Abbott Rapid Dx North America LLC Respiratory Test Kit ID NOW™ Molecular Diagnostic COVID-19 2.0 Nasal Swab / Nasopharyngeal Swab Sample 24 Tests - KT/1 - 192000-KT

TEST KIT, COVID-19 ID NOW 2.0 ASSAY

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 30 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