(Reuters) – US manufacturers are steadily increasing production of cheaper, faster – but less accurate – COVID-19 tests, aimed at 100 million per month by the end of the year, significantly testing schools and workplaces. Will enable to expand.
Manufacturing and government sources tell Reuters that more than half a dozen so-called antigen tests will be authorized by the end of October. In recent months US regulators have authorized antigen tests from Abbott Laboratories, Becton Dickinson & Co, Quid Corp and Lumirax.
When planned production of newly authorized tests is combined with previously approved diagnostics, the total monthly US testing capacity will exceed 200 million per month by the end of the year, these sources said.
Manufacturers of recently approved antigen tests have the potential to make about 40 million per month, but more than doubled by the end of the year, according to a Reuters analysis, which includes proprietary figures shared by companies have hope.
Unlike $ 100 and currently molecular diagnostics dominate US testing that must be sent to a laboratory and often takes several days for results, antigen tests can cost as little as $ 5. They can be performed anywhere and produce results in minutes.
Regular screening in schools and even heterogeneous people is likely to be an important tool for future outbreaks, experts said.
“If we can test on a scale where anyone you want to test can test in a quick and cheap way with quick rebound time (for results), you can screen people “Before they spread the virus,” said Dwayne Bracing, director of the lab, at Northwell Health, New York State’s largest hospital system.
He said that lab-based molecular testing is very difficult to make and deploy at that level.
Antigen tests detect some proteins that are part of the virus from samples taken through nasal or throat respiratory, similar to rapid tests for strep throat in the doctor’s office.
The onset of the epidemic lacks test capacity and little federal coordination to control the spread of the virus that infects more than 6 million people in the United States.
Nevertheless, regulators and health experts are concerned about antigen test reliability. They typically detect the virus approximately 80% to 90% of the time, well below the 95% rate of lab-based tests. Incorrect negative results increase the likelihood that sick people may inadvertently spread COVID-19.
There is also not enough data to ensure that new tests can detect viruses when infected people are in the early, pre-symptomatic stage, possibly limiting their usefulness.
According to data from the University of Oxford, the US conducted about 25 million tests in August, including lab and antigen tests. Antigen test makers and their suppliers are gearing up for a huge lead.
Biodot Inc. chief executive Tony Lemmo, who makes dispensers of chemicals used in the tests, says he has recently received orders that will turn into some 500 million trials in the coming months.
The United States may have the capacity to perform 3 million coronavirus tests per day this month, about half of them antigen tests. The monthly test could climb to 135 million in October, a top health official told a US Congress panel on Wednesday.
European diagnostics companies Roach Holding AG and Quizen NV have stated that they will apply to the US authority for their antigen tests.
The National Institutes of Health is working with companies on new tests that will likely add 30 million tests per month to overall capacity this year, a US official told Reuters. The agency also provided a grant in July to help Quid increase construction capacity, including $ 71 million.
US officials, who were not authorized to speak publicly, told Reuters that testing 100 million a month by the end of the year could potentially slip by a few months due to production challenges.
To make the ramp, companies need to hire enough skilled workers and the paper used in the tests, called nitrocellulose, the official said.
“That’s all that’s needed to go from zero to millions of tests,” said Kwid CEO Douglas Bryant, whose company is working with large US universities on daily testing of student athletes.
College football teams at the Big Ten Conference will use antigen testing after the announcement on Wednesday, which will proceed with the games starting next month.
Nursing homes are using Becton Dickinson’s antigen tests for screening residents and staff through a government program.
Even if the examinees are successful in increasing production, tests, officials and officials said that the capacity will remain tight for some time.
Quid has prioritized customer requests for its tests, Bryant said, with healthcare facilities and schools near the top, and industries such as tourism being in the front row.
Reporting by Carl O’Donnell; Editing by Caroline Humer and Bill Burcott