POCKIT™ Central C. difficile is intended for use with POCKIT™ Central system. The assay, targeting the toxin B (tcdB) gene, is an in vitro diagnostic1 molecular assay for qualitative detection of toxigenic C. difficile in liquid or soft stool from patients suspected of C. difficile infection. The assay is intended to aid in the diagnosis of C. difficile infection.
1 Not U.S. FDA cleared or approved yet.
Overall agreement………………………………………… 94.8% (CI95%, 90.97% to 98.64%) |
Positive agreement ……………………………………… 92.6% (CI95%, 84.50% to 100%) |
Negative agreement ……………………………………… 96.0% (CI95%, 91.50% to 100%) |
*Compared to a C. difficile real-time PCR assay
Reagent |
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Product Name
| Cat.No.
| Specifications
|
POCKIT™ Central C. difficile | apcri-110 | 24 tests/set including: - Stool Pretreatment Set - Extraction Cartridges - C. difficile Reagent Cartridges - C. difficile Internal Control |
Instrument |
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Product Name
| Cat.No.
| Specifications
|
POCKIT™ Central Nucleic Acid Analyzer | apcc-1i | Throughput: 1-8 samples |