BD Diagnostics has received 'Moderate Complexity' status from the US Food and Drug Administration for the BD Max GBS Assay for Group B Streptococcus (GBS) on the BD MAX System.
With the Moderate Complexity categorisation, awarded under the Clinical Laboratory Improvement Amendments (CLIA), the BD Max GBS Assay will increase access to cost-effective molecular testing for a range of laboratories performing GBS screening.
The BD Max GBS Assay is the only fully automated PCR method with a Lim broth claim.
PCR on Lim broth provides a high level of sensitivity and rapid results for detecting GBS.
With the added benefit of a CLIA Moderate Complexity rating, the BD Max GBS Assay is an efficient and effective option for laboratories looking to convert their GBS testing to a molecular method.
The BD Max GBS Assay is the first offering in a range of infectious-disease tests under development for the BD Max System.
