title: Performance of a commercial assay for the diagnosis of influenza A (H1N1) infection in comparison to the Centers for Disease Control and Prevention protocol of real time RT-PCR.
abstract: At the time of influenza A (H1N1) emergency, the WHO responded with remarkable speed by releasing guidelines and a protocol for a real-time RT-PCR assay (rRT-PCR). The aim of the present study was to evalúate the performance of the "Real Time Ready Influenza A/H1N1 Detection Set" (June 2009)-Roche kit in comparison to the CDC reference rRT-PCR protocol. The overall sensitivity of the Roche assay for detection of the Inf A gene in the presence or absence of the H1 gene was 74.5 %. The sensitivity for detecting samples that were only positive for the Inf A gene (absence of the H1 gene) was 53.3 % whereas the sensitivity for H1N1-positive samples (presence of the Inf A gene and any other swine gene) was 76.4 %. The specificity of the assay was 97.1 %. A new version of the kit (November 2009) is now available, and a recent evaluation of its performance showed good sensitivity to detect pandemic H1N1 compared to other molecular assays.
authors.affiliation: Laboratorio Central del Ministerio de Salud de la Provincia de Córdoba, Tránsito Cáceres de Allende 421 (5000) Córdoba, Argentina. labmolecularcba@yahoo.com.ar
authors.forename: María G
authors.initials: MG
authors.lastname: Barbás
authors.forename: Sandra V
authors.initials: SV
authors.lastname: Gallego
authors.forename: Gonzalo M
authors.initials: GM
authors.lastname: Castro
authors.forename: Elsa
authors.initials: E
authors.lastname: Baumeister
authors.forename: Silvia
authors.initials: S
authors.lastname: Kademian
authors.forename: Juan
authors.initials: J
authors.lastname: De Leon
authors.forename: Analía
authors.initials: A
authors.lastname: Cudolá
mesh_terms: D001118:Argentina / Q000453:epidemiology; D002487:Centers for Disease Control and Prevention, U.S.; D004196:Disease Outbreaks; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000235:genetics; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000235:genetics / Q000302:isolation & purification; D007251:Influenza, Human / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D009296:Nasal Cavity / Q000821:virology; D019590:Nucleocapsid Proteins; D010614:Pharynx / Q000821:virology; D012367:RNA, Viral / Q000235:genetics; D016601:RNA-Binding Proteins / Q000235:genetics; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States; D014758:Viral Core Proteins / Q000235:genetics
chemical_list: C543345:H1N1 virus hemagglutinin; D019267:Hemagglutinin Glycoproteins, Influenza Virus; C048842:NP protein, Influenza A virus; D019590:Nucleocapsid Proteins; D012367:RNA, Viral; D016601:RNA-Binding Proteins; D011933:Reagent Kits, Diagnostic; D014758:Viral Core Proteins