Home Pregnancy Test Study on BioBank Samples
Home Pregnancy Test Study on BioBank Samples
This is a non-clinical lay user study using stored clinical samples from the SPD BioBank.

 Volunteers recruited into the study and meeting the criteria will test a randomised pregnant
 or not pregnant urine sample sourced from SPD's biobank with a new home pregnancy test.
 Volunteers will be required to follow the product instructions for use (IFU).

 The order of testing will be randomised prior to execution of the protocol, and each urine
 sample will only be identifiable by a unique reference number. An independent study
 technician not involved in study conduct will be responsible for blinding the samples.
Women will be informed of the opportunity to participate in a study in which they will be
 required to use a home pregnancy test to test a urine sample provided to them. Interested
 applicants will be invited to join the study.

 Volunteers will be advised that the product they will be testing is under investigation and
 that the volunteer will not be testing their own urine and therefore volunteers will not
 learn their own pregnancy status.

 Volunteers will be required to consent to the study prior to participation. Each volunteer
 will test only one device, they will be provided with one investigational device and one
 urine sample. The order of testing will be randomised prior to execution of the protocol, and
 each urine sample will only be identifiable by a unique reference number.

 When ready the volunteer will be required to read the IFU prior to testing the urine sample
 provided with the investigational device according to the instructions. The volunteer will
 advise the study technician of the result, who will record this on the result sheet.
Inclusion Criteria:

 -  Female

 -  Aged ≥18 years

 -  Willing to give informed consent

 Exclusion Criteria:

 -  Currently or previously employed by SPD, Abbott, Alere, Unipath, P&G or affiliates

 -  Has an immediate relative currently or previously (within last 5 years) employed by
 SPD, Abbott, Alere, Unipath or P&G or affiliates

 -  Is a qualified or trainee Healthcare Professional (HCP)

 -  Has professional experience of using dipstick type tests or lateral flow devices

 -  Has previously taken part in this study

 -  Seen the product within the past 6 months