INTENDED USE

The Classical Swine Fever Virus Antibody Rapid Test is a lateral flow immunochromatographic assay for the qualitative detection of Classical Swine Fever Virus Antibody (CSFV Ab) in pig’s serum, or plasma specimen.

PRINCIPLE

The Classical Swine Fever Virus Antibody 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 CSFV antigens. If there are anti-CSFV antibodies in the specimen, a visible T line will appears. The C line should always appear after a sample is applied, which indicates a valid result. By this means, the device can indicate the presence of Classical Swine Fever Virus antibodies in the specimen.

KIT COMPONENT

-Test device

– Assay buffer

– Product Manual

STORAGE & SHELF LIFE

Store at 2-30°C, out of sun light and moisture.

Shelf Life: 24 months

TEST PROCEDURE

1.Collect pig’s fresh whole blood, and get the serum or plasma specimen for use. Immediately apply the testing once collected the specimen.

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

3.Place 3 drops (approx. 120μL) of serum or plasma specimen into the assay sample hole “S”.

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

INTERPRETATION OF RESULTS

Positive: Two lines appear, no matter T line is clear or vague.

Negative: Only C line appears.

Invalid: No line appears or only T line appears.

PRECAUTIONS

1. Expired test or the test with damaged foil pouch should not be used.

2. The test must be used within 10 minutes after opening the foil pouch.

3. Wear disposable gloves and eye protection when specimens are being tested.

4. Do not reuse the test kit and do not mix components from different lot numbers.

5. All specimens have potential infection. It must be strictly treated according to the rules by local states.

LIMITATION

The Classical Swine Fever Virus Antibody Rapid Test is for in vitro veterinary diagnosis use only. All results should be considered with other clinical information available from veterinarian. For an accurate result, it is suggested to apply other method such as PCR or pathogen isolation test for final determination in practice.