Home Pregnancy Test Evaluation, Lay User Study

Evaluation of Home Pregnancy Test by Lay Users Study

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related

Detailed Description

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 (Actual): 129

Contacts and Locations

Study Locations

• United Kingdom
  • Bedfordshire
    • Bedford, Bedfordshire, United Kingdom, MK44 3UP
      • SPD Development Company Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female volunteers representative of home pregnancy test users.

Description

Inclusion Criteria:

• Willing to give informed consent
• Willing to conduct a personal home pregnancy test and reveal their pregnancy status
• Seeking to conceive, wishing to conduct a pregnancy test or having recently found out they are pregnant

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
• Healthcare professionals (HCP's) with professional experience either using lateral flow-based devices or conducting near patient testing
• If pregnant, known to be beyond the first trimester (defined as last menstrual period, LMP +13 weeks)
• aken a hormonal preparation containing hCG in the last month, e.g. Pregnyl ®
• Has previously taken part in this study
• Seen the product within the past 6 months

Immediate relatives are defined as parents, children, siblings or partner/spouse

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
Comprehension of instructions for use	The percentage number of correct answers in the IFU comprehension exercise	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.	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.	3 months

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Investigators: Principal Investigator: Sarah Johnson, SPD Development Company Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): November 4, 2020
• Study Completion (Actual): November 4, 2020

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-1146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No