The Role of Clinical Laboratories in Emerging Pathogens—Insights From the COVID-19 Pandemic

This is the authors' abstract. We don't add key points for this paper.

In the second year of the COVID-19 pandemic, with new SARS-CoV-2 viral variants arising simultaneously across the globe, the laboratory community continues to provide critical testing while navigating numerous and recurrent challenges.While promising progress has been made in the rollout of vaccines in some countries, diagnostic testing continues to be a vital tool to identify infections, diagnose patients, and pinpoint and monitor outbreaks.Laboratory professionals across the US, including pathologists, doctoral scientists, and medical laboratory scientists, have been tirelessly working to provide critical testing during the pandemic, but have faced regulatory missteps, staffing strains, and supply-chain shortages.After reflecting on the insights learned over the past year, we offer recommendations to improve the US response moving forward and better prepare for the next pandemic. Clinical Laboratories in Response to the COVID-19 PandemicClinical and public health laboratories across the nation have served an essential role in developing and providing COVID-19 diagnostic tests.For example, the first laboratory-developed testing procedure (LDP) for SARS-CoV-2 in the United States was available on February 24, 2020, nearly 3 weeks before the first commercially manufactured testing kits. 1 In 2020, the Association for Molecular Pathology conducted surveys of laboratories performing SARS-CoV-2 diagnostic testing from April to September to assess their efforts and experiences in response to the pandemic.1 The April survey results included responses from over 100 laboratories, the majority of which were running full staffing, 7 days a week to perform SARS-CoV-2 testing, despite experiencing regulatory hurdles and supply-chain and staffing shortages.Flexibility, resourcefulness, and expertise of laboratory personnel have been key to providing consistent and timely COVID-19 testing amidst persistent challenges.Since the earliest days of the pandemic, it is clear that better coordination and integration are needed between clinical laboratories and the US federal government.In the communities first affected, academic and clinical laboratories were not utilized in the critical early weeks when the virus spread undetected.Early engagement of local clinical laboratories via state health laboratories and the Centers for Disease Control and Prevention (CDC) could enable the expertise and capacity available in our country to deploy and scale testing.In addition, the CDC should strive to include additional qualified clinical laboratories in their Laboratory Response Network to enable rapid deployment of clinical diagnostic testing.In the setting of new or novel pathogens, the medical and scientific understanding is constantly evolving, and we encourage the CDC to work with professional organizations to develop tools such as assay protocols, testing criteria, control materials, and practice guidelines to enable laboratories to stay at the vanguard of the response. Government Regulation and Clinical Laboratories During the PandemicIn early 2020, many laboratories encountered regulatory barriers that prevented diagnostic testing of symptomatic patients.Following the initial declaration of a public health emergency, the US Food and Drug Administration (FDA) required laboratories to obtain emergency use authorization for