Molecular Reagent QIAstat-Dx® SARS-CoV-2 Panel For QIAstat-Dx Instrument 6 Tests

Features

• QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid test intended for use with QIAstat-Dx system for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids
• For in vitro diagnostic use under Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• Intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures
• Multiplex syndromic cartridge detects and differentiates 21 respiratory targets, including SARS-CoV-2 from nasopharyngeal swabs (NPS) eluted in universal transport media (Enterovirus and Rhinovirus are both detected, but not differentiated)
• Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity and moderate complexity tests
• Please review the documents under the More Information tab prior to purchasing
• Link to FDA site: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• All reagents required for the complete execution of a test run are pre-loaded and self-contained in the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge
• Kit includes: (6) Individually packaged cartridges containing all reagents needed for sample preparation and multiplex real-time RTPCR, plus Internal Control, and (6) individually packaged transfer pipettes for dispensing liquid sample into the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge
• Intuitive workflow with less than one-minute hands-on time
• All wet and dry reagents onboard and room temperature stable
• Comprehensive qualitative results available in about an hour

More Information

• QIAstat-Dx FDA EUA Letter
• QIAstat-Dx Guide
• QIAstat-Dx Health Care Providers Fact Sheet
• QIAstat-Dx SARS-CoV-2 Patient Fact Sheet