Description
Instructions for Use of Vet Expert Rapid Leishmania Ab Test Kit
Basic Principles
The Vet Expert Leishmania Ab test is a chromatographic immunoassay for the qualitative detection of antibodies against Leishmania infantum in dog serum, plasma, or whole blood. The letters T and C on the test plate represent the test line (T) and the control line (C). The control line (C) is a procedural control and should always appear if the test procedure is performed correctly and the reagents are functioning properly. A colored test line (T) will be visible in the results window if antibodies are present in the sample.
- Sensitivity: 97.2%
- Specificity: 99.8%
Materials Provided (5, 10, or 20 Tests/Kit)
- 5/10/20 Vet Expert Leishmania Ab test plates
- 1/2/2 bottles of diluent solution
- 5/10/20 anticoagulant vials
- 5/10/20 pipettes (10 µl)
- Usage instructions
Precautions
- Diagnostic test for veterinary use only.
- Strict adherence to instructions is necessary for accurate results.
- The test plate is sensitive to moisture and heat; perform the test immediately after opening the pouch.
- All test materials are single-use only.
- Avoid touching the membrane in the results window.
- Do not use the test kit beyond the expiration date on the package.
- Do not use the test if the pouch is damaged.
- Do not mix test materials from different Lot numbers.
- Handle the sample as potentially infectious.
- Disinfect and dispose of all samples and materials according to local regulations.
- Consider test results invalid after the designated reading time.
Storage of the Test Kit
Store the test kit at 2 ~ 30 °C. The test remains stable until the expiration date. DO NOT FREEZE. Avoid exposing the test to direct sunlight.
Sample Collection and Preparation
The test can be performed with serum, plasma, or whole blood. Serum is the most suitable sample.
- [Serum] Collect whole blood (without any anticoagulant) and allow it to clot for 30 minutes. Then centrifuge to obtain serum.
- [Plasma] Collect whole blood into a collection tube (containing anticoagulant) and then centrifuge to obtain plasma.
- [Whole Blood] Collect whole blood into an anticoagulant tube (max. volume 1.5 ml). If the anticoagulated whole blood is not tested immediately, it should be refrigerated at 2~8°C and used within 24 hours.
Serum samples should be stored at 2~8°C. For extended storage, freeze samples at -20°C or lower. Avoid repeated freezing and thawing. Samples containing sediment may yield unreliable test results and should be clarified before use. Hemolyzed or contaminated samples may give false results.
Testing Procedure
- Bring all reagents to room temperature (15~30°C) before use.
- Remove the test from its foil pouch and place it on a flat, dry surface.
- Using one pipette (included), add 10 µl (marked on the pipette) of serum/plasma/whole blood to the sample well.
- Add 2 drops of the diluent solution to the sample well.
- The sample will begin to flow through the results window. If no flow is visible after 1 minute, add an additional drop of diluent solution to the sample well. Read the result after 20 minutes.
Test Interpretation
- Negative Result: Only the control line (C) appears in the results window.
- Positive Result: Both the test line (T) and control line (C) appear, indicating the presence of antibodies. Even a faint line indicates a positive result.
- Invalid Result: If the control line (C) does not appear, the result is invalid, and the sample should be retested.
Test Limitations
While the Vet Expert Leishmania Ab test is highly accurate, a small percentage of false results may occur. Additional clinical tests are recommended if the results are inconclusive. As with all diagnostic tests, a definitive clinical diagnosis should not rely on a single test result but should consider the entirety of clinical and laboratory findings.
