Clinical trial NCT04207554: Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
Official title: Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Pregnancy
hCG
IVD
POCT
Lead sponsor: Guangzhou Wondfo Biotech Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Nova Clinical Solutions, Inc.
First posted: 2019-12-23
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll healthy adult women of childbearing age.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall percent (%) agreement
timeFrame: 3 months
Secondary outcomes:
measure: Positive and negative percent agreement
timeFrame: 3 months
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: National Insitute of Clinical Research
state: California
city: Huntington Park
country: United States
facility: National Research Institute-Huntington Park
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center, Inc
state: California
city: Los Angeles
country: United States
facility: National Research Institute-Westlake
state: California
city: Panorama City
country: United States
facility: National Research Institute-Panorama City
state: California
city: Santa Ana
country: United States
facility: National Research Institute-Santa Ana
state: California
Study officials:
affiliation: Guangzhou Wondfo Biotech Co., Ltd
name: Rui Liu, Master
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
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. doi: 10.1016/0002-9378(76)90518-4.
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. doi: 10.7326/0003-4819-78-1-39. No abstract available.
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. doi: 10.1210/jcem-40-3-537.
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. doi: 10.1016/s0015-0282(16)46337-5.