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Thermo Fisher Scientific has launched AcroMetrix Coronavirus 2019 (Covid-19) RNA Control to monitor and validate Covid-19 molecular diagnostic tests.
The new quality control product is developed by formulating synthetic RNA transcripts that contain unique N, S, E and Orf1ab regions of SARS-CoV-2 genome into a proprietary buffer.
Thermo Fisher’s latest product launch is aimed at fighting the coronavirus outbreak.
As necessary for the test, the RNA is set for reverse transcription, PCR amplification and detection.
The kit contains two SARS-CoV-2 specific RNA vials at the concentration that will result in low-positive and ultra-low positive in commonly used Covid-19 nucleic acid testing methods that are based on Polymerase Chain Reaction (PCR).
Thermo Fisher speciality 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.”
The new RNA control is available as a Research Use Only (RUO) product globally and is not intended for clinical use.
Last month, the company announced that it expects to produce up to five million testing kits during April, to detect nucleic acid from the SARS-CoV-2 virus that causes Covid-19 disease.
Currently, the company has 1.5 million tests available to ship under the emergency use authorisation (EUA) label.
The test runs on Applied Biosystems TaqPath Assay technology and delivers patient results within four hours from when a lab receives a sample.