More Laboratory Simulations-Fewer Brain Complications: Prospects from the First Neurosurgery Laboratory in Iraq.

BACKGROUND: The intensive training requirements needed to achieve the requisiste microneurosurgical milestones makes proper training and skill acquisition a challenge to the novice neurosurgeon. This problem is compounded in low- and middle-income nations, where neurosurgery is subject to a myriad of human and financial resource constraints. A temporary solution may be provided by low-cost laboratories that are adaptive to local needs. METHODS: The "HOZ NeuroSurgery LAB" is a nonprofit facility dedicated to microneurosurgery education and skills training. The laboratory, established in June 2015, is housed at the Neurosurgery Teaching Hospital in Baghdad, Iraq. It operates under the motto "More Laboratory Simulation-Fewer Brain Complications.". The fundamental infrastructure of the facility consists of a relatively inexpensive microscope, indigenous locally created training equipment, and animal-based models. RESULTS: Since its inception, this lab has functioned as a hub for resident education and microneurosurgery service, in addition to contributing to the specialty's academic output in the nation. The lab is directly responsible for training 4 vascular neurosurgeons who are currently directing the nation's first organized neurovascular service. Also, it has delivered 53 microneurosurgery skills courses, coordinated 8 student neurosurgery elective cycles with a total of 532 participants, and published approximately 70 research articles. CONCLUSIONS: Our experience may serve as a model for other low- and middle-income countries interested in using the principle of "doing more with less" to overcome some of the challenges associated with microneurosurgery in these parts of the world.

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.

Laboratory medicine: The exemplar for value-based healthcare.

Value-Based Healthcare (VBHC) aims to improve the overall quality, safety, and sustainability of healthcare while reducing delivery costs of more effective care. Despite advantages associated with VBHC transformation, the road to its adoption has been lengthy. Laboratory Medicine (LM) is in a prime position to lead the transition to VBHC because of its key role in diagnosis and treatment of patients. Laboratory medicine results inform/influence 50% to 70% of all clinical decisions. This article summarizes some issues associated with adoption of VBHC and related healthcare innovations and suggests potential approaches using LM-specific examples to help accelerate adoption. Laboratory medicine is both a useful model for VBHC implementation and facilitator for related innovation adoption by helping to target patient populations that would benefit most from specific interventions. The critical value of rapidly adopted diagnostic technologies used during the COVID-19 pandemic and economic recovery provide important insights about the need to embrace and accelerate VBHC implementation.

Strengthening Applied Epidemiology in West Africa: Progress, Gaps, and Advancing a Regional Strategy to Improve Health Security.

The ability to prevent, promptly detect, and appropriately respond to a public health threat is essential for health security. Field epidemiology training has helped increase the quality and quantity of the public health workforce to strengthen disease surveillance, outbreak preparedness and response, and general public health capacity. We conducted a desk review on the status of the Field Epidemiology and Laboratory Training Program model in 16 countries in West Africa. We also developed a questionnaire and shared it with West African Health Organization (WAHO) member states to document their experiences and the status of training in their countries. WAHO organized a regional 3-day consultative meeting with major stakeholders in the region to examine progress, gaps, and challenges, and outline a roadmap to strengthen the Field Epidemiology and Laboratory Training Program. Stakeholders shared their experiences, engaged in discussions to identify strengths and gaps, and made plans on a way forward. Member states are at different levels of implementing field epidemiology and laboratory training programs in their countries, and, therefore, major gaps remain in the number and distribution of trained epidemiologists throughout West Africa. Member states implement different variants of the program and in some instances the same cadre of health workers are trained in different but comparable programs with different funding streams. Two member states had not begun implementing the training program. Developing regional centers of excellence was recommended in the long term while collaboration among member states to train the required number of epidemiologists to fill the acute needs could be helpful in the short and medium term. Curriculum harmonization and expansion, deployment and use of trained epidemiologists, accreditation of training institutions, and generation of indigenous funding streams are recommended to improve the Field Epidemiology and Laboratory Training Program in West Africa.

Epidemiological situation, laboratory capacity and preparedness for carbapenem-resistant Acinetobacter baumannii in Europe, 2019.

To update information on the epidemiological situation and national capacity for detection, surveillance and containment of carbapenem-resistant Acinetobacter baumannii (CRAb) in Europe, we performed a survey in 37 countries. Nine countries reported regional or inter-regional spread and seven an endemic situation. Laboratories with a reference function, surveillance systems, and a national containment plan for CRAb existed in 30, 23 and eight countries, respectively. A pan-European molecular survey would provide in-depth understanding of the CRAb epidemiology.

Fellowship Training for the Future Clinical Microbiology Laboratory Director.

Formal medical and public health microbiology (MPHM) fellowship programs play a key role in preparing future clinical microbiology laboratory directors for their leadership and management responsibilities. Given the continually evolving MPHM field, fellowships must remain adaptable to changes in the field, providing trainees with the opportunity to engage with newly emerging diagnostic modalities, while continuing to emphasize the "bread and butter" techniques of clinical microbiology. This article discusses the key components of a fellowship program and provides recommendations for incorporating educational best practices.

Negative results in nucleic acid test of COVID-19 patients: assessment from the perspective of clinical laboratories.

Since December 2019, there had been an outbreak of coronavirus disease 2019 (COVID-19). Pneumonia caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is prevalent around the world, and the number of infected cases has increased rapidly. Viral nucleic acid test of SARS-CoV-2 can provide direct evidence for rapid diagnosis, disease course monitoring, and therapeutic efficacy. However, in practice, false-negative results in nucleic acid test are common, causing missed diagnoses, which are not conducive to the prevention and control of this outbreak. This article analyzes the possible causes and proposed measures to reduce the false-negative rate of nucleic acid test results and more effectively curb the outbreak.

