Part 9 of IVD Hall of Fame
« Myocardial Infarction Panels
TDM Assays »
Prior to the introduction of group B Streptococcous bacteria tests, there were higher rates of early onset group B Strep in infants. The infant mortality rate was 55% for newborns with invasive group B Strep disease. Infection was largely due to transmission from mother to newborn at birth. Group B Strep infection can be a very serious disease, as the bacteria may cause sepsis, pneumonia, meningitis and even death.
The introduction of group B Strep tests made it possible to identify pregnant women who carry group B Strep. Group B Strep prenatal tests are used to screen pregnant women between the 35 to 37 weeks for the bacteria. Women who test group B positive are administered antibiotics during labor to help prevent early-onset group B Strep disease, thereby greatly reducing the risk of transmission to the infant during labor.
Prenatal group B Strep culture-based screening tests are Class I 510(k) exempt devices. In more recent years, Nucleic Acid Amplification Assays for group B Strep have also received 510(k) clearance. These tests are more rapid than the traditional culture tests, further improving the health and well-being of our youngest patients.