Principle
The HCG Pregnancy Test Cassette utilizes a combination of antibodies including a
monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay
is conducted by filling the urine specimen to sample well and observing the
formation of red-colored lines. The specimen migrates via capillary action along the
membrane to react with the colored conjugate. Positive specimens react with the
specific antibody-HCG-colored conjugate and form a red colored line at the test line
region of the membrane. The absence of this red colored line suggests a negative
result. To serve as a procedural control, a red colored line will always appear in the
control line region if the test has been performed properly.
Warnings and Precautions
1. For in vitro diagnostic use only.
2. Do not use test kit beyond the expiry date.
3. The test device should not be reused.
4. The test kit should remain in the sealed pouch until use. Do not use if the
pouch is damaged or opened.
5. Urine specimens may be infectious; ensure proper handling and dispose of all
used reaction devices into a biohazard container.
Materials and Reagents
Materials provided
The HCG Pregnancy Test Cassette
Dropper
Desiccant
Reagents
Coated Antibodies: Control region, Goat anti-mouse (IgG) polyclonal antibody. Test
region, Mouse monoclonal anti-HCG antibody A.
Labeled antibody: Colloidal gold conjugate of monoclonal anti-HCG antibody B.
