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

Completed

• Conditions: Pregnancy

• Registration Number: NCT04207554
• Lead Sponsor: Guangzhou Wondfo Biotech Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-05
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Primary Completion: 2020-12-29
• Study Completion: 2020-12-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall percent (%) agreement	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Positive and negative percent agreement	3 months	The secondary endpoint is the positive percent agreement and negative percent agreement.

Trial Locations

Locations (6)

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

National Research Institute-Panorama City; 🇺🇸 Panorama City, California, United States

National Research Institute-Santa Ana; 🇺🇸 Santa Ana, California, United States