Description
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.