Tuesday, October 19 2021

A Swiss pharmaceutical company has been authorized to sell Covid nasal tests at home.

Roche announced today that it has obtained CE marking to sell the kits in countries that accept administrative marking, including Ireland.

The test kits will be sold in packs of five at drugstores and other places.

Roche said the antigen test provides “fast and reliable” results, adding that it may play a role in bringing society back to normal.

“Individuals can perform the test at home using a nasal swab without special training or supervision from a healthcare professional,” the company said in a statement.

“The test provides results in as little as 15 minutes and can help people easily check if they are likely to be contagious from the comfort of their home.”

The HSE uses PCR tests for patients with suspected Covid and says it is more reliable than an antigen test. However, an antigen test doesn’t have to go to a lab, so it gives faster results.

Finbarr Kenny, director of Roche Diagnostics in Ireland, called the test easy to use.

“Our new nasal antigen self-test provides results in 15 minutes and has the added benefit of requiring only a sample from the lower part of both nostrils, making it relatively easy and less uncomfortable to perform,” a- he declared.

“The clinical performance of the test was measured by direct comparison with our PCR test. With a sensitivity between 86% and 91%, the self-test provides a fast and reliable result indicating whether a person is currently infectious with Covid-19.

“As we cautiously navigate the road to recovery from this pandemic, PCR and rapid antigen testing (lateral flow) for Covid-19 can both play a vital role in helping to allow normal activities to resume smoothly. safety and confidence. ”

The company said in a statement that a first version of the test was already available in some European markets.

With CE marking, the company said the SARS-CoV-2 Antigen Self-Test Nasal for Covid-19 Rapid Self-Test “has received official approval following the traditional registration route and can now also be used in markets that do not have established regulatory exemptions pathways ”.

A CE mark means that a product sold in the EEA has been assessed to meet high requirements for safety, health and environmental protection.

Last month, Chief Medical Officer Dr Tony Holohan came under fire for his stance on antigen testing.

Dr Holohan “urged caution” regarding the use of such tests in all situations other than where Covid-19 is very prevalent.

At a subsequent Oireachtas committee, he conceded that it would be a “good idea” to start a pilot program of rapid antigen testing for people embarking on international flights.


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