In response to requests from CDC, FDA has issued emergency use authorizations (EUAs) to make available to public health and medical personnel important diagnostic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the rRT-PCR Swine Flu Panel diagnostic test. In authorizing an EUA for the rRT-PCR Swine Flu Panel diagnostic test, FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests. This EUA allows CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results. The test amplifies the viral genetic material from a nasal or nasopharyngeal swab. A positive result indicates that the patient is presumptively infected with swine flu virus but not the stage of infection. However, a negative result does not, by itself, exclude the possibility of swine flu virus infection.
Here are some other developments regarding how the IVD industry has responded to the swine flu outbreak:
Prodesse Inc. (Milwaukee) announced the results of in silico testing of its ProFlu+ Assay that demonstrate the assay detects the currently circulating swine flu virus. ProFlu+ detects and differentiates Influenza A, Influenza B, and RSV. Prodesse is currently attempting to procure isolates so that reactivity with the swine flu strain can be confirmed.
Envision ALR (London)Â announced that it is commercializing a new form of nanotechnology-based infectious disease detection system with the capability to distinguish between different flu strains within seconds. The technology has already been shown to be effective in lab tests, and the company is now accelerating the commercialization program. The technology is based on printed electronics, making use of the unique properties of a number of nanoparticle-based inks. It is rapid and accurate, and the handheld device is easily portable for use in hospitals, or airports. The system works for both bacterial and viral pathogens, and tests performed by the Naval Research Lab in Washington, D.C. using Staphylococcus Enterotoxin B showed a two order of magnitude improvement over the current gold standard lab test.
Luminex Corp. (Austin, TX) announced that it has performed computer-based sequence analysis of the U.S. swine flu patient isolates and compared them to the primer sequences of the company’s xTAG RVP assay. In the interest of providing information to its customers and to public health labs, Luminex is reporting these interim computer-based results and will provide further updates once actual patient samples have been tested with the RVP assay. A computer-based analysis of the swine flu sequences compared to the primers in the xTAG RVP product indicate that a swine flu positive patient sample is likely to be correctly identified by the portion of the RVP assay which detects the flu A matrix gene. However, the H1 subtyping portion of the RVP assay is not predicted to identify the swine flu H1 gene, even though CDC has identified the swine flu strain as an H1 subtype strain. The reason for this finding is that the new swine flu strain is significantly different from normal, seasonal H1 subtype flu A.
