BD Diagnostics (Franklin Lakes, New Jersey), a segment of Becton, Dickinson and Company, reported that it has received FDA 510(k) clearance and a CLIA waiver for its BD Veritor System for rapid detection of Group A Strep. According to the company, this is the first commercially available rapid Group A Strep test system that incorporates a digital result to receive a CLIA waiver.
The new assay is cleared for use in hospitals, outpatient clinics and other patient-care settings. Group A Strep is the most common bacterial cause of pharyngitis, the company noted. BD added that more accurately determining the etiology of pharyngitis can help providers make more appropriate antibiotic treatment decisions.
Drew Hoffman, senior product and marketing manager at BD Diagnostics – Diagnostic Systems, Point of Care platform, told Medical Device Daily that what sets the assay apart from others on the market for this indication is the value of an objective read, which "confers great reliability and reduces the variability among users to interpret correctly the results."
Hoffman said there was a study done in 2006 at Dayton Children's Hospital in Ohio that identified differences between a lab-based operator used to interpreting many different types of tests and an outpatient operator. "That study really puts into perspective the differences that may occur when you rely on a non-instrumented read," he said.
The BD Veritor System for rapid detection of Group A Strep joins the previously FDA-cleared BD Veritor System for rapid detection of flu A+B and the BD Veritor System for rapid detection of respiratory syncytial virus (RSV). These assays work in conjunction with the BD Veritor System Reader, the company noted. BD said it plans to continue to launch additional assays on this new platform.
Hoffman noted that with the BD Veritor System Reader, operators are able to run one sample and get all three results, "which is really important when you're thinking about a two-year-old child that may not be prepared for the first swab but you don't want to go in a second time."
"The other thing that's just really wonderful about this product is that the instrument we ship to the end user, they open up the box, they turn it on, and it works," Hoffman said, explaining that there is no additional set up or calibration necessary on the customer's part. "It's all factory calibrated . . . it's a very, very easy instrument to start to deploy."
When used in conjunction with the BD Veritor System Reader, the Group A Strep test utilizes advanced nano-particle and Adaptive Read technologies to obtain an accurate result while providing objective results on a hand held reader with an easy-to-read digital display. This digital immunoassay (DIA) for rapid detection of Group A Strep offers healthcare professionals a new option for Group A Strep testing versus current visual read CLIA-waived assays.
Hoffman said BD already has 10,000 BD Veritor System Readers in the market place, which he added is a considerable number for the diagnostics industry.
"The BD Veritor System for Rapid Detection of Group A Strep has demonstrated proven performance as compared to bacterial culture methods, while delivering an objective test result in about eight minutes from specimen processing to results," said Alberto Mas, president, BD Diagnostics – Diagnostic Systems. "Rapid detection enables clinicians to initiate treatment immediately in cases of Group A Strep."
Hoffman also told MDD that the company worked with a nine-hospital system customer in Tennessee to do a "quick trial run" and the person in charge of the central lab ran the assay side-by-side with the lab's current system and found that BD's test was more sensitive. //