Bayer Healthcare Diagnostics Division (Tarrytown, New York) has received approval from the FDA for its automated hepatitis B surface antigen (HBsAg) and HBsAg confirmatory assays, which will allow the company to offer more tests on its Advia Centaur Immunoassay System, introduced in 1998.
With the approval, Bayer said, it will offer the industry’s “only complete FDA-approved” automated panel for acute hepatitis testing, including assays for HBsAg, HCV(1), Anti-HBc IgM and Anti-HAV IgM.
In addition to the panel for acute hepatitis, Bayer Diagnostics offers assays for HBsAg confirmatory, anti-HBs, anti-HBc Total and anti-HAV Total. That brings to eight the number of hepatitis assays available on the Advia Centaur, used in hospital laboratories, it said.
The Advia Centaur is an “automated immunoassay instrument,” Brad Ditmar, director of marketing for Bayer Health Diagnostics, told Medical Device Daily. “Why the tests are important on the Centaur is that these are qualitative tests, which are completely automated, so for the laboratorians today, in order to get these results, they have to go through semi-automated methods that can take quite a bit of man-hours.”
Ditmar said that the newly approved tests will be ready for the market in the “next few days.”
“The FDA gave us approval, the packaging is done and [the tests], are for all intents and purposes, waiting to ship immediately,” Ditmar said.
Some labs will be using the tests as a singular test, while other labs will use the tests as a screening device on a broader panel, Ditmar said, noting “one of the strengths of the Advia Centaur is the size of its menu, allowing laboratorians to consolidate many tests on one platform.”
He said Advia Centaur can turn around STAT tests in 18 minutes, which he termed “fast, very fast.”
Bayer said the Advia Centaur also has what it bills as a “smart algorithm” that can identify samples which require repeat or confirmatory tests. The company said it also provides a “hot zone” feature that determines, based on the value of the sample results, whether the specimen requires any follow-up tests, thereby reducing the number of tests to be conducted and hence saving time and labor resources in busy labs.
Arthur Rosenthal, PhD, director ESRD/nationwide laboratories (Fort Lauderdale, Florida), said that as part of a U.S. premarketing trial, his lab “reviewed the performance of [the] Advia Centaur HBsAg test in a large dialysis population.
“Results were compared with the currently used semi-automated method on several thousand specimens. The Bayer methodology gave very accurate results, including its performance in confirming positive results.”
He added: “The Bayer methodology . . . is far superior in terms of reduced turnaround time and labor requirements.”
John Nosenzo, senior vice president, North American Region for Bayer HealthCare’s Diagnostics Division, said “The Center for Disease Control and Prevention Control and Prevention [Atlanta] estimates that 1.25 million Americans are chronically infected with HBV(2). With such a staggering number of individuals affected, the demand on lab testing resources can be extreme. Bayer Diagnostics’ automated panel for acute hepatitis can benefit laboratories by enabling them to achieve testing efficiencies, while at the same time improving lab services to physicians by delivering accurate results in a rapid time-frame.”
Bayer said the Centaur Advia also offers “no-pause” loading of all reagents, samples and supplies, requires no daily start-up and has continuous sample loading. It has a dedicated STAT port which automatically prioritizes STATs, those tests whose results will be available within one hour of receiving the specimen, “without further operator intervention or disrupting work in progress.”
Bayer Diagnostics also offers molecular testing for hepatitis B and C with its Trugene genotyping kits and Versant assays.