Adenovirus – Rapid Test Kit

Product Purpose:
The Adenovirus Rapid Test Kit is designed for the in vitro qualitative detection of adenovirus (Adv) in nasal and oropharyngeal swabs. It is intended for professional and in vitro diagnostic use only.

Test Principle:
This test uses a double-antibody sandwich method. If adenovirus antigen is present in a sample, it reacts with the colloidal gold-labeled antibody on the conjugate pad, forming a labeled antibody-antigen complex. This complex migrates via capillary action to the test line (T line) coated with a different adenovirus antibody, forming a visible red line if antigen is detected. A control line (C line) confirms test validity by binding excess colloidal gold conjugate.

Sample Collection Instructions:

• Nasal Swabs: Insert swab 1-1.5 cm (1 cm for ages 2-14) into each nostril, rotate at least four times, ensuring contact for at least 15 seconds.
• Oropharyngeal Swabs: Hold mouth open, insert swab to tonsil area and posterior pharynx, swabbing both sides gently three times, followed by the posterior pharyngeal wall.

Sample Storage:

• Process samples immediately.
• If delayed, store at room temperature (≤ 24 hours), 2–8°C (≤ 72 hours), -20°C (≤ 3 months), or -70°C (long term).
• Thaw frozen samples completely before testing.

Preparation Before Testing:

1. Check kit for expiry and component integrity.
2. Return kits and samples to room temperature.
3. Clean/disinfect hands.

Testing Procedure:

1. Open the extraction tube and insert swab. Mix for at least 30 seconds, squeezing the swab tip against tube walls.
2. Cap tube, then open test card foil and place test card on a flat surface.
3. Dispense sample into test card, read results at 10-15 minutes.

Results Interpretation:

• Positive: Red bands on both T and C lines.
• Negative: Red band on C line only.
• Invalid: No red band on C line.

Storage and Handling Instructions:

• Store at 2–30°C, avoiding heat, humidity, and sunlight.
• Use the test pad within 1 hour after opening if in high humidity (>65%).

Important Warnings and Precautions:

• For in vitro diagnosis only.
• Follow instructions carefully.
• Single-use only; avoid using damaged kits.
• Sensitivity may vary between children and adults.
• Potential skin/eye irritation from sample diluent preservatives; rinse with water if contact occurs.
• Proper disposal of test materials according to local regulations.