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If you have been looking forward to a new kind of COVID-19 test, one which doesn’t involve any sort of implement being scrubbed around inside your nasal passages, you can stop holding your breath. In mid-April, the Food and Drug Administration granted emergency use authorization (EUA) to the InspectIR COVID-19 breathalyzer test. But don’t toss those rapid antigen tests (RATs) just yet.
The initial utility of the breath test is limited. The breathalyzer machine itself is about the size of a piece of carry-on luggage and requires trained personnel to supervise its operation. Therefore, while it will be a welcome addition to the existing rapid diagnostic tests in health care settings and mobile test sites, it won’t be for home use.
Now that they have received FDA authorization, InspectIR Systems is expected to bring their COVID-19 breathalyzers to market in ~ 10-12 weeks and will produce 100 devices per week. Each device can run approximately 160 samples per day. In the company’s study of ~ 2,400 asymptomatic people, the breathalyzer correctly identified 91% of positive infections and 99% of negative infections (PCR was used as the gold standard).
The sample—a breath of air—is blown into a straw attached to an analyzer called a gas chromatograph-mass spectrometer (GC-MS). Within 3 minutes, the GC-MS can identify whether the breath contains a mixture of volatile organic compounds (VOCs) which are associated with SARS-CoV-2 infection. It’s important to note that certain foods and substances can affect the breath test; the testing instructions specify to avoid eating, drinking, and tobacco products in the 15 minutes prior to taking the test. The FDA recommends positive breath tests be confirmed with a molecular test.
No doubt more breath tests are on the way to development and approval. It remains to be seen how they will change the COVID-19 testing landscape.
The other day I went online to order an at-home COVID-19 rapid antigen test (RAT). The number of options was mind-boggling! How are people supposed to choose? Are they just picking the cheapest test? Or the one at the top of the list?
Unfortunately, not all rapid antigen tests (RATs) are created equal. Although the FDA has not yet granted full approval to any at-home RATs, many have undergone an expedited review and subsequently received emergency use authorization (EUA).
The key takeaway as you scroll through the myriad options is to simply verify that the test which makes it into your shopping cart has also made it onto the Federal Drug Administration (FDA) updated list of authorized diagnostic tests: In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 | FDA.
The FDA’s list currently has seventeen antigen tests that have received EUA, listed in alphabetical order by manufacturer. If you click on the highlighted link for a test (on the left side of the screen) you will be linked to home use instructions for that test. Other information on the list includes the test type (antigen or molecular), when to use the test (for example, if you’ve experienced symptoms within the last 7 days), eligible age range, whether or not a smartphone is required to view the results, the type of sample (eg nasal swab), and how long it takes for test results to be available.
Reassuringly, the top three at-home rapid antigen COVID-19 tests at both Amazon (BinaxNOW, iHealth COVID-19 Rapid Test and BD Veritor) and CVS (iHealth, BinaxNOW, and FlowFlex) are all FDA authorized.
A test's accuracy can wane as new SARS-CoV-2 variants emerge. Therefore, it is important to continue to check the FDA’s updated site to make sure that the test you are ordering has received authorization or approval.
Amazon at-home COVID-19 tests (screenshot; not inclusive) FDA's list of authorized at-Home over-the-counter COVID-19 diagnostic tests (screenshot; not inclusive)
The Cost of COVID-19 Testing:
To date, the U.S. government has funded a huge COVID-19 relief effort, including covering the cost of medically indicated COVID-19 testing for Americans with and without health insurance under the CARES Act and the Families First Coronavirus Response Act, respectively. In March 2022, however, the House passed a federal spending bill that omitted ongoing funding for the program which pays for uninsured individuals to obtain COVID-19 testing, treatment, and vaccinations. The White House is working to secure additional funding, but if the program ends it will mean the end of free testing and treatments for millions of Americans.
The burden of COVID-19 testing costs, however, isn’t limited to the uninsured. Individuals with insurance may need to self-pay for COVID-19 testing if it is needed for a non-medical indication, such as travel or a return-work program, neither of which are included in the insurance coverage mandate.
So exactly what is the cost of a COVID-19 test?
The answer is that the cost varies hugely, even for the exact same type of test.
Consumer Reports recently investigated the out-of-pocket cost of COVID-19 tests. One of the issues they found is that testing manufacturers and labs are allowed to set their own prices and insurance providers are required to cover testing costs at the price set by the company. In addition, the number of FDA-approved tests is fairly limited, meaning that demand has consistently outstripped supply during COVID-19 surges. This combination has allowed companies to engage in price gouging, preying on desperate consumers.
A study by America’s Health Insurance Plans in July 2021 found that “On average, a COVID-19 test in the commercial market costs $130. In contrast, out-of-network test providers charged significantly higher (more than $185) prices for more than half (54%) of COVID-19 tests in March 2021—a 12% increase since the beginning of the pandemic. ”
More recently, in December 2021, Mira (a low-cost health care coverage provider) reported on a survey they conducted of the top twenty-three urgent care facilities in the United States to determine the out-of-pocket cost of COVID-19 diagnostic tests. They found that “the average reported cost of a PCR test is $137, and the average cost of a rapid antigen test is $189. Overall, most urgent care clinics offer diagnostic testing at a price between $100-$200.”
