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

Features

• The ID NOW™ COVID-19 assay is now available for use on the ID NOW platform under U.S. Food and Drug Administration Emergency Use Authorization (EUA): https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• Product ships with minimum 30 days dating
• ID NOW™ COVID-19 assay performed on the ID NOW™ Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology intended for the qualitative detection of nucleic acid from the SARS-CoV-2 viral RNA in direct nasal, nasopharyngeal or throat swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms
• Testing is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity/high complexity tests; The ID NOW™ COVID-19 assay is also 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 positive 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 tested with different authorized or cleared molecular 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 should be considered in the context of a patient’s recent exposures history and the presence of clinical signs and symptoms consistent with COVID-19
• The ID NOW™ COVID-19 test is intended for use by medical professionals or trained operators who are proficient in performing tests using the ID NOW™ Instrument
• Dimensions - 8.15 Inch W x 5.71 Inch H x 7.64 Inch D (207 mm W x 145 mm H x 194 mm D)
• Molecular technology targeting COVID-19 RdRp gene
• Small footprint enables ease of use at point of care
• Simple operation via visual touchscreen
• Positive result in as little as 5 minutes, negative results in 13 minutes
• Materials required but not provided: ID NOW Instrument

More Information

• ID NOW COVID-19 FDA EUA Letter Sept 2020
• ID NOW COVID-19 CLSI Packet
• ID NOW COVID-19 Product Insert
• ID NOW COVID-19 Quick Reference Instructions
• ID NOW COVID-19 Healthcare Providers Fact Sheet
• ID NOW COVID-19 Patient Fact Sheet
• ID NOW COVID-19 Sept 2020 Technical Brief - Labeling Update
• SARS-CoV-2 Genomic Variants Technical Brief 5.28.21
• SDS