Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test

Study Overview
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Brief Summary
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The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.

Official Title
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Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test

Conditions
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Pregnancy

Intervention / Treatment
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* Device: Test Device-Strip Format
* Device: Test Device-Cassette Format
* Device: Predicate Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult women of childbearing age. Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment. Signed and dated informed consent. Exclusion Criteria: Minors. Adults who are unable to independently give consent for study. Known pregnancy (i.e. - patient appears obviously pregnant). Recent miscarriage or abortion and yet to have 2 complete menstrual cycles before study start. History of ectopic pregnancy, fibroids, congenital uterine anomaly that causes an irregular-shaped uterus. Taken any of the medications of contraceptives containing estrogen in last two weeks. Hemodynamically unstable. Moderately to severely ill-appearing or in moderate to severe pain. Technically not possible to obtain blood or urine from the study subject.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnancy Positive<br>Pregnant subjects within 11 weeks since the first day of last period. | Device: Test Device-Strip Format<br>* Sponsor's investigational device<br>* Other names: Preview® hCG Urine/Serum Combo Pregnancy Test-Strip Format;Device: Test Device-Cassette Format<br>* Sponsor's investigational device<br>* Other names: Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette Format;Device: Predicate Device<br>* Commercially available device<br>* Other names: QuickVue+ hCG Combo Test;|
| Pregnancy Negative<br>Non-pregnant subjects. | Device: Test Device-Strip Format<br>* Sponsor's investigational device<br>* Other names: Preview® hCG Urine/Serum Combo Pregnancy Test-Strip Format;Device: Test Device-Cassette Format<br>* Sponsor's investigational device<br>* Other names: Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette Format;Device: Predicate Device<br>* Commercially available device<br>* Other names: QuickVue+ hCG Combo Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall percent (%) agreement | The primary endpoint is the overall percent (%) agreement, which is the percentage of total subjects where the test (Preview® hCG Urine/Serum Combo Pregnancy Test) and the reference test (QuickVue+ hCG Combo Test) agree. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and negative percent agreement | The secondary endpoint is the positive percent agreement and negative percent agreement. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, hCG, IVD, POCT