Immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy.

• Results in 5 minutes (serum), 3 minutes (urine).
• Plus/minus (+/-) readout.
• >99% accuracy.
• 10 mIU/mL sensitivity, serum; 20mIU/mL sensitivity, urine.
• Detects low hCG levels as early as 2-3 days before expected menses.
• CLIA-waived for urine; CLIA Moderately Complex when using serum.