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

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.

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.