Ortho Clinical Diagnostics announces FDA approval of the VITROS® hepatitis B surface antigen (HBsAg) assay for use on the VITROS 5600 Integrated and VITROS 3600 immunodiagnostic systems. This diagnostic assay enables the consolidation of hepatitis B testing with routine assays on the VITROS 5600 integrated system, which will help make labs more efficient in delivering quality results to physicians and patients.
“This approval underscores Ortho Clinical Diagnostics’ continuing commitment to providing clinical laboratories with a complete world-class menu on the VITROS Systems,” said Michael Samoszuk, MD, Chief Medical Officer, Ortho Clinical Diagnostics. “Since the introduction of the VITROS 5600 Integrated and VITROS 3600 Immunodiagnostic Systems, we have successfully released 113 assays and estimate that the complete VITROS menu of 114 assays is expected to be available by mid-2010.”
The VITROS HBsAg Assay eliminates the need for batch testing, decreasing turnaround time and increasing productivity. The assay can be run with excellent precision and sensitivity, with results readily available in as little as 37 minutes. In addition, the Intellicheck® technology used on the VITROS systems further enhances the quality of the test result by monitoring the integrity of the sample, process and results.
Source: Ortho Clinical Diagnostics
