Rapid leptospirosis test

diagnosticveterinaryfor canines

Overview
The ITGen Canine Leptospirosis Antibody Rapid Test provides a cost-effective on-site screening solution to assist veterinary clinics, breeding farms and kennels in early detection and control of canine leptospirosis. It enables rapid screening using whole blood, serum or plasma with results in 5–10 minutes.

Production Features

• Small sample volume required
• High analytical specificity
• Suitable for early screening

Product Parameters
Product name: ITGen Canine Leptospirosis Antibody Rapid Test
Target analyte: Canine Leptospirosis Antibody
Specimen type: Whole blood, serum or plasma
Storage temperature: 4–30°C
Result time: 5–10 Minutes
Packaging: Individually sealed tests
Packaging specification: 10T (10 tests per package)
Shelf life: See expiration date on package

Product Specifications
Sensitivity: 97.06%
Accuracy: 97.50%
Format: Cassette
Detection method: Chromatographic immunoassay / Lateral flow immunoassay (colloidal gold)
Specificity: 98%
Reading time: 5–10 Minutes
Usage: Veterinary diagnostics

Contents
Test device: 1
Capillary dropper: 1
Buffer: 1
Package insert: 1

Description
Based on colloidal gold immunochromatography (GICA) and the specific antigen–antibody binding principle, this ITGen rapid test qualitatively detects antibodies to Leptospira in canine serum, plasma or whole blood. Leptospirosis is a zoonotic disease; infected dogs can develop severe conditions such as renal failure and hepatitis.

How to use?

• Verify kit contents and perform the test at room temperature (15–30°C).
• Remove the test device from the aluminum pouch and place it on a clean, flat surface.
• Using the capillary dropper, collect whole blood, serum or plasma and add one drop (≈10 µl) to the specimen well (S).
• Add two drops (≈60 µl) of buffer into the specimen well (S).

Interpretation of Results

• Positive (+): Both C line and T line appear, regardless of T-line intensity.
• Negative (–): Only a clear C line appears.
• Invalid: No colored line appears at C, regardless of T-line.

Certifications & Quality
Manufactured in facilities complying with CE, ISO 13485 and GMP standards; ISO 9001 management and batch QC testing are applied to ensure consistency and quality.

Technical Specifications

• Target analyte: Canine Leptospirosis Antibody
• Specimen types: Whole blood, serum or plasma
• Detection method: Chromatographic immunoassay (LFA) using colloidal gold
• Result/reading time: 5–10 minutes
• Sensitivity: 97.06%
• Specificity: 98%
• Accuracy: 97.50%
• Format: Cassette; individually sealed tests
• Packaging: 10 tests per package (10T)
• Storage temperature: 4–30°C
• Shelf life: See expiration date on package