key: cord-0965849-fr28zt6k authors: Zehnbauer, Barbara title: Diagnostics in the Time of Coronavirus Disease 2019 (COVID-19): Challenges and Opportunities date: 2020-12-18 journal: J Mol Diagn DOI: 10.1016/j.jmoldx.2020.10.012 sha: 3905628024b5b7f0fbdc911323ef6f43f6bca8b5 doc_id: 965849 cord_uid: fr28zt6k nan From the Department of Pathology, Emory University School of Medicine, Atlanta, Georgia (Editor-in-Chief) Welcome to a new year and congratulations on surviving 2020. The demands for disease identification during this pandemic have brought an unprecedented focus on clinical laboratory diagnostic testing. Despite early shared data about the viral sequence, the rapid pace of changing knowledge about coronavirus disease 2019 (COVID-19) prevalence, transmission, symptoms, pathology, test implementation, and potential treatment options increased awareness around the globe of the value of professional communication and collaborations. Missteps were many and assigned to various sectors. Faulty test kits, restrictions of testing sites, limited clinical criteria to define patients eligible to receive testing, conflicting messages from health professionals and government policy makers, regulatory restrictions, compromised supply chains, and garbled public health messaging affected some countries more than others. These complexities produced scientific knowledge gaps about how to best combat the spread of the virus and protect the most vulnerable populations. The Journal of Molecular Diagnostics (JMD) provided insights from many of our professional colleagues. Dr. Karen Kaul 1 proposed a future framework for collaboration and oversight for better laboratory preparedness during a pandemic. Lefferts et al 2 described the experiences of the Dartmouth group for implementation of the Emergency Use Authorization requirements for diagnostic laboratorydeveloped procedures as initially specified by the US Food and Drug Administration. The leadership of the Association for Molecular Pathology (AMP) Infectious Disease Subdivision documented their perspectives about the multiple challenges for molecular diagnostic laboratories in effective responses to testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 3 The Journal began publishing multiple reports of emerging technologies for detection of SARS-CoV-2 in the June issue, 4e6 and the January issue features three new articles related to COVID-19 detection. 7e9 The editorial office continues to process new COVID-19 manuscripts through the peer review and revision process and looks forward to sharing the lessons, expertise, insights, and encouragement through published reports and social media platforms. Distributing timely information, knowledge, and experiences to our global molecular diagnostics community through JMD during this pandemic tested our editorial processes. Fortunately, the production of the journal was largely unaffected. Journal staff quickly adapted to successfully manage all journal operations remotely. Editors responded to the increased urgency for decisions affecting submissions focused on SARS-CoV-2 testing. The biggest challenge for rapid publishing was finding subject matter experts to provide timely peer reviews at a time when many experts were overwhelmed with laboratory services supporting care of patients with suspected COVID-19. Many of the submitted articles in JMD for 2020 related to SARS-CoV-2, but our other specialty areas of molecular diagnostics for cancer and inherited disorder were also well represented. One year ago, JMD transitioned to a monthly publishing format. Initial concerns about having sufficient articles for each issue proved to be unwarranted as both new submission numbers as well as the number of accepted articles in 2020 significantly surpassed the totals from 2019. The JMD impact factor realized a significant increase last summer, increasing to 5.552 (from 4.426). In 2020, Elsevier initiated publication discounts for AMP members publishing in JMD. These include page charges of $75 for AMP members and $100 for nonmembers plus Open Access charges of $2400 and $3000 for AMP members and nonmembers, respectively. We hope that these incentives, in addition to the reduced time intervals between acceptance and print publication, will encourage AMP members to send their manuscripts to JMD. In 2020, JMD also began a partnership with the newly structured AMP Publications Committee to replace the previous Joint Journal Oversight Committee. JMD editorial staff members contribute to the monthly publications committee conference calls. They collaborated to generate, distribute, and analyze data from a survey of AMP members to ascertain how JMD serves their professional needs. An in-depth report of the findings has been shared with the AMP leadership and the JMD Editorial Board to guide future developments for journal strategies, topics, and formats. While the world remains hopeful that safe and effective vaccines for SARS-CoV-2 will soon be available, future disease outbreaks will require our continued focus and action. The opportunities to demonstrate the strength and value of clinical laboratories, public health measures, and science itself should not be ignored. Leadership and responsible policy must be based in scientific and medical knowledge but tempered with reliable communication and compassionate support of at-risk populations. JMD will strive to publish high-quality studies in molecular medicine, diagnostic technologies, and professional practices guidance, and continue to disseminate timely peerreviewed articles to combat the ongoing pandemic. Laboratories and pandemic preparedness: a framework for collaboration and oversight Implementation of an Emergency Use Authorization test during an impending national crisis Responding to the challenges of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): perspectives from the Association for Molecular Pathology Infectious Disease Subdivision leadership Development of reverse transcription loop-mediated isothermal amplification assays targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is comparable in clinical samples preserved in saline or viral transport medium Proposal of RT-PCR-based mass screening for severe acute respiratory syndrome coronavirus 1 (coronavirus disease 2019) Dynamics of blood viral load is strongly associated with clinical outcomes in coronavirus disease 2019 (COVID-19) patients: a prospective cohort study External quality assessment for molecular detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in clinical laboratories Performance of severe acute respiratory syndrome coronavirus 2 realtime RT-PCR tests on oral rinses and saliva samples