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A sensitive immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. Detects 25 mIU/mL hCG in urine. Results in 3 minutes or less. Greater than 99% sensitivity, specificity and accuracy. Room temperature storage. Simple one-step procedure uses only 3 drops of sample. CLIA waived.