タイトルまたは説明

INTENDED USE

The African Swine Fever Virus Antigen Test is a lateral flow immunochromatographic assay for the qualitative detection of African Swine Fever Virus antigen (ASFV Ag) in pigs blood, liver, or spleen.

Assay Time:****5 minutes

Specimen: whole blood, liver, or spleen.

PRINCIPLE

The African Swine Fever Virus Antigen 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 ASFV antigen 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 accurately indicate the presence of ASFV virus antigen in the specimen.

REAGENTS AND MATERIALS

- *0 Test devices

- Disposable droppers

- 3 bottles of assay buffer (5mL each)  

- Products Manual

STORAGE AND STABILITY

The kit can be stored at room temperature (***0°C). The test kit is stable through the expiration date (*8 months) marked on the package label.DO NOT FREEZE.Do not store the test kit in direct sunlight.

SAMPLE PREPARATION

1. Specimen should be obtained and treated as below.

- Whole blood: collect fresh whole blood for use directly or make anticoagulant blood for storage at **8℃. Place **0uL of assay buffer into a centrifugal tube, and add 3 drops (around **0uL) of whole blood specimen into the tube and mix well. Apply the treated blood sample in the assay directly.

- Liver or Spleen: Place **0uL of assay buffer into a centrifugal tube. Weigh around 0.**0.3g of homogenized tissue specimen into the tube and mix well. Apply the extraction mixture in the assay.   

2.  All specimen should be tested immediately. If not for testing right now, they should be stored at **8℃.

TEST PROCEDURE

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

- Suck the sample and place 3 drops into the assay sample hole S.

- Interpret the result in ****5 minutes. Result after *0 minutes is considered as invalid.

INTERPRETATION OF RESULTS

Positive: The presence of both Cline and zone Tline, no matter Tline is clear or vague.

Negative:Only clear C band appear. No T band.

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

African Swine Fever Virus Antigen Test is for in vitro veterinary diagnosis use only. It is suggested to apply a further confirmative method such as RT-PCR when positive result was observed.