BD Veritor™ System for Rapid Detection

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.

Advantages

Displays easy-to-read digital results for SARS-CoV-2 in 15 minutes.
Easy operation and 1-button functionality may help reduce the potential for procedural errors.
Adapts easily to your workflow with 2 operational modes.

Other details

Positive Predictive Value: 100%; Overall Accuracy: 92-98%.
Cannot detect virus until 3rd-4th day of infection

Availability

Depending on volumes, typically available within a week of an approved order being accepted.

More information

For more information, e.g. product info sheets, safety data sheets, pricing and more contact us.

Simplify the testing process

Easy operation and 1-button functionality may help reduce manual test processing errors
Simple sample processing with colour-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™ System.

Collect patient sample
Remove cap & insert swab into tube
Mix sample with reagent, then remove swab
Close dispensing cap, then dispense sample into test device
Insert test device into the analyzer:
• For Walk Away mode, insert immediately
• For Analyze Now mode, insert after processing sample

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

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.