Objective Electronic (E) devices read and quantify lateral flow-based rapid tests, providing a novel approach to assay interpretation. We evaluated the performance of one E-reader for two dual HIV and syphilis immunoassays.
Methods We enrolled men who have sex with men and transgender women >18 years of age seeking medical services at an STD clinic in Lima, Peru, between October 2016 and April 2017. Venous blood was tested using two dual HIV and syphilis antibody immunoassays (SD BIOLINE HIV/Syphilis Duo, Republic of Korea, and First Response HIV 1+2/Syphilis Combo, India). Reference testing included a fourth-generation ELISA for HIV antibodies and use of the Treponema pallidum particle agglutination assay for syphilis antibodies. Trained clinic staff visually inspected the immunoassay results, after which the immunoassays were read by the HRDR-200 E-reader (Cellmic, USA), an optomechanical smartphone attachment. We calculated the concordance of the E-reader with visual inspection, as well as the sensitivity of both rapid immunoassays, in detecting HIV and T. pallidum antibodies.
Results On reference testing of 283 participant specimens, 34% had HIV antibodies and 46% had T. pallidum antibodies. Using First Response, the concordance of the E-reader with visual inspection was 97% (95% CI 94% to 99%) for T . pallidum and 97% (95% CI 95% to 99%) for HIV antibodies. Using SD BIOLINE, the concordance of the E-reader with visual inspection was 97% (95% CI 94% to 99%) for T. pallidum and 99% (95% CI 98% to 99%) for HIV antibodies. For both immunoassays, the sensitivity for HIV antibodies was 98% (95% CI 93% to 100%) and the sensitivity for T. pallidum antibodies was 81% (95% CI 73% to 87%).
Conclusions E-reader results correlated well with visual inspection. The sensitivities of both rapid assays were comparable with past reports. Further evaluation of the E-reader is warranted to investigate its utility in data collection, monitoring and documentation of immunoassay results.
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Handling editor Gwenda Hughes
Funding This research was supported by the US National Institutes of Health (grants 21AI117256 and R21AI109005), as well as the South American Program in HIV Prevention Research (R25MH087222). The assay used for HIV reference testing was donated by Diagnóstico UAL (Jesús María, Peru). The electronic reader was donated by Cellmic (USA).
Competing interests None declared.
Patient consent Obtained.
Ethics approval The study was approved by the institutional review board committee of the Universidad Peruana Cayetano Heredia (approval number 59996). For the secondary data analysis, the University of California, Los Angeles institutional review board committee deemed the analysis of de-identified data did not constitute human subjects' research (number 16–0 01 243).
Provenance and peer review Not commissioned; externally peer reviewed.