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Analytical and clinical validation of novel real-time reverse transcriptase-polymerase chain reaction assays for the clinical detection of swine-origi

tetano

Editor, Senior Moderator
Diagn Microbiol Infect Dis. 2011 Feb;69(2):167-71.
Analytical and clinical validation of novel real-time reverse transcriptase-polymerase chain reaction assays for the clinical detection of swine-origin H1N1 influenza viruses.

Duncan C, Guthrie JL, Tijet N, Elgngihy N, Turenne C, Seah C, Lau R, McTaggart L, Mallo G, Perusini S, Rebbapragada A, Melano R, Low DE, Farrell D, Guyard C.

Ontario Agency for Health Protection and Promotion (OAHPP), 81 Resources Road, Toronto, Ontario, M9P 3T1, Canada.
Abstract

During the early stages of the 2009/2010 swine-origin H1N1 influenza A (S-OIV H1N1 FluA) outbreak, the development and validation of sensitive and specific detection methods were a priority for rapid and accurate diagnosis. Between May and June 2009, 2 real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) assays targeting the hemagglutinin and neuraminidase genes of the S-OIV H1N1 FluA virus were developed. These assays are highly specific, showing no cross-reactivity against a panel of respiratory viruses and can differentiate S-OIV H1N1 from seasonal FluA viruses. Analytical sensitivities of the 2 assays were found to be 10(-1) tissue culture infectious dose, 50%/ml. Clinical testing showed 99.2% sensitivity and 94.6-98.1% specificity. A large prospective analysis showed that 94.8-95.5% of S-OIV positive specimens were negative by seasonal H1/H3 subtyping. The large-scale validation data presented in this report indicate that these novel assays provide an accurate and efficient method for the rapid detection of S-OIV H1N1 FluA viruses.
Crown Copyright © 2011. Published by Elsevier Inc. All rights reserved.

PMID: 21251560 [PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/21251560
 
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