MADRID — Mass testing is more than ever a necessity at this stage of COVID-19’s outbreak. But would you trust a testing kit with a 30 percent accuracy rate only? If America launched mass testing on these terms, would you feel safer?
Here in Spain — with the world’s fourth-largest case count at 70,000 — the point is moot. My country’s government returned more than 600,000 flawed kits to its manufacturer, a Chinese company by the name of Shenzhen Bioeasy Technology. So “easy” was the deal that when they bought the kits on Wednesday, Spanish health authorities didn’t seem the least concerned that the company isn’t even permitted to sell them in … China itself.
When microbiologists pre-trialed the kits on a sample of known COVID-19 patients and only 30 percent were accordingly diagnosed, Health Minister Salvador Illa tried covering his department’s back by claiming Bioeasy was licensed to sell kits across the EU — but provided no evidence to prove it. Spain may not be the only victim. The entire world is scrambling to sort the healthy from the ill.
As China keeps flattening its COVID-19 curve, Beijing is playing the world’s altruistic savior while its companies turn a juicy profit by stepping in to meet the demand. “It creates the poison and then sells the cure to it,” China expert Gordon Chang said — it now seems as though the cure isn’t one.
Spain’s purchase was part of a larger $467 million spend on medical equipment for frontline health staff to deal with a rampant inflow of patients and an aimed-for testing rate of 15,000 per day. Rapid test kits like the ones Spain bought take only 15 minutes to churn out a diagnosis, as opposed to real-time polymerase chain reaction tests (RT-PCR), the nurse-intensive, four- to six hour-long procedure undergone to this day.
The Czech Republic has also found itself on the short end of a similar bargain, finding out the 300,000 kits it’d bought this week for $1.83 million to carry out its 900 daily tests were only 20 percent accurate. The EU Medicine Agency’s guidelines, on par with the U.S. Centers for Disease Control and Prevention’s (CDC), require that tests be 80 percent accurate on average.
Spain’s press is reporting that 30 percent of the kits — 20 percent in the Czech Republic’s case — were valid. This is an understatement of the equipment’s defectiveness — likely fed to overworked and time-short reporters by ministry spokespeople looking to play down the disaster. If a certain type of testing kit fails to detect 7 out of every 10 known COVID-19 cases, it doesn’t mean you can somehow trust 30 percent of the kits to work fine.
Testing isn’t exact science, rapid testing even less so. The success rate of a test kit is assessed over a large number of trials and by no means equates to a sure outcome for every individual kit. You may even feed it the same swab sample twice and get two different results. If it shows to be insufficient after the kit has been tried many times, it means that none of the kits are valid, because none can be individually trusted to deliver an accurate result on average. In this case, there were 70 percent false negatives.
Shenzen Bioeasy’s response raises questions, too — a company spokesperson blamed the incorrect results on “a failure to collect samples or use the kits correctly,” adding that the company had not properly communicated with buyers on how the kits worked.
China’s embassy in Madrid cared to concoct an alibi slightly more plausible — but flawed nonetheless. It claims Bioeasy didn’t feature in a list released after the purchase of recommended Chinese suppliers available to Spain’s Health Ministry. Accepting this as an excuse would assume that any medical equipment Chinese firms have exported prior to the official list release is beyond Beijing’s responsibility to quality-control. How reassuring.
To be sure, the blame lies majorly with either Spain, or the EU’s Medical Agency (the bloc’s FDA-equivalent), which may have stealthily relaxed licensing standards to channel necessary medical equipment into Europe. Spain’s Health Ministry may have ceded to the urgency of the moment and placed an order for a batch of testing kits that didn’t meet the EU’s unchanged standards. It initially sought cover stating the purchase had been made by a trusted Spanish supplier, which merely budges the commercial nexus at which the sale occurred.
It also played down the scandal by claiming only 8,000 kits proved defective at first — by the minister’s own admission, the figure turned out to be 58,000, and then 640,000. The purchase was in fact part of a much larger deal to bring in 5 million test kits. Those undelivered as of yet will supposedly be replaced by functional kits, although no hint has been given as to how Bioeasy will meet EU standards this time — does this mean Spain’s COVID-19 preparedness is beholden to Bioeasy’s whims?
On top of the Spanish public’s outrage at both its health authorities and China, the main losers are the health care staff the tests were intended for. Along with scarcity of means and overburdened hospitals, primary care workers are “outraged, incredulous and strained to the limit as they take stock of the flawed test kits scandal,” per a union press release.
The bureaucrats who bought the kits will be duly held accountable for their careless illegality — but China is as much to blame as Bioeasy and the Spanish Health Ministry. Beijing is looking to play the role of world savior by dispatching medical staff and upping equipment sales. Other countries that have turned to China for help include Georgia, Serbia, Ethiopia, Liberia, Iran and Iraq.
But what friendly country allows exports of test kits that it wouldn’t use on its own population? Given the predatory nature of China’s development aid, likening its medical equipment sales to the Belt and Road initiative may turn an accurate parallel.
But when this is all over, ask yourself if China really helped your country flatten its curve.
• Jorge Gonzalez-Gallarza Hernandez (@JorgeGGallarza) is a writer based in Madrid.
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