COVID Catch-Up: Reflecting on COVID-19 Milestones over the First 6 Months of the Pandemic

Kimberly Zunker is a lab tech with a bachelor’s degree in clinical laboratory science, an ASCP medical laboratory scientist certification, and an MBA. She has served and worked in both civilian and military hospital and clinic laboratories, serving in the Air Force as a commissioned officer and laboratory officer in the Biomedical Science Corps where she led two Air Force laboratories.

Kimberly chose a laboratory career because it’s always changing. This has definitely proven to be true as the laboratory remains in the spotlight of the first pandemic in 100 years. For the last several months, Kimberly has buried herself in current research, attending weekly FDA and CDC calls, maintaining a technical test comparison of all FDA Emergency Use Authorizations (EUAs), and listening to labs across the nation share their experiences. Doing so has made her a sought-after expert in the field by hospitals and health systems nationally.

Now six months into the COVID-19 crisis, HPI caught up with Kimberly to reflect on where we are and how we got here relative to testing and supplies. Here she walks us through a timeline of events.

Kimberly Zunker, MBA, MLS (ASCP)

Kimberly Zunker, MBA, MLS (ASCP)

Consulting Manager
  • January 20

    First COVID-19 case identified in Washington State

  • January 31

    Secretary of Health and Human Services declares a public health emergency

    Note: Emergency declared on this date but is retroactive to January 27th

  • February 4

    First EUA issued to the CDC for the COVID-19 test they had developed and distributed 200 test kits

    200 test kids are able to test up to 60,000 to 80,000 patients to more than 100 state and county public health labs. This provided an average of 800 patient tests per public health lab.

    Note: Unfortunately, this test had contamination issues, throwing some false positive results. One of the probe and primer sets were removed, which resolved the issues. The CDC was the only location that could perform testing and it was highly restricted. Only symptomatic patients with a travel history including China and/or contact with somebody who tested positive for COVID-19 were tested.  In the meantime, other labs were not allowed to perform testing which is part of the reason we don’t definitively know when we had the first COVID-19 patient in the U.S. The CDC now outsources manufacturing of its tests.

  • February 29

    FDA makes groundbreaking decision to loosen regulations surrounding COVID testing

    Issuing a policy allowing laboratories and commercial manufacturers to begin testing and selling their molecular test kits as soon as the validation was complete. An EUA submission must be sent to FDA within 14 days as well.

    Note: An EUA is not the same as FDA approval and there is no guarantee that once the public health emergency is lifted, it will remain FDA approved. Manufacturers must still go through the regular de novo and 510K process per normal, non-emergency policies to get true FDA approval that allows them to sell beyond the emergency declaration.

  • February 29

    New York State issued second EUA for COVID test

  • March 12

    Roche issued EUA for COVID test

  • March 16

    FDA updates guidance for EUA approval of COVID-19 testing

    Create a process that allowed commercial manufacturers to more rapid distribute their SARS-CoV-2 diagnostic tests to laboratories for specimen testing after validation, which an EUA is prepared for submission to the FDA. This updated guidance also allowed Serology test manufacturers to notify the FDA of their intent to market a COVID-19 test but kept the submission of an EUA optional.

  • May

    COVID-19 tests increased from 2.1% the week of February 27th to 59%

    The College of American Pathologists released a survey that illustrates the percentage of labs now offering COVID-19 tests

  • May 4

    FDA issues guidance requiring EUA submission for all serology tests within 10 days of offering the test to the market.

    Within 10 business days, multiple tests are removed from the market. The FDA also recommended that laboratories and healthcare providers evaluate the clinical presentation and medical history of patient’s that received any of these tests to determine if the patient should be retested.

  • May 11

    FDA updates guidance for EUA approval of COVID-19 testing

  • June 4

  • June 12

    Preprint paper released at biorxiv.org noting a mutation that makes the virus markedly more efficient, with greater infectivity.

