At this point in the pandemic, rapid antigen and molecular tests were supposed to be ubiquitous and cheap.
Almost from the beginning, federal officials, including former President Donald Trump, touted the advantages of rapid tests, such as those made by medical giant Abbott Laboratories.
Dr. Michael Mina, an epidemiologist, immunologist and former professor at the Harvard T. H. Chan School of Public Health, has argued for months that rapid antigen tests are the country’s way out of the pandemic.
But at community testing sites across Colorado, testing contractor COVIDCheck Colorado and the state’s Department of Public Health and Environment have phased out rapid CUE molecular testing.
In its place, testing sites have returned to only free PCR testing.
With the phasing out of rapid testing at community sites, public health officials have lost a key tool as the state experiences a crushing surge in COVID-19 cases.
“While we are going into what appears to be a significant winter surge here in Colorado, we are still in a position where we just simply don’t have widespread access to rapid testing,” said Liane Jollon, executive director of San Juan Basin Public Health.
“We think that (rapid testing) would add to the toolbox of ways that we can contain disease,” she said.
In May 2020, the U.S. Food and Drug Administration announced it had authorized the first antigen test, which could help public health officials track the spread of the coronavirus.
“Antigen tests are also important in the overall response against COVID-19, as they can generally be produced at a lower cost than PCR tests, and once multiple manufacturers enter the market, can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time,” said former FDA Commissioner Dr. Stephen Hahn and Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release.
Since May 2020, the FDA has authorized 40 antigen tests, which detect proteins from the virus rather than genetic material, about a quarter of which are over-the-counter at-home tests.
At-home diagnostics have been a particular focus of federal and state testing efforts, the logic being that cheap, accessible tests will help Americans frequently screen themselves and limit transmission.
The Biden administration made free, rapid at-home tests a pillar of the president’s COVID-19 Action Plan. And the state announced in September that CDPHE would start a free, rapid at-home testing program in which Coloradans could request tests and the state would ship them to their home.
Yet, while the FDA has authorized a number of rapid at-home tests and governments have keyed in on the public health tools, they have remained in short supply and difficult to find across the country.
A recent study by the Kaiser Family Foundation found that the FDA’s regulatory framework, the federal government’s lack of initial investment, evolving messaging and guidance, the cost of over-the-counter at-home rapid tests, and the unpredictability of supply chains and demand have all limited the availability and access to rapid testing.
Some have argued that economics and profits have played an outsized role in rapid testing shortages.
The New York Times reported in August that Abbott Laboratories told a production factory to destroy tests after demand slouched with lower case rates.
In mid-September, San Juan Basin Public Health announced that community testing sites operated by COVIDCheck Colorado and CDPHE would phase out their use of CUE rapid tests by the middle of October.
“COVIDCheck Colorado has decided in coordination with CDPHE to cease offering the CUE COVID-19 tests in an effort to mitigate significant logistical and operational challenges experienced by staff,” the news release said.
A few days later, Gov. Jared Polis announced the state would send residents free at-home rapid tests.
A spokeswoman for CDPHE said in an email that the state, which purchased 2 million Abbott BinaxNOW rapid antigen tests in September and another 500,000 earlier this month, had no supply issues with its at-home testing program.
The state receives 97,768 per week and has shipped 907,470 over-the-counter tests as of Monday, the spokeswoman said.
According to Jollon, people would ideally test multiple times every week to more closely monitor transmission.
“That is a strategy that we are seeing some other countries develop, and (that) has been talked about in the U.S., but we are not there yet,” she said. “We are relying by and large on a more expensive diagnostic test to direct our disease containment strategies.
“If we had wider availability of rapid testing, we could develop disease control strategies that include everyone at a school or a workplace testing frequently,” she said. “That would require a tremendous amount of inexpensive, widely available rapid testing.”
By these standards, CDPHE’s testing program, while successful, falls short.
The total 907,470 BinaxNOW tests shipped, which includes two per box, would not even allow all Coloradans to test themselves once.
At Colorado community testing sites, PCR tests remain the only tool, leaving local public health officials wondering if rapid testing will be available anytime soon.
“The quicker the results come in, the better it is for us,” Jollon said. “We would love to see more rapid testing available.”
Traditional PCR tests are diagnostic tools that confirm disease and allow doctors to treat patients.
“That is the take-it-to-the-bank test for which we know for sure you had it,” said Dr. May Chu, a clinical professor at the Colorado School of Public Health.
“The PCR test is really a key diagnostic test,” she said. “We identify a patient and whether that patient needs treatment.”
But PCR tests require labs and specialized and expensive equipment to process samples, often taking between 24 and 72 hours.
The tests themselves are expensive costing $100 or more, she said.
By comparison, Abbott’s BinaxNOW COVID-19 tests costs $23.99 and can be taken at home and almost immediately yield a result.
For epidemiologists and public health experts, rapid antigen and molecular tests serve an essential function: surveillance.
“Public health testing is different from diagnostic testing,” Chu said. “… You’re looking at risk mitigation.
“When you’re doing surveillance, what’s important is to know is the rate of infection among that community,” she said.
While rapid antigen tests are less accurate than PCR tests by roughly 15% to 25% or more, the lower cost, faster turnaround and easier production allow for wider and more frequent screening.
Public health experts can then use that data to understand transmission and make critical decisions about quarantines and other precautions that can save lives.
“(Surveillance testing) gives you a sense of the load or burden of illness in the community,” Chu said. “The public health perspective is that keeping that burden down as low as possible is success.”
“Ideally, we would want access to both (PCR tests and) a fast-acting screening tool that we could widely deploy to people, whether they were symptomatic or not,” Jollon said. “You could take a test multiple times a week if you were going to school or you were going to work in a critical service. (Taking) a screening test multiple times would correct for the lower accuracy.
“If you have inexpensive, widely available rapid testing, even if they’re not 100% accurate, it gives you one more way to quickly identify individuals who are positive and pull them out of circumstances where they could spread infection,” Jollon said.