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

NCT04207554 | Completed FDA Device

• 1 other identifier: WF2019-01
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 6

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.

Conditions

Pregnancy

Keywords

Pregnancy; hCG; IVD; POCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Positive and negative percent agreement

  3 months

Study Arms (2)

Pregnancy Positive

Pregnant subjects within 11 weeks since the first day of last period.

Device: Test Device-Strip Format; Device: Test Device-Cassette Format; Device: Predicate Device

Pregnancy Negative

Non-pregnant subjects.

Device: Test Device-Strip Format; Device: Test Device-Cassette Format; Device: Predicate Device

Interventions

Test Device-Strip Format DEVICE

Sponsor's investigational device

Also known as: Preview® hCG Urine/Serum Combo Pregnancy Test-Strip Format

Pregnancy Negative; Pregnancy Positive

Test Device-Cassette Format DEVICE

Sponsor's investigational device

Also known as: Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette Format

Pregnancy Negative; Pregnancy Positive

Predicate Device DEVICE

Commercially available device

Also known as: QuickVue+ hCG Combo Test

Pregnancy Negative; Pregnancy Positive

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Healthy adult women of childbearing age.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enroll healthy adult women of childbearing age.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Wondfo Biotech Co., Ltd: lead
• Nova Clinical Solutions, Inc.: collaborator

Study Sites (6)

National Insitute of Clinical Research

Garden Grove, California, 92844, United States

Location

National Research Institute-Huntington Park

Huntington Park, California, 90255, United States

Location

Downtown L.A. Research Center, Inc

Los Angeles, California, 90017, United States

Location

National Research Institute-Westlake

Los Angeles, California, 90057, United States

Location

National Research Institute-Panorama City

Panorama City, California, 91402, United States

Location

National Research Institute-Santa Ana

Santa Ana, California, 92704, United States

Location

Related Publications (6)

• WIDE L, GEMZELL CA. An immunological pregnancy test. Acta Endocrinol (Copenh). 1960 Oct;35:261-7. doi: 10.1530/acta.0.xxxv0261. No abstract available.

  PMID: 13785019 RESULT

• Batzer FR. Hormonal evaluation of early pregnancy. Fertil Steril. 1980 Jul;34(1):1-13. doi: 10.1016/s0015-0282(16)44829-6. No abstract available.

  PMID: 6995156 RESULT

• 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. doi: 10.1016/0002-9378(76)90518-4.

  PMID: 984142 RESULT

• 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. doi: 10.7326/0003-4819-78-1-39. No abstract available.

  PMID: 4734160 RESULT

• 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. doi: 10.1210/jcem-40-3-537.

  PMID: 1117063 RESULT

• 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. doi: 10.1016/s0015-0282(16)46337-5.

  PMID: 7115557 RESULT

Study Officials

• Rui Liu, Master

  Guangzhou Wondfo Biotech Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 23, 2019
• Study Start: December 5, 2019
• Primary Completion: December 29, 2020
• Study Completion: December 29, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)