Clearblue Pregnancy Test - Lay User Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clearblue Pregnancy Test - Lay User Study

Conditions
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Pregnancy

Intervention / Treatment
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* Diagnostic Test: Clearblue pregnancy test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Clearblue pregnancy test|Urine pregnancy test|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Clearblue pregnancy test | Number of pregnancy test results in agreement with clinical pregnancy status | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sample method agreement | number of volunteers who record the same pregnancy test result using the 'in stream' and 'dip' method of sampling | 1 day | 
| Coordinator agreement | number of volunteers who record the same pregnancy test result as a trained study coordinator | 1 day | 
| Device usability | number of volunteers who record the device as easy to use | 1 day |