INTENDED USE

The Canine Distemper Virus Antigen Rapid Test is a lateral flow immunochromatographic assay for the qualitative detection of canine Distemper virus antigen (CDV Ag) in secretions from dog’s eyes, nasal cavities, and anus or in serum, plasma specimen.

Assay Time: 5-10 minutes

PRINCIPLE

The Canine Distemper 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 CDV 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 Distemper virus antigen in the specimen.

REAGENTS AND MATERIALS

- Foil pouches (each contains one test cassette,

- one disposable dropper and one desiccant)

- Assay buffer

- Cotton swabs

- 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 (24 months) marked on the package label. DO NOT FREEZE. Do not store the test kit in direct sunlight.

TEST PROCEDURE

- Collect dog’s ocular, nasal or anus secretions with the cotton swab and make the swab wet sufficiently.

- Insert the swab into the provided assay buffer tube. Agitates it to get efficient sample extraction.

- If serum or plasma specimen, place 3 drops of specimen into the assay buffer tube. Mix them well for use in the assay.

- Take out the test device from the foil pouch and place it horizontally.

- Suck the treated sample extraction from the assay buffer tube and place 3 drops into the sample hole “S” of the test device.

- Interpret the result in 5-10 minutes. Result after 10 minutes is considered as invalid.

INTERPRETATION OF RESULTS

- Positive (+): The presence of both “C” line and zone “T” line, no matter T line is clear or vague.

- Negative (-): Only clear C line appear. No T line.

- Invalid: No colored line appears in C zone. No matter if T line appears.

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

Canine Distemper 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.