Clearblue Pregnancy Test Lay User Usage Study

Swiss Precision Diagnostics (SPD)

Status: Completed

Conditions: Pregnancy

Treatments: Diagnostic Test: Clearblue Pregnancy Test

Study type: Observational

Funder types: Industry

Identifiers

NCT04746014

PROTOCOL-1133

Details and patient eligibility

About

The Clearblue home pregnancy test (HPT) is an over the counter urine hCG (human chorionic gonadotrophin) visual pregnancy test which is intended for the detection of pregnancy. This study will assess the performance of the HPT in the hands of the lay user by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.

Full description

The Clearblue HPT is an over the counter urine hCG visual-read test which is intended for the detection of pregnancy. This study aims to demonstrate that the pregnancy test has the required performance characteristics in lay user testing. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged over 18 years representative of the intended user.

A minimum of 300 women will be required to complete the study consisting of both pregnant and not pregnant volunteers. Each volunteer will conduct the pregnancy test using their preferred sampling method (either 'in-stream' or 'dip'). Volunteers will be evaluated against confirmed pregnancy status. Lay user comprehension of the device instructions and usability of the device will also be assessed.

Enrollment: 306 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Aged 18 and over
• Interested in conducting a personal pregnancy test to determine or confirm their pregnancy status
• Willing to reveal their pregnancy status
• Willing to provide a blood sample
• Willing to give informed consent

Exclusion criteria

• Significant affiliation with SPD
• Used the investigational pregnancy test previously
• Qualified or trainee healthcare professional (HCP)
• Has professional experience (in current or previous job) of using dipstick type tests or lateral flow devices
• Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)
• Has a medical condition that means that it is not appropriate to give a blood sample