US FDA Approves Ortho Clinical Diagnostics’ Vitros Anti-HCV Assay for use on Vitros 5600 Integrated And Vitros 3600 Immunodiagnostic Systems. This approval marks a major milestone in the successful launches of Ortho Clinical Diagnostics’ clinical laboratory testing platforms, and enables the consolidation of hepatitis C testing with routine assays on the VITROS 5600 Integrated System.
“This approval builds upon Ortho Clinical Diagnostics’ history as the innovator of automated hepatitis C testing for clinical laboratories,” said Michael Samoszuk, M.D., Chief Medical Officer, Ortho Clinical Diagnostics. “Clinicians can test for hepatitis C as a part of their routine assay testing on the VITROS Systems, which will help make labs more efficient in delivering quality results.”
According to the Centers for Disease Control and Prevention (CDC), a person can only be diagnosed with hepatitis C after a positive result for an anti-HCV screening test has been verified. Hepatitis C is often referred to as the “silent disease” because up to 70 percent of people with the disease do not typically experience any symptoms.
The VITROS Anti-HCV assay is an in vitro diagnostic immunoassay for the qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. It can be run with excellent precision, sensitivity, low sample volume requirements and quick, random access results on the VITROS Systems, with results readily available in 55 minutes.
The approval of the VITROS Anti-HCV assay will expand the availability of hepatitis C testing across all of Ortho Clinical Diagnostics’ VITROS immunoassay platforms, including the VITROS ECi/ECiQ and VITROS 3600 Immunodiagnostic Systems and the VITROS 5600 Integrated System. Standardized VITROS reagents and results will enable laboratories to better manage reagent inventories and costs in addition to producing consistent test results from platform-to-platform. This is particularly beneficial for laboratories with multiple VITROS platforms in their facilities.
The FDA has also approved the VITROS Anti-HBc IgM assay for use on the VITROS 5600 Integrated and VITROS 3600 Immunodiagnostic Systems for hepatitis B testing. Additional hepatitis B and HIV assays, already available for use on the VITROS ECi/ECiQ Immunodiagnostic Systems, are under review or pending submission to the FDA for approval for use on the VITROS 5600 Integrated and VITROS 3600 Immunodiagnostic Systems. Upon full menu approval, only Ortho Clinical Diagnostics’ VITROS 5600 Integrated System will offer a complete infectious disease testing menu in the US, including HIV, in addition to a comprehensive menu of routine assays that can be run on a single platform.