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.

A total of 502 subjects with ages from 18-55 years old were enrolled . Among the 502 total subjects, 369 subjects aged between 18 and 55 years old voluntarily participated in the Lay User Study.