Thermo Fisher has designed and developed the new synthetic RNA control to enable the labs validate and monitor COVID-19 molecular diagnostic tests
Thermo Fisher Scientific office in Canada. (Credit: Wikipedia/Raysonho @ Open Grid Scheduler / Grid Engine)
Global medical technology company Thermo Fisher Scientific has rolled out the new Thermo Scientific AcroMetrix Coronavirus 2019 (COVID-19) RNA Control, for monitoring and validating COVID-19 molecular diagnostic tests.
The new control has been designed and developed as a synthetic RNA, non-infectious control to enable the labs validate and monitor COVID-19 molecular diagnostic tests.
Thermo Fisher specialty diagnostics business senior vice president and president Gianluca Pettiti said: “Our team is committed to providing innovative solutions to support our customers with better diagnostic tools. 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 rolled out RNA control as Research Use Only (RUO) product
The company said that its AcroMetrix COVID-19 RNA Control is offered at two different concentrations, a low positive control and an ultra-low positive control, under the US FDA guidelines.
In addition, the new RNA control is prepared by formulating synthetic RNA transcripts that contain highly unique N, S, E and Orf1ab regions of SARS-CoV-2 genome into a proprietary buffer. The RNA can be readily used for reverse transcription, PCR amplification and detection.
The kit is comprises two vials of SARS-CoV-2 specific RNA at the concentration that will result low positive and ultra-low positive in Polymerase Chain Reaction (PCR) based Coronavirus 2019 (COVID-19) nucleic acid testing methods.
Thermo Fisher has rolled out the new AcroMetrix COVID-19 RNA Control across the world as a Research Use Only (RUO) product and is not available for clinical use.
In March, the company secured CE mark approval for its diagnostic test for the detection of nucleic acid from SARS-CoV-2, the novel virus responsible for COVID-19 disease.
The approval allows Thermo Fisher to market its diagnostic test across the European Union.