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27-May-2021

Thermo Fisher Scientific's TaqPath COVID-19 CE-IVD RT-PCR Kit Now Available for the Incoming International Travel Quarantine Protocol Testing in the United Kingdom

Thermo Fisher Scientific, the world leader in serving science, today announced that its TaqPath COVID-19 CE-IVD RT PCR Kit has been independently validated as meeting the performance characteristics for the Day 2 and Day 8 COVID-19 quarantine protocol testing required for international travellers arriving in the United Kingdom.

The United Kingdom has instituted quarantine rules for travellers entering the country that vary depending on the country of departure, but most people will be legally required to quarantine for ten days upon arrival. On days two and eight of their isolation, those travellers are obliged to take a PCR test to monitor for an active SARS-CoV-2 infection. Thermo Fisher's TaqPath kit is now permitted to be used by laboratories and clinics in that surveillance.

"Quarantine and surveillance programs such as the one in the United Kingdom are important for helping curb the spread of SARS-CoV-2 and its variants as countries begin to reopen," said Claire Wallace, vice president, commercial EMEA, life sciences at Thermo Fisher Scientific. "Thermo Fisher's strong supply chain of highly accurate COVID-19 PCR tests has been fundamental in the symptomatic testing for SARS-CoV-2 in the United Kingdom since the pandemic started and we are excited that independent validation for this additional use will help to increase testing availability as the international travel season begins."

The TaqPathCOVID-19 CE-IVD RT PCR Kit is a fast, highly sensitive multiplex diagnostic solution that contains both the assays and controls needed for the real-time PCR detection of RNA from the SARS-CoV-2 virus. In the independent validation study, the kit was shown to have clinical sensitivity of 100% with 95% Confidence Interval [97.9-100.0%] and a clinical specificity of 100% with 95% Confidence Interval [98.6-100.0%]. The limit of detection was determined as to be 250 copies/mL.

The TaqPathCOVID-19 CE-IVD RT PCR Kit received initial CE-IVD approval in March 2020 and is compatible with most widely used real-time PCR instruments. For more information on the platform, please visit: https://www.thermofisher.com/covid19ceivd

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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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Last Updated: 27-May-2021