IVD Hall of Fame: Prenatal Group B Strep Tests

Thursday, May 16, 2013

Part 9 of IVD Hall of Fame

View part: [ 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 ]

Previously:
« Myocardial Infarction Panels

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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.

 

Tags: IVD

Part 9 of IVD Hall of Fame

View part: [ 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 ]

Previously:
« Myocardial Infarction Panels

Next:
TDM Assays »


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