title: Clinical performance of the 3M Rapid Detection Flu A+B Test compared to R-Mix culture, DFA and BinaxNOW Influenza A&B Test.
abstract: BACKGROUND
  The rapid diagnosis of influenza allows for prompt patient management and the initiation of appropriate infection control measures to reduce spread in healthcare settings.
  
  
  OBJECTIVE
  To evaluate the clinical performance of the 3M Rapid Detection Flu A+B Test (3MA+B) as compared to R-Mix cell culture, direct immunofluorescence assay (DFA) and the BinaxNOW A&B Influenza Test (BinaxNOW).
  
  
  METHODS
  Five hundred fresh respiratory samples, collected from patients aged 5 days to 99 years with respiratory symptoms, were tested by R-Mix culture, DFA, 3MA+B and BinaxNOW. Analytical sensitivity of 3MA+B was compared to BinaxNOW using replicates of serially diluted clinical samples positive for influenza A or B.
  
  
  RESULTS
  Sensitivity, specificity, PPV and NPV for the detection of influenza A and B, respectively, were for R-Mix (96.9%, 100%, 100%, 99.3%; 98.1%, 100%, 100%, 99.8%), DFA (80.4%, 99.2%, 96.1%, 95.3%; 74%, 100%, 100%, 97%), 3MA+B (70.1%, 99.8%, 98.6%, 93%; 86.5%, 98.7%, 88.2%, 98.4%) and BinaxNOW (46.4%, 100%, 100%, 88.6%; 34.6%, 100%, 100%, 93%). R-Mix, DFA and 3MA+B were significantly (P<or=0.0001) more sensitive than BinaxNOW for the detection of both influenza A and B. The analytical sensitivity of 3MA+B was greater than BinaxNOW. Excessive blood in samples may cause 3MA+B false positive influenza B results.
  
  
  CONCLUSIONS
  The 3MA+B provided superior results compared to BinaxNOW. The 3MA+B Reader eliminated user misinterpretation and provided quality control and result documentation. The improved sensitivity and easy of use makes 3MA+B an effective first line triage test for emergency departments, clinics and rapid response laboratories.
authors.affiliation: Department of Laboratory Medicine, North Shore-Long Island Jewish Health System Laboratories, Lake Success, NY 11042, USA. cginocch@nshs.edu
authors.forename: Christine C
authors.initials: CC
authors.lastname: Ginocchio
authors.forename: Madhavi
authors.initials: M
authors.lastname: Lotlikar
authors.forename: Leon
authors.initials: L
authors.lastname: Falk
authors.forename: Suman
authors.initials: S
authors.lastname: Arora
authors.forename: Margaret
authors.initials: M
authors.lastname: Kowerska
authors.forename: Mark
authors.initials: M
authors.lastname: Bornfreund
authors.forename: Ryhana
authors.initials: R
authors.lastname: Manji
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007251:Influenza, Human / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009975:Orthomyxoviridae / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic