Rapid test for the qualitative detection of Streptococcus B antigen from a swab specimen taken from the vagina, rectum or neonate of a pregnant woman.
For in vitro diagnostic use by a qualified person only.
RECOMMENDED USE
The Strep B Rapid Test Strip (Swab) is a rapid, visual, immunochromatographic test for the qualitative detection of Group B Streptococcus (GBS) antigen in a swab specimen from a pregnant female vagina, rectum or neonatal swab. This test can be used for the diagnosis of Strep B infection.
SUMMARY
Group B Streptococci (GBS) or Streptococcus agalactiae are the most common cause of life-threatening infections in newborns. GBS colonize 5-30% of pregnant women. Several recent studies have shown that intrapartum treatment of women colonized with GBS significantly reduces the incidence of GBS-associated sepsis. The US Center for Disease Control (CDC) recommends routine testing for group B streptococcus between 35 and 37 weeks of pregnancy. A CDC study has shown that routine testing for pregnant women with clinical risk factors is 50% more effective than the use of antibiotics to screen for the risk factor.
Standard culture methods require 24-48 hours and results may not be available quickly enough for effective treatment. Therefore, the use of a rapid test is needed to meet this need.
