Clearblue Pregnancy Test Lay User Usage Study

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.

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