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.

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.