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Great Basin Group B Streptococcus Test
Qualitative detection of Group B Streptococcus (GBS)
Group B Streptococcus (GBS) or Streptococcus agalactiae is a Gram positive bacterium that remains a leading cause of serious illness and death in newborn populations born to women colonized with the microorganism1,2. Approximately 10 – 30% of all pregnant women are colonized with GBS in the genitourinary or gastrointestinal tract3. The CDC recommends that all pregnant women be screened for GBS colonization at 35 to 37 weeks gestation. Prior to the routine screening, approximately 7,600 cases of severe GBS infection occurred in newborns annually in the US, costing approximately $294 million4. However, conventional, culture-based laboratory methods require extensive hands-on labor, long incubation times, and often are unable to detect non-hemolytic strains of S. agalactiae.
INTENDED USE
The Great Basin Group B Streptococcus test is a qualitative in vitro diagnostic test, for the detection of Group B Streptococcus DNA from Lim broth-enriched vaginal/rectal swab specimens from antepartum women. This test utilizes automated sample preparation and polymerase chain reaction (PCR) to amplify a cfb gene sequence specific to the Streptococcus agalactiae genome.
This in vitro diagnostic test is configured for use on Great Basin GB Analyser with Great Basin GBS Assay Test Cartridge Kit.
Results from Great Basin Group B Streptococcus test can be used as an aid in determining colonization status in antepartum women. It does not provide susceptibility results. Cultured isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
The test is intended for clinical laboratories, hospital laboratories and reference laboratories. The Great Basin Group B Streptococcus test is not intended for point-of-care use.
FEATURES AND BENEFITS
Faster Clinical Decision Making and Improved Patient Outcomes
- Easy-to-use sample-to-result solution delivers more diagnostic data per sample than low-plex technologies
- Accurate results to direct appropriate antibiotic therapy
- High Sensitivity and Specificity
- Even detects non-hemolytic strains of S. agalactiae
Increased Lab Productivity
- Eliminates routine culture
- Produces definitive results from Lim-enriched specimens in under 2 hours
- Highly automated and easy-to-use
- Freeing up valuable laboratory resources
Increasing Laboratory Effectiveness
- Sample-to-result with less than <2 mins hands-on-time per sample
- Small instrument footprint
- Efficiency benefits to hospitals and shorter stays for patients
WORKFLOW
SPECIFICATIONS
| Attribute | Value |
|---|---|
| Analytical Sensitivity |
For ATCC strain BAA1177 (Serotype 1a): 5x103 CFU/mL For ATCC strain 12403 (Serotype 3): 8x103 CFU/mL |
| Analytical Reactivity |
Able to detect 100% of all 11 serotypes |
| Analytical Specificity |
No cross-reactivity with human DNA and 60 non-target microflora (50 bacterial, 5 yeast, and 4 viral stock strains) |
| Clinical Sensitivity |
97.9% |
| Clinical Specificity |
96% |
| Reproducibility | ≥98% |
| Sample Type(s) | Vagina/Rectal swabs |
ORDERING INFORMATION
| Product | Pack Size | Item Number |
|---|---|---|
| Great Basin Group B Streptococcus Test | 10 | 300781 |
References
1. Phares CR, Lynfield R, Farely MM, Mohle-Boetani J, Harrison LH, Petit S, et al. Epidemiology of invasive group B streptococcal disease in the United States, 1999-2005. JAMA 2008; 299:2056- 65.
2. Baker CJ. Early onset group B streptococcal disease. J Pediatr 1978; 93:124-5.
3. Regan JA, Klebanoff MA, Nugent RP. The epidemiology of group B streptococcus colonization in pregnancy. Vaginal Infections and Prematurity Study Group. Obstet Gynecol 1991; 77:604-10.
4. CDC: Clinical Overview, Group B Strep. https://www.cdc.gov/groupbstrep/clinicians/clinical-overview.html