GBS (Group B Streptococcus)

Max_078webGroub B Streptococcus (GBS, Streptococcus agalactiae) is the leading cause of life-threatening infections in newborns. Rapid and sensitive detection of neonatal infections and initiation of appropriate treatment is needed to minimize morbidity and mortality among newborns. PCR has proved to be a useful diagnostic tool due to its increased sensitivity and specificity and fast results.

For prenatal screening, the accuracy and timing of testing is important to prevent unnecessary use of intra-partum antibiotic prophylaxis (IAP).

The GenomEra® GBS assay simplifies and speeds up GBS testing by providing reliable results from enriched broth samples in less than one hour. The assay is suitable for both over-night and quick 4 h cultured broth enrichment samples and also for positive blood cultures.

Clinical performance

Over-night enrichment broth samples
Sensitivity: 97/99 = 98.0%
Specificity: 288/293 = 98.3%

Short 4 h enrichment broth samples
Sensitivity: 27/28= 96.4%
Specificity: 83/86 = 96.5%

Assay steps for broth cultures:

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Dispense suspension into tube and vortex.

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Pipette 35 ul to the test chip.

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Start the GenomEra CDX assay run.