Ortho Clinical Diagnostics receives FDA approval for two hepatitis B assays

Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, has received approval from the U.S. Food and Drug Administration (FDA) for Ortho's VITROS® Immunodiagnostic Products HBeAg Assay and the VITROS® Immunodiagnostic Products Anti-HBe Assay for use on Ortho's VITROS® 3600 Immunodiagnostic System and Ortho's VITROS® 5600 Integrated System.

Both assays, currently available on Ortho's VITROS® ECi/ECiQ Immunodiagnostic Systems in the US, are used as an aid in diagnosis of hepatitis B infection in individuals with acute or chronic hepatitis B or recovery from hepatitis B infection. This achievement allows customers the ability to consolidate all hepatitis tests onto Ortho's single high-throughput VITROS® System, enabling them to better manage large volumes of diagnostic tests.

"We are committed to designing assays to help our laboratory customers diagnose infectious diseases as early as possible in the disease cycle, while also supporting labs in managing their workloads as effectively and efficiently as possible," said Robert Yates, Ortho's chief operating officer. "The FDA's approval of our hepatitis B assays for use on our VITROS® automated analyzers is an important step toward achieving those goals."

According to the CDC, millions of Americans have chronic viral hepatitis and most of them do not know they are infected. An estimated 240 million people worldwide are currently living with chronic hepatitis B, a life-threatening infection of the liver.ii

Ortho has a long legacy in and commitment to the diagnosis of different forms of hepatitis. In 1989, Ortho introduced the first test for the detection of antibodies to hepatitis C. In 2000, Ortho released the first commercially available test for the direct detection in blood and plasma of hepatitis C core antigen, a marker of early infection in hepatitis C-infected individuals. Since then, Ortho has expanded its leadership in hepatitis testing by developing a growing portfolio of tests for Hepatitis A, B, and C. The introduction of Ortho's VITROS® Anti-HBe and HBeAg on VITROS® 3600 and 5600 Systems complements the other hepatitis tests already available on VITROS® 3600 and 5600 Systems:

VITROS® Immunodiagnostic Products HAV IgM
VITROS® Immunodiagnostic Products HAV Total
VITROS® Immunodiagnostic Products Anti-HBc
VITROS® Immunodiagnostic Products Anti-HBc IgM
VITROS® Immunodiagnostic Products Anti-HBs Quantitative
VITROS® Immunodiagnostic Products HBsAg
VITROS® Immunodiagnostic Products HBsAg Confirmatory
VITROS® Immunodiagnostic Products Anti-HCV

Source: https://www.orthoclinicaldiagnostics.com/


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