Preclinical coronavirus studies and pathology: Challenges of the high-containment laboratory.

The COVID-19 pandemic has highlighted the critical role that animal models play in elucidating the pathogenesis of emerging diseases and rapidly analyzing potential medical countermeasures. Relevant pathologic outcomes are paramount in evaluating preclinical models and therapeutic outcomes and require careful advance planning. While there are numerous guidelines for attaining high-quality pathology specimens in routine animal studies, preclinical studies using coronaviruses are often conducted under biosafety level-3 (BSL3) conditions, which pose unique challenges and technical limitations. In such settings, rather than foregoing pathologic outcomes because of the inherent constraints of high-containment laboratory protocols, modifications can be made to conventional best practices of specimen collection. Particularly for those unfamiliar with working in a high-containment laboratory, the authors describe the logistics of conducting such work, focusing on animal experiments in BSL3 conditions. To promote scientific rigor and reproducibility and maximize the value of animal use, the authors provide specific points to be considered before, during, and following a high-containment animal study. The authors provide procedural modifications for attaining good quality pathologic assessment of the mouse lung, central nervous system, and blood specimens under high-containment conditions while being conscientious to maximize animal use for other concurrent assays.

Interlaboratory assessment of quantification of SARS-CoV-2 RNA by reverse transcription digital PCR.

The pandemic of the novel coronavirus disease 2019 (COVID-19) has caused severe harm to the health of people all around the world. Molecular detection of the pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), played a crucial role in the control of the disease. Reverse transcription digital PCR (RT-dPCR) has been developed and used in the detection of SARS-CoV-2 RNA as an absolute quantification method. Here, an interlaboratory assessment of quantification of SARS-CoV-2 RNA was organized by the National Institute of Metrology, China (NIMC), using in vitro transcribed RNA samples, among ten laboratories on six different dPCR platforms. Copy number concentrations of three genes of SARS-CoV-2 were measured by all participants. Consistent results were obtained with dispersion within 2.2-fold and CV% below 23% among different dPCR platforms and laboratories, and Z' scores of all the reported results being satisfactory. Possible reasons for the dispersion included PCR assays, partition volume, and reverse transcription conditions. This study demonstrated the comparability and applicability of RT-dPCR method for quantification of SARS-CoV-2 RNA and showed the capability of the participating laboratories at SARS-CoV-2 test by RT-dPCR platform.

Behind Every Great Infection Prevention Program is a Great Microbiology Laboratory: Key Components and Strategies for an Effective Partnership.

A great clinical microbiology laboratory supporting a great infection prevention program requires focusing on the following services: rapid and accurate identification of pathogens associated with health care-associated infections; asymptomatic surveillance for health care-acquired pathogens before infections arise; routine use of broad and flexible antimicrobial susceptibility testing to direct optimal therapy; implementation of epidemiologic tracking tools to identify outbreaks; development of clear result communication with interpretative comments for clinicians. These goals are best realized in a collaborative relationship with the infection prevention program so that both can benefit from the shared priorities of providing the best patient care.

A Joint Action in Times of Pandemic: The German BioImaging Recommendations for Operating Imaging Core Facilities During the SARS-Cov-2 Emergency.

Operating shared resource laboratories (SRLs) in times of pandemic is a challenge for research institutions. In a multiuser, high-turnover working space, the transmission of infectious agents is difficult to control. To address this challenge, imaging core facility managers being members of German BioImaging discussed how shared microscopes could be operated with minimal risk of spreading SARS-CoV-2 between users and staff. Here, we describe the resulting guidelines and explain their rationale, with a focus on separating users in space and time, protective face masks, and keeping surfaces virus-free. These recommendations may prove useful for other types of SRLs. © 2020 The Authors. Cytometry Part A published by Wiley Periodicals LLC. on behalf of International Society for Advancement of Cytometry.

UV decontamination of personal protective equipment with idle laboratory biosafety cabinets during the COVID-19 pandemic.

Personal protective equipment (PPE) is crucially important to the safety of both patients and medical personnel, particularly in the event of an infectious pandemic. As the incidence of Coronavirus Disease 2019 (COVID-19) increases exponentially in the United States and many parts of the world, healthcare provider demand for these necessities is currently outpacing supply. In the midst of the current pandemic, there has been a concerted effort to identify viable ways to conserve PPE, including decontamination after use. In this study, we outline a procedure by which PPE may be decontaminated using ultraviolet (UV) radiation in biosafety cabinets (BSCs), a common element of many academic, public health, and hospital laboratories. According to the literature, effective decontamination of N95 respirator masks or surgical masks requires UV-C doses of greater than 1 Jcm-2, which was achieved after 4.3 hours per side when placing the N95 at the bottom of the BSCs tested in this study. We then demonstrated complete inactivation of the human coronavirus NL63 on N95 mask material after 15 minutes of UV-C exposure at 61 cm (232 µWcm-2). Our results provide support to healthcare organizations looking for methods to extend their reserves of PPE.

Increased Adherence to Infection Control Practices Among Medical Laboratory Technicians During the COVID-19 Pandemic: A Self-Reported Survey Study.

