Chrysovalantis Stafylis1, Claire C Bristow2, Lauren J Natoli3, Katheryn R Salow3, Emma Davidson3, Yancy Granados3, Mark McGrath3, Jeffrey D Klausner4. 1. David Geffen School of Medicine at UCLA, 10920 Wilshire Blvd, Los Angeles, CA, 90024, USA. Electronic address: chrstafylis@outlook.com. 2. Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, 9500 Gilman Dr 0507, La Jolla, CA 92093, USA. 3. AIDS Healthcare Foundation, 1811 N Western Ave, Los Angeles, CA, 90027, USA. 4. David Geffen School of Medicine at UCLA, 10920 Wilshire Blvd, Los Angeles, CA, 90024, USA.
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.
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.
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