Anti-HIV antibody screening and confirmatory tests include rapid diagnostics tests (RDT), which have limited sensitivity, and high-sensitivity ELISA and western blot tests, which are laborious and require technical proficiency. Thus, there is an unmet need for novel rapid, simple, and highly sensitive tests. A pilot study was conducted to assess the performance of a recently developed ultrasound particle agglutination (UPA) method for high-sensitivity HIV antibody detection using 51 confirmed positive and 310 presumably negative plasma samples, and 6 commercially available anti-HIV-1 seroconversion panels (total 56 members). Optimal cutoff value of the UPA method was determined by receiver operating characteristics (ROC) analysis, providing clinical sensitivity and specificity of 100% and 98.1%, respectively. The performance characteristics of UPA, compared with those of some established RDT's and ELISA tests using HIV seroconversion panels, showed 2 days earlier HIV antibody detection than other RDT's and 2nd-generation ELISA, and at approximately the same time as 3rd-generation ELISA. The preliminary analysis of the UPA method performance characteristics showed that it meets the minimum requirements of the WHO guidelines for RDTs as first-line assays. This pilot study paves the way for more detailed validation studies of the UPA method for HIV antibody detection in clinical practice.
Keywords: HIV early detection; UPArapid diagnostic test; clinical sensitivity and specificity; performance evaluation; point-of-care; ultrasound particle agglutination or.