First To Know Pregnancy Test - Clinical Evaluation Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic Test.
- Who it may be relevant to
- Registry conditions: Pregnancy Detection. Basic parameters: from 14 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
First To Know Pregnancy Test Clinical Evaluation Protocol
Overview
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.
Detailed 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.
Interventions
- Device Diagnostic Test
For this observational trial , the Intervention of interest is the First To Know Pregnancy Test
Primary outcome measures
- Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay [Time frame: Through study completion, an average of 6 months]
Secondary outcome measures (6)
- Assess the performance of the FTK Pregnancy test near the cutoff range [Time frame: Through study completion, an average of six months]
- Evaluate the test's specificity in pre-menopausal, peri-menopausal and post-menopausal women [Time frame: through study completion, an average of 6 months]
- Follow subjects to confirm pregnancy status [Time frame: through study completion, an average of 6 months]
- Evaluate lay user performance under real-world conditions [Time frame: through study completion, an average of 6 months]
- Assess the usability of the test [Time frame: through study completion, an average of 6 months]
- Evaluate testing precision [Time frame: through study completion, an average of 6 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Matrix Clinical Research Los Angeles — Los Angeles
- ERA Health Research — Midland
Identifiers
NCT: NCT07304531 · CR-STDY-8001-01