The ADA is urging dentists to be cautious about using novel coronavirus diagnostic tests before they have been properly evaluated and made available for dentists.
“The testing market is becoming a bit of the Wild West for companies right now,” ADA Executive Director Kathy O’Loughlin said in an interview. “There is very little scientific evidence that the tests being marketed to dentists are reliable, so be careful when you see an offer that seems ‘too good to be true.’”
The ADA Science & Research Institute is evaluating the evidence regarding tests and the level of specificity and sensitivity and is talking directly to manufacturers and distributors.
“All dentists need a fast point-of-care test that accurately predicts the presence or absence of COVID-19 virus in real time,” Dr. O’Loughlin said. “Unfortunately, very few tests have met a high standard for specificity and sensitivity, which means a potential for high rates of false negatives and false positives.“
In a letter dated April 17, ADA President Chad Gehani and Dr. O’Loughlin asked the Department of Health and Human Services to use its discretionary authority during public health emergencies to extend targeted liability protections for dentists who administer those COVID-19 diagnostic tests, similar to the protections offered to pharmacists on April 8.
In the meantime, the ADA is advising dentists to steer clear of so-called “gray market” point-of-care tests for COVID-19, recommending they follow the direction issued by the FDA regarding testing procedures in their practices. Dentists should also be aware that manufacturers and distributors are prioritizing the distribution of the available kits to facilities with high-level needs.
Dr. O’Loughlin noted that there is one test, ID Covid Now, that is being sold through Henry Schein to the medical community, but not to dentists. It is a fast point-of-care test manufactured by Abbott Labs, and they are reported to be only able to produce 50,000 tests per day.
Because of the medical demand, Henry Schein has informed the ADA that they are not planning on selling this point-of-care test to dentists in the very near future.
Some community health centers have also received tests because HHS is distributing the tests to Indian Health Service and Health Resources and Services Administration sites, Dr. O’Loughlin added.
The Association does not consider COVID-19 testing to be a scope of practice issue, in that dentists are expected to routinely screen for high blood pressure, smoking habits and in some offices blood sugar and A1c levels. The test is not diagnostic in a dental office, since dentists are not treating COVID-19 illness.
“Some community health centers may even have dentists doing the tests on behalf of the medical staff,” Dr. O’Loughlin noted.
“An accurate test for the presence of COVID is the most predictable way for dentists, dental teams and patients to be safely treated in traditional elective dental care,” Dr. O’Loughlin noted.
Licensed dentists are eligible to administer COVID-19 diagnostic tests within their scope of practice, provided they obtain (or already have) a Certificate of Waiver from the Centers for Medicare & Medicaid Services, as may be needed. Like physicians, dentists may need the certificate to administer FDA-waived COVID-19 diagnostic tests, as required by the Clinical Laboratory Improvement Amendments (CLIA) regulation. To obtain a CLIA waiver, dentists must submit an application and pay a $150 application fee, though the ADA is lobbying Congress to waive the certificate requirement or at least waive the application fee.
There is also a widely reported nationwide shortage of existing COVID-19 testing kits. To help alleviate the shortage, the FDA issued a policy in February authorizing laboratories to put COVID-19 diagnostic tests on the market prior to receiving FDA approval.
According to the FDA, “Currently there is no FDA-approved or cleared test to diagnose or detect COVID-19 because the virus that causes COVID-19 is new. Therefore, the FDA has issued several Emergency Use Authorizations (EUAs) for the use of new diagnostic tests to detect the SARS-CoV-2 virus, which causes COVID-19. During public health emergencies declared under section 564 of the FD&C Act, the FDA is able to issue EUAs when certain criteria are met that allows for the use and distribution of potentially life-saving medical products to diagnose, treat, or prevent the disease, which can include diagnostic tests … The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers on this goal.”
More than 100 companies have requested and received the FDA-developed Emergency Use Authorization template for diagnostics for this outbreak, the FDA said.
Currently, according to the FDA, testing for COVID-19 typically entails collecting a sample from the nose and/or throat with a special swab at a designated collection location staffed by health care professionals. “A health care professional swabbing the back of the nasal cavity through the nostril is the preferred choice,” the guidance said. Alternatively, the health care professional could swab the back of the throat, or for patients with symptoms of COVID-19, the sample may be collected by swabbing the inside of the front of the nose. “Depending on, among other things, the type of swab used, a health care professional may collect the sample, or you may be able to collect the sample yourself at the collection site under the supervision of health care personnel.”
A different type of testing — which typically identifies specific antibodies through a pin prick and testing strip — are the antibody tests, which determine if someone was previously infected.
Antigens are proteins that are found on the surface of the pathogen, according to the National Institutes of Health. Antigens are unique to that pathogen. When an antigen enters the body, the immune system produces antibodies against it. Lymphocytes, a type of white blood cell, recognizes the virus antigen as being foreign and then produces antibodies that are specific to that antigen. Once the invading pathogen has been destroyed the immune response usually winds down.
For the ADA News story on the April 17 letter from Drs. Gehani and O’Loughlin to the Department of Health and Human Services, visit the ADA News website.
Further guidance from the ADA in regards to the pandemic is available at ada.org/virus.