BD: Analyzer reader

Q: What are the brand names of your reader-based technologies for influenza?

The BD VeritorTM System and the BD Veritor Plus System are the only digitally read Flu A+B test whose results compare to Polymerase Chain Reaction (PCR), the gold standard in flu testing performance. The BD Veritor Plus System has an easy-to-read digital display that eliminates the subjective interpretation of visually read tests. The BD Veritor Plus System detects antigen levels below the visible limit.

 

Q: How long have they been on the market?

In recognizing the need to improve diagnostics, BD developed and launched the BD Veritor System for Rapid Detection of Flu A+B. This was the first Clinical Laboratory Improvement Amendments (CLIA)-waived flu test that provides objective results on an easy-to-read digital display. The now Class II BD Veritor System Flu A+B test became available in 2011. In 2016, BD launched the BD Veritor Plus System, which offers upgraded functionality from the BD Veritor System, and also meets the FDA reclassification requirements.

 

Q: CLIA certificates?

BD Veritor Plus System offers three CLIA-waived tests: Flu A+B, RSV, and Strep A. It also offers moderately complex tests for Flu A+B and RSV.

Q: Selling points

BD Veritor Plus System’s accuracy and fast time to results – 10 minutes for Flu A+B, and 5 minutes for Strep – make it ideal for testing at point of care. Pediatricians, General Practice Physicians, Family Medicine Physicians and Internists can now rely on the BD Veritor’s accuracy to properly diagnose flu patients at Point of Care.

• The BD Veritor Plus System Analyzer is a handheld device that uses optical technology to detect antigen levels below the visible limit. It is the only digitally read test that compares to PCR.

 

• The BD Veritor has an easy workflow with minimal hands-on time. Average hands-on time is 39 seconds.

 

• The BD Veritor Plus System has a low overall cost of ownership. BD offers a program for new and established customers, who can purchase two flu kits and receive the BD Veritor Analyzer at no additional cost. This program is offered year round.

 

• For the most part, flu tests have become standard practice. While BD does not provide coding or reimbursement guidance or recommendations regarding its products, the CPT codes which may be applicable to billing for influenza, RSV or Group A immunoassay diagnostics test, such as the BD Veritor Plus System include:

 

CPT code                                                                                     Description                                                                        Modifiers

87804	Infectious agent antigen detection by immunoassay with direct obstacle observation; influenza	-QW -59
87807	Infectious agent antigen detection by immunoassay with direct obstacle observation; RSV	-QW
87880	Infectious agent antigen detection by immunoassay with direct obstacle observation; Group A Strep	-QW