Diagnostic rapid test

veterinaryfor caninesfor antigens

Short description
This kit is intended for rapid on-site veterinary detection of Babesia Gibsoni antigen in whole blood, serum or plasma. It is suitable for clinical diagnosis in veterinary clinics, disease screening in kennels and monitoring in animal rescue stations. Babesia Gibsoni is a tick-transmitted haemoparasite that can cause hemolytic anemia in dogs; this test offers a rapid, easy-to-read alternative to microscopy and a cost-effective option compared with PCR.

Key features

• Rapid results in 5–10 minutes
• Simple cassette format for point-of-care use
• High sample compatibility: whole blood, serum, plasma
• Individually sealed tests for infection control

Manufacturing
Manufactured in China in a facility certified to CE, ISO 13485 and GMP standards.

Product Parameters

• Product name: ITGen Babesia Gibsoni Antigen Rapid Test
• Target analyte: Babesia Gibsoni antigen
• Specimen type: whole blood, serum, plasma
• Storage temperature: 4–30°C
• Result time: 5–10 minutes
• Packaging: individually sealed test cassettes
• Packaging specification: 10 tests per box
• Shelf life: see expiration date on package (FAQ: 24 months at 2–30°C)

Product Specifications

• Format: cassette (lateral flow immunoassay)
• Detection method: colloidal gold immunochromatography (GICA)
• Sensitivity: 98% (table); clinical FAQ reports up to 99%
• Specificity: 97.45% (table); clinical FAQ reports 98.8%
• Accuracy: 97.37%
• Reading time: 5–10 minutes
• Intended use: veterinary diagnostics, point-of-care antigen detection

Clinical trial notes (FAQ)
Reported clinical performance in FAQs: sensitivity up to 99% and specificity up to 98.8%; refer to product FAQ/clinical trial documentation for study conditions and sample sets.

Contents

• Test device — 1
• Quantitative dropper — 1
• Buffer tube (extraction tube) — 1
• Package insert — 1

Product Description
The ITGen Babesia Gibsoni Antigen Rapid Test employs colloidal gold immunochromatography using a double-antibody sandwich format to detect Babesia Gibsoni antigen. The assay provides visual T/C line results interpreted within 5–10 minutes.

How to use?

• Ensure test and samples are at room temperature (15–30°C).
• Open the extraction tube containing buffer and place it upright.
• Collect sample (whole blood/serum/plasma) with the provided dropper and transfer into the extraction tube; avoid bubbles.
• Mix sample and buffer thoroughly by gentle agitation.
• Remove test device from foil pouch and place on a flat surface.
• Add three drops (~90 μL) of the mixed specimen into the specimen well (S).
• Read the result between 5–10 minutes; do not interpret after the specified reading time.

Interpretation of Results

• Positive: both C (control) and T (test) lines appear (T may be faint or strong).
• Negative: only C line appears clearly.
• Invalid: C line absent (regardless of T line); repeat test with a new device.

Technical specifications

• Sensitivity: 98% (table) — clinical FAQ reports 99%
• Specificity: 97.45% (table) — clinical FAQ reports 98.8%
• Accuracy: 97.37%
• Storage: 4–30°C (FAQ guidance: stable at 2–30°C)
• Shelf life: see package; FAQ indicates 24 months at recommended storage
• Contents per kit: test device x1, dropper x1, buffer tube x1, package insert x1