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Dx Focus: Meridian Bioscience Illumigene Mycoplasma; CDC Novel Coronavirus Assay


Meridian Bioscience said this week that it has received US Food and Drug Administration clearance for Illumigene Mycoplasma, a molecular diagnostic test for Mycoplasma pneumoniae.

The test, the fourth in Meridian's Illumigene assay portfolio, is based on loop-mediated isothermal amplification and amplifies specific DNA to detect M. pneuomoniae from throat and nasopharyngeal swabs. The assay requires no expensive capital equipment, relies upon a simple procedure that takes less than one hour, is cost-efficient, and has a small footprint, Meridian said.

Often referred to as "walking pneumonia", M. pneumonia has been associated with up to 40 percent of community-acquired pneumonias, Meridian said.

The US Food and Drug Administration last week issued an Emergency Use Authorization for the US Centers for Disease Control Novel Coronavirus 2012 real-time RT-PCR assay.

This test is for the presumptive detection of Middle East respiratory syndrome coronavirus, or MERS-CoV, formerly known as novel coronavirus 2012, or NCV-2012, in patients with signs and symptoms of MERS-CoV infection in conjunction with clinical and epidemiological risk factors.

The device will be distributed by CDC to qualified laboratories.

On May 29, the US Department of Health and Human Services determined that MERS-CoV poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the department declared that circumstances exist to justify the authorization of emergency use of in vitro diagnostics to detect the virus.