Antibody tests to saliva-swabs: All you need to know about at-home coronavirus self-assessment kits
Many private companies are touting at-home coronavirus testing as a simpler alternative to conventional lab testing, allowing people to test themselves sitting in the comforts of their homes.
But their path to people's homes is not so rosy. The US Food and Drug Administration (FDA) has not approved any COVID-19 at-home tests yet. Moreover, companies that had launched these tests earlier have now pulled the plug on them, with just firms remaining that are yet to give up.
Meanwhile, in the UK, the government has reportedly announced that Britons can buy these tests from Amazon and Boots and test themselves at home. According to reports, the government has bought 3.5 million finger-prick antibody tests.
Besides, the at-home tests market has been growing. The market was expected to be worth $350 million this year, according to the 2018 Deloitte research.
What are the at-home tests and what are the concerns?
There are two ways of doing it. One, users can test themselves at home using antibody tests, which is expected to be sold in the UK. They work like pregnancy tests but require users to prick themselves for blood. In a couple of minutes, the test will be able to detect antibodies against the virus in the blood. But experts are worried about its accuracy.
There are other concerns too. For example, these antibody tests might produce incorrect results if they are taken too early in the disease. And people may wrongly conclude they did not catch the virus, only to test positive days later.
The FDA has recently approved only one antibody test. They, however, cannot be carried out at home.
The second allows users to collect saliva or swab themselves and mail their samples to the private labs for testing. The labs then look for the virus's RNA.
Concerns are surrounding this method too, including improper sample collection and other types of shipping issues as well. Explaining why sample collection is crucial, Dr Gary LeRoy, president of the American Academy of Family Physicians, told Time that a test is only as good as the specimen. "But most people are not experienced at collecting test samples, and so are likely to get it wrong, he added.
What is the FDA's stance?
The FDA has made its stand clear, it has not approved any at-home tests. “We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,” the FDA said in a statement.
But why? According to Epstein Becker Green, who specializes in FDA and CLIA legal and regulatory matters said the FDA does not regulate these tests for some historical reasons -- a position they have maintained for 30 years. He told STAT that federal agency can, however, reach in and regulate if they need to.
The FDA has concerns over fraudulent tests. Further, the federal agency said it had already identified and issued warning letters to companies found selling and promoting fraudulent items.
Which two companies are selling them in the US?
The two US companies going ahead with their at-home testing kits are Vault Health and MicroGen DX. The latter told STAT that it processes the test results in an accredited lab. Laboratory-developed tests, like MicroGen DX, do not need FDA approval. But the agency has warned that some of them could be faulty,
According to STAT, MicroGen DX tests, which require users to spit into a cup, costs $99. The company has worked on 7,000 tests so far.
The other company, Vault Health asks patients to spit into a tube. Launching on April 13, the tests are expected to cost $150. They told STAT their tests were “provisionally cleared,” but requires oversight from a clinician via video conferencing platforms such as Zoom.
“It’s not an at-home test. It’s a physician ordered, practitioner-monitored, physician-reported test,” Jason Feldman, Vault Health’s chief executive officer, told STAT.