Field evaluation of a smartphone-based electronic reader of rapid dual HIV and syphilis point-of-care immunoassays.

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.

Use of Oral Fluid With a Rapid Treponemal Test for Syphilis Evaluation.

We aimed to determine if rapid treponemal tests intended for whole-blood specimens could be used to detect treponemal antibody in oral fluid. We found a high sensitivity of oral fluid rapid testing, which increased with increasing rapid plasma reagin titer, suggesting potential for the development of accurate rapid oral syphilis tests.

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.

A Systematic Review of Point of Care Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

Objectives. Systematic review of point of care (POC) diagnostic tests for sexually transmitted infections: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Methods. Literature search on PubMed for articles from January 2010 to August 2015, including original research in English on POC diagnostics for sexually transmitted CT, NG, and/or TV. Results. We identified 33 publications with original research on POC diagnostics for CT, NG, and/or TV. Thirteen articles evaluated test performance, yielding at least one test for each infection with sensitivity and specificity ≥90%. Each infection also had currently available tests with sensitivities <60%. Three articles analyzed cost effectiveness, and five publications discussed acceptability and feasibility. POC testing was acceptable to both providers and patients and was also demonstrated to be cost effective. Fourteen proof of concept articles introduced new tests. Conclusions. Highly sensitive and specific POC tests are available for CT, NG, and TV, but improvement is possible. Future research should focus on acceptability, feasibility, and cost of POC testing. While pregnant women specifically have not been studied, the results available in nonpregnant populations are encouraging for the ability to test and treat women in antenatal care to prevent adverse pregnancy and neonatal outcomes.

Community-based Mobile Cervical Cancer Screening Program in Rural India: Successes and Challenges for Implementation.

BACKGROUND: The aim of this study is to demonstrate the feasibility; mention the challenges encountered and highlight the success of implementing a community-based mobile cervical cancer-screening program in rural India. METHODS: Communities were mobilized through extensive peer education and by screening in existing community spaces using a mobile clinic model. An initial "screen and treat" protocol was transitioned to "screen, test, and treat" using Pap smears for confirmatory testing, and cryotherapy or Loop Electrosurgical Excision Procedure (LEEP) for treatment. We trained 50 Peer Educators and conducted 190 screening camps in 58 locations. RESULTS: Of 3,821 registered women, 3,544 (92.8%) accepted screening. Overall, 440/3544 (12.4%, 95% CI 11.3-13.5%) women had VIA-positive lesions. Under "screen and treat", 56/156 (35.9%) women accepted same-day treatment. Under "screen, test, and treat", 555/762 (72.8%) women received a Pap smear. Overall, 83 women underwent cryotherapy (n=56) and LEEP (n=27). Of those, 49 (59.0%) participants were followed up, with normal VIA results up to two years after treatment. In summary, the peer educators promoted awareness of cervical cancer and helped in gaining buy-in from communities. Acceptance of same-day treatment was low and accompanied by loss to follow-up, limiting the utility of VIA in these studies. CONCLUSIONS: Mobile infrastructure utilized in community spaces brought screening directly to rural women. Culturally appropriate methods to increase linkage to treatment and additional screening options such as HPV DNA testing should be explored.

Regional differences in vision health: findings from Mwanza, Tanzania.

Background: Visual impairment in developing countries has both social and economic impact on individuals and communities. Understanding the subjective visual functioning of populations will allow for local policymakers to identify the need for optometric or ophthalmic services in their communities. Methods: The authors surveyed 644 adult patients in Mwanza, Tanzania at three clinics (Buzuruga, Mwananchi and Kisesa) using a modified Visual Functioning Questionnaire 25. Responses were categorized into General health, General vision, Ocular pain, Near activities, Distance activities, Social function, Mental health, Role difficulties, Color vision, Peripheral vision and Dependency. Results: Patients at Buzuruga reported the lowest scores on most subscales. Of 100 employed patients, 37% claimed to have at least some difficulty in performing job duties due to their eyesight. At Kisesa, 146 (246/221) patients (66.1%) had never had an eye exam, compared with 134/227 (59.0%) at Buzuruga and 69/173 (39.9%) at Mwananchi (p<0.01). Common reasons for not seeing an eye doctor were the perceived expense and lack of vision problems. Conclusions: Due to regional differences in visual functioning in Mwanza, a national effort for vision health cannot be entirely successful without addressing the individualized needs of local communities. Reducing the cost of vision care appointments may expand vision health care utilization in Mwanza.

Evaluation of a Structured Predeparture Orientation at the David Geffen School of Medicine's Global Health Education Programs.

Given the lack of a standardized approach to medical student global health predeparture preparation, we evaluated an in-person, interactive predeparture orientation (PDO) at the University of California Los Angeles (UCLA) to understand program strengths, weaknesses, and areas for improvement. We administered anonymous surveys to assess the structure and content of the PDO and also surveyed a subset of students after travel on the utility of the PDO. We used Fisher's exact test to evaluate the association between prior global health experience and satisfaction with the PDO. One hundred and five students attended the PDO between 2010 and 2014 and completed the survey. One hundred and four students (99.0%) reported learning new information. Major strengths included faculty mentorship (N = 38, 19.7%), opportunities to interact with the UCLA global health community (N = 34, 17.6%), and sharing global health experiences (N = 32, 16.6%). Of students surveyed after their elective, 94.4% (N = 51) agreed or strongly agreed that the PDO provided effective preparation. Students with prior global health experience found the PDO to be as useful as students without experience (92.7% versus 94.4%, P = 1.0). On the basis of these findings, we believe that a well-composed PDO is beneficial for students participating in global health experiences and recommend further comparative studies of PDO content and delivery.