RARITAN, NJ (May 5, 2003): Ortho-Clinical Diagnostics, a Johnson & Johnson company, has received approval for their Biologics License Application (BLA) for ORTHO Antibody to HBsAg ELISA Test System 3 (ORTHO HBsAg System 3-) from the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research. ORTHO HBsAg System 3 is a qualitative third-generation enzyme-linked immunosorbent assay for the detection of hepatitis B surface antigen (HBsAg) in human serum or plasma. It is indicated as a screening test and an aid in diagnosis of potential hepatitis B infection.
“The ORTHO HBsAg System 3 assay is an improved assay over the current product available in the U.S., and is part of our complete line of blood screening EIA tests,” said Catherine Burzik, President, Ortho-Clinical Diagnostics, Inc. “The addition of this new test underscores the continuing commitment of Ortho-Clinical Diagnostics to enhance our blood screening menu portfolio and ensure the safety of the blood supply.”
“The risk of hepatitis B virus transmission by blood transfusion is at present higher than that of hepatitis C or HIV transmission,” said David Ciavarella, M.D., Executive Director, Clinical and Medical Affairs, Ortho-Clinical Diagnostics. “ORTHO HBsAg System 3 assay represents a significant advance in our ability to detect infectious units prior to transfusion.”
The assay provides improved sensitivity and specificity, as well as several customer ease-of-use enhancements. The sensitivity is 0.10 ng/mL, with a specificity of 99.97%, based on clinical trial data. The newest feature of the assay is Sample Omission Monitoring (SOM). SOM is a qualitative color change technology that provides assurance that sample has been added. “We are excited to bring this new feature to our customers and believe it responds to the compliance needs of the marketplace,” states Phil Welch, Vice President, Sales and Marketing, U.S. Donor Screening, Ortho-Clinical Diagnostics. “This feature, along with other packaging modifications, was designed to make the product more customer friendly.”
Consistent with industry recommendations in providing a confirmatory test for HBsAg, Ortho-Clinical Diagnostics has also received BLA approval from the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research for ORTHO Antibody to HBsAg ELISA Test System 3 Confirmatory Test. This test is a third-generation assay used to confirm the presence of hepatitis B surface antigen in specimens found repeatedly reactive in ORTHO Antibody to HBsAg ELISA Test System 3. It utilizes a neutralization procedure in conjunction with the standard methodology of ORTHO Antibody to HBsAg ELISA Test System 3.
Approval of ORTHO HBsAg System 3 strengthens the assay portfolio run on the Ortho Summit™ System, the only fully automated system that performs all FDA-required screening tests and comprehensively documents the process. The performance is unmatched in small, mid-size and large-volume screening laboratories.
Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the Company brings products to market that provide timely information and help to facilitate better medical decisions. Ortho-Clinical Diagnostics also provides blood screening and typing products that help to ensure the safety of the world’s blood supply. In addition, through its patented dry slide and enhanced chemilluminescence technologies, the Company transformed the way that clinical laboratories perform testing. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions that promote effective diagnoses and enhanced patient care.
