Respiratory Test Kit ID NOW™ COVID-19 2.0 24 Tests CLIA Waived

Features

• ID NOW COVID-19 2.0 Assay is for use under an Emergency use Authorization Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2 To utilize the ID NOW COVID-19 2.0 assay
• a software upgrade to version 7.0.0.20 is required for all instruments; the software upgrade is backward compatible to support use of ID NOW COVID-19
• Influenza A & B 2
• Strep A 2
• and RSV inventory Product ships with minimum 60 days dating ID NOW COVID-19 2.0 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• 42 U.S.C. §263a
• that meet the requirements to perform high
• moderate or waived complexity tests The ID NOW COVID-19 2.0 assay is authorized for use at the Point of Care (POC)
• i.e.
• in patient care settings operating under a CLIA Certificate of Waiver
• Certificate of Compliance
• or Certificate of Accreditation Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status Positive results do not rule out bacterial infection or co-infection with other viruses Testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities Negative results should be treated as presumptive and
• if inconsistent with clinical signs and symptoms or necessary for patient management
• should be confirmed with a different authorized or cleared molecular test in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations
• patient history
• and/or epidemiological information Materials required but not provided: ID NOW Instrument
• Nasopharyngeal Swabs To utilize the ID NOW COVID-19 2.0 assay
• a software upgrade to version 7.0.0.20 is required for all instruments; the software upgrade is backward compatible to support use of ID NOW COVID-19
• Influenza A & B 2
• Strep A 2
• and RSV inventory ID NOW COVID-19 2.0 is intended for use by trained operators who are proficient in performing tests using the ID NOW Instrument Positive results as early as 6 minutes
• negative results in 12 minutes