The RDT for Antibodies for Classical Swine Fever is a immunochromatographic test intended for the visual qualitative detection or machine read quantitative detection of antibodies to CSFV in pig blood or serum. The test is intended for use by veterinarians and swine producers.
Classical swine fever (CSF) is a highly contagious viral disease of pigs, including wild boar. It is caused by the classical swine fever virus (CSFV), a member of the family Flaviviridae. CSF is characterized by a variety of clinical signs, including fever, lethargy, loss of appetite, difficulty breathing, and diarrhea. The disease can be fatal, and there is no treatment available.
Vaccination is one frequently recommended option to control CSF. However, it is important to be able to identify infected animals so that they can be isolated and prevented from spreading the virus to other pigs.
The RDT for Antibodies for Classical Swine Fever is a rapid and easy-to-use test for detecting antibodies to CSFV in pig whole blood or serum. The test is based on a lateral flow immunoassay, which uses dye-labeled particles to bind to CSFV antibodies in the sample. If CSFV antibodies are present in the sample, a colored line will appear on the test strip. The test contains a membrane strip, which is pre-coated with CSF-specific recombinant antigens in the test line (T). The another CSF antigen-conjugated gold particles and specimen moves along the membrane chromatographically to the test region (T) and
forms a visible line coming from the antigen-antibody-antigen colloid gold particle
complex with high degree of sensitivity and specificity.
This RDT for Antibodies for Classical Swine Fever can detect both natural or vaccinal antibodies, and is a valuable tool for veterinarians and swine producers to help identify infected animals and control the spread of CSF.
Each box contains 50 test kits. Each test kit contains:
The following materials are provided with the RDT for Antibodies for Classical Swine Fever:
Materials Required but not Provided:
Storage And Disposal
The product should be stored at 4-30°C. Do not freeze or overheat the test kit or kit reagents. Kit contents are stable until the expiration date printed on each test kit. The indicators must be kept in the foil pouch until use. Dispose of used contents in accordance with federal, state, and local requirements.
Before use, check the expiration date of the packaging. If the kit is past its expiration date, do not use. Confirm that all components needed are in the kit.
Whole blood is collected in anticoagulant tubes by syringe via ear prick collection. Clean the pig’s ear with a disinfectant. Apply the tourniquet to the pig’s ear above the vein where you will be collecting blood. Insert the needle into the vein and draw blood into the syringe. Release the tourniquet and remove the needle. Apply pressure to the puncture site with a gauze pad until the bleeding stops.
Whole blood specimens should be tested as soon as possible after collection in standard laboratory. To collect serum, use the same method for whole blood collection. Allow the blood to clot and then centrifuge to separate the serum. Transfer the serum to a clean tube. Specimen could be stored at 2-8°C for up to 72 hours, or could also be stored below -20°C for long-term until before used. Specimens should be avoided to repeat freezing and thawing. The frozen specimen should be thawed to 15-30°C and mixed well before testing. In addition, inadequate or inappropriate sample collection, storage, and transport may yield false test results. The training in specimen collection is highly recommended because of the importance of specimen quality.
Stand up the Spacket, and tear it open. Be careful not to spill the liquid reagent inside.
Sample 30 uL of blood into the Spacket.
Place the test indicator in the Spacket with the sample pad going down. Leave the test indicator in the Spacket for 10 minutes. Use the assaya timerDx to keep track of the test time.
Take out the test indicator and read the result at 10 minutes. Do not read the result after 20 minutes. The test indicator may also be read by the intelligent analyzer eXpress (iaX-2101) after 10 minutes.
Positive Indicator Line Legend
At 10 minutes, the appearance of the Control Line and Test Line on the Test Indicator, indicates a positive result for the presence of antibodies for CSFV. Positive test results only mean antibodies for CSFV exist in the specimen
At 10 minutes, the appearance of only Control Line indicates a negative result for the presence of antibodies for CSFV.
If at 10 minutes, the Control Line does not appear, even if a Test Line appears in the indicator, the result is considered invalid. If the test is invalid, a new test should be performed with a new patient sample and a new Test Indicator.
Two internal procedural controls are needed to confirm correct assay procedure and active kit components. One of two is a line appearing in the “Control Line” area in every run of the test to assess validity of the test. Another one is a clear background serving as an internal negative control. The background color should be white and not interfere with the reading of the test result. If the background color interferes with the reading, it is recommended to repeat the test.
Result Interpretation with the iaX-2101
Please refer to the full iaX-2101 Instructions for Use for complete instructions on how to operate the IaX.
Place the test indicator into the iaX-2101, with the barcode pointing in.
GREEN – (NEGATIVE)
YELLOW ! (INVALID)
RED + (POSITIVE)
Warnings & Precautions
The RDT for Antibodies for Classical Swine Fever has been evaluated for sensitivity and specificity using a panel of known CSFV-positive and CSFV-negative pig serum samples. The test was found to have a sensitivity of 99% and a specificity of 98%.
Adverse Events Reporting
Use this link to report any adverse events: assaya.com/ae
Catalog Number (REF): AKIT-CSF-AB-01
50 pcs per box (Carton of 50 test kits)
In Vitro Diagnostic Medical Device
No Direct Sunlight
Do not expose to water
Consult Package Insert
Do not reuse
Contains sufficient for <50> tests
Do not use if package is damaged