BD Diagnostics, a segment of BD (Becton, Dickinson and Company), has received Moderate Complexity status from FDA, under the Clinical Laboratory Improvement Amendments (CLIA), for the BD MAX GBS Assay for Group B Streptococcus (GBS) on the BD MAXSystem.
BD Diagnostics said that with the Moderate Complexity categorisation, the BD MAX GBS Assay will increase access to cost effective molecular testing for a broad range of laboratories performing GBS screening.
The US Centers for Disease Control and Prevention (CDC), in collaboration with the American Congress of Obstetricians and Gynecologists (ACOG) and other organisations, is updating guidelines for the prevention of neonatal GBS disease.
BD Diagnostics claimed that 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 current standard of care for preventing neonatal GBS disease is screening pregnant women at 35 to 37 weeks of gestation using culture methods, which are limited by sensitivity, turnaround time and the need for highly trained technologists to interpret the results.
Philippe Jacon, president of diagnostic systems at BD Diagnostics, said: “A shortage of highly skilled lab workers continues to challenge laboratories striving to deliver more advanced molecular testing in a cost-effective manner. We designed the BD MAX GBS Assay with those laboratories in mind providing them with a simplified, cost-effective molecular testing platform.”