Respiratory Test Kit LumiraDx™ SARS-CoV-2 Ag 48 Tests CLIA Waived

Features

• The LumiraDx SARS-CoV-2 Ag Test is for use under an Emergency Use Authorization ONLY: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations 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 moderate
• high or waived complexity tests Product ships with minimum 60 days dating This test 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 Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in nasal swab specimens during the acute phase of infection Positive results indicate the presence of viral antigens
• but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses Negative results
• from patients with symptoms onset beyond twelve days
• should be treated as presumptive and confirmation with a molecular assay
• if necessary
• for patient management
• may be performed Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions
• including infection control decisions Negative results should be considered in the context of a patient’s recent exposures
• history and presence of clinical signs and symptoms consistent with COVID-19 The LumiraDx SARS-CoV-2 Ag Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings
• and proficient in performing tests using the LumiraDx Instrument This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food
• Drug and Cosmetic Act
• 21 U.S.C. § 360bbb-3(b)(1)
• unless the authorization is terminated or revoked sooner The workflow process is comprised of a simple sample prep along with step-by-step guidance of the Instrument to report a patient result in under 12 minutes from sample application The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2