BD Veritor™ System for Rapid Detection of SARS-CoV-2

Description

• 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
• 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
• Easy Sample Preparation Workflow Gather test materials and label test device with specimen ID Remove cap from extraction reagent tube Insert patient sample swab and vigorously plunge the swab up and down for 15 seconds Remove swab while squeezing tube to extract liquid
• Properly dispose of swab Press dispensing tip on the tube firmly
• Mix the sample by flicking or swirling the bottom of the tube Kit Includes: BD Veritor™ System Test Devices (30 single use test devices) Extraction Reagent (30 single use reaction tubes, each with 325 μL extraction reagent and having an integral dispensing tip) Specimen sampling swabs (30 sterile, single use specimen sampling swabs) SARS-CoV-2 (+) Control Swab (1 each – individually wrapped for single use) SARS-CoV-2 (-) Control Swab (1 each – individually wrapped for single use) Assay documentation: (1) Instructions for use, (1) Quick reference instruction card and (1) Nasal sampling instructions Materials Required but not provided: BD Veritor™ Plus Analyzer (Cat
• No
• 256066) Timer Tube rack for specimens Any necessary personal protective equipment Optional Equipment: BD Veritor™ InfoScan Module (Cat
• No
• 256068) USB Printer cable for BD Veritor™ Plus Analyzer (Cat
• No
• 443907) Epson Printer model TM-T20 II BD Veritor™ Plus Connect (contact BD Technical Services for details)