Product Manual

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• The BD Veritor System for Rapid Detection of SARS-Cov-2 can detect both viable and non-viable SARS-CoV-2
material. The BD Veritor System for Rapid Detection of SARS-CoV-2 performance depends on antigen load and
may not correlate with other diagnostic methods performed on the same specimen.
• Negative test results are not intended to rule in other non-SARS-CoV-2 viral or bacterial infections.
• Positive and negative predictive values are highly dependent on prevalence rates. Positive test results are more
likely to represent false positive results during periods of little/no SARS-CoV-2 activity when disease prevalence is
low. False negative test results are more likely when prevalence of disease caused by SARS-CoV-2 is high.
• This device has been evaluated for use with human specimen material only.
• Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone
minor amino acid changes in the target epitope region.
• The performance of this test has not been evaluated for use in patients without signs and symptoms of
respiratory infection and performance may differ in asymptomatic individuals.
• Sensitivity of the test after the first five days of the onset of symptoms has been demonstrated to
decrease as compared to a RT-PCR SARS-CoV-2 assay.
• Negative results should be treated as presumptive and confirmed with an FDA authorized molecular assay, if
necessary, for clinical management, including infection control.
• The BD Veritor System kit was validated with the Copan Standard and Copan Minitip swabs. Use of
alternative swabs may result in false negative results.
• Specimen stability recommendations are based upon stability data from influenza testing and performance may be
different with SARS-CoV-2. Users should test specimens as quickly as possible after specimen collection, and within
one hour after specimen collection.
• The validity of the BD Veritor System for Rapid Detection of SARS-CoV-2 test has not been proven for
identification/confirmation of tissue culture isolates and should not be used in this capacity.
CONDITIONS OF AUTHORIZATION FOR THE LABORATORY
The BD Veritor System for Rapid Detection of SARS-CoV-2 Letter of Authorization, along with the authorized Fact Sheet
for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website:
https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-
emergency-use-authorizations-medical-devices.
However, to assist clinical laboratories using the BD Veritor System for Rapid Detection of SARS-CoV-2 (“your product” in the
conditions below), the relevant Conditions of Authorization are listed below.
• Authorized laboratories* using your product will include with test result reports, all authorized Fact Sheets. Under
exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may
include mass media.
• Authorized laboratories using your product will use your product as outlined in the “BD Veritor System for Rapid
Detection of SARS-CoV-2” Instructions for Use. Deviations from the authorized procedures, including the authorized
instruments, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents
and authorized materials required to use your product are not permitted.
• Authorized laboratories that receive your product will notify the relevant public health authorities of their intent to run
your product prior to initiating testing.
• Authorized laboratories using your product will have a process in place for reporting test results to healthcare
providers and relevant public health authorities, as appropriate.
• Authorized laboratories will collect information on the performance of your product and report to DMD/OHT7-OIR/
OPEQ/CDRH (via email: [e-mail]) and to BD by contacting BD Customer Support
Services at 800.638.8663 (in the U.S.) any suspected occurrence of false positive or false negative results and
significant deviations from the established performance characteristics of your product of which they become aware.
• All operators using your product must be appropriately trained in performing and interpreting the results of your
product, use appropriate personal protective equipment when handling this kit, and use your product in accordance
with the authorized labeling.
• Becton, Dickinson and Co., authorized distributors, and authorized laboratories and patient care settings using your
product will ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such
records will be made available to FDA for inspection upon request.
*The letter of authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement Amendments of
1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate, 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.” as “authorized laboratories”.