Q&A with Eugenio H. Zabaleta, PhD
Clinical Chemist
OhioHealth Mansfield Hospital  

Medical Lab Management: How has the coronavirus pandemic affected your clinical laboratory operations in general?

Eugenio Zabaleta: We are adjusting to the realities of attempting to perform clinical duties in absentia. While some clinical laboratorians and pathologists are used to traveling between different hospitals and care sites, many are site-based and have spent entire careers working inside a laboratory. Besides the fact that “working remotely” is rather anathema to health care practitioners in general, it is simply quite difficult if not impossible to execute the full range of laboratory-based actions without having skilled staff on-site, working with instruments. Now with that said, there are, it appears, many other clinically-related activities that can be performed outside the lab, including data analysis, administrative meetings, and other non-hands-on tasks.

MLM: What resources have you found particularly helpful for managing the COVID-19 response?

Zabaleta: As laboratories look to their respective state health departments, we have followed the Ohio Department of Health’s guidance in dealing with COVID-19. This is in addition to the federal government’s guidance. Of course, everyone is now aware of the FDA’s emergency use authorizations (EUAs), which are updated practically daily.1

Also, the CDC’s dedicated site for COVID-19 offers tools for health care professionals to manage patients with possible (or confirmed) cases of COVID-19 (see FIGURE 1).

MLM: What technology is primarily needed for testing?

Zabaleta: Although the vast majority of early testing for SARS-CoV-2 has been polymerase chain reaction (PCR) based, undoubtedly there are other methods being investigated, including isothermal loop amplification. There are two ways to amplify DNA—isothermal nucleic acid amplification or the more traditional PCR. Most of the EUAs thus far have been for PCR techniques, largely because PCR is a relatively rapid technology and is entrenched in many hospital laboratories already, so the manufacturers need only focus on developing the primers using the known sequence of the virus, which was established by mid-January of this year. Obviously, circumstances triggered an avalanche of need for this type of testing and the market has responded.

MLM: How can laboratories keep track of proper data related to COVID-19?

Zabaleta: One effective tactic is to maintain awareness of the LOINC codes being established for SARS-CoV-2 test kits. The Regenstrief Institute’s LOINC codes (set of identifiers, names, and codes for identifying health measurement, observations, and documents) are being regularly updated.2 In order to compare the various tests, the LOINC codes establish 6 properties: component, property, time, system, scale, and method. Manufacturers that have given the Institute permission to list their test kits and corresponding LOINC codes are available on the dedicated website. This is a good resource for finding the right testing fit for your laboratory.

MLM: How do you see testing for SARS-CoV-2 being applied moving forward?

Zabaleta: In the future, manufacturers will likely apply testing for SARS-CoV-2 into a common viral testing panel. Obviously, this is still so new, but as we continue to gather data and look at all the dynamics and ramifications of this pandemic on health care practice, the diagnostic testing market will adapt accordingly. This crisis, while terrible, will bring about fascinating changes to the entirety of the practice of health care.

It remains to be seen whether COVID-19 will become a seasonal virus or present a new infection pattern altogether. While there are many differences between the two viruses and resulting disease states, it is worth noting that the H1N1 pandemic of 2009 (H1N1pdm09 virus) remains a significant part of our lives despite rarely hearing it publicly mentioned. In fact, just this season in the US, H1N1pdm09 viruses are the most commonly reported influenza viruses.3 We have learned how to manage this virus and have developed vaccination against it, yet it remains a significant source of mortality in the US and around the world. As we grapple with the devastation of COVID-19, I am confident in our health care community’s ability to gain a full understanding of this virus and apply its substantial knowledge, effort, and resources in taking control.

Eugenio H. Zabaleta, PhD, is a clinical chemist at OhioHealth Mansfield Hospital in Mansfield, Ohio.

References

1. US FDA. Emergency Situations (Medical Devices); Emergency Use Authorizations. Accessed 5.5.20. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
2. LOINC from Regenstrief. SARS Coronavirus 2. Accessed 5.5.20. https://loinc.org/sars-coronavirus-2/
3. Centers for Disease Control and Prevention. Seasonal Influenza activity & surveillance. Weekly US Influenza Surveillance Report ending April 25, 2020. Accessed 5.5.20. https://www.cdc.gov/flu/weekly/#PublicHealthLaboratories