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May 29, 2020

Quest Diagnostics receives FDA EUA for Covid-19 self-collection kit

Quest Diagnostics has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a self-collection kit for Covid-19.

Quest Diagnostics has received emergency use authorisation (EUA) from the US F ood and Drug Administration (F DA) for a self-collection kit for Covid-19.

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The kit enables individuals to self-collect a nasal specimen at home by swabbing the front part of the nostril. It can also be used in healthcare settings when determined to be appropriate by a clinician.

The test is also available for children below 18-years-old, which must be used only under adult supervision.

Specimens are shipped overnight through F edEx at room temperature to Quest Diagnostics to be tested for Covid-19.

The company will use its SARS-CoV-2 RT-PCR test, which received EUA in March to analyse these samples.

Quest Diagnostics chairman, CEO and presidentSteve Rusckowski said: “Covid-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection.

“The self-collection kit enables an individual to self-collect at home and the process is far less invasive and uncomfortable than many traditional methods.”

The company noted that it has already tested specimens using a similar collection method in real-world settings in the drive-thru and other Covid-19 testing sites in the US.

The self-collection test kits will be available to healthcare providers, states and organisations for return-to-work testing programmes.

Quest Diagnostics plans to have approximately a half-million kits available by the end of next month and aims to scale up the production on an ongoing basis.

Quest Diagnostics senior vice-president and chief medical officer Jay Wohlgemuth said: “We plan to use this device with a range of populations, from state-run programmes and employers to healthcare providers and individuals.

“Our scientists at our advanced diagnostics laboratory in San Juan Capistrano, California developed the technology, which has been validated in real-world studies.”

Last month, the company partnered with Centene to expand real-time reverse transcription-polymerase chain reaction (rRT-PCR) Covid-19 testing across the US.

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COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
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