Quick tests of COVID-19 at home are fast, but the regulatory approval needed to get them into the hands of Americans has taken a long time to arrive.
Why it’s important: Rapid and comprehensive home testing of COVID-19 could make a vital contribution to curbing the pandemic and opening a new frontier for more consistent disease surveillance, but old assumptions about how diagnoses should be used brake.
Leading the news: On Wednesday, the Biden administration unveiled a $ 1.6 billion plan to accelerate COVID-19 testing in schools and other environments, strengthen supply chains to test materials, and improve genetic sequencing surveillance.
- “We don’t have enough evidence yet and we don’t have enough in all the places you need,” Biden testing coordinator Carole Johnson told reporters.
By numbers: The number of COVID-19 tests performed a day in the US has dropped by about 30% from the peak a month ago.
- The United States has conducted about 340 million tests in total, just over one per person during the nearly one-year pandemic.
Part of that dive probably due to the decrease in the number of cases. But for proponents of rapid testing at home, the fall also points to problems in the way we use testing and the type of testing passed.
- COVID-19 tests have been used primarily to diagnose people who may be ill, and most approved tests use highly accurate but often labor-intensive PCR methods, which require people to travel to clinics. .
- The logistics and manufacturing costs and execution of massive amounts of PCR tests make it difficult to constantly detect the population, which is precisely the cheapest and fastest way to do COVID-19 tests at home.
Context: Innova, based in Pasadena, California, produces COVID-19 tests that cost less than $ 5 and work with the ease of a home pregnancy test, giving results in 15-30 minutes.
- For months, Innova has sent millions of these tests to the United Kingdom, where they have been used as part of Prime Minister Boris Johnson’s “first moonlight” testing program. Innova CEO Daniel Elliott says the company can currently manufacture 15 million test kits a day, with plans to expand to 50 million a day by summer.
- But Innova’s rapid test, which was first submitted to the FDA for approval in August, has not yet received the emergency use authorization (US) needed for wide distribution. , a state he shares with many other complete quick tests at home, such as one developed by Gauss and Cellex that uses a smartphone to interpret the results.
- “The FDA has been a bit of a challenge,” Elliott says. “We are used to considering the tests as if they were practically laboratory and there is not so much experience in a kind of test so extensive that it is useful for different purposes.”
How it works: Rapid tests, such as Innova’s search for a specific viral protein called an antigen.
- Antigen testing is less accurate than PCR. An Innova study found that its test correctly identified 78.8% of cases in a group of 198 samples compared to laboratory-based PCR results, a lower rate that can lead to more false positives. and negatives.
- But proponents of rapid testing say the evidence is especially good at identifying people who are in a contagious state of their disease.
- That, combined with their superior ability to frequently test large numbers of people, it makes them a “public health tool to suppress outbreaks,” according to Michael Mina, an epidemiologist at Harvard TH Chan School of Public Health.
What they say: “We consider testing for home use to be a top priority,” Jeffrey Shuren, one of the top FDA officials who oversaw the testing, recently told The Hill. “And if they have their data and the data looks good, we authorize it.”
- Recently, the FDA granted a U.S. to a fully in-house test produced by Ellume that reported very accurate results, although with a potential price of $ 30 or less, it would cost more to raise.
The other side: Some experts, including those in the UK, where rapid testing is more widespread, worry that normal people will misread the evidence, further eroding its accuracy and giving them a false sense of security.
- But similar fears that occurred when home pregnancy tests were made available never materialized and proponents believe that rapid screening could be used to “leverage this technology for other home tests in the future, “according to Gauss CEO Siddarth Satish.
The summary: The U.S. healthcare system is set up to provide the highest quality care, often at equally high prices, but COVID-19 testing is an area where speed and economy can be the right focus in a real emergency.