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Technological advancements, advocacy needed before point-of-care COVID-19 testing will meet dental office needs

September 28, 2020 2879

Quick Summary:

Point-of-care tests that are appropriate for dental settings would ideally have negative test results that do not need additional confirmatory tests. Regardless of how testing technology advances, in order for dentists to perform rapid COVID-19 tests, the test must be considered "waived" by the FDA.

On Aug. 24, BinaxNow, a rapid antigen test for COVID-19 developed by Abbott Laboratories, received an emergency use authorization from the federal Food and Drug Administration, becoming the latest rapid and inexpensive antigen test to be preliminarily approved for wide use.  

While promising, the antigen test, like several others granted the authorization in recent weeks, is not advanced enough to enable dentists to definitively identify patients with or without COVID-19 ― primarily because a negative test result must be confirmed by a polymerase chain reaction, or PCR, test.

BinaxNow, for example, requires additional time and data because the test is currently only authorized for use with patients who have exhibited COVID-19 symptoms for seven days or less. The FDA’s preliminary tests were conducted on symptomatic patients and those patients are more likely to have high, detectable levels of the virus in their bodies. The test’s accuracy and sensitivity when given to asymptomatic individuals is not yet known.

In dentistry, the goal when screening patients who need dental treatment is to identify the patient who is COVID-19-negative so that dental treatment can proceed. Accuracy and sensitivity in testing are essential, especially in the dental office, because every false negative in dentistry potentially increases the risk of disease transmission to others.

Dentists are already screening for potentially positive patients by asking a series of questions before appointments and also through temperature checks on the day of the patient’s appointment. These steps are consistent with the California Department of Public Health’s May 7 dental guidance that states if tests are administered prior to a dental appointment, they should be combined with clinical signs and symptoms for decision-making.

Advantages of patient screening at dental offices

In California, COVID-19 testing is within the scope of practice for dentists when used for screening, rather than diagnosis.

Beyond treatment or referral decisions, COVID-19 rapid testing at the dental office has the additional advantage of identifying potentially positive individuals early in the disease process, facilitating referral to a medical professional for diagnosis and intervention and contributing to public health surveillance and contact tracing efforts. The value of testing as a public health tool has been well documented in various studies and by the Centers for Disease Control and Prevention.

With these considerations in mind, point-of-care tests that are appropriate for dental settings would ideally have negative test results that do not need additional confirmatory tests, allowing dental practices to return to pre-pandemic infection control and PPE standards. However, additional technological advances and studies on the SARS-CoV-2 virus must occur first in order to confirm that these test attributes are possible and affordable enough to be reproduced widely. 

Regulatory compliance requirements for in-office testing

Regardless of how testing technology advances, in order for dentists to perform rapid COVID-19 tests, the test must be considered “waived” by the FDA. Laboratory tests can vary in their complexity. The most commonly administered COVID-19 tests using nasal swabs are considered to be high complexity. A dental practice would have difficulty obtaining a license to perform medium- or high-complexity tests because of the necessary laboratory equipment to process tests and the personnel certification requirement among other reasons. 

Before dentists can administer waived rapid COVID-19 tests, they must first obtain the requisite licensing including a CLIA Certificate of Waiver from the Centers for Medicare & Medicaid Services. Additionally, health care providers who administer lab tests must also obtain the appropriate licensure from the CLIA state counterpart, Laboratory Field Services, a program within the California Department of Public Health. Currently, dentists are not eligible to obtain licensure from LFS.

CDA advocacy for licensure, reimbursement are ongoing

CDA is working with the governor’s office, state Legislature and the California Department of Public Health to allow dentists to immediately obtain LFS laboratory licensing. Additionally, CDA is working with the appropriate entities to advocate for reimbursement for rapid COVID-19 tests by medical and/or dental benefit plans, including Medi-Cal. 

Learn more in a CDA resource about the types of COVID-19 testing, including what they do, their reliability and required processing times and whether they are approved for use in the dental office. Also included are FAQ about dentistry’s scope of practice and more.