Bioeasy stands behind the accuracy of its coronavirus test kits and, in a statement, questioned whether they were being used correctly
How accurate are the SARS-CoV-2 test kits being offered by different in vitro diagnostics companies, as well as the internally-developed COVID-19 tests developed by individual medical laboratories, both here in the United States and in other countries? It’s a question that has not been addressed by the news media nor by healthcare regulators.
That is why a recent news story reported complaints by authorities in several European countries that COVID-19 tests they had purchased were “unreliable.” The source of the COVID-19 test kits was a Chinese company.
On Wednesday, government officials in China announced that manufacturers of test kits for SARS-CoV-2, the novel coronavirus that causes the COVID-19 illness, can no longer export their tests unless China’s National Medical Products Administration (NMPA) has licensed and registered those tests, the South China Morning Post (SCMP) reported.
China issued the new rules after receiving complaints from buyers in Europe about the quality and accuracy of tests kits and other products, including personal protective equipment (PPE), ventilators, and infrared thermometers, SCMP wrote. Previously, Chinese exporters were required only to have CE certification to indicate that their goods conformed to the health and safety standards required for sale in the European Economic Area, SCMP added.
In a joint statement issued March 31, China’s Ministry of Commerce, General Administration of Customs (GAC), and the National Medical Products Administration said the new rule applies to all companies seeking to export test kits, face masks, protective clothing, ventilators, and infrared thermometers.
Spain Discontinues Use of Rapid Diagnostic Tests from Bioeasy
The new rules came after health authorities in Spain stopped using a rapid diagnostic test (RDT) kit that required a nasopharyngeal (NP) swab to collect specimens to diagnose patients for the SARS-CoV-2 virus, saying the test kits from Shenzhen Bioeasy Biotechnology were unreliable. Turkey also rejected the Shenzen Bioeasy test kits after finding similar problems, according to The Middle East Eye. Ukraine and Georgia also bought kits from Bioeasy, according to published reports.
The Spanish Society of Infectious Diseases and Clinical Microbiology found that the Shenzen Bioeasy NP-swab tests had an accuracy rate of less than 30%, SCMP reported.
The low accuracy rate of the Bioeasy coronavirus test kits raises questions about the rapid rate of development for new tests in the United States and worldwide, said Michael Noble, MD, FRCPC, Chair of the University of British Columbia (UBC) Clinical Microbiology Proficiency Testing program and the UBC Program Office for Laboratory Quality Management, in Vancouver.
“There’s an inherent problem with building a test during a crisis,” Noble said in an interview with Dark Daily. “Clinical laboratory test developers are being forced into building tests in a hurry, and the highest likelihood is that they will fail because these tests take a lot of time if the aim is to get them right.
“When a company or a lab feels the need to go too fast, it is likely to take shortcuts,” he added. “And every time a shortcut is taken, an opportunity for error is created.
“Also, the federal Food and Drug Administration (FDA) may be going too fast to issue emergency use authorizations (EUAs). If laboratory test developers and the FDA go too fast, then both could make mistakes,” Noble noted.
Bioeasy Questions Whether Tests are Being Used Correctly
On March 27, SCMP reported that Shenzhen Bioeasy would send new kits to ensure that “patients get the best diagnostics” and to “ensure the test kits’ sensitivity and specificity.” The company also raised questions about whether the tests were used properly and promised to send a video explaining how those administering the tests should collect specimens using NP swabs.
“As it [is a] rapid test kit, following the protocol is very important,” the company added, according to SCMP.
Last week, Zhu Hai, a manager at Shenzen Bioeasy, said reports that the test kits had a low accuracy rate were untrue, SCMP reported. A more detailed explanation would be given via official Chinese government channels, he added.
Shenzen Bioeasy also issued a statement about the tests, saying, “The production export of our CE products to Spain has been done according [to] regulations. All Bioeasy COVID-19 rapid test [kits] are officially CE-IVD approved, so we are free to [export] and sell in [the EU],” SCMP reported.
The company exported 337,000 tests to South Korea and more than 420,000 test kits to at least 10 countries, including Italy, Qatar, and Ukraine, the company added. It had five million such kits under production, the company said.
Spain Purchased More than Half a Million Bioeasy Test Kits
One of the first publications to report the inaccuracy problems was El País, a Spanish language daily newspaper in Madrid.
The Shenzen Bioeasy tests functioned much like pregnancy tests, the newspaper wrote. Once the sample is taken, the NP swab is diluted and placed into a cartridge with a lined test strip showing whether the result is positive, negative, or invalid. “The tests detect the presence of antigen and the result is obtained in 10 or 15 minutes,” El País wrote.
Based in part on a claim that the medical laboratory test kits have an 80% accuracy rate, the government purchased 640,000 kits to screen health workers and the elderly. If the Chinese tests were of sufficient quality, negative or doubtful results would require a confirmatory molecular diagnostics test, the newspaper added.
The Chinese embassy in Spain also responded, saying on Twitter on March 26 that the country’s National Medical Products Administration had not approved the tests, and that they were not included in the medical supplies the Chinese government sent to Spain, SCMP reported. “The Chinese Ministry of Commerce offered Spain a list of approved suppliers, in which Shenzhen Bioeasy Biotechnology was not included,” the embassy added.
After the low accuracy rates were reported, the Spanish government said it ordered €432 million (US$468 million) worth of medical supplies from China, 5.5 million test kits, 550 million face masks, and 950 ventilators, SCMP added. But none of the kits in this order were from Shenzen Bioeasy, the government said.
SCMP quoted Professor Leo Poon Lit-man, BSc, MPhil, DPhil, FFPH, an expert in the SARS-CoV-2 coronavirus who helped design a testing protocol for the COVID-19 illness, and who is a Professor and Division Head of the Division of Public Health Laboratory Sciences at The University of Hong Kong. A claim of 80% accuracy for a test using nasal swabs was perplexing, because such tests are known to be inaccurate, Poon said. “It would be dangerous if it’s used on a large scale, since patients who are supposed to be positive might not be detected,” he added.
Pathologists and clinical laboratory scientists know there are many reasons why a clinical laboratory test can be unreliable or inaccurate. For example, during the production of a batch of tests, one step in the manufacturing process may have gone awry and that problem was not detected before those tests were shipped to a medical laboratory.
Unfortunately, when lab tests are proved to be “unreliable” or inaccurate, the public or the medical laboratory profession seldom learn the reasons for these problems and what steps were taken to resolve them.