Core HCG tests are rapid qualitative tests to detect the presence of HCG in urine. The tests utilize a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of HCG in urine. The test strips contain monoclonal HCG colored conjugate and polyclonal anti-HCG coated on a membrane. The assay is conducted by dipping the test into the urine specimen and observing for the formation of colored bands. The urine specimen migrates via capillary action along the membrane and reacts with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a colored band on the specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the control Zone will always appear regardless of the presence or absence of HCG. Sensitivity and specificity: Core pregnancy test kits detect HCG concentration of 25mIU/ml and greater. The test has been standardized to the world health organization third international standard of mIU or standard international unit. The addition of LH (300 mIU/ml), FSH (1000mIU/ml) to negative (0 mIU/ml HCG) and positive (20 mIU/ml HCG) urine showed no cross-reactivity.
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