Microbiology test kit Lyra®
C. difficilestoolmolecular

microbiology test kit
microbiology test kit
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Characteristics

Applications
for microbiology
Micro-organism
C. difficile
Sample type
stool
Analysis mode
lateral flow, molecular
Format
lyophilized
Result display time

70 min

Sample volume

0.005 ml
(0.00017 US fl oz)

Specificity

93.3 %, 93.4 %, 94.2 %

Sensitivity

89.7 %, 93.3 %, 94.3 %

Description

The Lyra Direct C. difficile assay is a qualitative, multiplexed in vitro  diagnostic test for the detection of toxin A gene (tcdA) or toxin B gene (tcdB) sequences of toxigenic strains of Clostridium difficile  from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridium difficile -associated disease (CDAD). A multiplex real-time PCR reaction is performed under optimized conditions in a single well generating amplicons for each of the targets present in the sample. Identification occurs using oligonucleotide primers and probes that are complementary to conserved regions in the  tcdA  and tcdB  genes of the pathogenicity locus. The Lyra Direct C. difficile assay has one-step reagent set-up and a three-step sample prep. Test results are available in less than 70 minutes. Lyra Direct C. difficile is a quality real-time PCR available for use on Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument, QuantStudioTM Dx Real-Time PCR Instrument and Cepheid® SmartCycler® II. The Lyra Direct C. difficile test is one in a growing menu of real-time PCR assays and intended to aid in the diagnosis of CDAD in humans. Features & benefits Rehydration solution is simply added to the lyophilized Master Mix for one-step reagent set-up Simplified and uniform workflow with standard pipetting volumes for easy training Long shelf life — two years from date of manufacture Specifications Product specification Sample type - Unformed (liquid or soft) stool samples Reagent storage conditions - 2°C to 8°C Controls storage conditions - 2°C to 8°C Sample preparation storage conditions - 2°C to 25°C LOD - 0.2 to 1 CFU Shelf life - 24 months
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