CorDx

HCG Pregnancy Test (Cassette)

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HCG Pregnancy Test is a self-testing immunoassay made for the rapid, visual and qualitative determination of human chorionic gonadotropin (HCG) in urine specimen to aid in the early detection of pregnancy.

Accessories:

Instruction for use, urine cup

Principle of Test:

immunochromatographic assay

Product Performance:

Sensitivity: 25mIU/ml  10mIU/ml  Accuracy: >99.5 %

INTENDED USE

HCG Pregnancy Test is a self-testing immunoassay made for the rapid, visual and qualitative determination of human chorionic gonadotropin (HCG) in urine specimen to aid in the early detection of pregnancy.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the provided pipette to withdraw urine specimen from the urine cup and dispense 3 drops into the sample well.
4. Wait for pink-colored lines to appear. Read results within 5 minutes. Do not read results after 5 minutes.

INTERPRETATION OF RESULTS

PREGNANT: Two distinct pink-colored lines appear, one in the test region (T) and one in the control region(C).

NOTE: The intensity of the pink color in the test region (T) may vary depending on the concentration of HCG present in the specimen. Therefore, any shade of pink color in the test region (T) should be considered positive.

NOT PREGNANT: Only one pink-colored line appears in the control region(C). No apparent pink line appears in the test region (T).

INVALID: Control Line fails to appear.

NOTE: 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. If the problem persists, please contact your local distributor.