title: Performance of rapid-test kits for the detection of the pandemic influenza A/H1N1 virus.
abstract: The early detection of pandemic influenza strains is a key factor for clinicians in treatment decisions and infection control practices. The aims of this study were to determine the analytical sensitivity and clinical performance of the commercially available influenza rapid tests in Taiwan. Four rapid tests for influenza virus (BinaxNow test, QuickVue test, TRU test, and Formosa Rapid test) were evaluated for their detection limit against four influenza viruses (the 2009 pandemic influenza A virus H1N1, seasonal influenza virus H1N1, H3N2, and influenza B virus) circulating in Taiwan. The viral load of these isolates were quantified by rtRT-PCR and then diluted 2-fold serially for the comparison. The lowest detectable viral load of the pandemic influenza A virus H1N1 by the Formosa Rapid test, QuickVue test, TRU test, and Binax Now test was 5.3×10(4), 1.0×10(5), 1.0×10(5), and 4.2×10(5)copies/μL, respectively. Of these four tests, the two most sensitive tests (the QuickVue test and the Formosa Rapid test) were chosen to evaluate 62 nasopharyngeal specimens from patients who were suspected of infection with pandemic influenza A virus H1N1. The positive rate for the Formosa Rapid test and the QuickVue test were 53.2% (33/62) and 45.2% (28/62) (McNemar's test, P=0.125), respectively. In conclusion, the Formosa Rapid test was the most sensitive test in the present study for the detection of influenza antigens and its clinical performance was similar to that of the QuickVue test (Kappa=0.776). This suggests that the Formosa Rapid test could be used to aid clinical decision making in primary health care settings during outbreaks of influenza.
authors.affiliation: Department of Laboratory Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Kuo-Chien
authors.initials: KC
authors.lastname: Tsao
authors.forename: Yung-Bin
authors.initials: YB
authors.lastname: Kuo
authors.forename: Chung-Guei
authors.initials: CG
authors.lastname: Huang
authors.forename: Shao-Wen
authors.initials: SW
authors.lastname: Chau
authors.forename: Err-Cheng
authors.initials: EC
authors.lastname: Chan
mesh_terms: D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000302:isolation & purification*; D053122:Influenza A Virus, H3N2 Subtype / Q000302:isolation & purification; D009981:Influenza B virus / Q000302:isolation & purification; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology; D011933:Reagent Kits, Diagnostic; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D013624:Taiwan; D019562:Viral Load; D014773:Virology / Q000379:methods*
chemical_list: D011933:Reagent Kits, Diagnostic