Can’t find a COVID quick test? Why they are so hard to find
Is it a tickle in the COVID-19 nose, or just a cold? Answering this question has proven difficult as Americans struggle to access coronavirus testing across the country.
Rapid at-home antigen tests sell for three times the retail price in some digital markets. Test sites in LA County have been swamped with long lines of miles, with some events being canceled due to traffic. Some would-be self-testers resigned themselves to driving between the CVS and Walgreens locations, hoping to get a reasonably priced kit.
Businesses are racing to meet excess demand.
Abbott Laboratories, which makes the BinaxNOW rapid antigen test, plans to produce 70 million tests this month and is working to bring that number to 100 million, said CEO Robert Ford.
In February, San Diego-based Quidel opened a manufacturing facility in Carlsbad with a capacity of 600 million tests per year.
Considering that the United States has been experiencing waves of COVID for almost two years, you might be wondering: how did we get into this situation? The Times spoke with public health experts to understand what is causing the shortfall and what could be done to avoid it next time around.
Who does rapid home antigenic testing?
The Centers for Disease Control and Prevention has authorized at least 12 rapid antigenic tests that can be done at home without a prescription. Half were approved between October and December.
The first to be approved were tests produced by Abbott Laboratories and Quidel Corp., which received emergency use approvals from the Food and Drug Administration in March 2021.
Abbott’s tests alone account for about 75% of retail sales in the United States, according to an October results call. For the third quarter of 2021, Abbott reported a 23.4% year-over-year revenue gain, largely driven by $ 1.9 billion in global test sales. Coronavirus testing accounted for $ 510 million of Quidel’s roughly $ 635 million in fourth quarter revenue.
So why aren’t they doing enough testing?
Bob Kocher, who co-led the California COVID-19 Testing Task Force, said the shortage of rapid tests ultimately resulted in a failure to anticipate demand.
“If you are a test maker, you have been reluctant to do tests that you are unsure of selling,” said Kocher, a physician and venture capitalist who served in the Obama administration as as special assistant to the president in charge of health and economic policy. “And if you go back a few months, before you had Omicron and even Delta, it felt like okay, we have a low number of cases in America, we are vaccinating people and COVID could go away.”
During this time, Abbott closed two production lines and closed a manufacturing plant. The shelf life of most rapid antigenic tests ranges from a few months to a year.
“The question is, is the government or someone willing to pay them and take the risk that you don’t use them?” Because the manufacturers don’t want to do that, ”Kocher said.
Why does the demand for home testing seem so much higher than it was in previous surges?
Perhaps because in previous waves the emphasis was on social distancing, masking, and ultimately vaccination as keys to blocking transmission of the virus.
“We were all hoping at some point earlier in , maybe just a year ago, this vaccination was going to be the answer, ”said Mara Aspinall, healthcare industry leader and professor at Arizona State University College of Health Solutions.
In the past year, vaccines have been shown to be very effective in preventing hospitalizations and deaths from COVID-19 – but the coronavirus has shown that it can evolve to be highly transmissible even in vaccinated and cautious people. With the Omicron and Delta variants causing new infections, the transmission rate in Los Angeles County is now estimated to be higher than at any time since the early months of the pandemic.
“So when you think of testing, why are we testing? We’re not just testing to count the number of people, we’re testing to slow the spread of disease, ”Aspinall said.
Is government bureaucracy a factor in scarcity?
Many have singled out the FDA for its slow approval of rapid antigenic testing at the start of the pandemic.
In March, consulting firm Booz Allen Hamilton conducted an independent review of the emergency use authorization process, which allows the agency to quickly approve medical devices and treatments in the event of a health emergency. public.
The firm found that the median number of days it took the agency to render a decision fell from 29 in April 2019 to 99 in November 2020. Refusals took up to 186 days for claims submitted in April 2020.
The director of the FDA office that authorizes the testing, Tim Stenzel, told ProPublica the office received many incomplete or bad data applications, and any delays were due to close scrutiny.
Kocher said the tests submitted at the start just don’t work well enough.
The FDA was getting a lot of “bad tests,” he said.
But Michael Mina, epidemiologist and scientific director of digital healthcare company eMed, said the FDA had set unrealistic standards for rapid antigenic testing that were inconsistent with the goal of rapid and frequent testing.
The FDA has asked companies to demonstrate that their rapid antigen tests are almost as sensitive as PCR tests, which can return a positive test for more than a month after infection by detecting the presence of any amount of material. genetics of the virus.
But antigen tests – which look for the presence of proteins on the surface of the virus – are specific to when a person is infectious and should only be positive when the person has a high viral load in their nose and throat, which does not last. sometimes only about six days, says Mina.
“The reality is, [the FDA is] ask for a mathematical impossibility unless the company intentionally skews the participants in their trial and very carefully selects or selects the participants who will join their clinical trial, ”said Mina.
This process is expensive and ultimately does not provide any useful data to the agency, Mina said. It also doesn’t make sense, given the reasons most Americans use rapid tests.
“They use them to ensure the safety of those around them, to ask the question: am I contagious right now? Am I a risk for my grandmother, am I a risk for my neighbors? Mina said.
Is there anything the government can do about this now?
In December, the Biden administration announced plans to purchase 500 million home test kits and send them free to Americans who want them starting this month.
Public health officials say the move comes too late, with Omicron’s push already well underway.
“All of these are reactive and not proactive,” said Aditi Nerurkar, a physician at Harvard Medical School. “It’s a wonderful idea to have a website and a central clearinghouse for people to get testing, but it should have happened in October, not January. “
In LA County, a free email PCR testing program that could deliver results within about four days was suspended Wednesday “due to the current backlog in kit processing logistics,” said county officials said.
Aspinall called the next three months “essential” for rapid testing, as the outbreak coincides with the return of the traditional flu season which was largely non-existent last year due to social distancing measures and masking.
Do other countries have the same problem?
It’s not just the United States – the demand for rapid antigenic testing is skyrocketing around the world. Obtaining the tests is becoming increasingly difficult in European countries, leading stores to limit the number of tests that each customer can purchase.
The shortage is however partially mitigated by the number of test manufacturers; At least 36 self-administered rapid antigen tests are approved for use according to standards set by the European Union, according to an Arizona State University database.
Tests are also cheaper and more easily accessible in some European countries, thanks to strong pre-existing public health systems. In the UK and Germany, the government has been purchasing hundreds of millions of home test kits for months to distribute free to its citizens, although Germany ended its program in October to focus on immunization people.
“In a pandemic, having this system… has helped lower the cost of distribution and make the process easier,” said Aspinall, with regard to the hurdles the US federal government faces in distributing the 500 million free tests.