Thermo Fisher Scientific, the world leader in serving science, today announced the availability of the Thermo Scientific AcroMetrix Coronavirus 2019 (COVID-19) RNA Control, its latest quality control product to monitor and validate COVID-19 molecular diagnostic tests.

In an effort to combat the recent Coronavirus outbreak, Thermo Fisher designed and developed this control as a synthetic RNA, non-infectious control to help labs validate and monitor COVID-19 molecular diagnostic tests. Taking FDA guidelines into account, the controls were carefully designed at two different concentrations: a low positive control and an ultra-low positive control.

AcroMetrix Coronavirus 2019 (COVID-19) RNA Control is prepared by formulating synthetic RNA transcripts that contain highly unique N, S, E and Orf1ab regions of SARS-CoV-2 (COVID-19) genome into a proprietary buffer. The RNA is ready for reverse transcription, PCR amplification and detection, as appropriate to the test. The kit contains two vials of SARS-CoV-2 specific RNA at the concentration that will result low positive and ultra-low positive in most commonly used Polymerase Chain Reaction (PCR) based Coronavirus 2019 (COVID-19) nucleic acid testing methods.

"Our team is committed to providing innovative solutions to support our customers with better diagnostic tools," said Gianluca Pettiti, senior vice president and president, Thermo Fisher's specialty diagnostics business. "The AcroMetrix Coronavirus 2019 (COVID-19) RNA Control is a positive control to aid in validating and monitoring COVID-19 diagnostic tests."

Thermo Fisher has created an online resource to make it easier to find up-to-date information about its response to the COVID-19 pandemic, including availability of its diagnostic test kits. 

The AcroMetrix Coronavirus 2019 (COVID-19) RNA Control is available globally as a Research Use Only (RUO) product and is not intended for clinical use