CLIA Complexity: Waived for Urine Only CPT Codes: 81025 (Waived), 84703 (Non-waived) Available with choice of sensitivity—10 or 20mIU/mL in Ultra Serum/Urine or 25mIU/mL in Serum/Urine and urine only tests Visual, one-step test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in early detection of pregnancy Results in four to eight minutes Utilizes combination of monoclonal and polyclonal antibody reagent to selectively detect elevated levels of hCG Positive specimens react with the specific antibody-hCG colored conjugate and form a colored line in the S (specimen) area; absence of this colored line suggests a negative result A colored line in the C (control) area will always appear regardless of the presence or absence of hCG Addition of LH (300mIU/mL), FSH (1000mIU/mL) and TSH (1000μIU/mL) to negative (0mIU/mL hCG) or positive (25mIU/mL hCG) serum/urine samples showed no cross-reactivity