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CLIA Complexity: Waived (Urine); Moderate (Serum)Sensitivity of 20mIU/mL for urine and 10mIU/mL for serumResults in three minutes for urine or five minutes for serumVisual, 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) areaAbsence of this colored line suggests a negative resultA colored line at the C (control) area will always appear regardless of the presence or absence of hCGUrine specimens collected at any time of day can be usedAddition of LH (300mIU/mL), FSH (1000mIU/mL) and TSH (1000μIU/mL) to negative or positive urine/serum showed no cross-reactivity with hCGSerum should be collected without anticoagulants and hemolysis should be avoidedFor professional in vitro diagnostic use only