In addition to the above, the availability of at-home tests has increased and may provide a lower-cost option if paying out of pocket. Rapid antigen tests (RATS) typically run ~$10 per test. Three at-home molecular tests are currently FDA approved for emergency use and do not require a prescription. These are more sensitive for detecting early COVID-19 infection but are considerably more expensive, ~$75-100 on average.
Bottom line: When purchasing a COVID-19 test, consider what type of test is best suited to your needs and then do a brief cost comparison before paying top dollar.
What is a rapid test?: An antigen-based COVID-19 test, often called a rapid test, can be purchased over the counter (online or in a pharmacy) and taken at home. It works by searching for protein pieces of the COVID-19 virus. Depending on the test, either a sample from the nose or mouth is obtained via a swab, then placed into a solution. In most kits, you put a few drops of the solution plus sample into a test disc and wait ~ 15 minutes. If the test is positive, there will be two-colored lines, the control line and the test line. If the test is negative, only the control line will be positive.
It is important to note that rapid antigen tests are less sensitive than polymerase chain reaction (PCR) tests which amplify even very tiny amounts of viral genetic material and thus rapid tests might be negative very early on in an infection. Also, whereas a PCR test can stay positive for weeks to months, even after you are no longer contagious, a rapid test will become negative once the virus count has dropped below the level of infectivity.
What does it mean if a test has been ‘authorized’, ‘unauthorized’, ‘approved’ or ‘unapproved’?: One of the responsibilities of the Federal Drug Administration (FDA) is ensuring that vaccines and medical devices are safe and effective. In order for a medical device, such as a COVID-19 test, to be deemed safe and effective it must undergo an extensive review. This time-consuming process is required for full FDA approval. If a product is needed urgently, though, it may undergo an expedited review; those that pass this more rapid review receive what is called an emergency use authorization (EUA).
Currently, none of the COVID-19 rapid antigen tests have received full FDA approval, but many have been authorized for emergency use. The FDA maintains an updated list of antigen and molecular diagnostic tests for SARS-CoV-2 which have received EUA: In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 | FDA.
It is particularly important to check the list of authorized products if you are buying a rapid test online, as the internet is rife with fraudulent and unauthorized tests. Most recently, on March 1st 2022, the FDA issues safety notices warning against use of unauthorized rapid tests made by ACON Laboratories, SD Biosensor and Celltrion.
How much does a rapid test cost?: The out-of-pocket cost of rapid antigen COVID-19 tests varies, averaging ~ $15-20 per kit (two tests per kit). Thankfully, the government has ramped up the accessibility of free rapid COVID-19 tests. In January 2022, all US households became eligible to request a one-time order of four free rapid COVID-19 tests, either via the website COVIDTests.gov or by calling 800-232-0233. At his State of the Union address, President Biden announced that Americans would be able to receive a second set of free rapid tests; four more per household for those who already ordered one set and eight tests (two sets) for those who haven't yet ordered. Private health insurers are also mandated to cover up to eight at-home antigen tests per month, per covered individual, with reimbursement capped at $12 per testing kit (two tests per kit). The insurance provider will usually cover the upfront cost for in-network pharmacies and retroactively reimburse members who buy test kits from out-of-network pharmacies. Original Medicare beneficiaries will be able to receive up to 8 free over-the-counter COVID-19 tests in the early spring of 2022. In the meantime, they can obtain free at-home tests from community health centers and Medicare-certified health clinics.
Ongoing supply shortages of COVID-19 tests have spawned a new online market for scammers: fake COVID-19 tests.
Shady companies are taking advantage of increased consumer demand to sell faux at-home test kits online.
If you do unwittingly use a fake COVID-19 test and receive a false negative result, you risk spreading the infection to others and not receiving appropriate treatment.
The counterfeit COVID-19 tests are widespread enough that the Federal Trade Commission published a statement in January warning consumers of the issue and advising them of steps to take to avoid the fake tests.
A legitimate COVID-19 test is one that has been authorized by the FDA. The FDA maintains an updated list of antigen and molecular diagnostic tests for SARS-CoV-2 (the virus which causes COVID-19) which have received emergency use authorization (EUA). If you are buying an at-home test kit online and want to make sure it is legit, you can check the list: In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 | FDA.
The FDA also has a list of fraudulent COVID-19 products you can search: Fraudulent Coronavirus Disease 2019 (COVID-19) Products | FDA
Additional steps you can take to avoid illegitimate COVID-19 test kits:
The new year found Americans mired in the peak of yet another SARS-CoV-2 wave, with the preceding holiday season scarred by overstretched health care systems and testing capacity. In response, the Biden administration has increased the accessibility of at-home COVID-19 tests on multiple fronts.
In January 2022, all US households became eligible to request four free rapid COVID-19 tests either via the website, COVIDTests.gov, or by calling 800-232-0233.
At the same time, the government also mandated that private health insurers cover up to eight at-home antigen tests per month, per covered individual, with reimbursement capped at $12 per testing kit (two tests per kit). Out of pocket costs vary between ~$10-25 per kit. Typically, the insurance provider will cover the upfront cost for in-network pharmacies and retroactively reimburse members who buy test kits from out-of-network pharmacies.
Although Medicare was not initially included in the coverage mandate, at the beginning of February the Biden administration announced that Medicare beneficiaries, including Medicare Advantage, would also become eligible for eight free at-home COVID-19 antigen tests per month, beginning in the early spring.
The expanded coverage will include over 60 million Americans, many of whom fall into the higher risk health category.
Medicaid recipients already have full coverage of at-home COVID-19 tests (8 per month).
