Urine is a rapid immunoassay for the qualitative detection
of human Chorionic Gonadotrophin (hCG) in urine for early detection
Urine is added to the Sample Well of the reaction disc with the aid
of a transfer pipette, and allowed to migrate through the membrane
until it reaches the End of Assay Window. As the urine proceeds
through the membrane, it mobilises the anti hCG monoclonal
antibody-colloid. If hCG is present in the sample, it will form a
complex with the antibody-colloid. The antibody-colloid complex
migrates through the membrane and is captured by the immobilised
anti hCG monoclonal antibody in the result window, providing a
visual indication of the presence of hCG.
The test should be read when the End of Assay Window has
turned pink/red. If hCG is present in the urine at levels of
25mIU/ml or greater, a Plus sign (+) appears in the result window.
A Minus sign (-) indicates no hCG was detected.
TestPack hCG Urine also
provides the following integral control features:
- The plus/minus format provides an easy to interpret result for
positive and negative patient samples.
- The appearance of a pink/red colour in the End of Assay Window
indicates that the test is complete.
- The appearance of the Positive On Board Control (POS CTL √ )
and the Minus Sign (–) gives an extra measure of quality control by
demonstrating the functionality of the antibody-colloid complex and
capture antibody systems, since they will only appear if the
reagents are chemically active. The POS CTL (√ ) and the Minus Sign
(–) should always appear for the test to be valid.
- An additional Negative On Board Control (NEG CTL X) indicates
non-specific binding and invalidates the test.