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

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.