Other rapid tests on the market – such as Abbott’s ID Now and Cepheid’s Xpert Xpress, which do not use antigen technology – are still scarce. Abbott President and CEO Robert Ford told investors in July that the company was working to expand production of its rapid test kits to more than 50,000 a day.
Meanwhile, deficiencies in antigen testing 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 will be able to buy.
“When our colleagues talked to distributors, they simply said it could be months before enough testing supplies are available,” she said.
States, which have spent months on protective equipment and testing supplies on the open market, are now competing for rapid testing. A bilingual group of seven executives said Tuesday that they had purchased a total of 3.5 million antigen tests from the only two companies now authorized to sell them – hoping to create an incentive for test makers to clean up production .
The Trump administration announced last month that it would send antigen test items, including the instruments that analyze samples, to each of the nation’s 15,000-plus nursing homes. The plan was to start with facilities at hot spots. But it had a catch: Each nursing home would get anywhere from 900 to 150 tests, depending on the size – and they could take up to three months to arrive. Once the nursing homes had exaggerated the federal shipments, they would have to buy more tests on themselves.
Giroir recently told POLITICO that he was not worried about jockeys with states for deliveries of scarce antigens because the federal government could “buy” his priority authority and just jumped the line. He also said that recent federal investments aimed at helping the two anti-test makers, BD and Qiagen, increase production capacity will soon pay off.
Other companies are trying to enter the antitrust market. OraSure Technologies is developing an over-the-counter antigen test that humans can take without a prescription from a healthcare provider. The company said this week that it expects to apply in advance for emergency authorization for the Food and Drug Administration in October. If the agency gives the test a green light, OraSure CEO Stephen Tang said the company could produce them by early 2021 at a rate equivalent to $ 55 million a year.
But even as the tests become more available, they will need to be deployed carefully, in ways that account for the increased risk of false negatives compared to tests analyzed in labs.
The FDA expects that every coronavirus test prescribed by a healthcare provider – a category that includes antigen tests currently on the market – should be able to detect the virus at least 80 percent of the time. The more complex PCR tests that need to be analyzed by labs are expected to show at least 95 percent of positive samples.
Some in the nursing home industry are already raising alarm bells about the risks of dealing with faster, but less accurate, antigen tests.
“In a nursing home, a false negative test would destroy disaster,” said Jabbar Fazeli, a spokesman for the Maine Medical Director Association, which also oversees medical care in several Maine nursing homes. Fazeli, a doctor of geriatric medicine, advises the three houses he oversees against the use of the tests.
