Product Manual

10
INTERPRETATION OF RESULTS
The BD Veritor Plus Analyzer (provided separately) must be used for interpretation of all test results. Operators should not
attempt to interpret assay results directly from the test strip contained within the BD Veritor assay device.
Display
Interpretation
CoV2: +
Positive Test for SARS-CoV-2 (antigen present)
CoV2: -
Presumptive Negative Test for SARS-CoV-2
(no antigen detected)
CONTROL INVALID
Test Invalid.* Repeat the test.
*Invalid Test – If the test is invalid, the BD Veritor System Instrument will display “CONTROL INVALID” and the test or control
must then be repeated. If the “CONTROL INVALID” reading recurs, contact BD.
REPORTING OF RESULTS
Positive Test – Positive for the presence of SARS-CoV-2 antigen. 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 Test – Negative results are presumptive. Negative test results do not preclude infection and should not be used as
the sole basis for treatment or other patient management decisions, including infection control decisions, particularly in the
presence of clinical signs and symptoms consistent with COVID-19, or in those who have been in contact with the virus. It is
recommended that these results be confirmed by a molecular testing method, if necessary, for patient management.
Control Invalid – Do not report results. Repeat the test.
QUALITY CONTROL
Each BD Veritor System SARS-CoV-2 test device contains both positive and negative internal/procedural controls:
• The internal positive control line validates the immunological integrity of the device, proper reagent function, and
assures correct test procedure.
• The membrane area surrounding test lines functions as a background check on the assay device.
The BD Veritor System Instrument evaluates the positive and negative internal/procedural controls after insertion of each
test device. The BD Veritor Plus Analyzer prompts the operator if a quality issue occurs during assay analysis. Failure of the
internal/procedural controls will generate an invalid test result. NOTE: The internal controls do not assess proper sample
collection technique.
EXTERNAL POSITIVE AND NEGATIVE CONTROLS
Positive and Negative control swabs are supplied with each kit. These controls provide additional quality control material to
assess that the test reagents and the BD Veritor System Instrument perform as expected. Prepare kit control swabs and test
using the same procedure as used for patient specimens.
BD recommends controls be run once for:
• each new kit lot,
• each new operator,
• as required by internal quality control procedures and in accordance with local, state and federal regulations or
accreditation requirements.
If the kit controls do not perform as expected, do not report patient results. Contact BD Technical Services
at 1.800.638.8663.
LIMITATIONS OF THE PROCEDURE
• Clinical performance was evaluated with frozen samples, and test performance may be different with fresh samples.
• Users should test specimens as quickly as possible after specimen collection.
• Positive test results do not rule out co-infections with other pathogens.
• Results from the BD Veritor System for Rapid Detection of SARS-CoV-2 test should be correlated with the clinical
history, epidemiological data, and other data available to the clinician evaluating the patient.
• A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test
or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the
possibility of SARS-CoV-2 infection.
• The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after
day 5 of illness are more likely to be negative compared to a RT-PCR assay.
• Failure to follow the test procedure may adversely affect test performance and/or invalidate the test result.
• The contents of this kit are to be used for the qualitative detection of SARS-CoV-2 antigens from nasal swab
specimens only.