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

Wondfo Biotech

Status

Completed

Conditions

Pregnancy

Treatments

Device: Test Device-Cassette Format

Device: Test Device-Strip Format

Device: Predicate Device

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT04207554

WF2019-01

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.