Clinical Study of a Diagnostic Device for NG, TV and CT in Women

This is a multi-center study with a minimum of three clinical sites across diverse
geographical areas 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 percent for any of the three targets. Sites with a prevalence higher than
2 percent for any of the three targets will be defined as high prevalence sites. The study
will enroll approximately 1750 female subjects, 14 years of age and older, 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, approximately 60 minutes in length. The hypothesis of this study is that Click
Diagnostics Sexual Health Test performs substantially equivalent to the NAAT (Nucleic Acid
Amplification Test) predicate system, and 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 and a Clinical Laboratory Improvement Amendments (CLIA) Waiver. 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 HCP 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.

3. Use of antiperspirants and deodorants or the following vaginal products: douches,
washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in
the genital area, within 48 hours prior to enrollment.