商品编号


M117



品牌


Quidel



公司


Quidel,inc.



公司分类


AmpliVue



Size

2.0 mL

商品信息

Description:
Quidel
Molecular Bordetella Control Set
Features & Benefits:






The AmpliVue Bordetella Assay is an
in vitro
diagnostic test for the qualitative detection of
Bordetella pertussis
nucleic acids isolated from nasopharyngeal swab specimens obtained from patients s
USP
ected of having respiratory tract infection attributable to
Bordetella pertussis
.

The assay utilizes helicase-dependent amplification (HDA) of the insertion sequence IS481 and a self-contained disposable amplification detection device that allows for visual evaluation of assay results.

A buffered 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 the insertion sequence IS481. 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.










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



Sample Type
Nasopharyngeal swabs



Time to results
Approximately 80 minutes



Reagent storage conditions
2?C to 8?C Process Buffer and Reaction Tubes; 2?C to 30?C Amplicon Cartridge and Detection Cassette



Controls storage conditions
2?C to 8?C



Sample preparation storage conditions
25?C ± 2?C for 2 days and then at 2?C to 8?C for up to 8 more days before testing or at
<
–15?C or
<
–70?C for up to 32 days before testing



Positive Percent Agreement*
97.0% (95% CI 89.5% to 99.2%)



Negative Percent Agreement*
98.1% (95% CI 96.8% to 98.8%)



LOD*
2,358 CFU/mL (3.93 CFU/assay)