The VITROS Immunodiagnostics Products Anti-HIV 1+2 Assay: A Rapid and Reliable Method for HIV Screening

Background: To ensure increased awareness of HIV status by patients, the Centers for Disease Control and Prevention (CDC) has issued new guidelines that greatly expand screening recommendations. The goal of the present study was to assess the overall reliability, sensitivity, specificity, and turnaround time (TNT) of the VITROS Anti-HIV 1+2 Assay (Ortho Clinical Diagnostics, Rochester, NY) in a large community hospital setting. The assay was recently approved by the Food and Drug Administration (FDA). Methods: We compared our current Abbott HIVAB assay (Abbott Laboratories, Abbott Park, IL) with how the VITROS performed on the random access VITROS ECVECiQ System in a head-to-head comparison of 298 patient samples and a retrospective comparison of TAT over an 8-month period of utilization. Results: Our data indicate that the VITROS is as sensitive (100%, n=298) and more specific (98% vs 83%) than the Abbott HIVAB and has a faster average TAT (156 minutes vs 1266 minutes). Conclusions: Use of this rapid and reliable assay will lead to greater awareness of HIV status and, hopefully, a decrease in incidence of HIV disease.