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

Completed

• Conditions: Pregnancy
• Interventions: Device: Test Device-Strip Format; Device: Test Device-Cassette Format; Device: Predicate Device

• 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

Arm && Interventions

Group	Intervention	Description
Pregnancy Negative	Predicate Device	Non-pregnant subjects.
Pregnancy Negative	Test Device-Strip Format	Non-pregnant subjects.
Pregnancy Negative	Test Device-Cassette Format	Non-pregnant subjects.
Pregnancy Positive	Test Device-Strip Format	Pregnant subjects within 11 weeks since the first day of last period.
Pregnancy Positive	Test Device-Cassette Format	Pregnant subjects within 11 weeks since the first day of last period.
Pregnancy Positive	Predicate Device	Pregnant subjects within 11 weeks since the first day of last period.

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

Downtown L.A. Research Center, Inc; 🇺🇸 Los Angeles, California, United States

National Research Institute-Huntington Park; 🇺🇸 Huntington Park, 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