Background: The adherence of medical laboratory technicians (MLT) to infection control guidelines is essential for reducing the risk of exposure to infectious agents. This study explored the adherence of MLT towards infection control practices during the COVID-19 pandemic. Method: The study population consisted of MLT (n = 444) who worked in private and government health sectors in Jordan. A self-reported survey was used to collect data from participants. Findings: More than 87% of the participants reported adherence to hand-washing guidelines and using personal protective equipment (PPE) when interacting with patients (74.5%), and handling clinical samples (70.0%). Besides, 88.1%, 48.2%, and 7.7% reported wearing of lab coats, face masks, and goggles, at all times, respectively. The majority reported increased adherence to infection control practices during the COVID-19 pandemic. This includes increased PPE use at the workplace (94.2%), increased frequency of disinfection of laboratory surfaces (92.4%) and laboratory equipment (86.7%), and increased frequency of handwashing/use of antiseptics (94.6%). Having a graduate degree was significantly associated with increased adherence of participants to the daily use of goggles/eye protection (p = 0.002), and the use of PPE while handling clinical samples (p = 0.011). Having work experience of >10 years was associated with increased adherence to the use of PPE while handling clinical samples (p = 0.001). Conclusion: MLT reported very good adherence with most assessed infection control practices. In addition, they reported increased conformity with infection control guidelines during the COVID-19 pandemic.

COVID-19-another influential event impacts on laboratory medicine management.

BACKGROUND: Before public health emergencies became a major challenge worldwide, the scope of laboratory management was only related to developing, maintaining, improving, and sustaining the quality of accurate laboratory results for improved clinical outcomes. Indeed, quality management is an especially important aspect and has achieved great milestones during the development of clinical laboratories. CURRENT STATUS: However, since the coronavirus disease 2019 (COVID-19) pandemic continues to be a threat worldwide, previous management mode inside the separate laboratory could not cater to the demand of the COVID-19 public health emergency. Among emerging new issues, the prominent challenges during the period of COVID-19 pandemic are rapid-launched laboratory-developed tests (LDTs) for urgent clinical application, rapid expansion of testing capabilities, laboratory medicine resources, and personnel shortages. These related issues are now impacting on clinical laboratory and need to be effectively addressed. CONCLUSION: Different from traditional views of laboratory medicine management that focus on separate laboratories, present clinical laboratory management must be multidimensional mode which should consider consolidation of the efficient network of regional clinical laboratories and reasonable planning of laboratories resources from the view of overall strategy. Based on relevant research and our experience, in this review, we retrospect the history trajectory of laboratory medicine management, and also, we provide existing and other feasible recommended management strategies for laboratory medicine in future.

Initial Clinical Laboratory Response to COVID-19: A Survey of Medical Laboratory Professionals.

OBJECTIVE: To explore the experiences of medical laboratory professionals (MLPs) and their perceptions of the needs of clinical laboratories in response to COVID-19. METHODS: We surveyed laboratory professionals working in United States clinical laboratories during the initial months of the pandemic. RESULTS: Overall clinical laboratory testing and overtime work for laboratorians decreased during the first months of the pandemic. Laboratory professionals reported better or unchanged job satisfaction, feelings toward their work, and morale in their workplace, which were related to healthcare facility and laboratory leadership response. They reported receiving in-kind gifts, but no hazard pay, for their essential work. Important supply needs included reagents and personal protective equipment (PPE). CONCLUSION: The response by healthcare facilities and laboratory leadership can influence MLPs job satisfaction, feelings toward their work, and laboratory morale during a pandemic. Current COVID-19 laboratory testing management, in the absence of sufficient reagents and supplies, cannot fully address the needs of clinical laboratories.

A proposal to leverage high-quality veterinary diagnostic laboratory large data streams for animal health, public health, and One Health.

Test data generated by ~60 accredited member laboratories of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) is of exceptional quality. These data are captured by 1 of 13 laboratory information management systems (LIMSs) developed specifically for veterinary diagnostic laboratories (VDLs). Beginning ~2000, the National Animal Health Laboratory Network (NAHLN) developed an electronic messaging system for LIMS to automatically send standardized data streams for 14 select agents to a national repository. This messaging enables the U.S. Department of Agriculture to track and respond to high-consequence animal disease outbreaks such as highly pathogenic avian influenza. Because of the lack of standardized data collection in the LIMSs used at VDLs, there is, to date, no means of summarizing VDL large data streams for multi-state and national animal health studies or for providing near-real-time tracking for hundreds of other important animal diseases in the United States that are detected routinely by VDLs. Further, VDLs are the only state and federal resources that can provide early detection and identification of endemic and emerging zoonotic diseases. Zoonotic diseases are estimated to be responsible for 2.5 billion cases of human illness and 2.7 million deaths worldwide every year. The economic and health impact of the SARS-CoV-2 pandemic is self-evident. We review here the history and progress of data management in VDLs and discuss ways of seizing unexplored opportunities to advance data leveraging to better serve animal health, public health, and One Health.

Starting a lab during the COVID-19 pandemic.

JCB asks early career investigators to share their experience launching a lab during the COVID-19 pandemic.