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

Pregnancy Clinical Trial

— Preview® hCG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207554
• Other study ID #: WF2019-01
• Status: Completed
• Start date: December 5, 2019
• Est. completion date: December 29, 2020

Study information

• Verified date: January 2021
• Source: Guangzhou Wondfo Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 29, 2020
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Test Device-Strip Format
Sponsor's investigational device
• Test Device-Cassette Format
Sponsor's investigational device
• Predicate Device
Commercially available device

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Wondfo Biotech Co., Ltd	Nova Clinical Solutions, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

Batzer FR. Hormonal evaluation of early pregnancy. Fertil Steril. 1980 Jul;34(1):1-13. Review. — View Citation

Braunstein GD, Rasor J, Danzer H, Adler D, Wade ME. Serum human chorionic gonadotropin levels throughout normal pregnancy. Am J Obstet Gynecol. 1976 Nov 15;126(6):678-81. — View Citation

Braunstein GD, Vaitukaitis JL, Carbone PP, Ross GT. Ectopic production of human chorionic gonadotrophin by neoplasms. Ann Intern Med. 1973 Jan;78(1):39-45. — View Citation

Catt KJ, Dufau ML, Vaitukaitis JL. Appearance of hCG in pregnancy plasma following the initiation of implantation of the blastocyst. J Clin Endocrinol Metab. 1975 Mar;40(3):537-40. — View Citation

Lenton EA, Neal LM, Sulaiman R. Plasma concentrations of human chorionic gonadotropin from the time of implantation until the second week of pregnancy. Fertil Steril. 1982 Jun;37(6):773-8. — View Citation

WIDE L, GEMZELL CA. An immunological pregnancy test. Acta Endocrinol (Copenh). 1960 Oct;35:261-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Positive and negative percent agreement	The secondary endpoint is the positive percent agreement and negative percent agreement.	3 months