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Background and Objectives: Trichomoniasis is a prevalent cause of vaginitis among adolescents that increases the risk of acquiring other sexually transmitted diseases and of negative pregnancy outcomes. Treatment of trichomoniasis is therefore essential for improving sexual and reproductive health outcomes. A timely, sensitive diagnostic test for T vaginalis may increase the accuracy of clinician's treatment decisions, resulting in more infected women receiving treatment and fewer uninfected women receiving treatment., Methods: This study was a retrospective observational assessment of electronic medical records before and after point-of-care (POC) implementation of the rapid antigen test. Records were collected from women aged 14 to 20 years who received a T vaginalis test in the emergency department during either study period. The main outcome measures were rates of accurate treatment, inaccurate treatment, and missed treatment of trichomoniasis in each study period., Results: Overall rates of accurate treatment increased from 78.7% pre-POC to 87.7% post-POC (P = .02). Specifically, rates of not treating uninfected women increased from 61.4% pre-POC to 70.4% post-POC (P = .06), and rates of treating infected women were the same pre-POC (17.3%) and post-POC (17.3%; P = .99). Rates of inaccurate treatment decreased from 23.1% pre-POC to 13.1% post-POC (P = .02). Changes in missed treatment rates (14.0% pre-POC; 8.8% post-POC; P = .73) were not statistically significant., Conclusions: POC testing can improve clinical care by decreasing the use of antibiotics in uninfected women. The results of this study support the use of a T vaginalis rapid antigen POC test for adolescents presenting to the emergency department., (Copyright © 2016 by the American Academy of Pediatrics.)

Objectives: We aimed to examine the impact of a point-of-care (POC) test on overtreatment and undertreatment of sexually transmitted infections (STIs) by comparing treatment patterns for gonorrhoea (detected with nucleic acid amplification testing (NAAT)) with trichomoniasis (detected by POC test) for young women seen in an emergency department (ED)., Methods: We reviewed the database of a quality improvement (QI) project that aims to improve follow-up care for STIs in the ED. Data included the test result and antibiotic given (if any) during visits by women age 14-21 for whom an STI test was ordered. We generated Shewhart control charts and compared overtreatment and undertreatment rates for gonorrhoea and trichomoniasis using χ(2) testing., Results: Of 1877 visits over 18 months, 8.8% of women had gonorrhoea and 16.5% had trichomoniasis. Overtreatment was higher for women with gonorrhoea than trichomoniasis (54% vs 23%, p<0.001). Overtreatment for gonorrhoea decreased from 58% to 47% (p<0.01) and overtreatment for trichomoniasis decreased from 24% to 18% (p<0.01), which corresponded to improvements in patient follow-up for the QI project. Undertreatment was higher for women with gonorrhoea than trichomoniasis (29% vs 21%, p=0.03), and did not change over time., Conclusions: A POC test improves the accuracy of STI care in an ED compared with NAAT testing. An unanticipated benefit of QI efforts to improve patient follow-up is the observed decrease in antibiotic use in the ED. Given the ability of gonorrhoea to develop antibiotic resistance, future efforts should focus on development of an accurate POC test for gonorrhoea.

Accurate point-of-care (POC) diagnostic tests for Chlamydia trachomatis infection are urgently needed for the rapid treatment of patients. In a blind comparative study, we evaluated microwave-accelerated metal-enhanced fluorescence (MAMEF) assays for ultrafast and sensitive detection of C. trachomatis DNA from vaginal swabs. The results of two distinct MAMEF assays were compared to those of nucleic acid amplification tests (NAATs). The first assay targeted the C. trachomatis 16S rRNA gene, and the second assay targeted the C. trachomatis cryptic plasmid. Using pure C. trachomatis, the MAMEF assays detected as few as 10 inclusion-forming units/ml of C. trachomatis in less than 9 min, including DNA extraction and detection. A total of 257 dry vaginal swabs from 245 female adolescents aged 14 to 22 years were analyzed. Swabs were eluted with water, the solutions were lysed to release and to fragment genomic DNA, and MAMEF-based DNA detection was performed. The prevalence of C. trachomatis by NAATs was 17.5%. Of the 45 samples that were C. trachomatis positive and the 212 samples that were C. trachomatis negative by NAATs, 33/45 and 197/212 were correctly identified by the MAMEF assays if both assays were required to be positive (sensitivity, 73.3%; specificity, 92.9%). Using the plasmid-based assay alone, 37/45 C. trachomatis-positive and 197/212 C. trachomatis-negative samples were detected (sensitivity, 82.2%; specificity, 92.9%). Using the 16S rRNA assay alone, 34/45 C. trachomatis-positive and 197/212 C. trachomatis-negative samples were detected (sensitivity, 75.5%; specificity, 92.9%). The overall rates of agreement with NAAT results for the individual 16S rRNA and cryptic plasmid assays were 89.5% and 91.0%, respectively. Given the sensitivity, specificity, and rapid detection of the plasmid-based assay, the plasmid-based MAMEF assay appears to be suited for clinical POC testing.

