Clin Microbiol Infect. 2023 Apr 21:S1198-743X(23)00192-1. doi: 10.1016/j.cmi.2023.04.019. Online ahead of print.
SCOPE: Since the onset of coronavirus disease 2019 (COVID-19), several assays have been deployed for the diagnosis of SARS-CoV-2. The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) published the first set of guidelines on SARS-CoV-2 in-vitro diagnosis in February 2022. Since the COVID-19 landscape is rapidly evolving, the relevant ESCMID guidelines panel releases an update of the previously published recommendations on diagnostic testing for SARS-CoV-2. This update aims to delineate the best diagnostic approach for SARS-CoV-2 in different populations based on current evidence.
METHODS: An ESCMID COVID-19 guidelines task force was established by the ESCMID Executive Committee. A small group was established, half appointed by the chair, and the remaining selected with an open call. The panel met virtually once a week. For all decisions, a simple majority vote was used. A list of clinical questions using the PICO (population, intervention, comparison, and outcome) format was developed at the beginning of the process. For each PICO, two panel members performed a literature search focusing on systematic reviews with a third panellist involved in case of inconsistent results. The panel reassessed the PICOs previously defined as priority in the first set of guidelines and decided to address 49 PICO questions, as 6 of them were discarded as outdated/non-clinically relevant. The "Grading of Recommendations Assessment, Development and Evaluation(GRADE)-adoption, adaptation, and de novo development of recommendations (ADOLOPMENT)" evidence-to-decision framework was utilized to produce the guidelines.
QUESTIONS ADDRESSED BY THE GUIDELINE AND RECOMMENDATIONS: After literature search, we updated 16 PICO questions; these PICOs address the use of antigen-based assays among symptomatic and asymptomatic patients with different ages, COVID-19 severity status or risk for severe COVID-19, time since onset of symptoms/contact with an infectious case, and finally, types of biomaterials used.