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Journal of Clinical Microbiology, July 2002, p. 2331-2334, Vol. 40, No. 7
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.7.2331-2334.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

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,{dagger} James R. Appleman,3,{ddagger} 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).


* Corresponding author. Mailing address: The Children's Mercy Hospital, Department of Pathology, 2401 Gillham Rd., Kansas City, MO 64108. Phone: (816)-234-3234. Fax: (816) 802-1492. E-mail: mhamilton{at}cmh.edu.

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

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


Journal of Clinical Microbiology, July 2002, p. 2331-2334, Vol. 40, No. 7
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.7.2331-2334.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.




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