by Sherri Mason, Consulting Director and Walt Valliere, Consulting Director
08/24/20

As a nurse with decades of experience, I have been perplexed by the ongoing reporting challenges related to testing for COVID-19. There are a multitude of vendors providing the various tests that determine if a patient is infected with the active virus and those that detect antibodies that indicate prior infection. There is a broad variation in turnaround time for results — from a few hours to a few days to even weeks for some. Then, there are media reports of false positives and false negatives and errors in tabulating results. It is an unprecedented health care issue with an unprecedented response.

To help sort all of this out, I reached out to several colleagues representing different areas in the health care industry to better understand the current situation. I began with Walter Valliere, doctor of sciences and a seasoned microbiologist and consulting director with Vizient’s laboratory practice. He said that the current laboratory testing situation for COVID-19 in the U.S. presents significant challenges. 

“From a scientific perspective, laboratory tests that have not been developed and vetted rigorously through standard scientific and industry processes may seem to be helpful as emergency measures, but the number and type of tests that are being used may contribute as much to the confusion as they do to the solution,” said Valliere.  

He explained that all tests currently in use are available under emergency use authorizations (EUA) from the Food and Drug Administration (FDA). An EUA authorizes the use of a test that has not been fully validated in order to collect scientific, epidemiological, and clinical data as part of the current pandemic response. However, once the current public health emergency declaration that provided for the EUA is lifted, these tests will no longer be available for use.  Unless the public health emergency is renewed, all EUA tests will be required to complete the full FDA 510K test review and validation process in order for them to be available for sale and use in CLIA certified laboratories.  Currently, to protect public interest, the FDA provides ongoing test oversight while the EUAs are in place, which has resulted in EUA revocations of more than 30 tests because their accuracies were deemed unreliable.

Valliere explained there are currently over 100 different tests for the SARS-Cov-2 coronavirus utilizing four sample types - nasopharyngeal swabs, venous blood, finger-prick assays, and saliva. He offered the following insights on the tests.

The two major test categories currently include direct detection of the presence of SARS-Cov-2 viral components and those that detect host antibodies that result from infection by the SARS-Cov-2 virus.

Direct detection of the SARS-CoV-2 coronavirus uses assays that detect certain RNA gene sequences using rt-PCR or assays that detect specific antigens present on the surface of the SARS-CoV-2 coronavirus. A positive test does not necessarily mean that a subject has a new and active infection. These assays can also be positive in asymptomatic subjects, recovering subjects, or due to cross reactivity with similar viral or host cellular components.

The antibody tests are not considered diagnostic for an active infection as the emergence of antibodies is a post-infection host response. There is very limited scientific evidence regarding the quality of the human host response to the SARS-CoV-2 coronavirus. As such, a positive antibody test cannot be correlated with a high degree of confidence to the establishment of long-lived host immunity; it is unclear if antibodies produced by an infected host neutralize the virus. This also does not translate to a valid assumption that so-called herd immunity will provide any benefit.

The recently approved “SalivaDirect” test was created by Yale School of Medicine and is offered as an open-source method. It is reported to provide results consistent with nasopharyngeal swabs but with less invasive sample collection, fewer reagents, and lower cost. It avoids viral genetic extraction and offers easier scale-up. Four other saliva tests had been approved but provided varying results.

Valliere also noted that ultimately establishing a clinical diagnosis of COVID-19 requires a physician or APP to assess and correlate a patient’s clinical findings with supporting evidence derived from laboratory testing, rather than relying heavily on the results of a test.

Vizient’s laboratory, clinical, and sourcing experts have developed a few recommendations to consider in the context of your approach to managing COVID-19 testing if you haven’t yet done so.

  1. Plan your strategy
    1. Determine if COVID-19 testing can be performed in your laboratory using existing testing systems.
    2. Verify if your laboratory’s current excess testing capacity will support the addition of COVID-19 testing.
    3. Project testing demand and its impact on resources such as production staff, testing supplies, reagents, and specimen collection supplies in order to avoid supply chain shortages and production delays.
    4. Calculate controllable costs for COVID-19 testing and determine if reimbursement will be based on the high throughput rate or the low throughput rate.
    5. Set up and test the order entry and billing processes for each new COVID-19 test.
  2. Educate and Train staff. Define specimen collection, handling, and testing processes to ensure compliance with clinical laboratory improvement certification, good laboratory practices, International Organization for Standardization standards, or other accreditations.
    1. Ensure that all laboratory production and supervisory personnel understand the quality management system processes for COVID-19 testing as well as limitations of each COVID-19 test.
    2. Develop COVID-19 test process flow charts and post as prescribed by ISO or other accrediting agencies.
  3. Define reporting measures
    1. Define reporting definitions and metrics for any COVID-19 test. Follow FDA and CLIA guidelines, GLPs, and standards set by the laboratory’s accrediting agency. Enter this information into the laboratory information system to standardize and facilitate test ordering, results reporting, and laboratory formulary requirements.
    2. Use internal and external dashboards for tracking production.

The reality of many false positive COVID-19 tests and undiagnosed asymptomatic coronavirus carriers makes for an incredibly difficult situation. To keep abreast of the situation may require putting guardrails in place to protect an organization’s ability to continue providing excellent care. It is important to implement reliable processes that ensure quality testing within the constraints of the organization. Most labs are experiencing profound supply chain interruptions, which adversely impact capacity and production.  As with all laboratory tests, but especially until there are tests for SARS-CoV-2 with FDA full market approval, it is imperative that the results are viewed in terms of their limitations and in context of the patients’ presenting symptoms and contact history.

About the authors. Sherri Mason’s 25 years of experience in the health care industry include critical care, cardiac cath lab, interventional radiology and emergency department practice; clinical trial management and IRB membership; and medical-legal and hospital consulting. She has been published as a contributing textbook author for health information management, medical assisting and legal aspects of nursing; and guided implementation and development of new clinical programs involving research and cardiovascular services. Mason is a member of American Association of Nurse Practitioners and holds certification as a family nurse practitioner.

Walter Valliere brings more than forty-five years of experience leading initiatives to grow market share and reduce operating costs through process improvements, strategic outsourcing, business restructuring, business consolidations, supply chain optimization, and new venture development. Nine years with Vizient, Valliere has also held principal leadership/ownership positions with both a multi-site independent laboratory and a specialty consulting firm that served healthcare, biotech, and biopharma industries