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AmpliVue Bordetella Assay
详见说明书
钰博生物
详见官方网站
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 suspected 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 visible 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 |
Sample Type | Nasopharyngeal swabs |
Time to results | Approximately 80 minutes |
Reagent storage conditions | 2ºC to 8ºC Process Buffer and Reaction Tubes; 2ºC to 30ºC Amplicon Cartridge and Detection Cassette |
Controls storage conditions | 2ºC to 8ºC |
Sample preparation storage conditions | 25ºC ± 2ºC for 2 days and then at 2ºC to 8ºC for up to 8 more days before testing or at <–15ºC or <–70ºC 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) |
Catalog Number | Description | Kit Size / Case Size |
---|---|---|
M209 | Assay Kit |
16 tests |
M117 | Quidel Molecular Bordetella Control Set |
2.0 mL |
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