News | June 15, 2008

Study Shows Rapid Flu Detection Test Demonstrates Better Sensitivity than Competitors

June 16, 2008 - 3M Health Care said today its 3M Rapid Detection Flu A B Test demonstrated better clinical and analytical sensitivity when compared to the BinaxNOW Influenza A & B Test for influenza A and B, according to research by clinical virology researchers from the North Shore-Long Island Jewish (LIJ) Health System.

The results of the study were recently presented at the 24th Annual Clinical Virology Symposium in Daytona Beach, FL.

The study evaluated the Rapid Detection Flu Test for the direct detection of influenza A and B in clinical respiratory samples and compared the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the 3M test to the BinaxNOW test. Both rapid tests provide results in less than 20 minutes. In addition, the study also evaluated the performance of the test as compared to two conventional methods of diagnosing influenza A and B, direct fluorescent antibody staining (DFA) (1.5 to 3 hours for results) and rapid cell culture (R-Mix) (24 to 48 hours to results).

“Clinicians battling infection during the height of the flu season have two great needs - tests that work rapidly and tests that can accurately pinpoint patients both with and without influenza,” said Christine Ginocchio, PhD., lead author and director of microbiology, virology and molecular diagnostics from the department of laboratory medicine at the North Shore–LIJ Health System Laboratories. “The results demonstrated that the 3M Rapid Detection Flu A B Test is more reliable and much more sensitive than the BinaxNOW test. This is positive news for clinicians as they prepare for this year’s flu season.”

Study results found the 3M test demonstrated superior analytical sensitivity for the detection of both influenza A and B as compared to the BinaxNOW test. The 3M test demonstrated superior clinical sensitivity for the detection of influenza A as compared to the BinaxNOW test (71 percent versus 46 percent, respectively) and was less sensitive than DFA (approximately 71 percent versus 81 percent).

The study showed the 3M test demonstrated superior clinical sensitivity for the detection of influenza B as compared to the BinaxNOW test and DFA (87 percent versus 38 percent and 74 percent, respectively).

The study included a total of 500 prospective respiratory specimens - from outpatients and inpatients ages two weeks to 99 years - submitted for routine viral culture and DFA. The evaluation was based on 464 samples with valid results for all four tests.

Expected to be available prior to the 2008-2009 flu season, the 3M Rapid Detection Flu A B Test quickly delivers results through an easy-to-use, self-timed reader. Requiring less than three minutes of prep time, positive or negative results are detected, differentiated as influenza A or B and displayed by the automated 3M Rapid Detection Reader. The fluorescent reader helps eliminate user interpretation errors, which can lead to both false negative or false positive results.

The Rapid Detection Flu Test is the first 3M diagnostic test to be launched following a 2006 agreement between 3M and Response Biomedical Corp. to develop and commercialize diagnostic products targeting hospital and community acquired infectious diseases using Response Biomedical’s technology.

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