COVID-19’s quick home tests are quick, but the regulatory approval needed to put them in the hands of Americans was slow to arrive.
Why does it matter: Rapid COVID-19 tests at home can make a vital contribution to containing the pandemic – and opening a new frontier for more constant surveillance of the disease – but old assumptions about how the diagnosis should be used are preventing them.
Driving the news: On Wednesday, the Biden administration unveiled a $ 1.6 billion plan to accelerate COVID-19 testing in schools and other settings, strengthen test material supply chains and improve surveillance of genetic sequencing.
- “We don’t have enough tests yet, and we don’t have enough tests everywhere they need to be,” Biden test coordinator Carole Johnson told reporters.
By the numbers: The number of COVID-19 tests performed per day in the United States has dropped about 30% from a peak a month ago.
- The United States performed around 340 million tests in total – just over one per person during the nearly one year pandemic.
A little bit of that dive it is probably due to the decrease in the number of cases. But for proponents of rapid home tests, the drop also points to problems in how we use the tests – and the type of tests that have passed.
- COVID-19 tests have been used primarily for the purpose of diagnosing people who may be ill, and most of the tests that have passed employ highly accurate but often laborious PCR methods that require people to travel to clinics.
- The logistics and costs of manufacturing and executing large amounts of PCR tests make it difficult to constantly screen the population – which is exactly how much cheaper and faster home COVID-19 tests could be employed.
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, yielding results in 15–30 minutes.
- For months, Innova sent millions of these tests to the UK, where they were used as part of Prime Minister Boris Johnson’s “moonshot” mass testing program. Innova CEO Daniel Elliott says the company can currently make 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 yet to receive the emergency use authorization (US) required for wide distribution, a status it shares with many other rapid tests entirely at home, as a developed by Gauss and Cellex who uses a smartphone to interpret the results.
- “The FDA has been a challenge,” said Elliott. “We are used to seeing the tests almost like in the laboratory, and there is simply not so much experience with a type of test so broad that it is useful for different purposes.”
How it works: Rapid tests like Innova’s search for a specific viral protein called an antigen.
- Antigen tests are 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 result in more false positives and negatives.
- But proponents of rapid tests say the tests are especially good for identifying people who are in the contagious state of the disease.
- What, combined with their superior ability to frequently test large numbers of people, makes them a “public health tool for suppressing outbreaks,” according to Michael Mina, an epidemiologist at the Harvard TH Chan School of Public Health.
What they are saying: “We consider testing for home use to be a top priority,” Jeffrey Shuren, a senior FDA official who oversees testing, told The Hill recently. “And if they have your data and the data looks good, we authorize it.”
- The FDA recently awarded a USA for a fully homemade test produced by Ellume that reported highly accurate results, although at a potential price of $ 30 or less, it would cost more to scale up.
The other side: Some experts – including in the UK, where rapid tests are more widespread – fear that ordinary people will misinterpret the tests, further undermining their accuracy, and that would give them a false sense of security.
- But similar fears that arose when home pregnancy tests were first made available never materialized, and advocates believe that rapid screening could be used to “leverage this technology for other home tests in the future,” according to the CEO of Gauss. , Siddarth Satish.
The end result: The US healthcare system is set up to provide the highest quality care – often at equally high prices – but the COVID-19 test is an area where quick and cheap can be the right approach in a real emergency.