COVID-19 rapid home tests are fast, but the regulatory approval needed to put them in the hands of Americans has been delayed.
Why does it matter: Rapid COVID-19 home tests could make a vital contribution to extinguishing the pandemic – and could open a new frontier for more consistent surveillance of the disease – but old assumptions about how diagnoses should be used prevent them.
News management: On Wednesday, the Biden administration unveiled a $ 1.6 billion plan to accelerate COVID-19 testing in schools and other settings, strengthen supply chains for testing materials, and improve sequential genetic surveillance.
- “We don’t have enough tests yet and we don’t have enough tests in all the places they need to be,” Cariden Johnson, Biden’s test coordinator, told reporters.
By numbers: The number of COVID-19 tests performed per day in the US has dropped by about 30% from its peak a month ago.
- The United States has conducted about 340 million tests in total – just over one per person during the pandemic for nearly a year.
Part of this dive it is probably due to the declining number of cases. But for proponents of rapid home tests, the decline also indicates problems with how we use the tests – and the type of tests that have been approved.
- COVID-19 tests have been used mostly to diagnose people who may be ill, and most of the tests that have been approved use highly accurate, but often intensive, PCR methods that require people to go to clinics.
- The logistics and manufacturing and execution costs of massive quantities of PCR tests make it difficult to constantly examine the population – just how cheap and fast COVID-19 tests could be used at home.
Context: Innova in Pasadena, California, produces COVID-19 tests that cost less than $ 5 and easily runs a home pregnancy test, with results in 15-30 minutes.
- For months, Innova has sent millions of these tests to the UK, where they have been used as part of Prime Minister Boris Johnson’s “month” mass testing program. Innova CEO Daniel Elliott says the company can currently do 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 (EUA) required for wide distribution, a status it shares with many other full-speed home tests. , 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,” says Elliott. “We are used to analyzing tests as being close to the lab and there is not as much experience in such a useful test that is useful for different purposes.”
How it works: Quick tests, such as searching for Innova for a specific viral protein called an antigen.
- Antigenic tests are less accurate than PCR. A study by Innova found that its test correctly identified 78.8% of cases in a group of 198 samples, compared to laboratory PCR results, a lower rate that can lead to more false positives and negatives. .
- But proponents of rapid tests say the tests are particularly good at identifying people who are infected with 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 are they saying: “We consider home use testing to be a top priority,” Jeffrey Shuren, a top FDA official overseeing testing, told The Hill recently.
- The FDA recently awarded a EUA to a full home test produced by Ellume, which reported extremely accurate results, although at a potential price of $ 30 or less, it would cost more to expand.
The other side: Some experts – including in the UK, where rapid testing is more widespread – worry that ordinary people will misinterpret tests, further eroding their accuracy and giving them a false sense of security.
- But similar fears raised when home pregnancy tests were first made available never materialized, and proponents believe that rapid screening could be used to “use this technology for other home tests in future “, according to Gauss’ CEO, Siddarth Satish.
Bottom line: The US healthcare system is set up to provide the highest quality healthcare – often at the same high prices – but COVID-19 testing is an area where fast and cheap can be the right approach in a real emergency. .