Article updated 05/05/21 to reflect that the Lucira test kit is now available over the counter and directly through the manufacturer. Formerly, it was available by prescription only.
Several national chain pharmacies, including CVS, Walgreens and Walmart, are now selling over-the-counter COVID-19 tests. While these tests have value in helping to reduce the spread of the coronavirus and potential future disease outbreaks, a rapid test appropriate for use in a dental or other health care setting has yet to be approved.
The OTC tests available through the three national retailers are:
Additional COVID-19 rapid tests that are similar to the three already approved tests will be available soon.
For example, Quidel’s QuickVue At-Home OTC COVID-19 test is an antigen test that will be sold in packs of two and require users to conduct both tests over two to three days, similar to the BinaxNow test.
Cue’s COVID-19 test is an OTC molecular test that provides results in 20 minutes. Cue has yet to announce a price or timeline for nationwide availability. Lastly, Lucira’s COVID-19 All-In-One Test Kit, similarly to Cue’s test, is a molecular test that takes 30 minutes to deliver results and is available over the counter directly through the manufacturer for $55 per kit.
The at-home tests will be helpful as society attempts to regain a sense of prepandemic normalcy. For example, hosts of large events like sporting events, concerts or conventions may begin to require proof of a negative test result prior to entering a venue. Individuals may want to take an OTC test to try to determine if the symptoms they are experiencing are a common cold or COVID-19.
However, public health experts agree that the rapid testing technologies cannot yet reliably replace “gold standard” PCR tests because, even though the rapid tests have been cleared for asymptomatic use, antigen tests miss many asymptomatic infections. For example, a January 2021 study by the Centers for Disease Control and Prevention showed that the BinaxNow test only identified 34% of COVID-19 infections in asymptomatic individuals. OTC tests are especially not comparable to the PCR tests when used for medical decisions or diagnoses.
Additionally, the cost of the OTC tests will put the tests out of reach for many individuals especially for use on a regular basis, and the tests are not covered by any insurances. And individuals who are uncomfortable operating or unable to own and operate a smartphone will not be able to utilize any new testing technology that requires a smartphone.
While health care providers require the accuracy of the more expensive and lengthy PCR tests, many epidemiologists and public health experts are calling for cheap, fast and technology-free COVID-19 testing to help end the pandemic.
Antigen tests are most accurate when used approximately one week after symptoms developed, underscoring how important serial testing is for public health surveillance of the disease. The at-home use of rapid tests would allow people to test themselves at home easily and at frequent rates, such as twice weekly, to help mitigate the tests’ reliability shortcoming. The frequent use of these tests could help route individuals into care and self-quarantine earlier and help prevent future waves of infection.
For now, CDA does not recommend that dentists administer the COVID-19 rapid tests in the dental office or require patients to purchase and administer the tests themselves prior to a dental appointment for several reasons.
First, regardless of whether the test is over the counter, all three of the approved rapid tests are considered “waived” tests that require a lab license to administer or interpret results.
Second, although CDA is sponsoring legislation to pave the way for dentists to obtain their requisite lab testing licenses, reimbursement by medical or dental plans, and at what rate, would remain an outstanding issue, even if the bill becomes law.
Lastly but importantly, under current state and federal requirements, a patient who has recently tested negative for or is fully vaccinated against COVID-19 does not indicate the provider should follow any new or lower requirements for PPE.
Until these issues are resolved, dentists should continue to ask their patients the questions on CDA’s COVID-19 Patient Screening Form, including if they have been tested for COVID-19 in the past 14 days. To keep patients and dental staff safe and to help end the pandemic, dentists should also remain vigilant in their infection control practices.