First To Know Pregnancy Test - Clinical Evaluation Protocol

NOWDiagnostics

Status: Enrolling

Conditions: Pregnancy Detection

Treatments: Device: Diagnostic Test

Study type: Observational

Funder types: Industry

Identifiers

NCT07304531

CR-STDY-8001-01

Details and patient eligibility

About

This study is evaluating the ADEXUSDx® hCG CLIA moderately complex, FDA-cleared test for potential over the counter (OTC) use and marketing as the First To Know® (FTK) Pregnancy test. The investigational FTK Pregnancy test will be used to assess its clinical performance in the intended use population (i.e., lay users) through self-testing in a simulated home setting.

Full description

The Investigational First to Know® Pregnancy test has been adapted from the CLIA moderately complex, FDA-cleared ADEXUSDx® hCG test for clinical evaluation to enable lay users to self-test in a simulated home environment in the US. The First To Know® Pregnancy test is currently CE marked in the EU for OTC use. The assays remain identical in their formulation and performance characteristics.

The clinical evaluation includes lay users self-testing and additional blood being drawn for comparator testing. All negative test results will be followed up for outcome. All subjects with positive test results or reporting negative results later resulted in pregnancy will be confirmed by obtaining data from standard of care assessment(s) for diagnosis of pregnancy.

Two (2) cohorts are planned to assess:

Cohort A: Cross sectional cohort evaluating clinical performance with enrollment up to 100 pregnant subjects across three (3) age groups conducted at clinical sites. Tests will be read and interpreted by the lay user. Blood will be collected at the time of testing for comparator method testing. Positive test results will be confirmed by obtaining data from standard of care assessment(s) for diagnosis of pregnancy.

Cohort A1: pre-menopausal women age 14-40

Cohort A2: peri-menopausal women age 41-55

Cohort A3: post-menopausal women age >55

Cohort B: Duplicate testing cohort designed to evaluate accuracy and precision in lay users. A subset of a minimum of 100 participants from Cohort A will co-enroll into Cohort B and conduct duplicate testing using the First To Know® Pregnancy test. Participants will independently self-administer two tests consecutively and visually interpret the results without assistance.

Enrollment will reflect the observed prevalence of positive and negative pregnancy results in Cohort A, ensuring adequate representation across all age cohorts (pre-menopausal, peri-menopausal, and post-menopausal). The results from the first test will be used to assess accuracy, while the second test will evaluate precision and agreement with the first test.

Enrollment: 1,705 estimated patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females whose pregnancy status is unknown (e.g., have not used urine test at home)
• Age Selection - must meet one of the following age groups:
• Cohort A1 - Pre-menopausal: ≥14 years of age and ≤ 40 years of age with menstrual cycles (cycle lengths of 25-35 days)
• Cohort A2 - Peri-menopausal: ≥41 years of age and ≤ 54 years of age
• Cohort A3 - Post-menopausal: ≥55 years of age
• Not menstruating at the time of the initial study visit
• Must be willing to complete all study activities, provide all specimens/samples, and conduct all required testing
• Willing to provide information regarding the diagnosis of pregnancy or details from their standard of care follow-up visit after initial visit
• Sexually active
• Not using contraceptives
• English/Spanish speaking

Exclusion criteria

• Males
• Females <14 years of age
• Recent pregnancy within the past 6 months
• Trophoblastic disease or non-trophoblastic neoplasms
• Downs syndrome (trisomy 21)
• People with limited or no reading skills
• Amenorrhea not related to peri or post menopause
• Use of medications or hormonal contraceptives that may interfere with hCG levels at the time of testing (e.g., Gonadotropins: Luteinizing hormone)

Trial design

1,705 participants in 6 patient groups

Cohort A1 - Pre-menopausal women ages 14-40

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, ages 14-40

Treatment:

Device: Diagnostic Test

Cohort A2 - Peri-menopausal women ages 41-55

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, ages 41-55

Treatment:

Device: Diagnostic Test

Cohort A3 - Post-menopausal women ages >55

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, age over 55

Treatment:

Device: Diagnostic Test

Cohort B1 - Subset of Cohort A1 Pre-menopausal women ages 14-40

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, ages 14-40

Treatment:

Device: Diagnostic Test

Cohort B1 - Subset of Cohort A2 - Peri-menopausal women ages 41-55

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, ages 41-55

Treatment:

Device: Diagnostic Test

Cohort B3 - Subset of Cohort A3 - Post-menopausal women ages >55

Description:

Participants must be a mixture of English and Spanish speaking, geographically diverse, ethnically and racially diverse, economically diverse, and with different levels of educations, age over 55

Treatment:

Device: Diagnostic Test