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Laboratory Evaluation of a Smartphone-Based Electronic Reader of Rapid Dual Point-of-Care Tests for Antibodies to Human Immunodeficiency Virus and Treponema pallidum Infections

Herbst de Cortina, Sasha BA*; Bristow, Claire C. PhD, MPH, MSc; Humphries, Romney PhD; Vargas, Silver Keith MSc§; Konda, Kelika A. PhD, MHS; Caceres, Carlos F. MD, MPH, PhD§; Klausner, Jeffrey D. MD, MPH

Sexually Transmitted Diseases: July 2017 - Volume 44 - Issue 7 - p 412–416
doi: 10.1097/OLQ.0000000000000628
Original Studies

Background: Dual point-of-care tests for antibodies to human immunodeficiency virus (HIV) and Treponema pallidum allow for same-day testing and treatment and have been demonstrated to be cost-effective in preventing the adverse outcomes of HIV infection and syphilis. By recording and transmitting data as they are collected, electronic readers address challenges related to the decentralization of point-of-care testing.

Methods: We evaluated a smartphone-based electronic reader using 201 sera tested with 2 dual rapid tests for detection of antibodies to HIV and T. pallidum in Los Angeles, USA, and Lima, Peru. Tests were read both visually and with the electronic reader. Enzyme immunoassay followed by Western blot and T. pallidum particle agglutination were the reference tests for HIV and T. pallidum, respectively.

Results: The sensitivities of the 2 rapid tests for detection of HIV were 94.1% and 97.0% for electronic readings. Both tests had a specificity of 100% for detection of HIV by electronic reading. The sensitivities of the 2 rapid tests for detection of T. pallidum were 86.5% and 92.4% for electronic readings. The specificities for detection of T. pallidum were 99.1% and 99.0% by electronic reading. There were no significant differences between the accuracies of visual and electronic readings, and the performance did not differ between the 2 study sites.

Conclusions: Our results show the electronic reader to be a promising option for increasing the use of point-of-care testing programs.

Evaluation of an electronic reader for point–of-care dual HIV/syphilis testing in Los Angeles, USA, and Lima, Peru, found the electronic reader to be as accurate as visual readings.

From the *Division of Infectious Diseases, Department of Medicine, University of California Los Angeles, Los Angeles, CA; †Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA; ‡Department of Pathology and Laboratory Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA; §Unit of Health, Sexuality and Human Development, and Laboratory of Sexual Health, Universidad Peruana Cayetano Heredia, Miraflores, Lima, Peru; and ¶Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA

The authors thank the participants in the study and the clinic staff at Epicentro and Barton clinics in Lima, Peru.

Conflict of interest: None declared.

This work was supported by the National Institutes of Health/National Institute of Allergy and Infectious Disease [R01AI099727]. Rapid tests were donated by Standard Diagnostics (Korea) and Premier Medical Corporation, Ltd. (India).

Correspondence: Sasha Herbst de Cortina, 10920 Wilshire Blvd, Suite 350, Los Angeles, CA 90024. E-mail: aherbstdecortina@gmail.com.

Received for publication September 6, 2016, and accepted February 13, 2017.

© Copyright 2017 American Sexually Transmitted Diseases Association