OraSure Technologies, Inc has announced that an evaluation by the Walter Reed Army Institute of Research of the OraQuick® HCV Test, currently in clinical development, was recently released at the Advanced Technology Applications for Combat Casualty Care meeting. The purpose of the evaluation, entitled “Laboratory Evaluation of Hepatitis C Rapid Test for Use in Screening Walking Blood Bank Donors,” was to determine the best rapid HCV test to use for screening blood donors for hepatitis C (“HCV”) in the theater of war. The OraQuick HCV test was selected as the preferred test based on all facets of the evaluation.

Blood that is donated to commercial or hospital blood banks is subjected to extensive testing for blood-borne pathogens before it is released to be used in transfusions. However, emergency battlefield conditions sometimes dictate that an available soldier, or Walking Blood Bank, donate without this normal lab-based testing being available. A rapid assay such as the OraQuick HCV test can add a measure of safety against this important blood borne virus.

Approximately 170 million people are chronically infected with hepatitis C worldwide, and there are approximately three to four million new HCV infections each year on a global basis

Five rapid tests were initially selected from the rapid HCV tests available worldwide, based on an evaluation of published claims and sensitivity testing using HCV positive samples. The tests were then compared in a comprehensive evaluation of test performance using plasma and blood specimens. The study indicated that the OraQuick HCV test had the highest sensitivity (99.4%) and the highest specificity (99.7%) among the tests evaluated.

In addition, the evaluation indicated that the test detected HCV antibodies approximately three days sooner than available laboratory-based enzyme immunoassays and approximately sixteen days earlier than the next most sensitive rapid HCV test. Early detection of seroconversion is an important measure of the sensitivity of a test and means that hepatitis C infection can be identified even with relatively recent exposure.

“We are very pleased with the results of the Walter Reed evaluation,” said Stephen R Lee, PhD, Chief Science Officer of OraSure Technologies. “We are eager to complete our clinical trials for the OraQuick HCV test and submit our applications for both FDA approval and CE registration for this product. Based on the performance data generated to date, we believe this test will play an important future role in identifying new HCV infections and enabling infected individuals to receive the care and treatment they need.”

The study was conducted at The Walter Reed Army Institute of Research. Additional conference information may be obtained at the ATACCC Web site.

Source – Business Wire