Description
Key Features:
- Rapid Results: Provides results within 15–20 minutes.
- Sample Types: Compatible with serum, plasma, or whole blood.
- Ease of Use: Simple, one-step test procedure suitable for various clinical settings.
- No Special Equipment Needed: Ideal for use in field and resource-limited settings.
- High Accuracy: Offers high sensitivity and specificity for reliable detection of HBsAg.
Test Procedure:
- Sample Collection: Collect serum, plasma, or whole blood from the patient.
- Test Setup: Place the test device on a flat surface and add the sample to the sample well.
- Buffer Addition: Add the buffer provided with the kit.
- Incubation: Allow the test to develop for 15–20 minutes.
- Result Interpretation:
- Positive: Both the control line (C) and test line (T) appear, indicating the presence of HBsAg.
- Negative: Only the control line (C) appears.
- Invalid: No control line appears, indicating an invalid test that should be repeated.
Result Interpretation:
- Positive Result: Indicates the presence of hepatitis B surface antigen, suggesting a current HBV infection.
- Negative Result: No detectable HBsAg, indicating no current infection.
- Invalid Result: Test must be repeated with a new device.
Applications:
- Clinical Diagnosis: For initial screening and diagnosis of hepatitis B infection.
- Public Health Programs: Useful in mass screening and surveillance programs.
- Emergency & Remote Settings: Suitable for use in non-laboratory environments for rapid results.
Storage and Stability:
- Store at 2–30°C (35.6–86°F).
- Keep the test away from direct sunlight and moisture.
- Do not open the test pouch until ready to use.
Limitations:
- A negative result does not rule out infection in the window period or low antigen levels.
- Positive results should be confirmed with additional laboratory tests.
- For professional use only.
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