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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 visible to the naked eye.

Features & Benefits

FeatureBenefit
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 NameProduct 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)

20⁰C to 25⁰C or 2⁰C to 8⁰C for up to 25 hours prior to testing

Sensitivity*

99.5%

Specificity*

92.7%

LOD*

1.39 x 106 CFU/mL

*Refer to Package Insert for additional performance claims.

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
M202

Assay Kit

16 tests
M116

Quidel Molecular GBS Control Set

1.0 mL (positive control) 2.0 mL (negative control)

Helicase Dependent Amplification Video