The Roche assay for the 2009 H1N1 influenza virus detects RNA from the 2009 H1N1 Influenza A virus and provides a rapid means of identification of patients infected with this virus.
In order to ensure continued specificity and sensitivity of the Roche's Influenza A/H1N1 assay, Roche performs sequence comparisons with all available 2009 H1N1 Influenza virus sequences on a regular basis.
The detection set primers and probes were evaluated in mid-November, and no significant or relevant changes were identified in the published 2009 H1N1 Influenza sequences that could affect the performance of the Roche assay.
Roche is cooperating with several research institutes around the world in tracking the virus development.
The real-time ready Influenza A/H1N1 Detection Set test has been available since May 2009, shortly after the first case was registered.
In mid-November, the test received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
Under the current EUA, Roche can provide the real-time ready Influenza A/H1N1 Detection Set to CLIA high-complexity labs for the duration of the declaration of emergency.
Laboratories around the world are using the Roche Influenza A/H1N1 assay to test for the 2009 H1N1 Influenza virus.
