Can other clinical laboratories purchase and perform the Influenza A H1N1 (2009) Real Time RT-PCR?
Yes, assuming certain conditions are met. Specifically, under the emergency use authorization, the Influenza A H1N1 (2009) Real Time RT-PCR is intended for use CLIA high-complexity laboratories, provided they also run the necessary equipment and meet other requirements for performing the test. High complexity laboratories must also include patient and healthcare provider fact sheets with test reports, have a process for reporting results to public health authorities, and inform Focus Diagnostics about reports of false results. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization. This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1). The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
Related Questions
- I heard that FDA changed its emergency use authorization for the Influenza A H1N1 (2009) Real Time RT-PCR -- why would the FDA do this?
- Can other clinical laboratories purchase and perform the companys 2009 H1N1 influenza virus test kits?
- Can other clinical laboratories purchase and perform the Influenza A H1N1 (2009) Real Time RT-PCR?
