Laboratory diagnostics for risk stratification in COVID-19
The project has two parts. Part 1 only involves data already collected within health service and we seek exemptions from confidentiality requirement in accordance with § 35 of the Health Research Act. Part 2 also entails analysis of sample material collected in the routine and applied for approval in accordance with § 28 of the Health Research Act. Part 2 is subject to approval of part 1, while part 1 can be implemented without part 2. We therefore ask for a separate assessment of the two parts as it is appropriate to proceed with only part 1.
1. At OUS, an internal quality register has been created in Medinsight where all patients with COVID-19 disease are registered on a consecutively. The register contains all essential information on outcomes, comorbidity, residence information, microbiological findings and in addition results from some laboratory analyzes. We want to link information from the registry with information from the laboratory data systems and laboratory instruments to study the relationship between laboratory findings within medical biochemistry and clinical outcomes of COVID-19. As COVID-19 is a new disease, there is limited knowledge of expected laboratory results. A number of analyzes are performed that are reported and used in the routine, the utility is not as well mapped for everyone. In addition, the hematology instruments in the laboratory analyze various parameters, regardless of whether they are ordered or not. These are available at no extra cost and can potentially provide useful information. The purpose of the project is to analyze the usefulness of already performed analyzes by comparing results against clinical outcomes. This may provide a better basis for selecting and interpreting laboratory analyzes for
2. Serum ACE as biomarker at COVID-19. The SARS-CoV-2 virus infects host cells through the membrane-bound enzyme ACE2. ACE2 is an enzyme in the renin-angiotensin system (RAS) where it counteracts the effect of ACE. Patients with high blood pressure are
overrepresented in severe COVID-19 disease. It is also previously known that patients with high blood pressure often have dysregulation of RAS with increased serum ACE. Serum ACE is a simple assay that is available on standard assay platforms. We want to investigate serum ACE upon entry, and development of serum ACE during the course of hospitalized patients with the hypothesis that patients with increased ACE or increasing ACE has poorer prognosis in COVID-19 disease. To our knowledge, this has not been examined before. We want to measure ACE in residual material from samples sent to the laboratory for routine diagnostics.