IntelligentMDx received a CE Mark for its qualitative Group B Streptococcus (GBS) in vitro diagnostic, IMDx GBS, for use on the Abbott m2000™ system. The assay is used to screen for Group B Streptococcus infection in at-risk pregnant women and women in labor.
The real-time PCR test can be carried out on either direct swabs or enriched culture broth samples, and generates results for up to 48 patient samples simultaneously in five hours. IntelligentMDx says the assay demonstrates 95.5% sensitivity and 98.3% specificity when carried out on swabs, and 100% sensitivity and specificity when used with enriched culture broth samples.
IMDx GBS for Abbott m2000 is the third CE-marked test developed under the two firms’ multiyear agreement to develop tests for the Abbott platform. Real-time PCR assays for detecting vancomycin-resistant enterococci, and toxigenic C. difficile, have previously received CE Mark approval. Under terms of the firms’ IVD agreement, IMDx is responsible for designing, developing, obtaining regulatory clearance, and manufacturing assays for the m2000 instrument.