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BD Veritor

$809.70

The BD Veritor™ Plus System Rapid (30 count), reliable SARS-CoV-2 testing at the point of care.

Simplify SARS-CoV-2 testing with the portable, easy-to-use BD Veritor™ Plus System provides reliable SARS-CoV-2 results read at 15 minutes.

The system has an unique adaptive read technology – helps reduce false-positive results by examining the sample and compensating for many of the effects of non-specific binding to help deliver a more accurate read. Eliminates the need for visual-read and subjective interpretation by providing objective results on an easy-to-read digital display. Delivers results read at 15 minutes.

*This test is only approved in a Point-of-Care setting

*CLIA Certificate of Waiver number required at purchase

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The BD Veritor™ Plus System Rapid (30 count), reliable SARS-CoV-2 testing at the point of care.

Simplify SARS-CoV-2 testing with the portable, easy-to-use BD Veritor™ Plus System provides reliable SARS-CoV-2 results read at 15 minutes.

The system has an unique adaptive read technology – helps reduce false-positive results by examining the sample and compensating for many of the effects of non-specific binding to help deliver a more accurate read. Eliminates the need for visual-read and subjective interpretation by providing objective results on an easy-to-read digital display. Delivers results in minutes.

INTENDED USE

The BD Veritor™ System for Rapid Detection of SARS-CoV-2 is a chromatographic digital immunoassay intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. In the USA, 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.

Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples 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. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results should be treated as presumptive, 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 the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.

The BD Veritor System for Rapid Detection of SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings. In the United States, the BD Veritor System for Rapid Detection of SARS-CoV-2 is only for use under the Food and Drug Administration’s Emergency Use Authorization.

*This test is only approved in a Point-of-Care setting