商品编号


M202



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 GBS Assay is an
in vitro
diagnostic test for the direct, qualitative detection of Group B Streptococcus from vaginal/rectal swabs following 18 to 24 hours incubation in Lim broth.

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

An overnight Lim Broth culture enriched from a swab 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 Thiolase (
atoB)
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.










Feature
Benefit



Small, self-contained hand-held Cassette
No isolation room needed

Convenient, easy-to-use, disposable device



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



Lyophilized Master Mix reagent
Easy-to-use format, just rehydrate and add sample.



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
24?months from date of manufacture



Room temperature set up
No ice or cooling block required












Product Specifications:




Product Spec Name
Product Spec Data



Sample type
Vaginal/rectal swab specimens



Time to results
Approximately 80 minutes



Reagent storage conditions
2?C to 8?C Lysis, Dilution 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 (cultured enriched broth)
20?C to 25?C or 2?C to 8?C for up to 25 hours prior to testing



Sensitivity*
99.5%



Specificity*
92.7%



LOD*
1.39 x 10
6
CFU/mL








*Refer to Package Insert for additional performance claims.