商品编号


M105



品牌


Quidel



公司


Quidel,inc.



公司分类


C. difficile



Size

96 tests

商品信息

Description:
Assay Kit
Features & Benefits:






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 s
USP
ected 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, QuantStudio
TM
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.










Feature
Benefit



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



Flex
IBL
e 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 Name
Product 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 ?L



Shelf life
24 months








*Refer to Package Insert for additional performance claims.