clinical study of a single-use, point-of-care molecular diagnostic device for the detection of neisseria gonorrhoeae (ng), trichomonas vaginalis (tv), and chlamydia trachomatis (ct) utilizing vaginal swabs

Conditions: Chlamydial Infection; Gonorrhoea; Trichomoniasis

Summary: this is a multi-center study with a minimum of three sites in the united states. the study will enroll approximately 1750 female subjects and will have a study duration of approximately 9 months after enrollment of the first subject. female subjects seen at the participating sites for any reason will be evaluated for enrollment in this study. all subjects will be managed per standard of care as applicable. subjects who are enrolled in the study will perform self-collection of a vaginal swab to be tested by click device, and allow the health care provider (hcp) to collect three additional vaginal swabs to be tested by recognized fda-cleared comparator methods. subjects will complete the study in a single visit. the primary objective is to assess the performance of the click device for detection of chlamydia trachomatis (ct), neisseria gonorrhoeae (ng), and trichomonas vaginalis (tv) in self-collected vaginal specimens as compared to patient infected status (pis) determined by three approved comparator assays using vaginal specimens collected by a qualified hcp in support of obtaining fda clearance.

this study is a multi-center study with a minimum of three clinical laboratory improvement amendments-waived (clia-waived) intended operator sites in the united states; approximately one-third of the total number of sites will have a patient population of low neisseria gonorrhoeae (ng), chlamydia trachomatis (ct), or trichomonas vaginalis (tv) prevalence. low prevalence sites are defined as sites with a prevalence \< / = 2% for any of the three targets. sites with a prevalence higher than 2% for any of the three targets will be defined as high prevalence sites. the study will enroll approximately 1750 female subjects and will have a study duration of approximately 9 months after enrollment of the first subject. approximately one-third of the total subjects shall be recruited from low prevalence sites for the infections of interest. female subjects seen at the participating sites for any reason will be evaluated for enrollment in this study. all subjects will be managed per standard of care as applicable. subjects who are enrolled in the study will perform self-collection of a vaginal swab to be tested by click device, and allow the health care provider (hcp) to collect three additional vaginal swabs to be tested by recognized fda-cleared comparator methods. subjects will complete the study in a single visit. the hypothesis of this study is that the identification of each organism (ct, ng, and tv) in self-collected vaginal swabs by women using the click device will agree with the patient infected status (pis) with a high sensitivity and specificity. the primary objective is to assess the performance of the click device for detection of ct, ng, and tv in self-collected vaginal specimens as compared to pis determined by three approved comparator assays using vaginal specimens collected by a qualified hcp in support of obtaining fda clearance. the secondary objectives are: 1) to assess the performance of the click device for detection of ct, ng, and tv in self-collected vaginal specimens among symptomatic subjects as compared to pis determined by three approved comparator assays using vaginal specimens collected by a qualified hcp; 2) to assess the performance of the click device for detection of ct, ng, and tv in self-collected vaginal specimens among asymptomatic subjects as compared to pis determined by three approved comparator assays using vaginal specimens collected by a qualified hcp.

Eligibility criteria:
inclusion criteria: 1. willing and able to give voluntary written informed consent (or the parent/legal guardian will provide parental permission) before any study-related procedure is performed. 2. female at birth. (pregnant and breastfeeding women are eligible) 3. age \> / = 14 years at the time of enrollment. 4. able to read and understand the procedural information provided for the study. 5. able and willing to follow all study procedures, including performing self-collection of one vaginal swab and permitting a licensed health care provider to collect three additional vaginal swabs. exclusion criteria: 1. have a medical condition, serious intercurrent illness, or other circumstance that, in the investigator's judgment, could jeopardize the subject's safety, or could interfere with study procedures. 2. enrollment in this study previously.

Keywords: chlamydia trachomatis device diagnostic molecular neisseria gonorrhoeae trichomonas vaginalis