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The Panther Fusion GBS assay is an automated qualitative in vitro diagnostic test utilizing real-time PCR for detection of Group B Streptococcus DNA from either Lim or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18-24 hours incubation. This test is performed on the Hologic Panther Fusion system and is intended to aid in determining the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. The Panther Fusion GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The Panther Fusion GBS assay involves the following steps: Sample lysis, nucleic acid capture and elution, and multiplex RT-PCR where analytes (when present) are simultaneously amplified, detected and differentiated. Nucleic acid capture and elution takes place in a single tube on the Panther Fusion system. The eluate is transferred to the Panther Fusion system reaction tube containing the assay reagents. RT-PCR is then performed for the eluted nucleic acid on the Panther Fusion system. Sample Collection and Enrichment: After collecting and transporting a swab sample to the laboratory, the swab is placed in Lim Broth or Carrot Broth for 18 to 24 hours of enrichment. Prior to testing on the Panther Fusion system, enriched specimens are then transferred to a tube containing specimen transport media (STM) that lyses the cells, releases target nucleic acid and protects them from degradation during storage. Nucleic Acid Capture and Elution: Specimens are then first incubated in an alkaline reagent (FER-X) to enable cell lysis. The Internal Control (IC-X) is added to each test specimen and controls via the working Panther Fusion capture Reagent-X (wFCR-X). The IC-X monitors specimen processing, amplification and detection. Magnetic particles with covalently bound oligonucleotides, contained in Panther Fusion capture Reagent-X (FCR-X), mediate the nucleic acid capture by hybridizing to total nucleic acid in the test specimen. The capture nucleic acids are then separated from residual specimen matrix in a magnetic field by a series of wash steps with a mild detergent. The captured nucleic acid is then eluted from the magnetic particles with a reagent of low ionic strength (Panther Fusion Elution Buffer). Elution transfer and PCR: During the elution transfer step, eluted nucleic acid is transferred to a Panther Fusion Reaction tube already containing oil and reconstituted mastermix. PCRbased target amplification subsequently occurs with target-specific forward and reverse primers, generating a fluorescence signal. The Panther Fusion GBS Software computes a cycle threshold result (Ct) to qualitatively determine the presence of the analyte targets and corresponding fluorescent channels used in the Panther Fusion GBS Assay are summarized in the Table 1 below.