Fast Strep Test for Pregnant Women

According to the US Centers for Disease Control and Prevention (CDC, Atlanta, GA, USA), an estimated 19,000 cases of GBS infection occur annually in the United States alone. Almost half occur in newborns, resulting in illness and sometimes death. Surviving infants may have long-term disabilities such as mental retardation or hearing or vision loss.

Called IDI-Strep B, the assay was developed by Infectio Diagnostic, Inc. (IDI, Sainte-Foy, Canada) and is run on the SmartCycler instrument of Cepheid (Sunnyvale, CA, USA), which is marketing the test. The SmartCycler can provide test results within one hour, in contrast to the standard culture method, which requires 18-48 hours for results. Cepheid states that the IDI-Strep B assay, with 85% sensitivity, is the first non-culture test that meets or exceeds the performance criteria recommended by CDC guidelines. It can be administered prior to delivery or at the time of labor or delivery.

Cepheid develops, manufactures, and markets integrated systems that offer genetic assessment when and where it is needed. The company is commercializing products requiring assessment of the human genome, infectious disease, and bioterrorism agents.