Diagnostic rapid test

veterinaryfor felineslipase

Product Overview
The ITGen Feline Pancreatic Lipase Rapid Test detects feline pancreas-specific lipase (FPL) to support the diagnosis and screening of pancreatitis in cats. The cassette format provides a quick, point-of-care result from serum or plasma with minimal handling.

Production Features

• Designed to support pancreatitis diagnosis in veterinary practice
• Minimally invasive sampling (serum or plasma)
• Clear cassette window for easy result reading
• Single-test packaging suitable for clinic or home screening
• Manufactured in a CE, ISO 13485 and GMP certified facility

Product Parameters
Production Name: ITGen Feline Pancreatic Lipase Rapid Test
Target Analyte: Feline Pancreas-Specific Lipase (FPL)
Specimen Type: Feline serum or plasma
Storage Temperature: 4–30°C
Result Time: 5–10 minutes
Packaging: Individually sealed tests
Packaging Specification: 1T (single test)
Shelf Life: See expiration date on package

Product Specifications
Sensitivity: 96.39%
Specificity: 97.50%
Accuracy: 96.28%
Format: Cassette (lateral flow)
Detection Method: Chromatographic immunoassay / lateral flow immunoassay
Reading Time: 5–10 minutes
Intended Use: Veterinary diagnostics (cats)

Contents
Test device: 1
Buffer tube: 1
Quantitative dropper: 1
Package insert: 1

Description
This rapid test enables early screening for pancreatic dysfunction in cats showing reduced appetite, vomiting, abdominal pain or behavioral changes. It is suitable for in-clinic use or as part of preliminary screening at home under veterinary guidance. Quick results facilitate timely decisions on further diagnostic work-up and patient care.

How to use

• Ensure test and specimen are at room temperature (15–30°C) and verify kit contents.
• Unseal the buffer-containing extraction tube and place it upright.
• Collect serum or plasma into the top chamber of the collection device; avoid bubbles.
• Transfer ~75 μL of sample into the buffer, cap and mix thoroughly until homogenous.
• Remove the test device from the foil pouch and lay it on a clean, flat surface.
• Add three drops (~90 μL) of the mixed sample vertically into the specimen well (S).
• Read the result at 5–10 minutes; do not interpret results after 15 minutes.

Interpretation of Results

• Abnormal (+): T1 line intensity equal to or darker than reference T2 line indicates elevated FPL.
• Normal (−): T1 line lighter than reference T2 line indicates normal FPL.
• Invalid: No colored line in the C region — test must be repeated.

Certifications & Quality

• ISO 9001 certified management system
• GMP compliant manufacturing
• CE marked
• ISO 13485 certified for medical device quality
• Batch traceability and QC testing to ensure consistency

OEM / ODM / Bulk & Logistics

• Private label and custom packaging options
• Product customization and design services
• Volume pricing, tiered discounts and flexible payment terms
• Worldwide shipping with options for cold-chain logistics when required

Technical specifications

• Product name: ITGen Feline Pancreatic Lipase Rapid Test
• Analyte: Feline Pancreas-Specific Lipase (FPL)
• Specimen: Feline serum or plasma
• Method: Chromatographic / lateral flow immunoassay
• Format: Cassette, individually sealed
• Result time / Reading time: 5–10 minutes
• Sensitivity: 96.39%
• Specificity: 97.50%
• Accuracy: 96.28%
• Storage temperature: 4–30°C
• Packaging specification: 1T (single test)
• Shelf life: See expiration date on package