Life Technologies Corporation has announced that its Applied Biosystems 7500 Fast Dx Real-Time PCR instrument is suitable for use with the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay, which has received Emergency Use Authorization for detection in patient specimens of the novel Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Additionally, the CDC Novel Coronavirus 2012 Assay can be performed using Life's SuperScript III One-Step qRT-PCR reagent kit. The SuperScript III One-Step qRT-PCR kit is for research use only; not for use in diagnostic procedures.
The assay is intended to quickly monitor the spread of the pathogen and thwart a potential pandemic. To support this global need, Life Technologies is increasing production of its reagents and shipping them to labs around the world. This test has been authorized only for the diagnosis of MERS-CoV and not for the diagnosis of any other viruses or pathogens.
The test has been authorized by the FDA under an Emergency Use Authorization for use by qualified laboratories. The CDC Novel Coronavirus 2012 Assay has not been FDA cleared or approved. The assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of MERS-CoV under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C section 360bbb-3(b)(1). Read the latest on MERS-CoV from the CDC.