商品编号


M201



品牌


Quidel



公司


Quidel,inc.



公司分类


AmpliVue



Size

16 tests

商品信息

Description:
Assay Kit
Features & Benefits:






The AmpliVue C. difficile Assay is an
in vitro
diagnostic test for the direct, qualitative detection of the
Clostridium difficile
Toxin A gene (tcdA) in unformed stool specimens of patients s
USP
ected of having
Clostridium difficile
-associated disease (CDAD).

The?assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence and a self-contained disposable amplification detection device that allows for visual evaluation of assay results.

A diluted sample is lysed by simple heat treatment, aliquoted and added to a Reaction Tube containing lyophilized mix of HDA reagents including primers specific for the amplification of a fragment from the conserved region of the
C. difficile
DNA. Competitive amplification of the process control DNA takes place unless amplification inhibitory substances are present or the sample processing fails.

After completion of the HDA reaction, the Reaction Tube is transferred to a Cassette for rapid detection with the test result displayed as test and/or control lines in the window of the Cassette. The dual-labeled probe-amplicon hybrid is then detected by the lateral flow strip within the Cassette. The bottom line captures the test amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the molecular test result is shown as colored lines vis
IBL
e to the naked eye.
c-diff cdiff
?










Feature
Benefit



Small, self-contained hand-held cassette
Convenient, easy-to-use, disposable device



HDA technology
Rapid method of nucleic acid amplification that does not require thermal cycler



Lyophilized reagents
Easy-to-use format, just rehydrate and add sample. Reagents are stable at higher temperatures than liquid reagents



Small easy-to-use heat blocks
Eliminates need for dedicated molecular space and costly capital equipment. Allows for testing in smaller labs



CLIA moderately complex
Requires minimal training



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












Product Specifications:




Product Spec Name
Product Spec Data



Volume/vial
2.0 mL



Specimen Type
Whole Antisera



Preservative
≤0.1% Sodium Azide



Storage
2°C to 8°C



Sensitivity*
93.6%



Specificity*
94.1%



LOD
4.2 CFU/assay



Shelf life
24 months








*Refer to Package Insert for additional performance claims.