Chlamydial Infection, Gonococcal Infection, Trichomoniasis
Conditions
Keywords
Chlamydia trachomatis, Device, Diagnostic, Neisseria gonorrohoeae, Trichomonas vaginalis
Brief 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, 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. 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. and a Clinical Laboratory Improvement Amendments (CLIA) Waiver.
Detailed description
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.
Interventions
DEVICEClick Device
A single-use device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for detection of deoxyribonucleic acid (DNA) from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Chlamydia Trachomatis (CT) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP | Day 1 | The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP) |
| The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Neisseria Gonorrhoeae (NG) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP | Day 1 | The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP) |
| The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Trichomonas Vaginalis (TV) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP | Day 1 | The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants | Day 1 | If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP) |
| The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants | Day 1 | If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP) |
| The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants | Day 1 | If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP) |
| The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants | Day 1 | If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP) |
| The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants | Day 1 | If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP) |
| The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants | Day 1 | If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP) |
Countries
United States
Participant flow
Recruitment details
Participants were females 14 to 80 years of age, inclusive, recruited from 10 clinic sites across 7 states at locations including but not limited to: OB/GYN and primary care offices, as well as sexually transmitted disease, teen, public health, and family planning clinics. Participants were enrolled from 27FEB2019 to 02DEC2019.
Participants by arm
| Arm | Count |
|---|---|
| Click Device Female participants \>=14 years of age who may have been symptomatic or asymptomatic for STIs. Participants who met the inclusion/exclusion criteria and were enrolled performed self-collection with a vaginal swab for the Click device, and allowed the health care professional (HCP) to collect three additional vaginal swabs for the comparator methods. | 1,585 |
| Total | 1,585 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Enrolled but Device not Utilized | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Click Device |
|---|---|
| Age, Categorical <=18 years | 9 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 1551 Participants |
| Age, Continuous | 35.1 years STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 310 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1168 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 107 Participants |
| Evaluable Results C.trachomatis | 1457 Participants |
| Evaluable Results N. gonorrhoeae | 1468 Participants |
| Evaluable Results T. vaginalis | 1449 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants |
| Race (NIH/OMB) Asian | 86 Participants |
| Race (NIH/OMB) Black or African American | 876 Participants |
| Race (NIH/OMB) More than one race | 70 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 121 Participants |
| Race (NIH/OMB) White | 414 Participants |
| Region of Enrollment United States | 1585 participants |
| Sex: Female, Male Female | 1585 Participants |
| Sex: Female, Male Male | 0 Participants |
| Symptomatic Status C. trachomatis : Asymptomatic | 722 participants |
| Symptomatic Status C. trachomatis : Symptomatic | 735 participants |
| Symptomatic Status N. gonorrhoeae : Asymptomatic | 722 participants |
| Symptomatic Status N. gonorrhoeae : Symptomatic | 746 participants |
| Symptomatic Status T. vaginalis : Asymptomatic | 715 participants |
| Symptomatic Status T. vaginalis : Symptomatic | 734 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,585 |
| other Total, other adverse events | 0 / 1,585 |
| serious Total, serious adverse events | 0 / 1,585 |
Outcome results
Primary
The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Chlamydia Trachomatis (CT) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP
The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP)
Time frame: Day 1
Population: Evaluable Population: This population included all samples which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Chlamydia Trachomatis (CT) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP | Sensitivity | 97.6 percentage of participants |
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Chlamydia Trachomatis (CT) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP | Specificity | 98.3 percentage of participants |
Primary
The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Neisseria Gonorrhoeae (NG) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP
The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP)
Time frame: Day 1
Population: Evaluable Population: This population included all samples which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Neisseria Gonorrhoeae (NG) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP | Sensitivity | 97.4 percentage of participants |
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Neisseria Gonorrhoeae (NG) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP | Specificity | 99.4 percentage of participants |
Primary
The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Trichomonas Vaginalis (TV) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP
The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP)
Time frame: Day 1
Population: Evaluable Population: This population included all samples which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Trichomonas Vaginalis (TV) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP | Sensitivity | 99.2 percentage of participants |
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device for Detection of Trichomonas Vaginalis (TV) in Self-collected Vaginal Specimens as Compared to PIS Using Vaginal Specimens Collected by a Qualified HCP | Specificity | 96.9 percentage of participants |
Secondary
The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants
If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP)
Time frame: Day 1
Population: Evaluable Asymptomatic Population: This population included all samples from asymptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants | Sensitivity | 95.8 percentage of participants |
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants | Specificity | 99.0 percentage of participants |
Secondary
The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants
If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP)
Time frame: Day 1
Population: Evaluable Symptomatic Population: This population included all samples from symptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for CT. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants | Specificity | 97.7 percentage of participants |
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of CT From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants | Sensitivity | 98.7 percentage of participants |
Secondary
The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants
If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP)
Time frame: Day 1
Population: Evaluable Asymptomatic Population: This population included all samples from asymptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants | Sensitivity | 94.4 percentage of participants |
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants | Specificity | 99.4 percentage of participants |
Secondary
The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants
If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP)
Time frame: Day 1
Population: Evaluable Symptomatic Population: This population included all samples from symptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for NG. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants | Sensitivity | 100 percentage of participants |
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of NG From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants | Specificity | 99.4 percentage of participants |
Secondary
The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants
If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP)
Time frame: Day 1
Population: Evaluable Asymptomatic Population: This population included all samples from asymptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants | Sensitivity | 100 percentage of participants |
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Asymptomatic Participants | Specificity | 98.0 percentage of participants |
Secondary
The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants
If a participant reported Yes to any of the following symptoms, the participant is classified as Symptomatic: Unusual vaginal discharge; Vaginal irritation (itching, burning, soreness); Lower abdominal/pelvic pain; Painful urination; Increased urinary frequency; Abnormal bleeding/spotting; Pain or bleeding with sex/intercourse. Otherwise, the participant is classified as Asymptomatic. The sensitivity of the Click device is defined as follows: TP = the number of specimens where both the Click result and the PIS designation are Positive. FN = the number of specimens where the Click result is Negative and the PIS designation is Positive. Sensitivity = 100 \* TP / (TP + FN) The specificity of the Click device is defined as follows: TN = the number of specimens where both the Click result and the PIS designation are Negative. FP = the number of specimens where the Click result is Positive and the PIS designation is Negative. Specificity = 100 \* TN / (TN + FP)
Time frame: Day 1
Population: Evaluable Symptomatic Population: This population included all samples from symptomatic participants which provide an evaluable Click Diagnostics Sexual Health Test result and an evaluable PIS result for TV. A sample provides an evaluable result if both the Click device and the PIS provide a valid positive or negative result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants | Sensitivity | 98.6 percentage of participants |
| Click Device | The i) Percent Sensitivity and ii) Percent Specificity of Click Device Using Self-collected Vaginal Swabs for Detection of TV From Self-collected Specimens as Compared to PIS Using Specimens Collected by a Qualified HCP Among Symptomatic Participants | Specificity | 95.8 percentage of participants |