Covid-19 Rapid Antigen Test Cassette Jeve (Nasopharyngeal Swab)

COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)

CE IVD – For Professional In Vitro Diagnostic Use Only

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✅ Intended Use

The COVID-19 Antigen Test Cassette is a rapid in vitro diagnostic tool designed to qualitatively detect the nucleocapsid protein antigen of the COVID-19 virus in nasopharyngeal swab specimens. It is used for individuals showing signs and symptoms of COVID-19 infection.

⚠️ For use by trained clinical or laboratory professionals only.

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🧪 Test Summary

• Method: Rapid chromatographic immunoassay

• Specimen: Nasopharyngeal swab

• Purpose: Qualitative detection of COVID-19 antigen

Interpretation of Results:

• Positive Result: Indicates presence of viral antigen. Must be interpreted with patient history and other clinical data.

• Negative Result: Does not rule out COVID-19 infection. Should be confirmed with molecular testing (e.g., RT-PCR) especially if symptoms persist.

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🔬 Principle of the Test

• The device uses a membrane-based immunoassay method.

• The test strip contains immobilized COVID-19-N antibodies on the test line region.

• When a specimen is added:

  • It reacts with antibody-coated particles on the specimen pad.

  • The mixture migrates across the test strip.

  • If the virus is present, a colored test line appears.

  • A colored control line should always appear to confirm the test is valid.

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🧴 Reagents

• Capture reagent: COVID-19-N antibody

• Detection reagent: COVID-19-N antibody

• Control line reagent: Goat anti-mouse IgG antibody

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📦 Storage & Stability

• Store at 4–30°C (40–86°F).

• Do not open the sealed pouch until ready to use.

• Use before the expiration date printed on the pouch.

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📃 Materials Provided

• Test cassette

• Nasopharyngeal swab

• Extraction tube

• Workstation

• Package insert

❌ Materials Required but Not Provided

• Timer

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⚠️ Precautions

1. For professional use only.

2. Do not use after expiration.

3. Do not eat, drink, or smoke near specimens.

4. Treat all specimens as potentially infectious.

5. Follow biosafety and disposal protocols.

6. Wear protective gear: lab coat, gloves, eye protection.

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🧪 Test Procedure

1. Insert swab into extraction tube. Rotate for 10 seconds, pressing against the tube walls.

2. Remove swab while squeezing the head to extract liquid.

3. Discard swab as per biohazard protocol.

4. Cover the extraction tube with the cap.

5. Add 3 drops (~90μL) of the specimen into the sample well (S) of the cassette vertically.

6. Wait 15 minutes before reading the result.

   ⚠️ Do not interpret results after 20 minutes – results become invalid.

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📌 Important Notes

• Ensure adequate specimen volume is applied.

• If fluid migration is not observed within 1 minute, add one more drop.

• A control line must appear for the test to be considered valid.

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📊 Result Interpretation

*Note: Negative results should be confirmed if necessary using molecular testing (e.g., RT-PCR).