Avian Influenza Virus Antigen Rapid Test

INTENDED USE

The Avian Influenza Virus Antigen Rapid Test is a lateral flow immunochromatographic assay for the qualitative detection of avian influenza virus antigen (AIV Ag) in secretions from bird’s trachea, cloaca, or feces.

Assay Time:  5-10 minutes

Specimen: secretions from avian trachea, cloaca, or feces

PRINCIPLE

The Avian Influenza Virus Antigen Rapid Test is based on sandwich lateral flow immunochromatographic assay. The test device has a testing window for the observation of assay running and result reading. The testing window has an invisible T (test) zone and a C (control) zone before running the assay. When the treated sample was applied into the sample hole on the device, the liquid will laterally flow through the surface of the test strip and react with the pre-coated monoclonal antibodies. If there is AIV antigen in the specimen, a visible T line will appear. The C line should always appear after a sample is applied, which indicates a valid result. By this means, the device can accurately indicate the presence of AIV virus antigen in the specimen.

REAGENTS AND MATERIALS

• 20 Test devices, with disposable droppers
• 20vials of Assay buffer
• 20 Swabs
• 1 Products Manual
• 

STORAGE AND STABILITY

The kit can be stored at room temperature (4-30°C). The test kit is stable through the expiration date (18 months) marked on the package label. DO NOT FREEZE. Do not store the test kit in direct sunlight.

TEST PROCEDURE

• Collect aviantrachea or cloacal secretions or feces with the swab and make the swab wet sufficiently.
• Insert the wet swab into the provided assay buffer tube. Agitate the swab to assure good sample extraction.
• Allow all materials, including specimen and test device, recover to 15-25℃before running the assay.
• Take out the devicefrom the foil pouch and place it horizontally.

Suck the treated sample extraction from the assay buffer tube and place 4drops into the sample hole “S” of the test device.

Note: If the liquid will not flow through the surface of the test strip in 30 seconds, please add another drop of the treated sample extraction.

• Interpret the result in 5-10 minutes. Result after 15minutes is considered as invalid.
• 
• • Positive(+): The presence of both “C” line and zone “T” line, no matter T line is clear or vague.
  • Negative(-): Only clear C line appears. No T line.
  • Invalid: No colored lineappears in C zone. No matter if T line

  PRECAUTIONS

  • All reagents must be at room temperature before running the assay.
  • Do not remove test cassette from its pouch until immediately before use.
  • Do not use the test beyond its expiration date.
  • The components in this kit have been quality control tested as standard batch unit. Do not mix components from different lot numbers.
  • All specimens are of potential infection. It must be strictly treated according to the rules and regulations by local states.

  LIMITATION

  The Avian Influenza Virus Antigen Rapid Test is for in vitro veterinary diagnosis use only. All result should be considered with other clinical information available with veterinarian. It is suggested to apply a further confirmative method such as RT-PCR when positive result was observed.