1.\tINTENDED USE
FUSIDA Leishmania Ab Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Leishmania antibody (LSH Ab) in dog’s serum.
Assay Time: 5-10 min
Sample: Serum
2.\tPRINCIPLE OF THE ASSAY
FUSIDA Leishmania Ab Rapid Test is based on sandwich lateral flow immunochromatographic assay. The test device has a testing window. The testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough Leishmania antibodies in the sample, a visible T band will appear. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of Leishmania antibodies in the sample.
3.\t COMPONENT
-\t10×foil pouches, each containing a cassette and desiccant
-\t1×assay buffer
-\t10×Pipette 1, 10×Pipette 2(5μl)
-\t10×centrifugal tubes
-\tProduct Manual
4.\tTEST PROCEDURE
-Use Pipette 1 to collect dog’s serum, plasma or whole blood (fresh or stored at 2-8℃ for use within 3 days) as sample into centrifugal tube.
-Take out the cassette from the foil pouch and place it horizontally.
-Use Pipette 2 gradually drip serum, plasma or whole blood(blow 5 μl) into the sample hole.
-Wait for the sample to be completely absorbed into the sample hole. Then add 2 drops of the assay buffer. Wait for 5-10 minutes and interpret results. The result is considered invalid after 10 minutes.
5.\tINTERPRETATION OF RESULTS
Positive: The presence of both “C” band and “T” band, no matter T band is clear or vague.
Negative: Only clear C band appears.
Invalid: No colored band appears in C zone, no matter whether T band appears.
6.\tSTORAGE
The can be stored at room temperature (2-30°C). The test is stable through the expiration date (18 months) marked on the foil pouch. DO NOT FREEZE. Do not store the test in direct sunlight.
7.\tPRECAUTIONS
-\tFor best results, please strictly adhere to these instructions.
-\tAll reagents must be at room temperature before running the assay.
-\tDo not remove test cassette from its pouch until immediately before use.
-\tDo not reuse the test .
-\tDo not use the test beyond its expiration date marked on the foil pouch.
-\tThe components in this have been quality control tested as standard batch unit. Do not mix components from different lot numbers.
8.\tLIMITATION
FUSIDA Leishmania Ab 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 ELISA for final determination in practice.