title: Clinical evaluation of the ZstatFlu-II test: a chemiluminescent rapid diagnostic test for influenza virus.
abstract: 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).
authors.affiliation: University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, USA. mhamilton@cmh.edu
authors.forename: Marilyn S
authors.initials: MS
authors.lastname: Hamilton
authors.forename: David M
authors.initials: DM
authors.lastname: Abel
authors.forename: Yolanda J
authors.initials: YJ
authors.lastname: Ballam
authors.forename: Mary K
authors.initials: MK
authors.lastname: Otto
authors.forename: Angela F
authors.initials: AF
authors.lastname: Nickell
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Pence
authors.forename: James R
authors.initials: JR
authors.lastname: Appleman
authors.forename: Craig D
authors.initials: CD
authors.lastname: Shimasaki
authors.forename: Komandoor E
authors.initials: KE
authors.lastname: Achyuthan
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology; D008163:Luminescent Measurements; D008297:Male; D008828:Microbiological Techniques; D009975:Orthomyxoviridae / Q000302:isolation & purification*; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods* / Q000706:statistics & numerical data; D014776:Virus Cultivation