To monitor and validate COVID-19 molecular diagnostic tests
FREMONT, Calif., March 31, 2020 /PRNewswire/ -- 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. Please refer to https://corporate.thermofisher.com/en/COVID-19.html for current news, information and frequently asked questions about COVID-19-related products and services that are vital to researchers, labs, healthcare workers and first responders worldwide.
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. For more information, visit www.thermofisher.com/covid-19-control
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
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SOURCE Thermo Fisher Scientific