Performance of BD MAX Group B Streptococcus (GBS) Assay without Enrichment for the Detection of GBS.

Group B streptococcus (GBS) is an important pathogen causing neonatal early-onset disease. We evaluated the diagnostic performance of BD Max GBS assay (Becton Dickinson, Franklin Lakes, NJ, USA) without enrichment (direct BDM) for detecting GBS using vaginal and rectal specimens in comparison with culture. In total, 716 specimens collected from 358 pregnant women between June 2018 and May 2020 were included in this study. Bacterial culture was performed using ChromID Strep B agar (bioMérieux, Marcy-l'Étoile, France), and species identification results were confirmed using the VITEK-MS system (bioMérieux). The sensitivity of direct BDM for vaginal and rectal specimens was 75.0% and 100%, respectively. Thirteen specimens showed discrepant results: 10 false-negative results in the vaginal specimens and three false-positive results in the rectal specimens. The overall agreement between direct BDM and culture was 98.9% (354/358). The final sensitivity and specificity of direct BDM were 98.5% and 99.0%, respectively. Discrepant results-one false-negative and three false-positives-were obtained for four specimens. Direct BDM shows a good diagnostic performance and will be useful for GBS screening within a few hours.