Coronavirus: Chinese test kits approved for use across Europe, United States

Echo Xie

With the coronavirus outbreak seemingly coming under control in China, local manufacturers are ramping up their production of test kits for export, as demand for them soars around the world.

Genome sequencing company BGI Group, which was one of the first Chinese firms to develop a test kit after being granted approval to do so by Beijing in late January, said its RT-PCR product became commercially available in the United States on Wednesday.

It had also been granted a CE certification mark to sell the product within the European Economic Area, the company said.

According to its website, BGI has performed more than 500,000 tests in China and is now distributing its kits to over 50 countries and regions around the world.

The announcement of the kit’s availability in America came after the US Food and Drug Administration (FDA) decided to expedite clinical testing for SARS-CoV-2 – the official name for the novel coronavirus – by allowing companies to start selling tests before they have been reviewed by federal authorities or granted official emergency clearance.

As of Sunday, the United States had reported more than 26,000 infections and 340 deaths, according to figures provided by Johns Hopkins University.

A coronavirus test kit made by Chinese company BGI Group is now available in the US. Photo: Xinhua

While authorities in the US are ramping up testing for suspected cases, the situation in China has improved significantly in recent days. On Saturday, 46 new cases were reported across the country, though all but one were imported, and the domestic case was the first in four days.

The dip in local cases means China has been able to sell and donate vast quantities of essential supplies to other countries.

The arrival of the Chinese test kits in the US also suggests there is scope for Beijing and Washington to work together to battle the Covid-19 pandemic – which has killed almost 13,000 people around the world – despite the war of words being waged by diplomats and politicians from the two countries.

Also in the United States, vitro-diagnostics company Todos Medical on Wednesday signed a non-exclusive agreement to distribute coronavirus test kits produced by Chinese cancer precision medicine company 3D Biomedicine Science & Technology in the US and Israel.

3D BioMed’s test kits are approved by the Chinese Food and Drug Administration, have been granted a CE mark in Europe, and talks between the company and the US FDA are under way.

After weeks of China being the focus of the world’s attention, the spotlight on the health crisis has now shifted to the United States and Europe, both of which seen infections spike.

Italy has now reported more than 53,000 cases and 4,825 deaths – more than anywhere else in the world – while Spain has almost 25,000 cases and 1,326 fatalities.

In Germany, the total number of infections stood at 16,600 as of Saturday, with 46 deaths.

China’s National Medical Products Administration said last weekend that it had approved 11 nucleic acid test kits and eight antibody test kits. Of those, 11 had been granted a CE mark.

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