Abbott Rapid Dx North America LLC Respiratory Test Kit BinaxNOW™ Professional Use Antigen Detection COVID-19 Ag Nasal Swab Sample 40 Tests - KT/1 - 195000-KT

TEST KIT, COVID-19 AG BINAX NOW PROFESSIONAL USE

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
• Product ships from McKesson with minimum 30 days dating
• 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
• This test is authorized for use with direct anterior nasal (nares) swab samples from individuals with symptoms of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests; this test is also authorized for use with direct anterior nasal (nares) swab samples from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests
• 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
• The BinaxNOW COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests
• Sensitivity (PPA) 84.6% (entire population)
• Sensitivity (PPA) 95.6% (those with PCR cycle threshold [Ct] < 33)
• Specificity (NPA) 98.5%
• Supplemental data indicates that antigen tests have demonstrated positive percent agreement as high as 100% for symptomatic patients (3 serial tests, 2 days after first PCR positive) and as high as 88.9% for asymptomatic patients (3 serial tests, 6 days after first PCR positive)
• Onboard extraction allows the swab to be directly inserted into the test card
• Visually read results in 15 minutes - no instrument required
• The BinaxNOW COVID-19 Ag Card does not differentiate between SARSCoV and SARS-CoV-2