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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04207554

Acronym

Preview® hCG

Enrollment

132

Registered

2019-12-23

Start date

2019-12-05

Completion date

2020-12-29

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Pregnancy, hCG, IVD, POCT

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.

Interventions

DEVICETest Device-Strip Format

Sponsor's investigational device

DEVICETest Device-Cassette Format

Sponsor's investigational device

DEVICEPredicate Device

Commercially available device

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Overall percent (%) agreement	3 months	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.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026