Clearblue Pregnancy Test - Lay User Study
Clearblue Pregnancy Test - Lay User Study
The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic
 gonadotropin) integrated digital test which is intended for the detection of pregnancy. This
 study will assess the performance of a HPT in the hands of lay-users 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.
The Clearblue product is an over-the-counter urine hCG (human chorionic gonadotropin)
 integrated digital test which is intended for the detection of pregnancy. The test is
 indicated for use from 6 days before the day of the missed period (5 days before the day of
 the expected period). The test is intended for home use.

 This study aims to demonstrate that the Pregnancy Test has the required performance
 characteristics in lay-user testing, and when testing samples provided by lay-users. The
 study will recruit a cross-section of the target pregnancy test user population, that is,
 women aged between 18 and 45 representative of the intended user.

 A minimum of 204 volunteers will be required to complete the study. The study site will aim
 to recruit an equal number of pregnant and not-pregnant volunteers (a minimum of 102 of
 each). Each volunteer will conduct the pregnancy test using both the 'in stream' and 'dip'
 method of sampling. Volunteer results will be evaluated against confirmed pregnancy status.
Inclusion Criteria:

 -  Female

 -  Aged 18 to 45

 -  Willing to conduct a 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

 -  Has professional experience of using lateral flow-based devices

 -  Beyond the first trimester of pregnancy

 -  Taken a hormonal preparation containing hCG in the last month.

 -  Has a medical condition that means that it is not appropriate to give a blood.