Thermo Fisher Scientific has secured the expanded US Food and Drug Administration (FDA) emergency use authorization (EUA) for its multiplex real-time PCR test to detect nucleic acid from SARS‑CoV‑2, which causes Covid-19.
The company’s Applied Biosystems TaqPath COVID-19 Combo Kit was initially granted EUA on 13 March and subsequently expanded on 20 April.
Thermo Fisher Scientific chairman, president and chief executive officer Marc N Casper said: “Increasing COVID-19 testing is a top priority in re-opening global economies.
“With this expanded authorization, additional instrumentation can be brought on line in labs around the world and the number of tests they can run will increase, which will help to support the need for more testing as people start returning to work.”
The expanded EUA enables labs to run diagnostic tests on variety of PCR instruments
The Applied Biosystems TaqPath Covid-19 Combo Kit is designed to deliver test results within four hours of a sample being received and processed by a CLIA high-complexity laboratory.
The current EUA expansion allows the labs to increase the number of high-throughput PCR instruments to run the diagnostic tests.
It also facilitates the usage of reagents and consumables in sample preparation and extraction to provide enhanced flexibility in testing workflows.
In addition to the Applied Biosystems 7500 Real-time PCR series and a version of the Applied Biosystems QuantStudio 5, the EUA allows labs to run tests on specific configurations of QuantStudio 7 Flex and QuantStudio 5 Real‑time PCR instruments.
The expanded EUA also increases the availability of RNA extraction reagents by adding Thermo Fisher’s MagMAX viral or pathogen II nucleic isolation kit as an alternative.
According to the company, the sample purification procedure has also been updated for various microplate options.
In March, Thermo Fisher Scientific secured CE mark approval for its Covid-19 diagnostic test.
