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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 by the use of 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

FeatureBenefit
One-step reagent set-up

Rehydration solution is simply added to the lyophilized Master Mix

Speed

Results in less than 70 minutes

Easy training

Simplified and uniform workflow with standard pipetting volumes

Refrigerated storage

No freezer needed. 2°C to 8°C storage

Long shelf life

2 years from date of manufacture

Room temperature set up

No ice or cooling block required

Flexible 96-test format

Kit includes vials of 12x8 Master Mix, Rehydration Solution and liquid Process Controls. Sample preparation kit includes all consumables

Product Specifications

Product Spec NameProduct Spec Data
Sample type

Unformed (liquid or soft) stool samples

Time to results

Less than 70 minutes

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

Sensitivity*

94.3% AB 7500 Fast Dx, 93.3 % QuantStudio Dx; 89.7% Smart Cycler II

Specificity*

94.2% AB 7500 Fast Dx; 93.4% QuantStudio Dx; 93.3% SmartCycler II

LOD

0.2 to 1 CFU

Processed sample needed to test

5 µL

Shelf life

24 months

*Refer to Package Insert for additional performance claims.

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
M105

Assay Kit

96 tests
M207

Sample Preparation Kit

96 tests
M108

Quidel Molecular C. difficile Control Set

40 reactions

To better serve your molecular diagnostic needs Quidel offers two instruments