Abbott Rapid Dx North America LLC Antigen Test Control Swab BinaxNOW™ COVID-19 Ag Positive Level 10 Swabs - KT/1 - 195080-KT

CONTROL, COVID-19 AG BINAX NOW10 POS SWAB

Features

• BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration’s Emergency Use Authorization: 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; 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
• The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from anterior nasal (nares) swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within seven days of the onset of symptoms
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• 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 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