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IDI group B Streptococcus assay

FDA approved for group B streptococcus screening of pregnant women Indications: - genital/rectal group B streptococcus colonization Specimen: vaginal or rectal swab Method: - detects DNA of group B streptococcus using specialized instrument - sensitivity: > 85% - turnaround time: 1 hour

General

special chemistry test

References

  1. Action Report, Medical Board of California, 85:7 (April) 2003
  2. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01172.html
  3. http://www.fda.gov/cdrh/mda/docs/k022504.html