Quidel™ Lyra Direct C. difficile Molecular Assay

Description

Multiplex RT-PCR IVD test detecting tcdA or tcdB sequences of Clostridium difficile from unformed stool specimens collected from patients suspected of having CDAD, FDA approved for use on Applied Biosystems™ 7500 FastDx RT-PCR, QuantStudioDx RT-PCR, and Cepheid™ SmartCycler™ II

• RT-PCR
• One-step reagent setup
• Results in <70 minutes
• No freezer necessary
• Refrigration storage
• Long shelf-life
• Flexible testing format
• Includes 12 x 8 master mix, rehydration solution and liquid process controls
• Sample preparation kit includes all consumables

Specifications

• Certifications/Compliance: FDA approved*
• Content And Storage: 2°C to 8°C
• Control Sets: Included
• Description: Direct detection of toxin A gene (tcdA) or toxin B gene (tcdB) sequences of toxigenic strains of Clostridioides (Clostridium) difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridioides (Clostridium) difficileAssociated Disease (CDAD)
• CE Marker: Yes
• Clia Complexity: High
• Detectable Analytes: Toxin A gene (tcdA), Toxin B gene (tcdB), Toxigenic strains of Clostridioides (Clostridium) difficile
• DoA Calibrators: No
• Sample Type: Unformed (liquid or soft) stool samples
• Sensitivity: 94.3% AB 7500 Fast Dx, 93.3 % QuantStudio Dx, 89.7% Smart Cycler II
• Type: Molecular Testing
• For Use With (Application): RT-PCR
• For Use With (Equipment): FDA approved for use on Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument, QuantStudioTM Dx Real-Time PCR Instrument and Cepheid™ SmartCycler™ II
• Includes: Tests and controls
• Packaging Type: Kit
• Quantity: 96 Tests/Kit
• Specificity: 94.2% AB 7500 Fast Dx; 93.4% QuantStudio Dx; 93.3% SmartCycler II
• Test Time: <70 min.
• Form: Liquid