Product Manual

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Veritor™ System
For Rapid Detection of SARS-CoV-2
For In Vitro Diagnostic Use
For use with the BD Veritor™ Plus Analyzer running firmware version 5.4 or later
For use under an Emergency Use Authorization only
Please read these instructions completely before beginning testing of specimens.
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. 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.
SUMMARY AND EXPLANATION OF THE TEST
A novel coronavirus (2019-nCoV) was identified in December 2019, which has resulted in hundreds of thousands of
confirmed human infections worldwide. Cases of severe illness and deaths have been reported. On February 11, 2020 the
International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2.
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The median incubation time is estimated to be approximately 5 days with symptoms estimated to be present within 12 days
of infection.
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The symptoms of COVID-19 are similar to other viral respiratory diseases and include fever, cough, shortness
of breath.
The BD Veritor System for Rapid Detection of SARS-CoV-2 is a rapid (approximately 15 minutes) chromatographic digital
immunoassay for the direct detection of the presence or absence SARS-CoV-2 antigens in respiratory specimens taken from
patients with signs and symptoms who are suspected of COVD-19. The test is intended for interpretation in both laboratory
and near patient testing environments only with the BD Veritor Plus Analyzer Instrument. The test is not intended to be
interpreted visually. Procedures to evaluate test devices depend on the BD Veritor Plus Analyzer workflow configuration
chosen. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk
Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and
analysis is automated. Additionally, connection of a BD Veritor Plus Analyzer to a printer or IT system is possible if desired.
Additional result documentation capabilities are possible with the integration of a BD Veritor InfoScan (“InfoScan”) module.
Please refer to the BD Veritor Plus Analyzer Instructions for Use for details on how to implement these features.
PRINCIPLES OF THE PROCEDURE
The BD Veritor System consists of a dedicated opto-electronic interpretation instrument and immunochromatographic assays
for the qualitative detection of antigens from pathogenic organisms in samples processed from respiratory specimens. The
BD Veritor System for Rapid Detection of SARS-CoV-2 is designed to detect the presence or absence of SARS-CoV-2
nucleocapsid proteins in respiratory samples from patients with signs and symptoms of infection who are suspected of
COVID-19. When specimens are processed and added to the test device, SARS-CoV-2 antigens present in the specimen
bind to antibodies conjugated to detector particles in the test strip. The antigen-conjugate complexes migrate across the test
strip to the reaction area and are captured by a line of antibodies bound on the membrane. A positive result is determined
by the BD Veritor Plus Analyzer when antigen-conjugate is deposited at the Test “T” position and the Control “C” position on
the assay device. The instrument analyzes and corrects for non-specific binding and detects positives not recognized by the
unaided eye to provide an objective result.