Certified new diagnostic test kits for novel coronavirus, COVID-19, will soon be made available in the EU, Curetis N.V., a developer of molecular diagnostic solutions, announced on Monday (16 March).
The test kit, which has been developed and is manufactured by Curetis’ strategic partner BGI in Shenzhen, China, enables diagnostic laboratories to test for SARS-CoV2, the virus causing COVID-19, in only a matter of hours.
The kit contains enough reagents and controls to test up to 48 patients in just a few hours.
The test kit was cleared by Chinese authorities in January. In compliance with European regulations for in-vitro-diagnostics (IVD) tests, the test kit was CE-IVD certified at the end of February.
The test will now be made available to diagnostic laboratories in Europe through Curetis’ network of distribution partners. In countries where Curetis does not have distribution partners, it will ensure that it directly supplies the test kits.
Oliver Schacht, CEO of Curetis, said that they will leverage their sales channels “to make coronavirus testing available as broadly as possible in Europe.”
Europe is now the world centre for the coronavirus outbreak, according to the WHO director-general, Tedros Adhanom Ghebreyesus.
In a press briefing at the WHO headquarters, he said Europe had more cases and deaths than the rest of the world combined, apart from China.
As the virus is rapidly spreading, many countries have been struggling to administer and process the number of tests that are required.
Many countries are having to restrict the number of those tested for COVID-19, prioritising those most at risk. Belgium’s health ministry decided this week to limit tests to seriously ill patients and healthcare professionals, due to shortages of reagents.
There is, therefore, an urgent need for a more efficient diagnostic system.
[Edited by Zoran Radosavljevic]