Chlamydia trachomatis is a common sexually transmitted infection in young women. Available point-of-care (POC) diagnostic tests perform poorly, but development of new devices can be costly and time consuming. We explored the feasibility (user friendliness) and test characteristics (sensitivity and specificity) of a new prototype device to detect Chlamydia in adolescent women by using small numbers of subjects and rapid communication with the manufacturer. We compared cervical POC test results to the gold standard (cervical nucleic acid amplification testing). We also assessed the accuracy of the POC test on self-collected vaginal swabs by comparing results to cervical nucleic acid amplification test and to the cervical POC test. We frequently reviewed user experience and test results with the manufacturer. The results showed the feasibility and accuracy of the device. Feasibility--initial device malfunctions were identified and corrected. This device would be easy to use in a nonclinical setting, as it is self-contained and the color change for some specimens was dramatic and immediate. Accuracy--initial prototypes demonstrated low sensitivities (38%) for vaginal and cervical swabs. After feedback, the company developed new prototypes with improved sensitivity (80%). However, the increased sensitivity was accompanied by a high percentage of indeterminate results and false positives that lowered specificity.

Objectives: To compare the accuracy (ie, correlation, sensitivity, specificity) of self-performed point-of-care (POC) tests with clinician-performed tests for trichomoniasis in adolescent women., Methods: Sexually experienced women aged 14-22&emsp14;years (n=209) collected a vaginal swab and performed a POC test for trichomoniasis. Using a speculum, the clinician obtained vaginal swabs that were tested for trichomoniasis using the POC test, wet mount, culture and transcription-mediated amplification (TMA) using standard and alternative primers. Self and clinician results were compared with true positives, defined as either culture-positive or TMA-positive with both sets of primers., Results: Participants' mean age was 17.8&emsp14;years; 87% were African-American; 74% reported vaginal itching or discharge and 51 (24%) had trichomoniasis. Over 99% correctly performed and interpreted her self-test. Self and clinician POC tests were highly correlated (95.7% agreement, κ 0.87). Compared with true positives, the sensitivity of the self-POC test was 78% (CI 65% to 89%), similar to that of the clinician-POC test (84%, CI 71% to 93%) and culture (82%, CI 69% to 92%), and significantly better than wet mount (39%, CI 26% to 54%). The specificity of the self-POC test was 99% (CI 96% to 100%), similar to that of the clinician-POC test (100%, CI 98% to 100%). The sensitivity of the self-POC test was not affected by vaginal symptoms or other variables., Conclusions: Young women performing a self-POC test detected as many trichomoniasis infections as clinician-POC tests or culture, twice as many as wet mount and slightly fewer than an amplified test. Incorporating self-obtained or self-performed POC tests into routine practice could effectively increase the identification and treatment of trichomoniasis in this vulnerable population.

Abstract: Purpose: Two point-of-care tests are available to detect bacterial vaginosis (BV), a common vaginal condition. This study aimed to (1) compare the accuracy of two self-performed BV tests with clinician-performed BV tests and with clinical diagnosis of BV; and (2) compare trust of results for self-performed BV testing with clinician-performed BV testing. Methods: Participants (14–22 years old) in a study assessing self-testing for Trichomonas vaginalis were also asked to perform a self-test for BV (using a pH or sialidase test). Results were compared with clinician-performed tests and with clinical diagnosis of BV (defined by modified Amsel criteria). A two-item subscale from a larger acceptability scale was used to assess trust at baseline, after testing, and after discussion of results. Results: All 131 women performed self-BV testing correctly. Agreement between self- and clinician-performed tests was good (κ: .5–.7) Compared with clinical diagnosis of BV, self-pH was 73% sensitive and 67% specific, and self-sialidase was 40% sensitive and 90% specific. Trust in self-performed BV testing was lower than trust in clinician-performed BV testing at baseline, but increased after testing and discussion of results. Conclusions: Young women can perform self-tests for BV with reasonable accuracy, which could increase testing when pelvic examinations are not feasible. Trust in self-testing increased after experience and after discussion of test results. Although the pH test is available over the counter, young women may continue to rely on clinicians for testing. [Copyright &y& Elsevier]