    Note: Genetic variants were analyzed from GenBank, the NIH (National institutes of Health) genetic sequence database, an annotated collection of all publicly available DNA sequences. Researchers noted a genotype that was not detected in February but by March detection was at 26%, April at 65% and May at 70%. The mutation does not appear to affect neutralizing effects of antibodies, which means it does not affect current antibody tests, convalescent plasma use, or possible vaccine development. However, this mutation does make the virus more transmissible without resulting in major observable differences in disease severity or death. So, we, in the US, have a version of the virus that is more contagious but not more deadly than was previously circulating.

  • June 14

    174 total EUAs issued to-date for diagnostic tests; includes molecular tests, serology (antibody) tests, antigen tests, and one test indicating severity of disease.

    Note: With EUA approval volume, we thought the large national labs would be able to ramp up test capacity and take care of us effectively. Unfortunately, Lab Corp and Quest have been unable to keep up with the volume of tests being sent their way. This in turn has created a need for hospital laboratories to be able to provide their own COVID-19 testing locally. With this, another problem presented itself – the impact of the severe PPE shortages on the ability for hospitals to test. If somebody came in with respiratory symptoms, we would use full protective gear. Without a negative test result, we would continue using all of that additional PPE. A negative test results allows hospitals to use the appropriate amount of PPE, thereby conserving precious resources. Faster turnaround times also help to reduce length of stay. A COVID patient tends to get really bad, really fast. The decision to send a patient home changes if they have the flu or a cold versus a positive COVID-19 test result. Beyond that, the main purpose of testing is to be able to identify hot spots and then, through contact tracing, attempt to contain them before they get to a point where hospitals can’t handle the patients that are coming in.

  • July 21

    Worldometers.info records 3.9M cases in the US and 143,864 deaths

    Ranking the U.S. #10 in the world on both metrics and have performed 49.2M which is 148,489 tests/1M population ranking the U.S. #24 in the world.

  • July 22

    Rt values* tell a more robust story as we see a resurgence of spikes and hot spots in certain states.

    All states are either leveling off or decreasing their Rt values on July 22. Spikes are not as severe as what we saw in New York, and curves are generally still flat enough that we are not overwhelming the hospital systems in most areas. Hot spots are very localized within their respective states as well.

    Note: Florida (#1 for daily new cases) has a Rt value of 1.01, down from its peak of 1.35 on June 2nd. Arizona is currently below 1, down from 1.25 in mid-May, California is at 1.04, down from its peak of 1.12 on June 11th, and Texas is at 1.02, down from 1.17 at the end of May.

    * Rt values are a key measure of how fast the virus is spreading, the average number of people who become infected by an infectious person. If the Rt value is above 1, the virus is spreading quickly. (rt.live graphs daily updated Rt values by state).

  • July 22

    California reports the highest number of daily cases seen so far in the U.S. throughout the pandemic, 12,137

    Their Rt value is leveling off at 1.03. Any number above 1 indicated continued spread. Although that spread has slowed some since their peak of 1.12.

In reflection of the timeline above and how it will impact tomorrow and the months ahead, Kimberly points out that we’ve never stopped testing which in turn has not allowed us to find relief, take a deep breath and recover. The seasonality effect that we see with flu and other respiratory viruses never occurred, so labs are still experiencing all of the same supply shortages even as we’ve increased manufacturing as well as the number of manufacturers. Many labs have brought on multiple instrument platforms from multiple vendors simply to alleviate their supply allocation issues. Even with all of that, we’re still seeing labs that are coming up short, especially labs in hotspots. Many labs are sending out up to 50% of their tests even though they have three or four COVID testing platforms in house because there are not enough reagents to perform the tests that are coming in. These labs are subsequently no longer testing asymptomatic patients. Adding to these concerns, Lab Corp and Quest have both announced increased turnaround times due to demand overwhelming their test capacity. Net-net, it’s a vicious cycle in which we are still spinning. Kimberly remains focused on finding solutions to these problems, and ultimately seeing a light at the end of the tunnel. Stay tuned for the sunshine . . .