Konforte, Danijela

The COVID-19 pandemic has significantly impacted the production, distribution, and demand of essential laboratory supplies worldwide. In 2021, severe shortages in required laboratory supplies such as blood collection tubes, butterfly needles, and blood gas syringes became a critical issue across Canada. Many hospitals or institutions had to instruct physicians and patients to limit laboratory testing where possible and, in some cases, required emergency shipments of tubes from alternative vendors or nearby hospitals. Laboratory testing is ubiquitous in managing patients. It is used for screening, diagnosis, and monitoring purposes. With limited blood collection tubes, consideration for restricting non-urgent testing is needed to conserve supply and protect acute care departments that manage critically ill patients. In addition, laboratories across Canada have experienced significant staffing shortages, resulting in an even greater need for appropriate laboratory utilization. Consequently, the Canadian Society of Clinical Chemists (CSCC) and the Canadian Association of Medical Biochemists (CAMB) curated utilization recommendations for both hospital and primary care settings in collaboration with Choosing Wisely Canada (CWC). These recommendations were specifically selected from those previously published by Choosing Wisely Canada (CWC), with impact statements and rationales added to conserve at-risk laboratory resources. Supply chain disruptions of clinical laboratory resources are expected to continue throughout 2022, indicating that now, more than ever, a focus on appropriate laboratory utilization is essential.

Abstract Background The clinical laboratory continues to play a critical role in managing the coronavirus pandemic. Numerous US Food and Drug Administration emergency use authorization (EUA) and laboratory-developed test (LDT) serologic assays have become available. The performance characteristics of these assays and their clinical utility continue to be defined in real time during this pandemic. The AACC convened a panel of experts from clinical chemistry, microbiology, and immunology laboratories; the in vitro diagnostics industry; and regulatory agencies to provide practical recommendations for implementation and interpretation of these serologic tests in clinical laboratories. Content The currently available EUA serologic tests and platforms, information on assay design, antibody classes including neutralizing antibodies, and the humoral immune responses to SARS-CoV-2 are discussed. Verification and validation of EUA and LDT assays are described, along with a quality management approach. Four indications for serologic testing are outlined. Recommendations for result interpretation, reporting comments, and the role of orthogonal testing are also presented. Summary This document aims to provide a comprehensive reference for laboratory professionals and healthcare workers to appropriately implement SARS-CoV-2 serologic assays in the clinical laboratory and to interpret test results during this pandemic. Given the more frequent occurrence of outbreaks associated with either vector-borne or respiratory pathogens, this document will be a useful resource in planning for similar scenarios in the future.