BinaxNOW COVID-19 Ag Card, ABBOTT, OTC, At Home Use, 2 test per kt, 6 kits per cs
- BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration's Emergency Use Authorization
- 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
- 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
- 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
Manufacturer #: | 195000 |
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Brand BinaxNOW$trade; | Professional Use |
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Manufacturer: | Abbott Rapid Dx North America LLC |
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Country of Origin: | Unknown |
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Application: | Rapid Test Kit |
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Contents: | (40) Test Cards, 7.5 mL Extraction Reagent, (40) Sterile Nasal Swabs, Positive Control Swab, Negative Control Swab, Product Insert, Procedure Card |
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Number of Tests: | 40 Tests |
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Product Dating: | McKesson Acceptable Dating: we will ship >= 30 days |
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Reading Type: | Visual Read |
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Sample Type: | Nasal Swab Sample |
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Test Format: | Card Format |
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Test Method: | Lateral Flow Immunoassay |
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Test Name: | COVID-19 Ag |
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Test Type: | Antigen Detection |
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Time to Results: | 15 Minute Results |
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UNSPSC Code: | 41116144 |
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