ANTIGEN DETECTION; DIAGNOSIS; HIV; HIV TESTING; PRIMARY HIV INFECTION