Vetscan FLEX4 Rapid Test Kit (Canada)

HEARTWORM ANTIGEN-ANAPLASMA-BORRELIA BURGDORFERI-EHRLICHIA ANTIBODY TEST KIT

I. INTENDED USE

The Vetscan^® FLEX4 Rapid Test is a visual rapid test for the qualitative detection of antibodies to Anaplasma phagocytophilum, antibodies to A. platys, antibodies to Borrelia burgdorferi, antibodies to Ehrlichia canis, antibodies to E. chaffeensis, antibodies to E. ewingii, and Dirofilaria immitis antigens in canine anticoagulated whole blood, serum or plasma. This test is for veterinary use only.

II. INSTRUCTIONS FOR USE

This Test is for the detection of antibodies to certain Anaplasma spp., Borrelia spp., and Ehrlichia spp., and Dirofilaria immitis antigens in canine whole blood, serum or plasma samples.

● Samples must be at room temperature (15-27 °C/59-80 °F), before running the assay - DO NOT HEAT.

● Canine whole blood collected in any type of EDTA, heparin, or citrate tubes may be used within one day of collection provided no visual clotting has occurred.

● Do not freeze whole blood or use whole blood that has been frozen. If whole blood is not used within two hours of draw, store refrigerated (2-8 °C /35-46 °F).

● Serum or plasma, either fresh, previously frozen, or stored at 2 to 8 °C (35 to 46 °F), may be used in this test.

● Serum or plasma may be stored for use up to 7 days at 2 to 8 °C (35 to 46 °F). For longer storage, samples may be frozen at -20 °C (-4 °F) or colder.

● Previously frozen or older serum or plasma samples must be centrifuged at >1600g to remove any particulate material before use.

● Excessive hemolysis may obscure the results.

● EDTA, heparin, or citrate will not affect the results.

III. PRECAUTIONS AND WARNINGS

● Important: Do not remove device from the pouch until ready for use.

● The Test Device must be used as soon as possible after removing from pouch and within a maximum of 15 minutes.

● For veterinary use only.

● Do not use the components after expiration date.

● The Test Device should be in a horizontal position on a flat surface while the test is performed.The Test Device should not be tilted during the test procedure.

● Use a separate transfer pipette for each patient.

● The chase buffer is not interchangeable from lot to lot.

● Do not use a Test Device from a pouch that is obviously torn or damaged.

● Do not use a Test Device if it appears cracked, broken, or otherwise damaged.

● The kit components must not be frozen.

● Contains sodium azide as preservative.

● The test devices and chase buffer can be stored at room temperature or refrigerated (2-27 °C/35-80 °F) and should never be frozen.

● Test devices and chase buffers are stable until expiration when stored at recommended temperatures.

● Chase Buffer: Harmful to aquatic life with long lasting effects. Avoid release to the environment. Wash hands after handling. Store away from incompatible materials.

● Dispose of contents/container in accordance with local/regional/national/international regulations.

IV. KIT COMPONENTS

● Test Devices

● Chase Buffer Bottles (6 mL)

● Transfer Pipettes

● Instructions for Use

V. TEST PROCEDURE

1. Remove the Test Device from the protective pouch and place on a flat surface. Label the Test Device with the patient I.D. or control identification. Only use the provided white space for this purpose. Do not cover up the test name.

2. Gently mix the sample by inverting.

3. Using a provided Transfer Pipette, hold the pipette vertically and dispense one drop of sample (whole blood, serum or plasma) into each sample well.

4. Holding the Chase Buffer Bottle vertically, add 3 drops of the chase buffer into each sample well.

5. Read the results at 8 minutes. Do not read the results after 10 minutes. Colored lines that appear after 10 minutes are not diagnostic and should be ignored.

VI. INTERPRETATION OF TEST RESULTS

Positive Results

A test is positive if a colored line appears under the Lyme (L), Anaplasma (A), Heartworm (H), or Ehrlichia (E) areas and a line appears under the Control (C) area in the same row. Any intensity of the Test Line (L, A, H, or E) area should be considered positive. Colored lines may be lighter or darker than each other.

Negative Results

The test lines for each row are negative if only one line appears at the Control line (C) area on that row.

Invalid Results

The test row is invalid if no colored line appears at the Control line (C) area on a given row. Even if a colored line appears in the Test line (L, A, H, or E) areas, there must be a control line (C) on that same row.

Manufacturer

SA Scientific, 4919 Golden Quail, San Antonio, TX 78240 USA

VLN/PCN 373/5P23.00

1-210-699-8800

Distributor

Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 USA

US 1-888-963-8471

Canada 1-800-461-0917

Imported by

Zoetis Belgium S.A., Rue Laid Burniat 1, 1348 Louvain-La-Neuve Belgium

www.zoetis.com

51012801

Presentation: 5 and 25 test kits.

CPN: 1198130.0