Clinical evaluation of the ZstatFlu-II test: a chemiluminescent rapid diagnostic test for influenza virus.
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).
Hamilton
Marilyn S
MS
University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, USA. mhamilton@cmh.edu
Abel
David M
DM
Ballam
Yolanda J
YJ
Otto
Mary K
MK
Nickell
Angela F
AF
Pence
Lisa M
LM
Appleman
James R
JR
Shimasaki
Craig D
CD
Achyuthan
Komandoor E
KE
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