title: Validity of two rapid point of care influenza tests and direct fluorecence assay in comparison of real time PCR for swine of origin Influenza virus.
abstract: BACKGROUND
  A novel swine origin influenza virus (S-OIV) is continue to spread worldwide and a global declaration of 2009 influenza pandemic was made by World Health Organization (WHO) June 2009, this along with approaching the winter season at the northern hemisphere, increase the interest to provide a quick, easy, affordable and available point of care testing for S-OIV.
  
  
  OBJECTIVE
  To determine the performance of two rapid point-of-care (POC) tests for influenza virus as well as direct fluorescence assay for the detection of the recently emerged a novel swine origin influenza virus (S-OIV).
  
  
  METHODS
  A total of 143 respiratory samples which was submitted to Pathology and Laboratory Medicine at King AbdulAziz Medical City in Riyadh, Saudi Arabia from June 6th 2009 till June 28th 2009. All samples were tested in parallel using two rapid assays (BD Directigen EZ Flu®) and (TruFlu, Meridian®) as well as (Imagen Flu A/B DFA, Oxoid®) and compare it with RT-PCR. Each test's performed by different team, who were blinded for other team's result. Data gathered and we analyzed the analytical validity of each test.
  
  
  RESULTS
  The analytical sensitivity of the two influenza antigen detection tests for S-OIV was very low in comparison with RT-PCR, BD Directigen EZ performance was better than TruFlu test with sensitivities of 20.6% and 9.7% respectively. DFA perform much better than POC tests with sensitivity of 32.35%, specificity of 99.08% and PPV, NPV of 90% and 81.20% respectively.
  
  
  CONCLUSIONS
  The analytical sensitivity of the selected influenza A antigen detection tests for detection of S-OIV was very low, and should not be used to exclude S-OIV, DFA may be used as first line test especially during after hours or weekends, but negative results must confirmed by RT-PCR.
authors.affiliation: College of Medicine, King Saud Bin AbdulAziz University for Health Science, Saudi Arabia. johanis@ngha.med.sa
authors.forename: S M
authors.initials: SM
authors.lastname: Al Johani
authors.forename: M
authors.initials: M
authors.lastname: Al Balawi
authors.forename: B
authors.initials: B
authors.lastname: Al Alwan
authors.forename: R
authors.initials: R
authors.lastname: Al Hefdhi
authors.forename: A
authors.initials: A
authors.lastname: Hajeer
mesh_terms: D019085:Fluorescent Antibody Technique, Direct / Q000379:methods; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology; D019095:Point-of-Care Systems; D016133:Polymerase Chain Reaction / Q000379:methods; D012529:Saudi Arabia; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods*