This study is a performance evaluation study to assess the performance of a home pregnancy test (HPT) in the hands of lay users by comparing their results, when used according to the Instructions for Use (IFU), to (a) the lay user confirmed pregnancy status, as determined by a CE marked product, and (b) to trained technicians testing the same urine samples. The study will also assess the lay user's ability to correctly read results from randomised standards, in addition to leaflet comprehension and product ease of use.
This is an observational study, designed to assess the performance of a home pregnancy test. The study aims to recruit at total 120 volunteers, being approximately equal numbers of 'pregnant' and not-pregnant' women. Volunteers will be recruited either via direct invitation or advertisement and will attend the study site for one visit lasting 30-40 minutes Written informed consent will be obtained from all volunteers prior to starting the study. All volunteers will be issues a unique study number on admission to the study. All data and samples collected will be anonymised throughout the study. Volunteers will be provided with one investigational home pregnancy test and instructions for use. They will be asked to conduct the test, following the product instructions to obtain a test result which will be recorded on the result sheet. Volunteers will be instructed the product is investigational and the results should not be relied upon to determine their pregnancy status. Study volunteers will then be interviewed by the study technician, with regards to their understanding of the product instructions and complete an ease of use questionnaire. The comprehension interview may be recorded. The study technician will then perform 2 further investigational home pregnancy tests on randomised urine standards and the volunteer will read the results. Finally, the study technician will test the volunteer's urine sample with a marketed pregnancy test and record these results on the results sheet. The results of this test will be used to provide the volunteer with her pregnancy status at the end of the study. Urine samples provided by the volunteers will be tested with the investigational HPT by an independent technician and also measured for hCG by quantitative immunoassay. Samples may also be measured for other hormones related to pregnancy and fertility. With participant permission, the samples may be retained frozen within the SPD BioBank and used for future product evaluation or research purposes.
Study Type
OBSERVATIONAL
Enrollment
129
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom
Agreement with pregnancy status
The accuracy of the investigational HPT will be calculated against the confirmed pregnancy status of the sample. The corresponding 95% confidence interval will also be calculated for the measure.
Time frame: 3 months
Agreement with technician results
The agreement between the lay-user and technician results when both testing the same sample with the investigational HPT as per the IFU. The corresponding 95% confidence interval will also be calculated for the measure.
Time frame: 3 months
Comprehension of instructions for use
The percentage number of correct answers in the IFU comprehension exercise
Time frame: 3 months
Ease of product use
The cumulative Likert scores for ease of use questions on the device usability questionnaire will be calculated, using a 7 point likert scale, where 1 is equivalent to very easy and 7 is equivalent to very difficult.
Time frame: 3 months
Ability to read result
The agreement between the lay-user read of a investigational HPT tested with a spiked standard against the expected result of the spiked standard. The corresponding 95% confidence interval will also be calculated.
Time frame: 3 months
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