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Clinical Evaluation of the ZstatFlu-II Test: a Chemiluminescent Rapid Diagnostic Test for Influenza Virus

Marilyn S. Hamilton,^1,2* David M. Abel,² Yolanda J. Ballam,² Mary K. Otto,² Angela F. Nickell,² Lisa M. Pence,^3, James R. Appleman,^3, Craig D. Shimasaki,³ and Komandoor E. Achyuthan³

University of Missouri—Kansas City School of Medicine,¹ The Children's Mercy Hospital, Kansas City, Missouri,² ZymeTx, Inc., Oklahoma City, Oklahoma³

Received 15 January 2002/ Returned for modification 1 March 2002/ Accepted 5 April 2002

Exploiting the high sensitivity of the chemiluminescence phenomenon, an accurate and sensitive point-of-care test, called the ZstatFlu-II test (ZymeTx, Inc., Oklahoma City, Okla.), was developed to detect influenza virus infections. The ZstatFlu-II test takes 20 min and requires approximately 2 min of "hands-on" time for operational steps. The ZstatFlu-II test does not distinguish between infections with influenza virus types A and B. ZstatFlu-II test results are printed on Polaroid High-Speed Detector Film, allowing test results to be archived. A prototype version of the ZstatFlu-II test was evaluated during the 2000-to-2001 flu season with 300 nasal aspirate specimens from children at a pediatric hospital. Compared to culture, the ZstatFlu-II test had 88% sensitivity and 92% specificity. The Directigen test had a sensitivity of 75% and a specificity of 93%. The sensitivity of the ZstatFlu-II test was significantly higher than that of the Directigen test (P < 0.0574).

Present address: National Center for Toxicological Research, Jefferson, AR 72079.

Present address: Anadys Pharmaceuticals, Inc., San Diego, CA 92121.

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