Simplexa influenzaA H1N1 (2009) assay for detection of 2009 pandemic influenzaH1N1 with Microfluidic real-time PCR system
Abstract number: P1090
Aye M., Chen J., Dempsey S., Eleazar E., Mai H., Nair L., Xie Y., Chen Y.P., Exner M.
Objective: In 2009, a new strain of Influenza A (H1N1) virus emerged and rapidly spread into a global influenza pandemic. Because of its unique sequence divergence by genetic shift, this virus was not readily subtyped by pre-existing tests. In this study, we report development of a real-time PCR-based Simplexa Influenza A H1N1 (2009) assay for rapid detection and differentiation of pandemic influenza virus from seasonal influenza A viruses.
Methods: Limit of detection studies and specificity studies were performed to determine analytical performance characteristics of the Simplexa Influenza A H1N1 (2009) assay. Clinical performance of the was determined by testing blind panels of clinical specimens and comparing results to those obtained using the CDC real-time RT-PCR assay for Detection and Characterization of Swine influenza (version 2009).
Results: Limit of detection studies showed that the Simplexa assay detected influenza A H1N1 (2009) and seasonal influenza H1 and H3 subtypes at less than 101 TCID50/mL. Sensitivity and specificity of the Simplexa assay for influenza A H1N1 (2009) and, seasonal influenza were 98.3% (59/60) and 99.1% (119/120), and 100% (118/118) and 96.8% (60/62), respectively, compared to CDC real-time RT-PCR assay.
Conclusions: The Simplexa assay (CE IVD) was demonstrated to be a sensitive and specific method for detecting and discriminating influenza A H1N1 (2009) from other seasonal influenza viruses. The assay is compatible with automated and manual sample preparation methods, and can produce the results in less than 90 min. Thus, Simplexa assay provides a compact high throughput system for detection and identification of 2009 pandemic influenza H1N1 virus.
|Session name:||Abstracts 20th European Congress of Clinical Microbiology and Infectious Diseases|
|Location:||Vienna, Austria, 10 - 13 April 2010|
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