Field evaluation of a dual rapid Human Immunodeficiency Virus and treponemal syphilis rapid test in community-based clinics in Los Angeles and New York

Abstract

Introduction: Dual human immunodeficiency virus/syphilis rapid diagnostic devices can play an important role in prevention efforts. The field performance of the INSTI Multiplex HIV-1/HIV-2/Syphilis Antibody Test (Multiplex) was evaluated.

Methods: Fingerstick whole blood was tested using the rapid test. A fourth-generation HIV laboratory assay and treponemal-specific laboratory assays were used as reference. Rapid plasma reagin (RPR) was used to stratify treponemal results. Sensitivity and specificity were calculated.

Results: Overall, 274 patients participated. Sensitivity of the Multiplex for detection of HIV was 98.8% (95% CI, 93.4-100%), and specificity was 100% (95% CI, 98.1-100%). Sensitivity for detection of syphilis antibodies was 56.8% (95% CI, 44.7-68.2%), and specificity was 98.5% (95% CI, 95.7-99.7%). Sensitivity for treponemal antibodies improved with increasing RPR and was 100% (95% CI, 78.2-100%) among samples with RPR titers ≥1:8.

Conclusions: The Multiplex showed excellent performance for detection of HIV antibodies and increasing sensitivity for detection of treponemal antibody with increasing RPR titer.

Keywords: Diagnosis; Dual test; HIV; Rapid test; Treponema pallidum.