nal von minden tamaVet Instructions D'utilisation page 5

tamaVet®
Canine Lyme Borreliosis Test
1. Intended Use
The tamaVet® Canine Lyme Borreliosis Test is for use in the
detection of anti-Borrelia burgdorferi antibodies in canine
whole blood, serum or plasma. The test is intended for use as
an aid in the diagnosis of a Lyme disease and is designed for
professional use only.
2. Introduction and Clinical Significance
Lyme disease is one of several diseases transmitted by ticks.
The pathogen Borrelia burgdorferi is a gram-negative, spiral-
shaped, motile spirochete bacterium. Worldwide, at least 13
genospecies belong to the Borrelia burgdorferi sensu lato (Bsl)
complex. The three most important species B. burgdorferi
sensu stricto (Bss), B. garinii (Bg) and B. afzellii (Ba) are
pathogenic for humans, and B. burgdorferi is also pathogenic
for dogs.
The natural reservoir of Borrelia is in wild animals. They are
transmitted by ticks of the species Ixodes ricinus. An infection
does not always lead to an immediate disease, but rather may
take a long time (2 to 5 months) before a disease outbreak.
The clinical picture of the disease in dogs often develops
insidiously and is characterized by non-specific symptoms such
as apathy, lymphadenopathy and intermittent fever. Other
possible clinical manifestations include infection-related
arthritis in one or more joints, with partially changing
lameness and occasionally glomerulopathies. Even with
effective antibiotic therapy, complete elimination of the
pathogens is difficult.
The detection of a Borrelia burgdorferi infection at an early
stage is essential. The tamaVet® Canine Lyme Borreliosis Test
is a useful tool for veterinarians for the accurate and rapid
detection of Borrelia burgdorferi antigens.
3. Test Principle
The tamaVet® Canine Lyme Borreliosis Test is a sandwich
immunoassay which was developed for professional use by
veterinarians. The assay employs specific antigens which
capture anti-Borrelia burgdorferi antibodies from the sample
and thus visualise the agent. The tamaVet® Canine Lyme
Borreliosis Test is a highly sensitive immunoassay and
comprises a test strip housed in a handy test cassette.
The tamaVet® Canine Lyme Borreliosis test strip consists of a
sample pad, one conjugate pad, a reaction membrane and an
absorption pad. The conjugate pad contains gold-labeled
Borrelia burgdorferi antigens. The reaction membrane is
precoated with complex
immobilised in the test line region and, as a control,
antibodies immobilised in the control line region. The
absorption pad takes up the fluid applied to the test cassette.
Following the application of the specimen onto the test strip
anti-Borrelia burgdorferi-antibodies in the sample material
react with the specific gold-labeled complexes in the
conjugate pad. The fluid then migrates along the strip by
capillary action. In the test line region the formed complexes
are captured by the immobilised capture reagent, causing the
formation of a red line. The presence of a red line in the test
line region indicates a positive result. If the sample does not
tamaVet® Ref. 1172046N-05
binding capture molecules
contain anti-Borrelia burgdorferi antibodies no line will form in
the test line region. Additionally, a red line must form in the
control line region, irrespective of the presence of anti-
Borrelia burgdorferi antibodies in the specimen. The control
line serves as an internal control and indicates that sufficient
sample fluid has been applied to the test strip and that proper
wicking of the membrane has occurred.
4. Reagents and Materials Supplied (5 tests/kit)
 5 tamaVet® Canine Lyme Borreliosis Test cassettes
 2.5 mL buffer solution
 5 pipettes (single use)
 1 package insert
5. Additional Materials Required
Timer
6. Storage & Stability
The tamaVet® Canine Lyme Borreliosis Tests must be stored at
room temperature or refrigerated (2-30°C). The test is stable
until the expiration date printed on the foil pouch. The test
cassette should remain in the sealed foil pouch until use. Do
not freeze tests.
7. Warnings and Precautions
 For veterinary use only.
 For professional in-vitro diagnostic use only.
 For single use only.
 Store tests between 2-30°C. Do not freeze tests.
 Do not use tests beyond the expiry date.
 Do not use tests with damaged pouches.
 Perform the test within 60 minutes of removing the test
cassette from the pouch.
 Consider the test results as invalid after more than
10 minutes.
 Please use the stated amount of sample. An incorrect
number of drops can lead to a false result.
 The test cassette must be in a horizontal position on a
smooth surface while the test is performed.
 Do not touch the reaction field.
 Use only the test components included in the kit. Do not
mix or replace the test components with components from
a different kit.
 Avoid cross contaminations by using a new sample tube and
a new pipette for each sample.
 Sample materials are potentially infectious. During the test
procedure, adhere to standard guidelines for the handling
of potentially infectious material and chemical reagents.
The use of protective clothing (laboratory coat, gloves, eye
protection) is recommended. Materials that have come into
contact with the sample material should be disposed of in
accordance with local regulations.
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