AffiVET® Canine Leishmania (LSH Ab) Antibody Test

Test Principal:

AffiVET® Canine Leishmania (LSH Ab) Antibody Test is a chromatographic immunoassay designed for the qualitative detection of Leishmania infantum antibodies in canine whole blood, plasma, or serum.

This kit features two distinct lines on the device's surface: the test (T) line and the control (C) line. Initially invisible in the result window, these lines become visible upon the application of a sample. The control line serves as a crucial reference, confirming the proper execution of the test and is expected to appear with every test conducted.

Utilizing highly selective Leishmania antigens as capture and detector materials, this kit offers precise and accurate detection of Leishmania antibodies in canine samples.

Material Required:

Storage & Stability:

• Store the test kit at 2~30°C. DO NOT FREEZE.
• Do not store the test kit in the direct
  sunlight.
• The test kit is stable within the expiration
  date marked on the package label.
  

Sample collection & Preparation:

1. For this test, only canine whole blood, serum, or plasma should be used.

   Whole blood

   • Collect blood in an anticoagulant tube. If not tested immediately, refrigerate at 2-8°C and use within 24 hours.

   Serum

   • Collect blood in a tube without anticoagulants (e.g., heparin, EDTA, sodium citrate).
   • Let it settle for 30 minutes to clot, then centrifuge to obtain serum.

   Plasma

   • Collect blood in a tube with anticoagulants, then centrifuge to obtain plasma.

   2. If serum or plasma samples are not tested immediately, refrigerate at 2-8°C. For longer storage, they can be stored frozen at -20°C. Before use, thaw frozen samples to room temperature (15-30°C).

   3. Samples with precipitates may give unreliable results. Clarify such samples before testing.

   4. Avoid using samples that are hemolytic or contaminated with bacteria, as they may cause incorrect results.

Test Procedure:

1. Ensure all reagents and samples are brought to room temperature (15~30°C) before use.
2. Collect fecal samples using a swab.
3. Insert the swab into the assay diluent tube and thoroughly mix until the sample is dissolved into the diluent (approximately 10 seconds).
4. Allow the mixture to settle for 1 minute to allow large particles to precipitate.
5. Remove the test device from the foil pouch and place it on a flat, dry surface.
6. Using the disposable dropper, transfer the supernatant sample from the tube.
7. Add 4 drops of the mixed sample into the sample hole(s), dropping vertically.
8. Begin the timer and allow the sample to flow across the result window. If no flow is observed after 1 minute, add one additional drop of the mixed sample to the sample hole.
9. Interpret test results at 10 minutes. Do not read the results after 20 minutes.

Result Interpretation:

Negative result

This means that there is no LSH antibodies in the sample or the level is lower than the test detection limit.

Positive result:

This confirms the presence of the LSH antibodies in the sample.

Invalid Result:

Absence of C-Line
Presence of T-Line

Or

Absence of C-Line
Absence of T-Line

This means that the procedure was not applied correctly or that the test is invalid.

Cautions:

• Use this test kit exclusively for canines; do not use it for other animals.
  
• The test device is sensitive to both humidity and heat. Conduct the test immediately after removing the device from the foil pouch.
  
• Avoid reusing any components of the test kit.
  
• Apply the sample and assay diluent vertically. Refrain from touching the membrane within the result window of the test device.
  
• Do not use the test kit after the expiration date indicated on the package label.
  
• Do not use the test kit if the pouch appears damaged or if the seal is broken.
  
• Do not combine components from different lot numbers; each kit has undergone quality control testing as a standard batch unit.
  
• Handle all samples as potentially infectious. Wear protective gloves when handling samples and wash hands thoroughly afterward.
  
• Dispose of all samples, reaction kits, and potentially contaminated materials safely and in compliance with national and local regulations.
  
• Strictly adhere to the test procedures to minimize the risk of obtaining false or invalid test results due to improper administration or usage.