CSFV Anti-body Test Kit
（immune colloidal gold）
Intended Use
This kit is an in-vitro assay designed for the detection of Anti-Classical Swine Fever Virus antibody in blood or serum samples from pigs .
Introduction
Classical swine fever, caused by classic swine fever virus (CSFV) or hog cholera virus, is a highly pathogenic disease in swine and responsible for a serious economic loss to the pig industry. Pigs infected with highly virulent CSFV strains may shed high amounts of virus before showing clinical signs of the disease. Animals that survive an acute or subacute infection develop antibodies and will no longer spread the virus. Moderately virulent, less pathogenic strains may lead to chronic infection when pigs excrete the virus continuously or intermittently until death. Meanwhile, Pigs may also be infected with bovine viral diarrhea virus (BVDV) or border disease virus (BDV). Although these infections in pigs are usually mild and self-limiting, it is important to reliably distinguish them from the CSFV infection.
The RapidbioTM CSFV Ab is based on a solid phase immunochromatographic assay. The nitrocellulose membrane contains CSFV antigen (inactivated) precoated lines, a Test-Line “T” and a Control-Line “C”. The mobile CSFV-antibody is bonded to colloidal gold particles (mAb/cG) located in the conjugate pad and the second immobilized antibody is pre-coated in the T-Line. Once the sample containing detectable amounts of CSFV antibodies is added they will form an antibody-mAb/cG-complex migrating along (“lateral flow”) the test membrane. The antibody-mAb/cG-complex reaching the “T-line” is going to be captured by the second immobilized mAB, which leads to form a pink-purple “T-line”.
The Control Line “C” is also used for procedural control, therefore it should always appear in the assay if the test procedure is performed properly and the test reagents supplied are in good quality.
Kit Contents(20 tests/kit)
20 pouches/kit.
Each pouch contains:
One Test device coated with monoclonal antibodies
One disposable dropper for sample collection
Test Procedure
a)When specimen and test kits are stored at cold circumstances(2-8℃), keep them at room temperature for 15-30 minutes before testing.
b)Remove a test device from a pouch and place it on a horizontal surface.
c) Using a dropper as a pipette, obtain the
specimen and dispense 2 drops (70-100μl) of the fluid into the specimen well(S).
d)Allow to stand for at least 5 minutes
e)Read the test results within 20 minutes.
* Consider the test results as invalid if incubation more than 20minutes.
Interpretation of Results
The test is VALID if the control line (purple band) develops in the device. The absence of the control line indicates that the test is invalid and must be repeated.
NEGATIVE: A single Control line is present. A NEGATIVE result indicates that no detectable Anti-Classical Swine Fever Virus antibody is present in the sample.POSITIVE: Two pink/purple bands (Test Line and Control Line) are clearly visible on the test device. A POSITIVE result indicates that detectable level of Anti-Classical Swine Fever Virus antibody is present in the sample
Special Notes
Not for in vitro diagnostic use
Negative samples should be submitted to an approved reference laboratory for confirmation.
General Precautions
All specimens should be handled as being potentially infectious and disposed accordingly.
Use within 20 minutes after opening the pouch because the test kit is very sensitive to moisture and its performance may decrease dramatically.
Avoid contact with the surface of result window.
Use a separate dropper for each sample.
Do not use specimen showing hemolysis or being contaminated with microbes, which may cause false positive or negative result.
Always wear disposable gloves when working with samples.
Dispose solid wastes after steam sterilization.
Do not use kit components from different kit lot numbers.
Do not use kit if package is broken.
Do not use kit after expiration date.
Storage and Handling
Test kits should be stored between 2℃ and 30℃. Under this condition, kits can be stored up to 18months after manufacturing. DO NOT FREEZE.
Manufactured by
Beijing Rapidbio Co. ltd.
Tel: 86-10-63395349
Fax: 86-10-62132608
E-mail: rxn_rapid@126.com
liuhb@hotmail.com
Website: http://www.rapid-bio.com/honor.asp
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