BD Diagnostics has received 510(k) clearance from the US Food and Drug Administration to market its BD Max GBS Assay for Group B Streptococcus on the PCR-based BD Max System.
The current standard of care for prevention of prenatal GBS disease is by screening pregnant women at 35 to 37 weeks by using cultures. Such methods, however, have limited sensitivity, long turnaround time, and depend on highly trained staff to interpret the results, BD said in a statement.
The new assay on the BD Max system can identify GBS in about one hour in Lim broth, and because it automates sample lysis through PCR, the system can analyze up to 24 samples in about two and a half hours, the company said.
"As new [Centers for Disease Control and Prevention] guidelines emerge to include molecular testing as an alternative to culture for detecting GBS, the BD Max GBS assay could serve as an efficient, sensitive, and specific option for laboratories desiring to utilize a molecular method," said Steve Young, scientific director for microbiology and virology at TriCore Reference Laboratories, in a statement.