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|Quidel Receives FDA Clearance for Its New Solana® Molecular Assay for the Detection of Group B Streptococcal Infections|
GBS is responsible for illness in people of all ages, but it is a
particularly serious pathogen for newborns in whom the infection can
cause life-threatening sepsis, pneumonia and sometimes meningitis with a
risk for long lasting effects, including deafness and developmental
disabilities.1 According to the
Although more rare, serious GBS infections can also occur in adults, leading to bloodstream infections, pneumonia, and other infections that can be fatal.3
The Solana GBS Assay is an easy-to-use, molecular diagnostic test that generates an accurate result from either LIM or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation.
“We are pleased to receive 510(k) clearance for our Solana GBS assay, a
test that can potentially be life-saving or life-changing for those that
are most vulnerable: newborns,” said
The commercial introduction of
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