Molecular Reagent Starter Pack Biofire® Spotfire® Respiratory Panel Mini CLIA Waived For BioFire SpotFire System 30 Tests

Features

• Starter Kit, Spotfire Respiratory Panel Mini (1 Kit reagents, 1 set of pos and neg controls)
• Included controls intended for use as an external assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens on the BIOFIRE® SPOTFIRE Respiratory (R) Panel and BIOFIRE SPOTFIRE Respiratory (R) Panel Mini assays performed on the BIOFIRE SPOTFIRE System
• SPOTFIRE® Respiratory (R) Panel Mini is designed to run on the BIOFIRE® SPOTFIRE® System and provides PCR-based results for 5 common viral respiratory targets in ~15 minutes
• BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE R Panel Mini) is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® SPOTFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19
• The following organism types are identified and differentiated using the SPOTFIRE R Panel Mini: Coronavirus SARS-CoV-2, Human rhinovirus, Influenza A virus, Influenza B virus, Respiratory syncytial virus
• Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, or lower respiratory tract infection that may not be detected by an NPS specimen
• Positive results do not rule out coinfection with other organisms
• Sample Type: Nasopharyngeal swab in 1-3 mL of viral transport media
• Hands-on time: 1-2 minutes
• Each kit contains sufficient reagents to test (30) samples: Individually packaged SPOTFIRE R Panel Mini Pouches, Single-use Sample Buffer Ampule, Single-use pre-filled Hydration Injection Vial (blue), Single-use Sample Injection Vial (red), Fixed-volume transfer pipette