Spain’s health ministry says they’re “defective.” So does Turkey. Now Georgia has canceled its contract. Rapid COVID-19 tests made by Chinese company Bioeasy seemed like a great solution to the coronavirus testing shortage—and the gear was quickly bought up by one government after another. Then the complaints started rolling in, that one of the company’s products is wildly inaccurate.
So how big is the problem? How many more countries are dealing with Bioeasy’s busted COVID tests? And how do COVID-19 tests work?
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Testing time
Spain’s health ministry says that COVID-19 tests it bought from Shenzhen Bioeasy Biotechnology Co are “defective” after El Pais reported that lab tests show the China-made tests are only 30 percent accurate in detecting the virus. Bioeasy makes a number of COVID-19 rapid tests but the ones labeled defective by Spanish health authorities are 10-minute nasal swabs that are supposed to fluoresce in the presence of proteins associated with COVID-19 antigens.
Spanish officials sent the tests back to the company but even despite the apparent failures, Madrid isn’t abandoning the tests altogether and is instead accepting replacements from the company.
Where else? The Daily Beast reviewed Ukrainian public procurement records and found over 34 records of public contracts for a different brand of rapid COVID-19 tests made by Bioeasy. Those tests use blood samples, rather than nasal swabs, to search for the virus and as yet there are no known complaints about the accuracy of those devices. Bioeasy has a Ukraine-based distributor which advertises the antigen fluorescence test which suffered from accuracy issues in Spain but The Daily Beast could not confirm whether any had been sold in Ukraine since the pandemic began.
Health officials in the Czech Republic are also using a Bioeasy antibody-based test for COVID-19 separate from the antigen tests rejected over accuracy concerns.
Explaining to do
Bioeasy did not respond to The Daily Beast’s requests for comment. In a letter to the Spanish government obtained by Spanish news outlets, Bioeasy defended itself by pointing out its record of shipping thousands of tests to countries across Europe, the Middle East, and Asia, but it’s unclear from the letter whether the claim refers to COVID-19 tests or the specific model of antigen test rejected by Spain—and other European countries (more about that in a bit).
In a statement issued to Chinese-language media, the company appeared to blame Spanish officials for using the tests incorrectly.
“During the process of sampling and sample extraction, [entities in] Spain may not have strictly followed the operational instructions, leading to reduced accuracy in [COVID-19] detection. At present, the Spanish ministry of health has stated that it will maintain and continue with the [business] agreement with Bioeasy,” the company wrote on its WeChat account.
In the meantime, China’s Shenzhen Municipal Market Supervision Administration has reportedly launched an investigation into the company.
Diplomatic incident
The testing scandal briefly rattled China’s international aid efforts as Beijing has tried to position itself as a leader in responding to the pandemic. The Chinese government and Alibaba founder Jack Ma have donated medical supplies to Spain, which has suffered heavily from the pandemic, with nearly 5,000 dead and 64,000 infected from the virus.
Both the Chinese embassy in Spain and the Spanish government have emphasized that the Bioeasy tests were separate from Ma and Beijing’s aid deliveries, which included no test kits from the company. Bioeasy, the Chinese embassy emphasized, was not licensed to sell medical products within China.
The company is licensed to sell COVID-19 medical within the European Union, and the EU certified at least five separate tests made by Bioeasy, according to documents released by the Spanish government. Spanish officials say they purchased the tests from a domestic vendor rather than directly from Bioeasy itself.
Thumbs down
Turkey may have confirmed the same failures within Bioeasy’s tests, according to a report from Middle East Eye. Turkish officials told the outlet that the government “received some samples” of Bioeasy’s tests but didn’t find them “viable” and ordered separate tests from a different company. In a nod to Spain’s findings, Turkish officials told Middle East Eye that they too found the tests accurately detected COVID-19 around 30-35 percent of the time.
The Georgian government also announced that it was suspending an agreement with Bioeasy to purchase tests following the accuracy complaints from Spain. Ekaterine Tikaradze, the country’s health minister, said Georgia is looking to buy new tests from a different vendor.
Testing mechanics
So how do COVID-19 tests work and what kinds of tests are available? There are three kinds of tests that laboratories can use for finding viruses like the flu and COVID-19—polymerase chain reaction (PCR) tests, antigen tests, and antibody tests—each with different use cases and tradeoffs involved.
The tests used in the U.S. so far are almost all PCR tests. “It looks for the genetic material for the coronavirus. It will be positive before your symptoms start. It finds the virus circulating in your body. Those tend to be very sensitive because they’re genetic based tastes and they’re looking for that genetic material,” Dr. Brian Labus, an assistant professor at UNLV’s school of public health, told The Daily Beast.
PCR tests are the most accurate but generally require a lab to process the result, which can lead to delays in getting results when there’s a large number of tests and a fixed number of labs to run them.
The other two tests, antigen and antibody, work a little differently. Instead of looking for the virus itself, those tests look for subtle clues the virus leaves behind in your body in order to confirm an infection.
Antigen tests confirm a viral infection by hunting for telltale proteins left behind by the virus, known as antigens. “It’s looking for little chunks of the virus that aren’t the virus’s genetic material,” said Labus. “They’re not as good at finding things because they’re not looking for a specific genetic code. They’re looking for a protein and those tests generally have a lower sensitivity and specificity than a PCR test.”
Finally, antibody tests rely on your body’s production of virus-fighting proteins called antibodies. These are the tiny little compounds that help you get better once infected, but since it relies on an immune response, there can be a lag. “An antibody test is only usually useful late in the infection or after the infection depending on what it is. You can test too early with an antibody test and just miss it,” according to Labus.
Not all tests
Even with the known sensitivity problems associated with antigen tests like the ones purchased by the Spanish government, the 30 percent accuracy rate El Pais found on the Bioeasy tests is still far short of commercial standards. By comparison, in the U.S. the FDA requires that rapid antigen tests for the common flu virus have a sensitivity rate of at least 80 percent.
In the case of the Czech Republic, the issue with their testing accuracy complaints may be more complex. Czech news outlets reported that healthcare workers were using Bioeasy antibody tests. Since antibody tests can only detect a COVID-19 infection once the body has begun to fight the virus with antibodies, that could explain why the Bioeasy antibody tests were unable to correctly detect the virus in a large number of asymptomatic patients. Antibody tests aren’t designed to catch viruses in asymptomatic patients and Czech authorities reportedly told health care workers to expect those kinds of problems before distributing the tests.
—with additional reporting from Brendon Hong
