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The Great Basin Portrait™ GBS Assay, performed on the PA500 Portrait™ Analyzer System, is a qualitative in vitro diagnostic test (IVD) for the detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swabs from antepartum women, following enrichment in LIM Broth for 18 - 29 hours. The assay utilizes automated sample preparation and polymerase chain reaction (PCR) to amplify a cfb gene sequence specific to the Streptococcus agalactiae (GBS) genome which is detected by hybridization probes immobilized on a silica chip surface. Results from the Portrait™ GBS Assay can be used as an aid in determining colonization status in antepartum women. The Portrait™ GBS Assay does not provide susceptibility results. Cultured isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. The Portrait™ GBS Assay is intended for use in clinical laboratory, and reference laboratory settings. The Portrait™ GBS Assay is not intended for point of care use.

The Great Basin PA500 Portrait Analyzer System is a fully automated system that includes the Portrait Analyzer, single-use Portrait GBS Assay Test Cartridges, and the Portrait data analysis software. The PA500 Portrait Analyzer System is designed to perform automated sample preparation, PCR, and optical chip-based detection with integrated data analysis in approximately 90 minutes. The Great Basin Portrait™ GBS Assay utilizes automated hot-start PCR technology to amplify target nucleic acid sequences that are detected using species-specific S. agalactiae DNA hybridization probes immobilized on a modified silicon chip surface.