Search form

The Solana 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 or Carrot broth cultures.

The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly conserved fragment of the Thiolase (atoB) gene sequence and is intended for use only with the Solana instrument.

An overnight LIM or Carrot 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.

The target sequence is amplified inside Solana by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target-specific primers and detected by a PRC specific fluorescence probe.

Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s four USB ports. Solana GBS is supported by the power of Virena®.

Features & Benefits

FeatureBenefit
HDA technology

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

Lyophilized Master Mix reagent

Easy-to-use format, just add processed sample to rehydrate

Small, easy-to-use instrument

Eliminates the need for dedicated molecular space and costly capital equipment, allowing 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

Currently 12 months from date of manufacture

Room temperature at set up

No ice or cooling block required

Product Specifications

Product Spec NameProduct Spec Data
Sample type

Vaginal/rectal swab specimens cultured for 18 to 24 hours in either LIM or Carrot Broth

Time to results

30 minutes

Reagent storage conditions

Lysis, Dilution and Reaction Tubes; 2˚C to 8˚C

Control storage conditions

2˚C to 8˚C

Clinical Sensitivity (LIM broth)

100%

Clinical Specificity (LIM broth)

95.9%

Clinical Sensitivity (Carrot broth)

100%

Clinical Specificity (Carrot broth)

96%

LOD
2.6x105 CFU/mL

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
M311

Solana GBS Assay Kit

48 tests
M116

Quidel Molecular GBS Control Set

20 reactions

Product Documentation

Product documentation is best viewed in Internet Explorer