Panther Fusion® GBS Assay

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    Package Inserts

    An accurate PCR NAAT test for group B strep detection

    With performance you can trust, the Panther Fusion® GBS assay transforms your laboratory workflow and expands the molecular menu on the Panther Fusion® system. The assay detects the gram-positive bacterium Streptococcus agalactiae (GBS) from antepartum women, which demonstrated 100% sensitivity.1 

    Using a NAAT increases the opportunity to identify additional mothers

    The Panther Fusion® GBS PCR nucleic acid amplification test (NAAT) detected 31% more positives than culture.2 All women should be screened for GBS between 36 0/7 and 37 6/7 weeks per the ACOG Guidelines. Emerging research suggests that PCR NAATs are highly sensitive and should be considered the preferred method for GBS screening in the prenatal period.2

    The Panther Fusion GBS assay design1

    Illustration of a DNA

    Detects Group B Streptococcus DNA from antepartum women, following an 18–24-hour incubation in selective enrichment broth culture of Lim Broth or Carrot Broth

    Illustration of a target

    Features dual-target detection of the Cfb and SIP genes, showing 100% clinical sensitivity and 96.5% specificity in a clinical trial.

    Assay Specifications

    Screening window:

    Antepartum women

    Specimen type:

    Single vaginal-rectal swab3

    Media Type:

    Liquid Stuart or Amies without charcoal

    Enrichment broth:

    Lim Broth or Carrot Broth

    Turnaround time (TAT):

    Quick TAT, <2.4 hours4

    How much time and money could you save?

    The Panther Fusion GBS assay run on the Panther Fusion system offers: 

    • Full automation 
    • High throughput  
    • Ready-to-use reagents with 30-60 day on board stability, eliminating reagent prep and waste1
    • A non-batch workflow 

    Consolidate your group B strep testing on the Panther Fusion system with other Aptima® and Panther Fusion® assays for women's health, virology, respiratory and sexually transmitted infections.

    Lab tech walking to Panther system
      1. Panther Fusion GBS assay. US package insert AW-23714-001. Hologic, Inc.; 2022. 2. Shin JH and Pride DT. Comparison of Three Nucleic Acid Amplification Tests (NAATs) and Culture for Detection of Group B Streptococcus (GBS) from Enrichment Broth. J Clin Microbiology JCM.01958-18; DOI: 10.1128/JCM.01958-18 3. American Society for Microbiology. Guidelines for the Detection and Identification of Group B Streptococcus. website. Last reviewed July 23, 2021. Accessed April 27,2023. 4. Data on file