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Clinical and Analytical Sensitivity of a Rapid Detection Flu A+B Assay: Presented at IDSA By Kristina R. Anderson SAN DIEGO, CA -- October 10, 2007 -- A new rapid 15-minute influenza diagnostic assay test -- the 3M(TM) Rapid Detection Flu A+B Test -- is at least as sensitive as the currently available test for influenza virus A+B, according to research findings presented here at the Infectious Diseases Society of America (IDSA) 45th Annual Meeting. Lead author Suzanne E. Dale, PhD, Assistant Professor, Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada, discussed the study in an oral presentation on October 5. The research was conducted while she was Clinical Microbiology Fellow, University of Rochester Medical Center, Rochester, New York. Dr. Dale and colleagues analyzed 249 clinical specimens submitted for routine respiratory virus culture between January and March 2007. They instituted a start/stop protocol to ensure they had enough positive specimens. They then compared the 3M Rapid Detection Flu A+B Test to culture in primary Rhesus monkey kidney cells and other tests currently on the market. Findings from this study were originally presented to the US Food and Drug Administration (FDA) as part of the submission for approval. They included the following: · For influenza A the 3M Rapid Detection Flu A+B Test was clinically more sensitive than the BinaxNOW(R) Influenza A&B test and equally sensitive to the Quidel QuickVue(R) Influenza A+B test. · For influenza A, the 3M test was analytically more sensitive than the BinaxNOW and BDTM Influenza tests and equally sensitive to the Quidel QuickVue Influenza A+B test. · For influenza B the 3M test was analytically more sensitive than the BinaxNOW, BD Directigen(TM) Influenza Test Kits, and Quidel QuickVue(R) influenza tests. The 3M rapid test is a lateral-flow immunochromatographic assay that detects the nucleoprotein of the influenza virus and is used with an automated reader for the detection and differentiation of influenza A and B. It is useful for nasal swabs and washes and nasopharyngeal swabs and aspirates. Also, results are achieved in about 15 minutes. "The 3M test for influenza provides point-of-care testing and gives physicians a mechanism for facilitating their clinical decision making. It also reduces time spent ordering tests and eliminates specimen transport and handling," Dr. Dale said. Rapid influenza testing leads to reductions of antibiotic use in hospitalized adult populations and is important for infection control with the commencement of an antiviral therapy. By differentiating between A and B, the 3M test will help physicians in selecting an appropriate therapy. Another advantage of this new test is that a patient's treatment can be initiated quickly, thus reducing transmission. The 3M test is currently undergoing drug application review with the FDA. The product will be priced competitively with other similar tests on the market, according to a 3M spokesperson. Dr. Dale said: "Our study is very important in that it shows the 3M test is, at a minimum, the same or equivalent to the other tests on the market. This new 3M test may be another option in the diagnostic influenza market." Funding for this study was provided by 3M and Response Biomedical. [Oral Abstract Session: Viral Pathogenesis: The Clinical and Analytical Sensitivity of the 3M TM Rapid Detection Flu A+B Assay. Abstract 37] E-mail this page to a friend or colleague! To print, use this version