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.
Study Type
OBSERVATIONAL
Enrollment
132
Sponsor's investigational device
Sponsor's investigational device
Commercially available device
National Insitute of Clinical Research
Garden Grove, California, United States
National Research Institute-Huntington Park
Huntington Park, California, United States
Downtown L.A. Research Center, Inc
Los Angeles, California, United States
National Research Institute-Westlake
Los Angeles, California, United States
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.
Time frame: 3 months
Positive and negative percent agreement
The secondary endpoint is the positive percent agreement and negative percent agreement.
Time frame: 3 months
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National Research Institute-Panorama City
Panorama City, California, United States
National Research Institute-Santa Ana
Santa Ana, California, United States