AffiVET® Canine babesia Antibody Rapid Test Kit

AffiVET® Canine babesia Antibody Rapid Test Kit

Overview

The AffiVET® Canine Babesia Antibody Rapid Test Kit is a chromatographic immunoassay for the qualitative detection of antibodies against canine babesia gibsoni in canine serum, plasma, or whole blood.

The AffiVET® Canine Babesia Ab Rapid Test device has two windows on the surface which are test (T) line and control (C) line. The test line and control line are not visible before applying any samples.

The control line is a reference line which indicates the test is performing properly. The control line must appear every time the test is performed. If the antibodies against canine babesia gibsoni are present in the sample, a purple test line would appear in the result window.

The highly selective canine babesia gibsoni antigens are used as a capture and detector in the assay. These antigens are capable of detecting antibodies against canine babesia gibsoni in canine serum, plasma, or whole blood with a high accuracy.

Material provided

A black line on the capillary tube is the indicator line for 10 μL.

Materials required, but not provided

1. Timer

Precautions

1. The test kit is for canine use only. Do not use it for other animals.
2. The test device is sensitive to humidity as well as heat. Perform the test immediately after removing the test device from the foil pouch.
3. Do not reuse the test components.
4. Apply the sample and assay diluent vertically.
5. Do not touch the membrane in the result window of the test device.
6. Do not use the test kit beyond the stated expiration date marked on the package label.
7. Do not use the test kit if the pouch is damaged or the seal is broken.
8. Do not mix components from different lot numbers because the components in this kit have been quality control tested as standard batch units.
9. All samples should be handled as being potentially infectious. Wear protective gloves while handling samples. Wash hands thoroughly afterwards.
10. Decontaminate and dispose of all samples, used kits and potentially contaminated materials safely in accordance with national and local regulations.

Storage and 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 and Preparation

1. Canine whole blood, serum, or plasma should be used with this test.
2. [Whole blood] Collect the whole blood into the anticoagulant tube (Maximum Volume 1.5 mL) provided. If anticoagulated whole blood is not immediately tested, they should be refrigerated at 2~8°C and used within 24 hours.
3. [Serum] Collect the whole blood into the collection tube (NOT containing anticoagulants such as heparin, EDTA and sodium citrate), leave to settle for 30 minutes for blood coagulation and then centrifuge to get serum supernatant.
   
4. [Plasma] Collect the whole blood into the collection tube (containing anticoagulants such as heparin, EDTA and sodium citrate) and then centrifuge to get plasma.
5. If serum or plasma samples are not tested immediately, they should be refrigerated at 2~8°C. For longer storage, freeze at -20°C or below. Frozen samples should be brought to room temperature (15~30°C) prior to use.
6. Specimens containing precipitate may yield inconsistent test results. Such specimens must be clarified prior to assaying.
7. The use of hemolytic or bacterially contaminated specimens should be avoided. Erroneous result may occur.

Test Procedure

1. All reagents and samples must be at room temperature (15~30°C) before use.
2. Remove the test device from the foil pouch and place it on a flat and dry surface.
3. Using the disposable capillary tube, 10 μL of the sample into the sample hole, and then add 3 drops of the assay diluent.
4. Start the timer. The sample will flow across the result window. If it does not appear after 1 minute, add one more drop of assay diluent to the sample hole.
5. Interpret test results in 15 minutes. Do not interpret after 25 minutes.

Result Interpretation

1. Negative result:

Only the control (C) line appears in the result window.

 2. Positive result:

Test (T) line and control (C) line in the result window indicate the presence of antibodies against canine babesia.

3. Invalid Result:

If the control (C) line does not appear, the result might be considered invalid. The sample should be retested.

IX. Test Limitations

• Although the AffiVET® Canine Babesia Antibody Rapid Test kit is very accurate for detecting antibodies against canine babesia gibsoni, a low incidence of false results can occur. Other clinical and/or laboratory tests might be required if questionable results are obtained. As with other diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test but should be diagnosed by veterinarian after all clinical and laboratory findings have been evaluated.
• The reading window may show a light pink background coloration; this will not affect the accuracy of the results.
• AffiGEN and its distributors cannot be held responsible for the consequences of misuse or misinterpretation of the results given by the test.