CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
The NeuMoDx GBS Assay is a qualitative in vitro diagnostic test designed to detect group B Streptococcus DNA from antepartum pregnant women. The assay incorporates sample lysis and automated DNA extraction to isolate nucleic acid from the specimen and real-time polymerase chain reaction to detect an 88 bp region of the pcsB gene sequence in the Streptococcus agalactiae chromosome. In a multicenter clinical performance study, the NeuMoDx GBS Assay results yielded a sensitivity of 96.9 percent and specificity of 96 percent, when compared with the gold standard culture method.
NeuMoDx, 734-477-0111
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