Fifteen private companies have ramped up production of COVID-19 test kits to millions to help meet a major U.S. shortfall in diagnostic capabilities after the Food and Drug Administration (FDA) granted them emergency use approval between March 12 and March 27.
Previously, test kits distributed to state and local labs, which were developed by the U.S. Centers for Disease Control and Prevention (CDC), had faulty components and produced inconclusive results. For more than five weeks after the first U.S. case was confirmed only seven labs in New York had the ability to test for the CCP virus locally. Governors across the country have been pleading for more test kits.
The Epoch Times refers to the novel coronavirus, which causes COVID-19, as the CCP virus because the Chinese Communist Party’s coverup and mismanagement allowed the CCP virus to spread throughout China and create a global pandemic.
However, even with commercial backing and regulatory approvals, limited testing infrastructure at hospitals and the availability of personnel to perform the tests have led to a bottleneck, Severin Schwan, CEO of COVID-19 test kit manufacturer Roche, told Reuters.
Roche, a Swiss-based multinational healthcare company, received an emergency use authorization for its first commercial COVID-19 test from the FDA on March 13, according to a company statement. The company each month can produce millions of tests, which are compatible with 110 of Roche’s fully automated laboratory systems available in the United States, and 717 more around the world, according to a Nasdaq report. The throughput of Roche’s laboratory equipment varies on the model, from 96 results in about 3 hours to 960 results in 8 hours, the statement said.
The company started to ship its test kits to hospitals and laboratories at a rate of 400,000 a week in early March, according to a Nasdaq report.
Schwan said that the testing capacity in hospitals and laboratories, given the number of personnel who can perform testing, is insufficient to test everyone, and doing so may delay the diagnosis time for high-risk patients. Only those representing a high transmission risk and those showing symptoms of the CCP virus should be tested, he added.
Thermo Fisher Scientific
The FDA also issued an emergency use authorization to Thermo Fisher Scientific, an American provisioner for life sciences research, on March 13 for its COVID-19 test kit. Thermo Fisher’s test kit can evaluate up to 94 samples at a time with a four-hour turnaround time, according to a company statement.
The company said it was looking to produce about 2 million tests per week, with plans to ramp up production to 5 million per week during April.
Thermo Fisher CEO Marc Casper told CNBC that its tests kits have been shipped to 200 laboratories across the country to which doctor’s offices or testing centers can send their patient samples.
In addition, the company’s Lithuanian-based subsidiary, Thermo Fisher Scientific Baltics, will be producing test kits to detect COVID-19 in Lithuania, according to a government press release on Monday, reported public broadcaster LRT.
Only some components of the test kits will be manufactured in Lithuania and some will be imported from other countries. The test kits produced in Lithuania are intended for the Lithuanian market, LRT reported.
“This is great news for us, especially given the difficulties we are facing today both in procuring test kits and in bringing them from abroad,” Lithuanian Prime Minister Saulius Skvernelis said, reported Baltic Times.
The capacity of the testing system used in Lithuania will be up to 2,000 tests per day, according to the outlet.
On March 18, the FDA also granted emergency use authorization to healthcare company Abbott Laboratories to sell test kits for COVID-19. Abbott responded by immediately shipping 150,000 test kits and will ramp production to up to 1 million tests per week, according to a company statement.
Abbott’s test kits are manufactured in the United States and are made to be performed on Abbott’s testing equipment that is already installed in 175 hospitals and laboratories across the United States, the statement said. The throughput of Abbott’s test kits are up to 470 tests in 24 hours per machine.
Abbott Chairman and CEO Miles D. White said in the statement, “A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it.”
“This is an example of what people can achieve when they come together in a moment of great need,” John Hackett, divisional vice president of applied research and technology at Abbott, told Reuters.
Isabel van Brugen and Reuters contributed to this report.