TestPack hCG Combo is a rapid immunoassay for
the qualitative detection of human Chorionic Gonadotrophin (hCG) in
serum and urine for early detection of pregnancy.
Serum or 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. As the serum or 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 polyclonal
antibody in the result window, providing a visual indication of the
presence of hCG.
The test should be read after 5 minutes. If hCG is present in
the urine or serum 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 Combo
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 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.