Key Features

• Specific Assay Design

Designed based on the cctA gene, a toxin-associated gene specific to Clostridium chauvoei, ensuring precise detection.

• Clinically Validated Performance

Demonstrated 100% clinical sensitivity and specificity based on 408 clinical samples.

• High Specificity Without Cross-Reactivity

No cross-reactivity observed with other Clostridium spp. (e.g., Clostridium septicum, Clostridium perfringens, Clostridium novyi) or major bovine pathogens.

• Consistent Performance Across Sample Types

Stable detection across various sample types including liver, spleen, kidney, muscle, and cultured colonies, regardless of cattle type (beef cattle and dairy cattle).

• Reliable Detection Across Sample Matrices

Consistent Ct values observed across diverse clinical samples without performance variation.

Storage

• Storage Temperature

: Below -20°C

• Shelf Life

: 12 months (Stable within 6 months after opening)

Kit Contents

Technical Data

1. Clinical Performance

•  Total samples : 408 clinical samples (308 positive and 100 negative, based on the reference method)

•  Clinical sensitivity : 100% (308/308, 95% CI : 98.62 ~ 100%)

•  Clinical specificity : 100% (100/100, 95% CI : 96.38 ~ 100%)

•  Agreement with reference method : 100% (408/408, 95% CI : 99.10 ~ 100%)

2. Detection Performance

Stable Ct values were observed across different sample types and bacterial concentrations, demonstrating robust detection performance.

The assay demonstrated consistent detection performance across a wide range of clinical sample types, maintaining comparable Ct values regardless of sample type or target concentration. Reliable detection was achieved in various specimen types, including liver, heart, kidney, spleen, muscle, tissue homogenates, and cultured isolates derived from clinical samples. Furthermore, stable detection of Clostridium chauvoei was confirmed irrespective of cattle breed (beef cattle and dairy cattle), indicating robust performance across different animal sources.