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September 1, 2021

Zymo Research’s at-home sample collection kits obtain CE mark

The SafeCollect Sample Collection Kits provide maximum safety for reliable sampling. 

Zymo Research has received a CE mark for its new line of at-home sample collection kits for sale in the European Union (EU).

The SafeCollect Sample Collection Kits were created to ensure maximum user safety for the unsupervised self-collection of samples.

A sample collection device specifically made for at-home use, SafeCollect offers customers safety and utility for reliable sampling.

At present, the SafeCollect technology is offered in both swab and saliva collection formats.

Zymo Research noted that the SafeCollect Sample Collection Kits’ patented tube has a safety seal that prevents the sample stabilisation medium from being accidentally spilt, contacted and/or ingested.

Furthermore, SafeCollect devices contain the company’s DNA/RNA Shield stabilisation solution that upholds deoxyribonucleic acid and ribonucleic acid at ambient temperature for a minimum of 30 days.

Such preservation is economical and essential for shipping samples where costly dry ice and other cold shipping approaches are not viable.

In March, the US Food and Drug Administration granted 510(k) clearance to Zymo Research’s DNA/RNA Shield Collection Tube as a Class II medical device.

It is the first transport medium intended for collecting, preserving and inactivating the SARS-CoV-2 virus.

This medium also offers a further layer of protection to people who come in direct contact with samples such as couriers and laboratory staff.

Zymo Research scientist Dr Stanislav Forman said: “At-home testing and self-collection of biological specimens are no longer reserved for niche consumer genetic tests but will be essential to facilitating broad information-based screening and surveillance efforts, as well as being a critical aspect of the emerging telehealth market.

“The SafeCollect Sample Collection Kits were developed to help meet this demand without compromising customer convenience or safety, while also safeguarding collected sample integrity for robust analysis.”

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