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Ortho HBsAg System 3 BLA gains approval

This article was originally published in The Gray Sheet

Executive Summary

Third-generation enzyme-linked immunosorbent assay to detect hepatitis B surface antigens in human serum or plasma includes color-coded microplate rims and a sample omission monitor as a process control enhancement, according to Raritan, N.J.-based Ortho-Clinical Diagnostics, which announced the approval May 5. The firm touts the new screening assay as having both increased specificity (0.10 ng/mL) and sensitivity (99.97%) and says it plans to phase out the second-generation product gradually as clients opt for upgrades...
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