Shortages threaten Trump’s plan for rapid coronavirus testing

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Other rapid tests on the market – like Abbott’s ID Now and Cepheid’s Xpert Xpress, which don’t use antigen technology – are still hard to come by. Abbott chairman and chief executive 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 antigen testing are already causing confusion and frustration.

Katie Smith Sloan, CEO of LeadingAge, an association of nonprofit aging service providers, said nursing homes were unsure how many tests they could buy.

“When our colleagues spoke to distributors, they simply said that it could be months before sufficient testing supplies are available,” she said.

States, which have spent months searching for protective gear and testing supplies on the open market, are now vying for rapid testing. A bipartisan group of seven governors said on Tuesday they would jointly buy 3.5 million antigen tests from the only two companies now authorized to sell them – in hopes of creating an incentive for test makers to step up production .

The Trump administration announced last month that it would send antigen testing supplies, including the instruments that analyze the samples, to each of the country’s more than 15,000 nursing homes. The plan was to start with installations in hot spots. But there was a catch: Each nursing home would receive 900 to 150 tests depending on its size – and it could take up to three months to arrive. Once nursing homes run out of federal mailings, they would have to purchase more tests themselves.

Giroir recently told POLITICO that he was not afraid to fight states for rare antigen testing supplies because the federal government could use its “priority purchasing authority” and simply skip the line. He also said recent federal investments to help two antigen test makers, BD and Qiagen, increase their production capacity should soon pay off.

Other companies are trying to enter the antigen testing 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 that it plans to seek emergency clearance from the Food and Drug Administration in October at the earliest. If the agency gives the green light to the test, 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 tests become more available, they will need to be deployed with care, so as to account for the increased risk of false negatives compared to tests analyzed in the lab.

The FDA expects any coronavirus test ordered by a healthcare provider – a category that includes antigen tests currently on the market – to be able to correctly detect the virus at least 80 percent of the time. More complex PCR tests that must be analyzed by laboratories should detect at least 95% of positive samples.

Some in the nursing home industry are already sounding the alarm about the risks of using faster, but less accurate, antigen testing.

“In a nursing home, a false negative test would spell disaster,” said Jabbar Fazeli, a spokesperson for the Maine Association of Medical Directors who also oversees medical care at several nursing homes in Maine. Fazeli, a geriatric doctor, advises the three homes he supervises against using the tests.

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