BIONOTE Anigen Rapid CaniV-4 (Leish) – 4-in-1 Canine Vector-Borne Disease Test – 10 Tests

Description The BIONOTE Anigen Rapid CaniV-4 (Leish) is a rapid veterinary diagnostic test designed for simultaneous screening of four important canine vector-borne disease markers. The test detects: Dirofilaria immitis antigen — Heartworm disease Ehrlichia canis antibody — Canine ehrlichiosis Leishmania infantum antibody — Canine leishmaniasis Anaplasma phagocytophilum / Anaplasma platys antibodies — Anaplasmosis The test uses a chromatographic immunoassay and can be performed with canine whole blood, serum, or plasma. This 4-in-1 format allows veterinary clinics to screen for multiple important infectious and vector-borne disease markers using a single test device. Key Features 4-in-1 canine vector-borne disease screening Detects Heartworm (Dirofilaria immitis) antigen Detects Ehrlichia canis antibodies Detects Leishmania infantum antibodies Detects Anaplasma antibodies Suitable for canine whole blood, serum, or plasma Chromatographic immunoassay Rapid visual results No dedicated analyzer required 10 tests per kit Storage at 2–30°C Veterinary diagnostic use What Does It Detect? Target Marker Disease / Condition Dirofilaria immitis Antigen Heartworm disease Ehrlichia canis Antibody Canine ehrlichiosis Leishmania infantum Antibody Canine leishmaniasis Anaplasma phagocytophilum / A. platys Antibody Canine anaplasmosis Important: The Anaplasma component cannot differentiate between A. phagocytophilum and A. platys. A positive result indicates antibodies to one or both of these organisms. Product Specifications Specification Details Brand BIONOTE Product Name Anigen Rapid CaniV-4 (Leish) Product No. RC2127DD Test Type 4-in-1 canine vector-borne disease test Method Chromatographic immunoassay Animal Dog Specimens Whole blood, serum, plasma Targets D. immitis Ag, E. canis Ab, Leishmania Ab, Anaplasma Ab Package Unit 10 Tests/Kit Storage 2–30°C BIONOTE Listed Testing Time 20 minutes IFU Result Reading 15 minutes Intended Use Veterinary diagnostic use BIONOTE's official product page confirms RC2127DD, 10 Tests/Kit and storage at 2–30°C. BIONOTE's product list gives a 20-minute testing time, while the current accessible IFU instructs users to interpret results at 15 minutes and not after 25 minutes. Sample Types The test can be performed using: Canine whole blood Canine serum Canine plasma For whole blood, the supplied anticoagulant tube can be used. General Test Procedure Bring the test device, reagents, and samples to room temperature before testing. Collect the appropriate canine sample. Add 20 µL of whole blood, or 10 µL of serum/plasma, to the sample hole. Add 3 drops of assay diluent. Start the timer and allow the sample to migrate through the result window. If the sample does not appear after 1 minute, the IFU allows adding one additional drop of assay diluent. Interpret the results at 15 minutes. Do not read the result after 25 minutes. Result Interpretation Negative Only the appropriate Control (C) line appears. Positive A Control (C) line and the corresponding Test (T) line appear for the relevant disease marker. A positive line indicates the presence of the corresponding target antigen and/or antibody. Invalid If the required Control (C) line does not appear, the result is invalid and the sample should be retested using a new test device. Kit Contents For the 10 Tests/Kit configuration: 10 × Anigen Rapid CaniV-4 (Leish) test devices 1 × Assay diluent bottle 10 × Anticoagulant tubes 10 × Disposable capillary tubes 1 × Instructions for Use The IFU specifies the 10-test configuration and included components. Storage & Handling Store at 2–30°C Do not freeze Keep away from direct sunlight Protect the test from heat and humidity Use the test device immediately after removing it from the foil pouch Do not reuse test components Do not use after the expiration date Do not use if the pouch is damaged or the seal is broken Do not mix components from different lot numbers Handle all samples as potentially infectious Important Diagnostic Note CaniV-4 (Leish) is a diagnostic aid and screening test. A positive antibody result does not necessarily establish active infection by itself, and results should be interpreted together with the dog's clinical history and other laboratory findings. BIONOTE's IFU states that additional clinical or laboratory testing may be required for questionable results and that a definitive clinical diagnosis should not be based on a single test result.