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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.

Features & Benefits

FeatureBenefit
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 NameProduct Spec Data
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)

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
M209

Assay Kit

16 tests
M117

Quidel Molecular Bordetella Control Set

2.0 mL

Helicase Dependent Amplification Video