hCG Pregnancy Rapid Combo Test

SPECIFICATION:

Method: Double antibody sandwich immune-chromatographic assay

Time to Result: 5-10 minutes

Storage Condition: Stored at 4°C~30°C in a dry place and avoid direct sunlight

Shelf Life: 24 months

Sample Type: Urine and Serum

Cut-Off Level: 10 mIU/mL for serum and 20 mIU/mL for urine.

Kit Sizes: 25 tests/box

Kit Contents:

• 1 x IFU

• 25 x Test cassette

• 25 x Pipette

SPECIMEN COLLECTION AND HANDLING:

Serum

1. For serum specimens, collect blood in a tube without anticoagulant and allow it to clot.

2. Separate serum from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.

3. Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for long periods.

4. If specimens cannot be tested immediately, they may be stored at 2~8℃ for up to 48 hours or 3 months at -20℃.

Urine

1. Any urine specimen is appropriate for HCG testing. However, urine specimens collected early in the morning are mostly recommended as the HCG concentration is the highest at that time.

2. Urine specimens may be collected in any clean and dry plastic or glass container (not provided).

3. If specimens cannot be assayed immediately, they may be stored at 2~8℃ for up to 48 hours before testing.

HOW TO USE:

Step 1: Please allow refrigerated or frozen specimens to equilibrate to room temperature before testing.

Step 2: Remove the test device from the foil pouch by tearing at the notch. Place the test device on a flat surface.

Step 3: Apply 3 drops (around 80μL) of the specimen without air bubbles into the specimen well.

Step 4: Read results in 5 minutes. Follow the instructions under the “Results Interpretation” section.

Step 5: Some specimens may produce positive results in as fast as 1 minute. Do not read the result after 10 minutes.

INTERPRET THE RESULTS:

1. Positive: Two purple-red lines appearing at both test line (T) and control line (C) indicates positive result.

2. Negative: Only one red line appears in the control region (C). No apparent line in the test region (T).

3. Invalid: Control line (C) fails to appear. Insufficient specimen volume or incorrect test procedure 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, you should immediately stop using the kit with the same LOT No. and contact your local distributor.

LIMITATION & PRECAUTION:

• As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

• The HCG Pregnancy Rapid Combo Test is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in hCG can be determined by this test.

• Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a first-morning urine specimen should be collected 48 hours later and tested.

• This test may produce false positive results. Several conditions other than pregnancy can cause elevated levels of hCG.

• This test may produce false negative results. False-negative results may occur when the levels of hCG are below the sensitivity level of the test.

• This test provides a presumptive diagnosis of pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Use fresh specimens whenever possible.

• Do not read the results after 10 minutes as they are invalid and may be wrong.

• The product should be used as soon as possible once the foil pouch is opened, in case of long-term exposure to the environment.

• Follow standard biosafety guidelines for handling and disposal of potentially infectious material.