Last updated April 15, 2020
Marathon Health Weekly Customer update
Marathon Health COVID-19 Testing Guidance
Testing for COVID-19 is currently one of the most often requested services by the employer organizations we serve. At this time, based on the availability of FDA-approved tests and a shortage of personal protective equipment (PPE), we are not able to test for COVID-19 in most of our health centers. We are monitoring advancements and changes regarding testing availability approved for health centers to perform at point of care (CLIA waived testing). We will continue to provide assistance with assessment of options as they become more readily available and as access to PPE is more attainable.
For employer organizations with first responders and in locations where we can partner with local health systems, reference laboratories, and health departments for PPE and collection kits, we are selectively testing essential workers.
In order to fully understand the issues around providing testing, here is a description of several considerations:
- Types of Tests:
- PCR (Polymerase Chain Reaction) Testing - This is a method for analyzing a short sequence of DNA. For COVID-19, the test uses nasopharyngeal swab and looks for viral shedding/virus DNA. When the virus DNA is identified, the person is considered positive for COVID-19. This test is the only way to determine active infection during the initial illness. If a test is positive, it would then require self-isolation.
- Antibody Testing/Serology Testing - These tests are performed to see if someone has developed antibodies to the virus. The presence of antibodies indicates a recent or past infection. Package inserts on the antibody tests state that the test cannot be used to rule out infection and that PCR testing should be used in conjunction with antibody testing to confirm if a patient is contagious due to active infection. Additionally, serology testing only indicates whether a person has built antibodies against COVID-19. Antibodies do not occur until 5-10 days after symptom onset. The antibody test can tell us if a person is recovering from the infection and has some immunity but it is unknown how long immunity lasts. These tests cannot be used alone to identify those that may still shed virus.
- Levels of FDA Approval - There are two levels of approval granted by the FDA, FDA Approval and FDA Emergency Authorization. Authorization under emergency orders has been granted to a number of tests, while others are being marketed without any approval or authorization. While all tests must submit data and use guidelines to the FDA, the sensitivity and specificity of each test may differ making some more or less reliable. We are continuing to monitor the approvals to ensure they meet the standard scientific guidelines for specificity and sensitivity (false positive and false negative results).
- CLIA-Waived Tests - The lab tests performed at doctors’ offices and health centers are CLIA-Waived and only these tests can be performed in such settings. Waived testing is designated by CLIA as a simple test that carries a low risk for an incorrect result. At this time, we are evaluating any CLIA-waived tests that are coming to market to determine best use case in the event we obtain sufficient PPE to be able to assist with testing in the center or in an outside area near the center.
In summary, our ability to offer wide scale COVID-19 testing is limited by access to PPE, the availability of FDA-approved, CLIA-waived tests, and protocols set in place for safe testing methods. We are hopeful that this type of test can become more widely available to health centers and physician offices in the near future.
Marathon Health recommends visiting the following websites for the latest information on COVID-19:
Centers for Disease Control and Prevention (CDC)
OSHA Guidance for preparing workplaces for COVID-19