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Quidel™ Lyra Direct C. difficile Molecular Assay

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
Supplier: Quidel™ M105
Description
- 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
FDA approved* | |
Included | |
Yes | |
Toxin A gene (tcdA), Toxin B gene (tcdB), Toxigenic strains of Clostridioides (Clostridium) difficile | |
Unformed (liquid or soft) stool samples | |
Molecular Testing | |
FDA approved for use on Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument, QuantStudioTM Dx Real-Time PCR Instrument and Cepheid™ SmartCycler™ II | |
Kit | |
94.2% AB 7500 Fast Dx; 93.4% QuantStudio Dx; 93.3% SmartCycler II | |
Liquid |
2°C to 8°C | |
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) | |
High | |
No | |
94.3% AB 7500 Fast Dx, 93.3 % QuantStudio Dx, 89.7% Smart Cycler II | |
RT-PCR | |
Tests and controls | |
96 Tests/Kit | |
<70 min. |
Safety and Handling
ShelfLife : 2 Years from DOM
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