Several clinical laboratories using the Prodesse ProFlu+ Assay have received CDC confirmation of positive swine flu from specimens initially identified as Influenza A by ProFlu+. The accounts are geographically dispersed throughout the US. Some of these positive samples were not detected by the commonly used rapid tests, and there are many reports now of samples negative by rapid tests that have ultimately been confirmed as swine flu by CDC.
As noted in a statement issued by the company last Tuesday, results of in silico
testing demonstrated the Assay would detect the currently circulating swine flu virus. With many more sequences (about 40) now available, further in silico
testing has been performed. ProFlu+ sequences are a nearly perfect match to every known swine flu sequence, meaning that users can have high confidence that swine flu will be detected by ProFlu+.
Because ProFlu+ uses real-time PCR technology, it is simple to use and easily integrates into existing lab workflow. The product has been optimized for the use of automated extraction technology so that minimal hands-on time is required. This ease-of-use enables labs to quickly validate the product for use; a number of new users are bringing the assay online as a result of the swine flu outbreak. A result can be obtained in as little as 3 hours using the assay - a significant improvement over culture-based methods which can take days to weeks for a result. During a public health emergency, this speed to result and the exceptional sensitivity of molecular testing is extremely important from an infection control perspective.
Health care professionals should consult the latest CDC guidelines (http://www.cdc.gov/h1n1flu/guidance
) for instructions on how best to handle suspected cases of swine flu.