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BD Veritor™ Plus System for rapid COVID-19 (SARS-CoV-2) testing
The portable, easy-to-use BD Veritor™ Plus System provides reliable COVID-19 (SARS-CoV-2) results in 15 minutes
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The BD Veritor™ System for Rapid Detection of SARS-CoV-2 is a chromatographic immunoassay for the direct and qualitative detection of SARS-CoV-2 antigens in nasal swabs from patients with signs and symptoms who are suspected of COVID-19.
Achieve fast test results
Displays easy-to-read digital results for SARS-CoV-2 in 15 minutes.
Simplify the testing process
Easy operation and 1-button functionality may help reduce the potential for procedural errors.
Provide workflow efficiency
Adapts easily to your workflow with 2 operational modes: Walk Away and Analyze Now.
Easy to use. Flexible workflow. Fast, traceable results.
Meet patient and staff needs with simple, timely point-of-care testing.
Simplify the testing process
- Easy operation and 1-button functionality may help reduce manual test processing errors
- Simple sample processing with color-coded tubes
Achieve fast, reliable results
- Displays easy-to-read digital results for COVID-19 in 15 minutes: “CoV2: +” for positive, “CoV2: -” for negative
- Records results on secured internal drive
- Advanced particle technology helps improve test performance*
Provide workflow efficiency
- Adapts easily to your workflow by offering 2 operational modes
- Walk away: Test device is inserted immediately into Analyzer, so staff can multi-task while sample incubates (15 minutes)
- Analyze now: Test device is inserted after incubation time is complete, allowing batches of samples to be tested (results in seconds)
Provide result traceability
- Download and display Lot number, patient/specimen ID, Operator ID and test records with BD Veritor™ InfoScan module
- Offers result-printing capabilities via USB port
*in comparison to visually read tests
Easy sample preparation workflow
These are the steps for sample preparation, including the process for each workflow mode of the BD Veritor™ Plus System.
Step 1
Collect patient sample
Step 2
Remove cap & insert swab into tube
Step 3
Mix sample with reagent, then remove swab
Step 4
Close dispensing cap, then dispense sample into test device
Step 5
Insert test device into the analyzer
For Walk Away mode, insert immediately
For Analyze Now mode, insert after processing sample
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Step 1
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Step 2
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Step 3
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Step 4
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Step 5
Interpreting test results
It is important to understand how local disease prevalence rate and test performance characteristics interact to influence the proportion of false positive test results compared to all positive results. The infographic below demonstrates how very low, low, medium and high prevalence rates make a difference. It is important to note that your institution’s specific prevalence rates can be used to calculate the potential in your facility. Understanding that false positive test results are a possibility is important. Please, follow your institution or state and local guidance for both addressing a patient with a positive test result. Guidance may include precautionary isolation procedures and a second mode of testing for confirmation.
Hypothetical false positive rates based on prevalence
Why false positives might occur
Even the most highly-accurate tests can produce false positive results. False positives are expected for all diagnostic tests, involving all detection technologies: PCR, antigen assays, etc. In the case of antigen tests (such as BD Veritor™ Plus System), test results could be influenced by a number of factors:
- Workflow inconsistencies
- Quality of test sample
- Not following instructions for use
BD Veritor™ Plus System has a 98%-100% specificity, which means the false positive rate is less than 2% of all the tests performed. This means, when you use your BD Veritor™ Plus System you might see 0-2 false positives for every 100 tests you conduct. If a customer sees rates of false positives higher than 2% of all the tests performed, this would be outside of the performance we would expect. Any false positive should be reported to BD for further investigation.
Key terms to understand with COVID-19 testing
Understanding the specifics of test performance can be complex. Below is the list of test performance terminology which may help you to better understand. For additional information, review the fact sheet for healthcare providers.
- Pretest Probability: Probability of a patient having an infection before the test result is known; based on the proportion of people in a community with the disease at a given time (prevalence) and the clinical presentation of the patient.
- Negative Predictive Value: Probability that a patient who has a negative test result truly does not have the infection.
- Positive Predictive Value: Probability that a patient who has a positive test result truly does have the infection.
- False Positive Result: A test result indicating the infection is present when it is not.
- True Negative Result: A test result correctly indicating that the infection is not present.
- False Negative Result: A test result indicating the infection is not present when it is.
- True Positive Result: A test result correctly indicating that the infection is present.
Learn more about prevalence rates and testing outcomes: https://www.cdc.gov/coronavirus/2019-ncov/downloads/lab/fda-calculator.pdf
Learn more about interim guidance for rapid antigen testing for SARS-CoV-2: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html#
Point of care (POC) testing
- Rapid diagnostic testing plays a key role in clinical and hospital lab settings because it enables the lab to provide a test result to the clinician in a timely manner
- POC testing means that testing is performed at or near the site of patient care
- Laboratories using tests being marketed under the FDA's EUA policy should be mindful of CLIA requirements which are enforced by CMS and certain State authorities, and CMS guidance for laboratories during the COVID-19 public health emergency
- Appropriate use settings will vary depending on local licensing status but may include temporary sites set up by hospitals
Product Brochure (1)
Simplify SARS-CoV-2 testing with BD Veritor™ Plus - Brochure
Downloads (5)
BD Veritor™ Plus SARS-CoV-2 Assay instructions for use (IFU)
BD Veritor™ Plus SARS-CoV-2 Assay fact sheet for health care providers
BD Veritor™ Plus SARS-CoV-2 Assay fact sheet for patients
Department of Health and Human Services COVID-19 response data reporting guidelines
Simplify COVID-19 testing infographic
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FDA Disclaimers:
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and,
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.