I. INTRODUCTION

Canine Parvovirus (CPV) is a member of the feline parvovirus subgroup.

It is closely related to feline panleukopenia virus and mink enteritis virus,

and is considered endemic to nearly all populations of domesticated and

wild canines.

CPV causes two forms of disease: myocarditis and enteritis. Due to

maternal antibody protection, the myocardial form is rare. The enteric

form, however, is prevalent and can be fatal to puppies and geriatric dogs.

CPV enteritis causes severe, often bloody diarrhea, vomiting, leukopenia

and dehydration.

Transmission is fecal-oral and most infections occur from exposure to

contaminated feces. CPV is highly contagious and stable under a variety of

environmental conditions. Rapid diagnosis of CPV allows for quarantine

and prompt treatment of infected dogs. Diagnosis may be difficult in

milder cases. WITNESS® CPV detects all strains of canine parvovirus shed

in the feces. Positive results with WITNESS® CPV indicate the presence of

canine parvovirus .

II. TEST PRINCIPLE

The WITNESS® CPV test is a simple test, based on rapid immunomigration

(RIM) technology, which detects the presence of canine parvovirus

antigen in canine feces. Sensitized particles bound to the CPV antigen

present within the sample (fecal extract) migrate along a membrane. The

complex is then captured on a sensitized reaction zone where its accumulation

causes the formation of a clearly visible purple band. A purple band

in the control window ensures that the test was performed correctly.

III. SAMPLE INFORMATION AND STORAGE

Canine fecal material is required for this test. Stool samples may be stored

at room temperature for 24 hours or at 2° to 7°C (35° to 45°F) for 7 days.

If longer storage is required, the samples may be frozen.

IV. KIT CONTENTS

• 5, 10 or 25 pouches, each containing 1 test device.

• 5, 10 or 25 tubes containing 1.0 mL of sample extraction buffer

• 5, 10 or 25 sampling swabs

• 5, 10 or 25 transfer pipettes

• Instructions for use

V. PRECAUTIONS

• Do not use components after expiration date.

• Refrigeration is not required. Store the test kit at 2° to 25°C (35° to

77°F). Do not freeze.

• Use the test within 10 minutes after opening the sealed pouch.

• Avoid touching or damaging the membrane at Windows #1, #2 or #3.

• The WITNESS® CPV device should be placed on a flat horizontal

  surface while performing the test.

• Use a separate extraction pipette for each sample.

• Hold extraction pipette vertically when dispensing sample.

• For Veterinary Use Only.

NOTE:

Samples from healthy vaccinated animals may falsely produce

a positive result when tested 4–10 days after canine parvovirus

vaccination.

VI. TEST PROCEDURE AND RESULTS

1. SAMPLE EXTRACTION:

• For each sample to be tested, you will need one sampling swab and one

tube of pre-dispensed sample extraction buffer. Remove the stopper

from the tube. Coat the swab with a thin layer of feces.

• Immerse the feces coated swab into the sample extraction buffer in the

tube. Swirl the swab in the buffer. Remove as much fecal material from

the swab as possible by swirling vigorously and pressing the swab

against the side of the tube.

• When removing the swab from the test tube, press the swab against the

side of the tube repeatedly until no more liquid comes from the swab.

• Completely remove the swab from the tube and discard appropriately.

2. SAMPLE APPLICATION:

• For each sample to be tested, you will need one device, one pipette and

the tube of extracted sample.

• Prepare the device by tearing open the pouch and placing the test device

on a flat horizontal surface for the duration of the test.

• Squeeze the pipette near the sealed end. Immerse the open end of the

pipette into the extracted fecal solution. Release the pressure slightly to

draw up a small amount of sample into the pipette.

• Holding the pipette vertically, transfer three drops of sample to the

sample well, Window #1. Allow sample drops to fall onto membrane at

Window #1. Do not touch pipette tip directly to the membrane.

• If migration does not pass Window #2 by one minute, add one

additional drop of sample.

3. READING TEST:

• Wait ten minutes, observe the presence or absence of pink/purple bands

in Windows #2 and #3.

• Sample results are read in Window #2. The control band is read in

Window #3.

NOTES:

The test is complete and may be read before 10 minutes if pink/purple

bands are visible in both Windows #2 and #3. The presence of a

pink/purple band only in Window #3 does NOT mean that the test is

complete as a band in Window #2 may develop slower than the

control band in Window #3. Wait a full 10 minutes before declaring

a result as negative.

4. RESULTS:

Validation: Test is validated if a pink/purple band is present in Window #3.

Interpretation:

• Negative for canine parvovirus (CPV) antigen: No band in Window #2,

with one pink/purple band in Window #3.

• Positive for CPV antigen: One pink/purple band in Window #2, with one

pink/purple band in Window #3.

• Samples with low levels of CPV antigen may produce a lighter colored

yet distinct pink/purple band.

Invalid test: No pink/purple band in Window #3.

NOTE:

A test result should always be interpreted in the context of all available

clinical information and history for the dog. If clinical signs