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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 Food and Drug Administration (FDA) for a self-collection kit for Covid-19.

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 FedEx 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.

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“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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