Comparison between the accuracy of a rapid point-of-care HIV test TOYO versus ELISA, Western Blot, and RT-PCR analysis

Abstract

Background: The human immunodeficiency virus (HIV) is considered one of the most serious health challenges worldwide. Early detection and diagnosis are key elements in the effort to control HIV. Rapid tests for the detection of HIV-antibody allow timely point-of-care provision of results and do not require the laboratory facilities needed for conventional enzyme immunoassays (enzyme-linked immunosorbent assay [ELISA]) and Western blot (WB) testing. Regardless of the advantages of these tests, other studies showed that the sensitivity of the performance of some rapid test brands comparing with the lab standard methods have some limitation. Objective: This study evaluated and compared the performance of commercially available HIV rapid test TOYO against the gold standard tests used in the clinical laboratories at Saudi Arabia. Materials and Methods: Forty-two male and female patient samples were tested with real-time polymerase chain reaction (RT-PCR), ELISA, and/or WB followed by TOYO rapid test to compare their results when performed under similar conditions. Results: The higher compatibility of TOYO results was observed with RT-PCR with 81% followed by WB and ELISA with 76% and 63%, respectively. However, more than 25% of the results showed either false positive or false negative results when compared with either of the standard diagnostic tests used in this study. Conclusion: This study have provided evidence that TOYO rapid HIV assay cannot perform equally as RT-PCR, ELISA, or WB for the detection of HIV antibodies. A further study is suggested to compare the performance of TOYO rapid test against standard diagnostic tests with larger number of patients’ samples.