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

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 Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Test Device-Strip Format; Device: Test Device-Cassette Format; Device: Predicate Device

• Study Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92844
      • National Insitute of Clinical Research
    • Huntington Park, California, United States, 90255
      • National Research Institute-Huntington Park
    • Los Angeles, California, United States, 90017
      • Downtown L.A. Research Center, Inc
    • Los Angeles, California, United States, 90057
      • National Research Institute-Westlake
    • Panorama City, California, United States, 91402
      • National Research Institute-Panorama City
    • Santa Ana, California, United States, 92704
      • National Research Institute-Santa Ana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study will enroll healthy adult women of childbearing age.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnancy Positive; Pregnant subjects within 11 weeks since the first day of last period.	Device: Test Device-Strip Format; Sponsor's investigational device; Other Names: Preview® hCG Urine/Serum Combo Pregnancy Test-Strip Format; Device: Test Device-Cassette Format; Sponsor's investigational device; Other Names: Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette Format; Device: Predicate Device; Commercially available device; Other Names: QuickVue+ hCG Combo Test
Pregnancy Negative; Non-pregnant subjects.	Device: Test Device-Strip Format; Sponsor's investigational device; Other Names: Preview® hCG Urine/Serum Combo Pregnancy Test-Strip Format; Device: Test Device-Cassette Format; Sponsor's investigational device; Other Names: Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette Format; Device: Predicate Device; Commercially available device; Other Names: QuickVue+ hCG Combo Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and negative percent agreement	The secondary endpoint is the positive percent agreement and negative percent agreement.	3 months

Collaborators and Investigators

• Sponsor: Guangzhou Wondfo Biotech Co., Ltd
• Collaborators: Nova Clinical Solutions, Inc.
• Investigators: Study Chair: Rui Liu, Master, Guangzhou Wondfo Biotech Co., Ltd

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2019
• Primary Completion (ACTUAL): December 29, 2020
• Study Completion (ACTUAL): December 29, 2020

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (ACTUAL): December 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; POCT; hCG; IVD
• Other Study ID Numbers: WF2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No