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

Abstract

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., Richmond, BC, Canada) used by untrained operators on finger-stick whole blood to results obtained by trained laboratory professionals using FDA-cleared comparator methods (CM) on matching venous blood. A total of 1388 subjects were recruited into the study in three diverse US POC sites. One central laboratory was used for CM testing. Untrained operators and experienced laboratory professionals also conducted a study on prepared plasma specimens to compare limit of detection (LoD) abilities.

Results: Of the 517 HIV positive subjects (34 new positives and 483 known positives) the concordance between INSTI performed by untrained operators and CM performed by trained laboratory professionals was 100% (95% CI=99.3-100%). Concordance for HIV negative results (n=871) was 99.8% (95% CI=99.2-99.9%). There were no significant differences in INSTI limit of detection between untrained operators and laboratory professionals.

Conclusions: Untrained operators with no laboratory background were able to perform and interpret the results of INSTI on finger-stick blood and LoD specimens with a high degree of accuracy by following only the manufacturer's written instructions.

Keywords: Antibody; Ease-of-use; HIV; Point-of-care; Rapid; Test.