(CercleFinance.com) – BioMérieux announces that it has obtained 510(k) approval and CLIA (Clinical Laboratory Improvement Amendments) waiver from the US Food and Drug Administration (FDA) for its range of rapid and innovative Biofire Spotfire Respiratory/Sore tests Throat (R/ST).
BioMérieux indicates that its solution is a unique multiplex PCR test capable of detecting and identifying, in approximately 15 minutes, the nucleic acids of 15 of the bacteria, viruses and viral subtypes most commonly responsible for respiratory or pharyngeal infections.
Samples can be obtained by nasopharyngeal or oropharyngeal swab.
This test allows clinicians to screen for several pathogens whose signs and symptoms are identical for patients, which ultimately allows informed decisions to be made during the outpatient consultation. These results make it possible to advance the proper use of antibiotics and modernize patient care,” underlined Doctor Charles K. Cooper, Executive Director, Medical Affairs, bioMérieux.
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