- 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
- 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
- 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%
- 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
Product Specifications
| Manufacturer # | 195000 |
| Brand | BinaxNOW„¢ Professional Use |
| Manufacturer | Abbott Rapid Dx North America LLC |
| Country of Origin | United States |
| Application | Rapid Test Kit |
| Number of Tests | 40 Tests |
| Reading Type | Visual Read |
| Sample Type | Nasal Swab Sample |
| Test Format | Card Format |
| Test Method | Lateral Flow Immunoassay |
| Test Name | COVID-19 Ag |
| Test Type | Antigen Detection |
| Time to Results | 15 Minute Results |
| UNSPSC Code | 41116144 |
