Pharmacists Might Test for COVID-19 At Some Point; How Does It Work?
ATLANTA – Pharmacy associations have joined together to urge that pharmacists should play an enhanced role in testing and treating COVID-19.
“Allow pharmacists to order, collect specimens, conduct and interpret tests and, when appropriate, initiate treatment for infectious diseases including COVID-19, flu, strep, and interpret and discuss with patients,” according to a statement from the American Pharmacists Association and 11 other groups. “Expand current state pharmacists immunization authority to include all FDA approved vaccines, including the forthcoming novel vaccine for COVID-19, for all indicated populations.”
While a vaccine has yet to be developed and approved for human use, testing options are continuing to grow. What does that look that now?
According to the national Centers for Disease Control and Prevention, healthcare professionals considering COVID-19 testing should continue to work with their local and state health departments to coordinate testing through public health laboratories, or use COVID-19 diagnostic testing, authorized by the Food and Drug Administration under an Emergency Use Authorization (EUA) through clinical laboratories, which adds, “Increasing testing capacity will allow clinicians to consider COVID-19 testing for a wider group of symptomatic patients.”
Healthcare professionals are asked to use their own judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Most patients with confirmed COVID-19 have developed fever1 and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). Priorities for testing currently are:
- Ensure optimal care options for all hospitalized patients, lessen the risk of nosocomial infections, and maintain the integrity of the healthcare system
- Hospitalized patients
- Symptomatic healthcare workers
- Ensure that those who are at highest risk of complication of infection are rapidly identified and appropriately triaged
- Patients in long-term care facilities with symptoms
- Patients 65 years of age and older with symptoms
- Patients with underlying conditions with symptoms
- First responders with symptoms
- As resources allow, test individuals in the surrounding community of rapidly increasing hospital cases to decrease community spread, and ensure health of essential workers
- Critical infrastructure workers with symptoms
- Individuals who do not meet any of the above categories with symptoms
- Health care workers and first responders
- Individuals with mild symptoms in communities experiencing high COVID-19 hospitalizations
- Individuals without symptoms
The CDC says other considerations that might justify testing are epidemiologic factors such as the occurrence of a widespread local community transmission of COVID-19 infections in a jurisdiction. Clinicians are strongly encouraged to test for other causes of respiratory illness, however.
Healthcare professionals who suspect a patient has COVID-19 should immediately implement recommended infection prevention and control practices and notify infection control personnel at their healthcare facility and their state or local health department.
For initial diagnostic testing for COVID-19, CDC recommends collecting and testing upper respiratory tract specimens with a nasopharyngeal swab, as well as testing lower respiratory tract specimens, if available.
For patients who develop a productive cough, sputum should be collected and tested for COVID-19, according to public health officials, although they do not recommend the induction of sputum.
An article in JAMA written by the deputy editor for the general public explains that RNA is extracted and converted to complementary DNA for testing. “The PCR test involves binding sequences on the DNA that only are found in the virus and repeatedly copying everything in between. This process is repeated many times, with doubling of the target region with each cycle,” according to the explanation. “A fluorescent signal is created when amplification occurs, and once the signal reaches a threshold, the test result is considered positive. If no viral sequence is present, amplification will not occur, resulting in a negative result.”
The JAMA article explained that rollout of testing was delayed in the United States because of:
- Regulatory process and time required to validate clinical tests. The policies were loosened on February 29, 2020, to allow use of tests before approval, which has improved access.
- Initial lack of certified laboratories with PCR capabilities. Most clinical laboratories did not have the capability to perform PCR at the beginning of the outbreak.
- Shortage of chemicals and supplies.Certain chemicals and supplies, such as those used in extraction and PCR kits, were initially in short supply. Reagents have become more available as alternative PCR tests are developed.
- Lack of availability of personal protective equipment for technicians handling specimens has also been limited.
That now appears to be turning around. In late March, Abbott announced it had received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the fastest available molecular point-of-care test for the detection of novel coronavirus, with positive results delivered in as little as five minutes and negative results in 13 minutes.
That test runs on Abbott's ID NOW platform—a lightweight box (6.6 pounds and the size of a small toaster) that can sit in a variety of locations. The pharmaceutical company says it is ramping up production to deliver 50,000 ID NOW COVID-19 tests per day as of early April.
The previous week, Abbot’s RealTime SARS-CoV-2 EUA test became available under FDA EUA. That runs on m2000 RealTime molecular system for centralized lab environments. Combined with ID NOW, Abbott expects to produce about five million tests in April.
Other tests that might be coming online include blood antibody testing and viral antigen testing in respiratory samples, similar to the rapid influenza test, the JAMA authors write. “The clinical value of these tests is not known yet, and challenges such as cross-reactivity with other viruses, and that sometimes the test does not detect the virus when it is there, need to be addressed.”