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
| Feature | Benefit |
|---|---|
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 | 24 months from date of manufacture |
Room temperature at set up | No ice or cooling block required |
Product Specifications
| Product Spec Name | Product 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 Number | Description | Kit Size / Case Size |
|---|---|---|
M311 | Solana GBS Assay Kit | 48 tests |
M116 | Quidel Molecular GBS Control Set | 20 reactions |
Product Documentation
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