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.
The goal of the Point-of-Care (POC) Sexually Transmitted Infection (STI) Diagnostics meeting was to review the state-of-the art research and develop recommendations for the use of POC STI diagnostics. Experts from academia, government, non-profit and industry discussed POC diagnostics for STIs such as Chlamydia trachomatis, Human Papillomavirus, Neisseria gonorrhoeae, Trichomonas vaginalis and Treponema pallidum. Key objectives included a review of current and emerging technologies, clinical and public health benefits, POC STI diagnostics in developing countries, regulatory considerations and future areas of development. Key points of the meeting are as follows: (i)while some rapid point-of-care tests are affordable, sensitive, specific, easy to perform, and deliverable to those who need them for select sexually transmitted infections, implementation barriers exist at the device, patient, provider and health system levels; (ii) further investment in research and development of point-of-care tests for sexually transmitted infections is needed and new technologies can be used to improve diagnostic testing, test uptake and treatment; (iii) efficient deployment of self-testing in supervised (i.e., pharmacies, clinics etc.) and/or unsupervised (i.e., home, offices etc.) settings could facilitate more screening and diagnosis that will reduce the burden of sexually transmitted infections; (iv) development of novel diagnostic technologies has outpaced the generation of guidance tools and documents issued by regulatory agencies and (v) questions regarding quality management are emerging including the mechanism by which poor performing diagnostics are removed from the market and quality assurance of self-testing is ensured.
Abstract. 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.
dCombining the detection of syphilis and HIV antibodies into one point-of-care test integrates syphilis screening into already existing HIV screening programs, which may be particularly beneficial in settings such as antenatal care. Using the INSTI Multiplex downward-flow immunoassay, we tested 200 stored serum samples from high-risk patients enrolled in a longitudinal study on HIV infection and syphilis in Peruvian men who have sex with men and transgender women. This rapid assay detected HIV and Treponema pallidum serum antibodies with sensitivities of 100% (95% confidence interval [CI], 95.9% to 100%) and 87.4% (95% CI, 81.4% to 92.0%), respectively, and specificities of 95.5% (95% CI, 89.9% to 98.5%) and 97.0% (95% CI, 84.2% to 99.9%), respectively (n ؍ 200). The sensitivity for syphilis antibody detection was higher in patients with a rapid plasma reagin titer of >1:8 (97.3%) than in those with a titer of <1:4 (90%) or a nonreactive titer (66.7%). While syphilis, an infection caused by the spirochete Treponema pallidum, is a curable disease, it is estimated that there are 5.6 million new syphilis infections in adults annually (1) compared to approximately 2 million new HIV infections (2). Although new syphilis infections are more common, HIV screening has become a priority in low-and middle-income countries. Syphilis frequently presents atypically, which can make it difficult to clinically differentiate from other sexually transmitted infections; thus, effective diagnostic tests are crucial for correctly identifying and managing syphilis infections (3). Highly accurate diagnostic tests for HIV infection and syphilis exist, but they are often inaccessible to people living in areas with the highest burden of disease. Point-of-care tests provide an opportunity to reach those populations through tests that are inexpensive, easy to perform, and rapid, which enables same-day testing and treatment. Combining the detection of syphilis and HIV antibodies into one point-of-care test integrates syphilis screening into already existing HIV screening programs, which might be particularly beneficial in settings such as antenatal care (4).The INSTI Multiplex downward-flow immunoassay (bioLytical Laboratories, Inc., Canada) is for the simultaneous detection of HIV and T. pallidum antibodies. Results can be read in less than 1 min. Previous studies of the INSTI HIV-1/HIV-2 antibody test found it to be highly sensitive, specific, and easy to use (5-11). The INSTI Multiplex assay was developed recently, and no published data on its accuracy, feasibility, or acceptability exist yet.Using the INSTI Multiplex, we tested 200 stored (Ϫ80°C) serum samples from high-risk patients enrolled in a longitudinal study on HIV infection and syphilis in Peruvian men who have sex with men and transgender women (12). Genital lesions are a sign of primary syphilis, and 14 of the 200 serum samples were from patients who had primary syphilis, confirmed by T. pallidum DNA detection using PCR (12). The sera were tested for HIV and T. pallidum ant...
Background Dual point of care tests for antibodies to human immunodeficiency virus (HIV) and Treponema (T.) 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 two 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 two rapid tests for detection of HIV were 94.1% and 97.0% for electronic readings. Both tests had specificity of 100% for detection of HIV by electronic reading. The sensitivities of the two 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 two study sites. Conclusions Our results show the electronic reader to be a promising option for increasing the utility of point of care testing programs.
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