AffiVET® Camel MERS CoV Antigen Rapid Test Kit

AffiVET® Camel MERS CoV Antigen Rapid Test Kit

Intended Use:

Qualitative detection of Middle East Respiratory Syndrome coronavirus (MERS-CoV) antigen in camel nasal/oral secretions.

Principle of the Assay:

Type: Lateral flow immunochromatographic assay.

Mechanism:

• Sample added to cassette → migrates by capillary action.
• If MERS-CoV antigens are present → form complex with pre-coated antibodies.
• Colored T line (test) appears → positive.
• C line (control) must always appear to confirm valid test.

Storage and Stability:

• Temperature: 2–30 °C (room temperature or refrigerated).
• Do not freeze.
• Stable until expiry date printed on pouch.
• Keep sealed until use.

Precautions:

• Do not use after expiration or if pouch is damaged.
• Treat all specimens as potentially infectious.
• Use gloves and eye protection.
• Humidity and temperature may affect results.
• Do not reuse test components or mix lots.
• Single-use only.

Kit Components:

• Test Cassettes ------------------------ (10 Devices)
• Disposable Droppers ---------------- (10 Pieces)
• Assay Diluents ------------------------ (10 Pieces)
• Disposable Swabs -------------------- (10 Pieces)
• Instruction Manual ------------------- (1 Piece)

Required but not provided: Timer

Test Procedure:

1. Bring cassette, specimen, and buffer to 15–30 °C.
2. Open pouch and use cassette within 1 hour.
3. Collect sample: nasal/oral secretion using provided swab (ensure sufficient wetting).
4. Insert swab into buffer tube and mix thoroughly.
5. Using dropper, add 3 drops (~120 µL) of extracted sample to sample well (S).
6. Start timer and read at 15 minutes (ignore results after 25 minutes).

Interpretation of Results:

• Positive: Both C and T lines visible (T may be faint or strong). [MERS-CoV antigen detected].
• Negative: Only C line visible. [No MERS-CoV antigen detected].
• Invalid: No C line visible. [Test failed – repeat].

Limitations:

• For camel application only.
• Results should be interpreted with clinical context.
• Confirmatory testing (e.g. PCR) recommended for verification.

Validation Data:

• Sensitivity > 95%
• Specificity > 95%
• Accuracy > 95%

Cross Reactivity:

The test was evaluated using samples positive for other viruses including Coronavirus, SARS-CoV, Influenza A, Influenza B, and Camel Pox.
No cross-reactivity observed with these pathogens.