Molecular Reagent Respiratory / Sore Throat Panel CLIA Waived For BioFire SpotFire System 30 Tests

Features

• The SPOTFIRE R/ST Panel is a rapid multiplex PCR test offering two uses based on patient signs and symptoms: either a respiratory test with a nasopharyngeal swab or a sore throat test with a throat swab
• The SPOTFIRE R/ST Panel, designed for use with the SPOTFIRE System, is a polymerase chain reaction (PCR) based sample-to-answer diagnostic test that simultaneously identifies nucleic acids from 15 different bacterial and viral organisms from nasopharyngeal swab (NPS) specimens, or 15 different bacterial and viral organisms from throat swab (TS) specimens, in transport media collected from individuals with signs and symptoms of respiratory infection or pharyngitis, respectively
• Overall Respiratory Performance (NPS specimens): PPA: 98.5% NPA: 99.1%
• Overall Sore Throat Performance (TS specimens): PPA: 95.9% NPA: 99.0%
• Each kit contains sufficient reagents to test 30 samples