Principle
The test is based on a chromatographic immunoassay principle. The strip contains:
Test line (T): coated with anti-alpha HCG antibodies to capture HCG.
Control line (C): coated with anti-mouse antibodies to verify proper test performance.
If HCG is present in the specimen, a pink line will appear in the test region along with the control line. The control line must always appear to validate the result.
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Kit Components
Individually packaged test device.
Buffer solution.
Instructions for use.
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Storage
Store at 2–30°C.
Do not freeze.

Stable until the expiration date printed on the pouch.

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Specimen Collection

Serum: Separate from whole blood and refrigerate (2–8°C) for up to 3 days or freeze for long-term storage.

Urine: Collect in a clean, dry container. First morning urine is preferred for higher HCG concentration.
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Test Procedure

1. Bring the test device and specimen to room temperature before use.

2. Open the pouch and place the device on a flat surface.

3. Add 3 drops of serum or urine into the sample well.

4. Wait 5–8 minutes for lines to appear. Do not read after 10 minutes.

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Interpretation of Results

Positive: Two pink lines appear (T and C) → HCG detected (pregnant).

Negative: One pink line at C only.

Invalid: No control line (C) appears.
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Performance Characteristics

Analytical sensitivity: 25 mIU/ml or less.

Diagnostic sensitivity: 100%.

Diagnostic specificity: 100%.

No cross-reaction with LH, FSH, or TSH at specified concentrations.
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Limitations

Avoid excessive fluid intake before testing.

Certain tumors or HCG-containing medications may cause false positives.

Very early pregnancies may not be detected; retest after 48 hours.

A confirmed diagnosis of pregnancy should only be made by a physician.