Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System

Andon Health Co., Ltd502 enrolled

Overview

This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals. Lay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire.

Study Type

OBSERVATIONAL

Enrollment

502

Conditions

Early Pregnancy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Method comparison study exclusion criteria * Female； * 18-55 years of age； * Voluntary and sign informed consent form. 2. Lay user study inclusion criteria * Female； * 18-55 years of age； * Voluntary and sign informed consent form； * Willingness to perform self-test of investigational device； * Have the ability to read English. Exclusion Criteria: 1. Method comparison study exclusion criteria * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)； * Within 8 weeks of childbirth or abortion； * The investigator has reason to believe that it is inappropriate for subjects to participate in the study. 2. Lay user study inclusion criteria * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)； * Within 8 weeks of childbirth or abortion； * The investigator has reason to believe that it is inappropriate for subjects to participate in the study； * Background in a medical or laboratory testing.

Locations (1)

First Teaching hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Outcomes

Primary Outcomes

Comparison results

Compare the test results conducted by professionals using investigational device and the comparator, and the positive percent agreement (PPA=100%), negative percent agreement (NPA=100%) and overall percent agreement (OPA=100%) were calculated.

Time frame: 30minute

Secondary Outcomes

Evaluate the usability and user comprehension of investigational device

The accuracy rate of the critical task is 100%. The Overall Percent Agreement for investigational device is 100% when conducted by a lay user. The accuracy rate of the each questions in the Knowledge assessment is 100%, and 100% of the Ease of operation assessment chose normal, easy, or very easy.

Time frame: 30minute

Data from ClinicalTrials.gov

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