The Rapid Antibody Test for Foot and Mouth Disease (FMD) is an immunochromatographic assay intended for the visual qualitative detection or machine read quantitative detection of antibodies for FMDV in blood or serum. Foot and Mouth Disease (FMD) is a highly contagious viral disease that affects cloven-hoofed animals, including cattle, pigs, sheep, goats, deer, and bison. It is not related to hand, foot, and mouth disease in humans. FMD is not a threat to human health. The virus does not cause disease in humans. However, people can carry the virus on their clothing, shoes, and vehicles and spread it to animals. FMD can have significant economic and agricultural impacts due to its ability to spread rapidly among livestock herds and the trade restrictions it can trigger. Timely and accurate detection of FMD is essential for effective disease management and containment. FMD is caused by the FMD virus (FMDV), a member of the Picornaviridae family. It spreads through direct contact with infected animals or their saliva, milk, or manure, contaminated equipment, clothing, aerosols containing the virus, or contaminated feed and water.
FMD is characterized by a range of clinical symptoms, including high fever, blisters and sores on the mouth, tongue, nostrils, or feet, excessive salivation, weight loss, and reduced milk production (in dairy cows). There is no specific treatment for FMD. The disease is usually self-limiting, but affected animals may need supportive care, such as fluids and pain medication. In some cases, antibiotics may be necessary to prevent secondary infections. The best way to prevent FMD is to vaccinate animals against the virus. Vaccination is required for all livestock in many countries. Other preventive measures include biosecurity practices such as quarantine of new animals and disinfection of equipment.
This user-friendly and reliable FMD Rapid Antibody Test has been designed to assist veterinarians, animal health professionals, and farmers in quickly identifying FMD-infected animals, allowing for prompt action to limit the spread of the virus and minimize its economic impact.
This test utilizes a lateral flow immunoassay, employing dye-labeled particles that bind to FMDV antibodies in the sample. The test kit contains a test strip with nitrocellulose membrane coated with FMD virus antigens. When a blood sample is applied to the test strip, the FMD antibodies in the sample bind to the antigens and form a colored complex. The appearance of a colored line on the test strip indicates the presence of FMDV antibodies.
Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results should be considered in the context of recent exposures, history and the presence of clinical signs and symptoms. The Rapid Antibody Test for FMD is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel.
Each box contains 50 test kits. Each test kit contains:
The following materials are provided with the RDT for Foot and Mouth Disease:
Materials Required but not Provided:
Storage And Disposal
The product should be stored at 2-30°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.
Blood samples can be collected from various sites on the animal’s body, depending on the species. For bovine and ovine species, blood can be collected from the jugular vein. For caprine species, blood can be collected from the jugular vein or the saphenous vein. For porcine species, blood can be collected from the jugular vein or the anterior ear vein.
To collect blood, clean and disinfect the collection site. Apply a tourniquet to the animal’s limb proximal to the collection site. Insert the needle into the vein and collect the blood into the syringe. Release the tourniquet and remove the needle. Transfer the blood to a blood collection tube and label it with the animal’s identification number and the date of collection.
Whole blood specimens should be tested as soon as possible after collection in a 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. Specimens 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 use. 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 FMDV. Positive test results only mean antibodies for FMDV exist in the specimen
At 10 minutes, the appearance of only Control Line indicates a negative result for the presence of antibodies for FMDV.
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 FMD has been evaluated for sensitivity and specificity using a panel of known FMD-positive and FMD-negative animal 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-FMD-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