On April 8, the Office of the Assistant Secretary for Health issued new guidance authorizing licensed pharmacists to order and administer COVID-19 tests that have been authorized by the Food and Drug Administration (FDA). This new measure expands the role pharmacists play in fighting the pandemic and increases community access to testing. For pharmacies interested in providing these services, here’s what you need to know.
Q: What types of COVID-19 tests are available?
There are two primary types of tests: Polymerise Chain-Reaction (PCR), which is a form of molecular testing, and Serological Antibody tests.
- PCR tests detect viral particles in a patient’s nose or secretions. Samples are taken via nasopharyngeal swab. This test should be administered only when a patient is showing symptoms. The PCR tests require confirmation through further chemical analysis (lab) and typically take 24-36 hours or longer for results.
- Serological tests measure the amount of antibodies or proteins present in the blood when the body has responded or is responding to an infection. In other words, they detect the body’s immune response to the infection rather than detecting the virus itself. In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. However, the tests may still be helpful for identifying asymptomatic patients. Antibody tests typically use a presumptive testing technique, don’t require a lab for further chemical analysis, and generate visual results in approximately 15 minutes or less. Serological tests should only be conducted on asymptomatic patients who have either never had symptoms or haven’t had symptoms in at least 7 days.
Q: Are all tests “approved” by the FDA through the Emergency Use Authorization (EUA)?
In March, the FDA issued a policy to make certain serology tests available for use once they had performed specific testing and evaluation to confirm accuracy. Not every available test has been approved or authorized by the FDA, so some due diligence is required when ordering tests. If you’re not sure about a particular test, the NCPA has some recommendations on how to properly vet a company. There’s also the FDA’s list of current and terminated EUAs. Note that the FDA has issued the following guidelines specific to the serology tests:
- All tests have not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
Q: What tests are available and where can I get them?
There are limited numbers of PCR tests available in the market currently and are typically administered in hospitals, doctors’ offices or health systems. There are numerous serology tests on the market that have been submitted to the FDA and all should be properly vetted.
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Q: Does my pharmacy need a CLIA waiver to administer COVID-19 tests?
Yes, you will need a CLIA Certificate of Waiver to offer COVID-19 testing at your pharmacy. The healthcare settings in which an EUA-authorized test may be used are described in the Letter of Authorization. According to the FDA’s guidance for Emergency Use Authorization of Medical Products and Related Authorities, point-of-care tests (including SARS-CoV-2 point-of-care test systems) authorized under an EUA are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver or Certificate of Compliance.
Additional information from the FDA is available here.
Q: What if I do not have a CLIA Certificate of Waiver?
You will need to apply for one. For the most part, it is a straightforward process — fill out the required form and mail it to the state agency.
Q: Who is allowed to conduct the test?
A licensed healthcare professional must administer COVID-19 tests in a licensed healthcare setting.
Q: How will I be reimbursed for testing?
Currently, reimbursement for pharmacies is under a cash model. As reimbursement models evolve, community pharmacies may have opportunities to engage with local payers or employers to conduct testing for members.
Q: What should I do with test results?
Advise the patient as to the results of the tests and notify local health departments of any positive results. Here’s a directory for all state and local health departments.