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

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

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.

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.