The hCG Card Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding a urine specimen to the specimen well of the test device and observing the formation of 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 to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Reagents: The test card contains anti-hCG particles and anti-hCG coated on the membrane.
Directions for use: 1. Allow the test device, urine specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing. 2. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible. 3. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 180 μl) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below. 4. The result should be interpretated between 3-5 minutes.
- Please confirm negative results at 10 minutes - Do not interpretate result exceeding 10 minutes
POSITIVE:* Two distinct red lines appear. One line should be in the control region (C) and another line should be in the test region (T).
*NOTE: The intensity of the red color in the test line region (T) will vary depending on the concentration of hCG present in the specimen. Therefore, any shade of red in the test region (T) should be considered positive.
NEGATIVE: One red line appears in the control region (C). No apparent red or pink line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device.