According to a new analysis by the Kaiser Family Foundation (KFF), the United States has limited access to rapid Covid-19 testing due to five key factors—and while efforts are being made to increase the supply and availability of the tests, it may not be enough to meet rising demands as employers and other businesses implement testing requirements for the unvaccinated.

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1. A slow and difficult FDA regulatory process

All Covid-19 tests in the United States, including rapid or antigen tests, must first be reviewed by FDA before they are authorized for use in the public, but a stringent review process for rapid tests has made it difficult for many to gain authorization, KFF writes.

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In particular, FDA recommends antigen tests have an efficacy rate similar to "an authorized high sensitivity molecular test"—a benchmark that some people have argued is too difficult for developers to meet.

According to ProPublica, companies that are unable to meet FDA's guidelines or answer the agency's mid-review questions quickly enough have their applications "deprioritized," making it more difficult for them to potentially gain authorization. In addition, some companies, including Roche, have reported that FDA rejected their applications after discovering trials were conducted outside of the United States.

Currently, FDA has authorized 12 rapid tests for emergency use, nine of which are available without a prescription. In contrast, the European Union, which has applied less stringent regulatory standards to antigen tests, has authorized 39 rapid tests—several of which are still stuck in FDA's authorization process, ProPublica reports.

2. Limited government investment in Covid-19 testing

In contrast to the billions of dollars used to accelerate vaccine development and purchase millions of doses in advance, the federal government did not initially invest as much in Covid-19 testing, KFF writes.

According to ProPublica, without public funding, many companies did not feel like going through FDA's authorization process would be financially worthwhile. In addition, many companies were reluctant to invest in Covid-19 testing technologies in an uncertain market.

Nigel Reuel, a professor at Iowa State University who developed a mailable paper test for Covid-19, said it's difficult for companies to "invest tons in [developing Covid-19 tests] when we don't know what the long-term market for it is."

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"Where we have seen tests truly coming to the marketplace, the big difference has been government investment,” said Jeff Shuren, head of the FDA's Center for Devices and Radiological Health, which authorizes tests. "Folks will come and do larger volumes because you're supporting production, which can also help drive down prices."

3. Supply chain issues and fluctuating demand

Supply chain issues have been a significant challenge throughout the pandemic, KFF writes, and rapid test manufacturers have sometimes had difficulty accessing the raw materials and diagnostic components needed to manufacture their products.

For example, in a filing to the Securities and Exchange Commission, Quidel Corporation wrote, "As a result of the Covid-19 pandemic, we have seen delays in receipts for certain raw materials and components for our products. Such delays can result in disruption to our business operations."

In addition, many manufacturers have struggled to predict fluctuating demand for rapid tests, KFF writes, which has led production to decrease at critical junctures.

For example, Abbott Laboratories, which manufactures one of the most popular rapid tests for Covid-19 in the United States, began discarding millions of products in its inventory after demand dipped in the spring as vaccination rates increased and cases fell. However, as the delta variant spread across the United States and cases surged, Abbott struggled to produce enough tests to meeting the rising demand.

4. Shifting expert guidance on testing

Another challenge regarding Covid-19 testing in the United States has been shifting expert guidance on testing over the course of the pandemic, KFF writes.

Before vaccines were available, CDC recommended that people who were in close contact with someone with Covid-19 should get tested. Later, as vaccines became more widely available, CDC adjusted its recommendation, saying that fully vaccinated individuals without symptoms did not need to be tested after being exposed to someone with Covid-19. Then, in August as the delta variant caused cases to surge, CDC changed its guidance again to recommend fully vaccinated people be tested after Covid-19 exposure.

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Although CDC's evolving guidance was necessary to respond to the rapidly changing pandemic and new evidence about the coronavirus, several manufacturers, including Abbott and Quidel, noted that it affected manufacturing demand for tests. In addition, KFF writes that these shifts in guidance may have affected people's understanding of testing and their confidence in CDC's recommendations.

5. Cost to consumer

According to KFF, the cost of rapid tests may make it difficult for consumers to access them, even if supply is readily available.

Rapid tests available for purchase in the United States range from $7 to $38.99 per test. If someone tested themselves twice a week using the least expensive test, it would cost them $728 a year, and the cost increases to over $4,000 a year for the most expensive test, KFF writes.

In comparison, many rapid tests costs as little as a dollar outside of the United States, and in several countries, including the U.K., Israel, and Singapore, rapid tests are available for free to all or most people.

In the United States, rapid tests are covered by insurance only if they have been ordered by a health care provider, meaning that consumers must cover self-administered rapid tests out of pocket.

U.S. implements new efforts to ramp up supply—but they may not be enough.

The United States has recently introduced several new efforts to increase the country's access to and supply of rapid tests, KFF writes.

President Joe Biden in September said he would use the Defense Production Act to acquire 280 million rapid tests and work with retailers, such as Kroger, Walmart, and Amazon, to increase the availability of these tests nationwide. The White House has also invested $3 billion to significantly expand the country's supply of rapid Covid-19 tests.

In addition, HHS in October announced NIH would "would establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing" through a new Independent Test Assessment Program (ITAP). Through ITAP, HHS said several agencies, including NIH, FDA, and CDC, will "identify manufacturers of high quality tests and encourage them to bring those tests to the U.S. market, increasing options for people and overall supply and potentially lowering costs."

These new investments from the federal government are expected to result in 200 million rapid antigen tests per month by December, and 300 million tests by February 2022, KFF writes. However, it is unclear whether this supply will be sufficient to meet growing demand, especially as employers and other businesses implement mandatory vaccination and testing requirements.

According to KFF, 300 million tests would equal less than one test per month per person in the United States. And even if half of the U.S. population was tested weekly, supply would have to double to 600 million tests a month to meet the demand.

"We need to have a rethinking, during and after this pandemic, to talk about the role of testing," said Mara Aspinall, co-founder of the biomedical diagnostics program at Arizona State University’s College of Health Solutions. "It's a fundamental piece of our fight. And that was realized too late." (Fernandez, Axios, 11/5; Dawson/Kates, Kaiser Family Foundation, 11/4; DePillis/Umansky, ProPublica, 11/4)