CLIA Complexity: Waived (Urine); Moderate (Serum) Sensitivity of 20mIU/mL for urine and 10mIU/mL for serum Results in three minutes for urine or five minutes for serum Visual, one-step test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in early detection of pregnancy Combination of monoclonal and polyclonal antibody reagent selectively detects elevated levels of hCG Positive specimens react with the specific antibody-hCG colored conjugate and form a colored line at the T (test) area Absence of this colored line suggests a negative result A colored line at the C (control) area will always appear regardless of the presence or absence of hCG Urine specimens collected at any time of day can be used Addition of LH (300mIU/mL), FSH (1000mIU/mL) and TSH (1000μIU/mL) to negative or positive urine/serum showed no cross-reactivity with hCG Serum should be collected without anticoagulants and hemolysis should be avoided For professional in vitro diagnostic use only