ubio quickVET Canine Leishmania Antibody Rapid Test
ubio quickVET Canine Leishmania Antibody Rapid Test
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In vitro Diagnostics
INTENDED USE
ubio quickVET Canine Leishmania Antibody Rapid Test is a qualitative
immunochromatographic assay for the detection Leishmania antibodies in Canine serum
or whole blood.
SUMMARY & TEST DESCRIPTION
Canine leishmaniasis is caused by Leishmania infantum and is transmitted by the bite of
phlebotomine sand flies. Infected dogs constitute the main domestic reservoir of the
parasite and play a key role in transmission to humans, in which the parasite produces
visceral leishmaniasis. Clinical manifestations can include conjunctivitis, ocular signs
(anterior uveitis, retinitis), facial alopecia, severe muscle atrophy, lymphadenopathy,
polyarthritis, and protein-losing nephropathy, which may lead to renal failure. Infection
may result in severe systemic disease with hair loss, skin lesions, epistaxis, anemia,
wasting, swollen limbs and joints, lameness, renal failure, lymphadenopathy, ocular
lesions, and diarrhea. Anemia, thrombocytopenia, lymphocytosis, hypoalbuminemia,
hyperglobulinemia, hyperamylasemia, and azotemia are the most frequently detected
laboratory abnormalities.
ubio quickVET Canine Leishmania Antibody Rapid Test is for the qualitative
determination of antibody developed during infection.
TEST PRINCIPLE
ubio quickVET Canine Leishmania Antibody Rapid Test works on chromatographic
immunoassay. Basic components of test strip includes: a) Conjugate pad, which contains
Detection molecule, colloidal gold conjugated; b) a nitrocellulose membrane strip
containing two lines T: Leishmania antigen and C: Goat Anti Mouse.
Sample Well
Test Line
Control Line
Use only for in‐vitro diagnostic purpose.
Wear protective gloves while handling specimens. Clean up spills
thoroughly using an appropriate disinfectant.
Treat all specimens, used tests and other contaminated materials as
infectious, and dispose accordingly.
Do not use with specimen containing precipitates
SAMPLE PREPARATION
Blood Specimen: Collect the whole blood using a syringe or vacutainer into
a container containing anticoagulants such as heparin, EDTA or sodium
citrate by venipuncture.
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Serum: Collect the whole blood using a syringe or vacutainer (NOT
containing anticoagulants such as heparin, EDTA or sodium citrate) by
venipuncture. Leave the syringe or vacutainer, preferably at an angle, to
settle for 30 minutes. Once blood coagulates, centrifuge the blood to get
serum specimen as supernatant.
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If the specimen is not used for testing immediately, they should be
refrigerated at 2~8°C.
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For storage period longer than 5 days, freezing is recommended. Store at 200C
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The specimen should be brought to room temperature prior to use.
Treat the specimen as infectious and handle with standard biosafety measures.
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TEST PROCEDURE
Take out the test card from the foil pouch and place it on a horizontal surface.
Add 5 µl of serum or 10 µl whole blood to the Sample well “S”
When the sample is fully absorbed, add 3 drops of the diluent provided with the
assay to the sample hole.
Wait for 15 minutes and interpret results. The result is considered invalid after
20 minutes. All results where control band does not appear are considered
invalid
INTERPRETATION OF TEST RESULT
Positive: Color bands at position C and T.
Negative: Color band at position C.
Test sample that is added to the sample well, with adequate amount of buffer migrates
from the sample pad along the conjugate pad where any antibody present in the sample
will bind to the colloidal gold conjugate. The sample then continues to migrate across
the membrane until it reaches the capture zones where the antibody-Detection
conjugate complex will bind to the immobilised Leishmania antigen (on test line)
producing a visible line on the membrane. If the respective antibody is not present in the
sample, no reaction occurs in the capture zones and no test line is formed in the zone
corresponding to Leishmania antigen. The sample then migrates further along the strip
until it reaches the control zone, where it produces a second visible line on the
membrane. This control line indicates that the sample has migrated across the
membrane as intended.
REAGENTS & MATERIALS PROVIDED
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Each Kit contains 10 test devices, each sealed in a foil pouch containing
following items:
a.
One test card
b.
Dessicant
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Assay Diluent- In dropper bottle
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Instruction Leaflet
STORAGE & STABILITY
Store the test kit between 2-30°C till the expiration date indicated on the pouch / carton.
DO NOT FREEZE. Ensure that the test device is brought to room temperature before
opening.
PRECAUTIONS & WARNING
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Use within 10 minutes after opening pouch.
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Do not touch result window.
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Use only the buffer supplied along with the kit.
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Do not mix components from different kits.
Invalid: Color band at C does not appear
Reference:
1.
Lemos EM, Laurenti MD, Moreira MAB, Reis AB, Giunchetti RC, et al. (2008)
Canine visceral leishmaniasis: Performance of a rapid diagnostic test
(Kalazar Detect) in dogs with and without signs of the disease. Acta Trop
107: 205–207. doi: 10.1016/j.actatropica.2008.04.023.
2.
Reithinger R, Quinnell RJ, Alexander B, Davies CR (2002) Rapid detection of
Leishmania infantum infection in dogs: Comparative study using an
immunochromatographic dipstick test, enzyme-linked immunosorbent
assay, and PCR. J Clin Microbiol 40: 2352–2356. doi:
10.1128/JCM.40.7.2352-2356.2002.
Manufactured by
ubio Biotechnology Systems Pvt Ltd
XII-111-E/F, Technology Incubation Centre
KINFRA Hi-Tech Park, Kalamassery
Cochin, Kerala, India 683503
Ph:, +91-484-2532966
Doc. No. ub0171301/V.1.0