Coronavirus: China ramps up Covid-19 test kit exports amid global shortage, as domestic demand dries up
More than 100 Chinese companies are selling coronavirus testing kits to Europe, but most are not licensed to sell in China
A global shortage of kits has sparked a scramble for resources, but the specialist nature of the production process provides limitations
As the horror of the coronavirus outbreak in China was unfolding over January’s Lunar New Year holiday, a group of technicians were holed up in a Nanjing facility with a supply of instant noodles, working long hours to develop testing kits for diagnosing the virus.
Already at that point, the coronavirus had ripped through the city of Wuhan and was spreading rapidly around China. A handful of diagnostic tests had already been approved by the central government in Beijing, but hundreds of firms in China were still scrambling to develop new ones.
“I did not think about applying for approvals in China,” said Zhang Shuwen, founder of Nanjing Liming Bio-products. “The application takes too much time. When I finally get the approvals, the outbreak might already be finished.”
Instead, Zhang is part of a legion of Chinese exporters selling testing kits to the rest of the world amid the rapid spread of the pandemic outside China, where the outbreak is now increasingly under control, leading to a fall in domestic demand.
In February, he applied to sell four testing products in the European Union, receiving official CE accreditation in March, meaning they complied with health, safety and environmental standards set by European regulators. Now, Zhang has an order book brimming with clients from Italy, Spain, Austria, Hungary, France, Iran, Saudi Arabia, Japan, and South Korea.
“We have so many orders now that we are working until 9pm, seven days a week. We are considering working 24 hours a day, asking workers to take three shifts every day,” Zhang said.
Infection hotbeds have exploded across Europe and the United States, with the epicentre shifting out of Wuhan in central China to Italy, then Spain and now New York. The chronic shortage of testing equipment means that rather than being diagnosed, potential patients considered “low-risk” are being asked to stay at home.
“At the start of February, about half of our testing kits were being sold in China and half abroad. Now, there are almost none being sold domestically. The only ones we sell here now are for passengers arriving from outside [China] who need to be tested,” said a senior executive at the BGI Group, China’s largest genome sequencing company, who spoke under the condition of anonymity.
At the start of February, BGI was making 200,000 kits a day out of its plant in Wuhan, the original epicentre of the outbreak. The plant, with a “few hundred” workers, was kept running 24 hours a day while most of the city was closed.
Now, he said the company is producing 600,000 kits per day and has just become the first Chinese company to gain emergency approval to sell its fluorescent real-time polymerase chain reaction (PCR) tests in the US.
Chinese-made testing kits are becoming a more common presence throughout Europe and the rest of the world, adding a new dimension to the roaring debate over dependence on medical supplies from China.
As of Thursday, 102 Chinese firms have been granted access to the European market, according to Song Haibo, chairman of the China Association of In Vitro Diagnostics, compared with just one being licensed in the US. Many of these companies, though, do not have the required National Medical Products Administration permission to sell in China.
In fact, just 13 companies have been licensed to sell PCR testing kits in China, with eight selling the simpler antibody version.
A manager at a biotechnology firm in Changsha, who wished not to be identified, said the company is only licensed to sell PCR testing kits for animals in China, but is preparing to ramp up production of 30,000 newly-designed Covid-19 kits to sell in Europe, after “just receiving a CE certificate on March 17”…
Last week, Spanish newspaper El País reported that antigen testing equipment from the Shenzhen-based firm Bioeasy Biotechnology only had a 30 per cent detection rate for Covid-19, when they were supposed to be 80 per cent accurate. Bioeasy, it emerged, was not included on an approved list of suppliers offered to Spain by China’s Ministry of Commerce.
Bioeasy subsequently denied that the equipment was faulty, suggesting instead that the Spanish researchers had not correctly followed instructions.
Filipino authorities also said on Saturday they had discarded testing kits imported from China, claiming they had only a 40 per cent rate of accuracy.
“I guess, given the desperate situation, maybe the focus is now on speed, and maybe the process has not been that thorough,” said a European Union source, who asked not be named.
“But this should be a rude awakening not to give up on quality control, or we will be throwing precious scarce resources out of the window and bringing further weaknesses to the system, allowing the virus to expand further.”
The more complex PCR test tries to find genetic sequences of the virus by deploying primers – chemicals or reagents which are added to test if a reaction occurs – that attach to the targeted genetic sequences. The so-called “rapid testing” is also carried out with a nasal swab, and can be done without the subject leaving their car. The sample is then quickly analysed for antigens that would suggest the virus is present.
Leo Poon, head of public health laboratory sciences at Hong Kong University, said PCR testing is “much preferable” to antibody or antigen testing, which can only detect coronavirus once the patient has been infected for at least 10 days.
However, PCR tests are far more complex to develop and manufacture, and with an acute global shortage of quality testing equipment, countries around the world are stocking up on the simpler format.
Part 1