Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care.

Background: For broader utilization of rapid HIV antibody assays in point-of-care (POC) settings, methods should be simple enough to be performed with accuracy by untrained test providers, using only the test manufacturer's written instructions.

Objective: To demonstrate that the INSTI HIV-1 Antibody Test is simple and accurate enough to be successfully run by untrained operators in a POC setting.

Study Design: A prospective study was conducted to compare the results of the FDA-cleared, INSTI HIV-1 Antibody Test (INSTI, bioLytical Laboratories Inc.