Other rapid tests on the market — like Abbott’s ID Now and Cepheid’s Xpert Xpress, which do not use antigen technology — are still hard to come by. Abbott President and CEO Robert Ford told investors in July that the company is working to expand production of its rapid test kits to more than 50,000 per day.
Meanwhile, shortages of the antigen tests are already causing confusion and frustration.
Katie Smith Sloan, president and CEO of LeadingAge, an association of nonprofit providers of aging services, said nursing homes are in the dark about how many tests they’ll be able to purchase.
“When our colleagues have talked to distributors, they have simply said that it could be months before ample testing supplies are available,” she said.
States, which have spent months scrambling for protective equipment and testing supplies on the open market, are now competing for the rapid tests. A bipartisan group of seven governors said Tuesday that they would jointly purchase 3.5 million antigen tests from the only two companies now authorized to sell them — in the hopes of creating an incentive for test makers to ramp up production.
The Trump administration announced last month that it would send antigen test supplies, including the instruments that analyze samples, to each of the nation’s 15,000-plus nursing homes. The plan was to start with facilities in hot spots. But it had a catch: Each nursing home would get anywhere from 900 to 150 tests depending on its size — and they could take up to three months to arrive. Once the nursing homes exhausted the federal shipments, they’d need to purchase more tests on their own.
Giroir recently told POLITICO he wasn’t worried about jockeying with states for scarce antigen testing supplies because the federal government could use its “priority authority to purchase” and simply jump the line. He also said that recent federal investments aimed at helping the two antigen test-makers, BD and Qiagen, increase production capacity should soon pay off.
Other companies are trying to enter the antigen test market. OraSure Technologies is developing an over-the-counter antigen test that people could take without a prescription from a health care provider. The company said this week it expects to apply for Food and Drug Administration emergency authorization in October at the earliest. If the agency gives the test a green light, OraSure CEO Stephen Tang said the company could produce them at a rate equivalent to 55 million per year by early 2021.
But even if the tests become more available, they’ll have to be deployed carefully, in ways that account for the increased risk of false negatives compared with tests analyzed in labs.
The FDA expects any coronavirus test prescribed by a health care provider — a category that includes antigen tests now on the market — should be able to correctly detect the virus at least 80 percent of the time. The more complex PCR tests that must be analyzed by labs are expected to spot at least 95 percent of positive samples.
Some in the nursing home industry are already raising alarm bells about the risks of going with faster, but less accurate, antigen tests.
“In a nursing home, a false negative test would spell disaster,” said Jabbar Fazeli, a spokesperson for the Maine Medical Directors Association who also oversees medical care in several Maine nursing homes. Fazeli, a geriatric medicine physician, is advising the three homes he supervises against using the tests.