Field Evaluation of a Dual Rapid Diagnostic Test for HIV Infection & Syphilis in Lima, Peru

OBJECTIVES:

Screening for HIV and syphilis in key populations is recommended by the WHO to reduce the morbidity, mortality and transmission associated with undiagnosed and untreated infections. Rapid point-of-care tests that can detect multiple infections with a single fingerprick whole blood specimen using a single device are gaining popularity. We evaluated the field performance of a rapid dual HIV and syphilis test in people at high risk of HIV and syphilis infections.

METHODS:

Participants included men who have sex with men and transgender women recruited in Lima, Peru. Reference standard testing for detection of HIV and syphilis infections, conducted using blood samples from venipuncture, included Treponema pallidum particle agglutination and fourth-generation HIV enzyme immunoassay for which positive results had a confirmation HIV Western blot test. For the evaluation test, SD BIOLINE HIV/Syphilis Duo test (Standard Diagnostics, Korea), a fingerprick blood specimen was used. Sensitivity and specificity were calculated and the exact binomial method was used to determine 95% CIs.

RESULTS:

A total of 415 participants were recruited for the study. The dual test sensitivity for detection of T. pallidum infection was 89.2% (95% CI 83.5% to 93.5%) and specificity 98.8% (95% CI 96.5% to 99.8%). For detection of HIV infection, the sensitivity of the dual test was 99.1% (95% CI 94.8% to 100%) and specificity 99.4% (95% CI 97.7% to 99.9%).

CONCLUSIONS:

This high performing dual test should be considered for the use in clinical settings to increase uptake of simultaneous testing of HIV and syphilis and accelerate time to treatment for those who need it.

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By:   Bristow CC1, Leon SR2, Huang E3, Brown BJ4, Ramos LB2, Vargas SK2, Flores JA2, Caceres CF2, Klausner JD3.

• 1Division of Global Public Health, Department of Medicine, University of California, San Diego, La Jolla, California, USA.
• 2Unit of Health, Sexuality and Human Development, and Laboratory of Sexual Health, Universidad Peruana Cayetano Heredia, Lima, Peru.
• 3Division of Infectious Diseases: Global Health, Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA.
• 4Program in Public Health, University of California, Irvine, Irvine, California, USA.

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