Assessment of biorisk management systems in high containment laboratories, 18 countries in Europe, 2016 and 2017.

Europe-wide activities to improve biosafety and biosecurity performed within the frameworks of the European Union (EU)-funded Joint Actions EMERGE and QUANDHIP led to the development of an Integrated European Checklist for Laboratory Biorisk Management (ECL).To better understand different approaches shaping biorisk management (BRM) systems on an operational level in high containment laboratories, the ECL was used to map the implementation of BRM in 32 high containment laboratories in 18 countries in Europe. The results suggest that the BRM elements referring to standard microbiological working practices and the handling of infectious material were fulfilled particularly well. The elements safety exercises involving internal and external emergency responders, and appropriate decommissioning plans were not fulfilled particularly well. BRM in Biosafety Level (BSL) 4 laboratories handling Risk Group (RG) 4 viruses appear to vary among each other less than BSL3 laboratories handling RG 3 bacteria. It is important to agree on comparable regulations in Europe as high containment laboratories are indispensable for a safe, quick and effective response to public health threats. As high containment laboratories may also present a public health risk it is crucial to have robust BRM on organisational and operational levels.

The Development of New Diagnostic Tests for Neurologic Disorders in the Commercial Laboratory Environment.

Development of new diagnostic tests in a commercial laboratory for neurologic disorders is challenging. Development occurs in a highly regulated environment. Relevant research infrastructure may not be readily available in-house and may require outsourcing with additional management and costs. Clinically characterized specimens for validation of biomarkers for esoteric diseases may be difficult to acquire, and market size may be difficult to predict. More common diseases with heterogeneous subsets may require better clinical definition. Absence of guidelines may delay health provider acceptance of novel testing. Regulatory agency approval and categorization of tests affects validation requirements and impacts market acceptance and reimbursement.

Biorisk assessment for infrastructure & biosafety requirements for the laboratories providing coronavirus SARS-CoV-2/(COVID-19) diagnosis.

Novel coronavirus infection [coronavirus disease 2019 (COVID-19)] has spread to more than 203 countries of various regions including Africa, America, Europe, South East Asia and Western Pacific. The WHO had declared COVID-19 as the global public health emergency and subsequently as pandemic because of its worldwide spread. It is now one of the top-priority pathogens to be dealt with, because of high transmissibility, severe illness and associated mortality, wide geographical spread, lack of control measures with knowledge gaps in veterinary and human epidemiology, immunity and pathogenesis. The quick detection of cases and isolating them has become critical to contain it. To meet the increasing demand of the diagnostic services, it is necessary to enhance and expand laboratory capabilities since existing laboratories cannot meet the emerging demand. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a BSL-2 (Biosafety Level 2) agent and needs to be handled in biosafety cabinet using standard precautions. This review highlights minimum requirements for the diagnostic laboratories opting testing of material for the diagnosis of COVID-19 and associated biorisk to the individuals and to the community.

Commutability of external quality assessment materials for point-of-care glucose testing using the Clinical and Laboratory Standards Institute and International Federation of Clinical Chemistry approaches.

OBJECTIVES: The aim of this study was to assess the commutability of three external quality assessment (EQA) materials for point-of-care (POC) glucose testing using two approaches, to identify suitable EQA materials to evaluate and monitor the quality of POC testing. METHODS: Commercial control materials (CCMs), pooled human serum samples (PHSs), and homemade human whole-blood samples (HWBs) were measured along with 33 individual clinical samples using five POC instruments and a Hitachi 7600 analyzer. Data were analyzed by Deming regression analysis with a 95% prediction interval as described in Clinical and Laboratory Standards Institute (CLSI) EP30-A, and by difference in bias analysis as described by the International Federation of Clinical Chemistry (IFCC) Working Group on Commutability. RESULTS: Using the CLSI approach, HWBs, CCMs, and PHSs were commutable with five, one, and two instruments, respectively. With the IFCC approach, HWBs were commutable with two instruments, while CCMs and PHSs were largely inconclusive or non-commutable on five instruments. CONCLUSIONS: HWBs were commutable on all instruments by the CLSI approach and may be a suitable EQA material for POC testing. Although some results differed between the IFCC and CLSI approaches, both indicated that HWBs were far superior to CCMs and PHSs in commutability.

Industrial cryo-EM facility setup and management.

Cryo-electron microscopy (cryo-EM) has rapidly expanded with the introduction of direct electron detectors, improved image-processing software and automated image acquisition. Its recent adoption by industry, particularly in structure-based drug design, creates new requirements in terms of reliability, reproducibility and throughput. In 2016, Thermo Fisher Scientific (then FEI) partnered with the Medical Research Council Laboratory of Molecular Biology, the University of Cambridge Nanoscience Centre and five pharmaceutical companies [Astex Pharmaceuticals, AstraZeneca, GSK, Sosei Heptares and Union Chimique Belge (UCB)] to form the Cambridge Pharmaceutical Cryo-EM Consortium to share the risks of exploring cryo-EM for early-stage drug discovery. The Consortium expanded with a second Themo Scientific Krios Cryo-EM at the University of Cambridge Department of Materials Science and Metallurgy. Several Consortium members have set up in-house facilities, and a full service cryo-EM facility with Krios and Glacios has been created with the Electron Bio-Imaging Centre for Industry (eBIC for Industry) at Diamond Light Source (DLS), UK. This paper will cover the lessons learned during the setting up of these facilities, including two Consortium Krios microscopes and preparation laboratories, several Glacios microscopes at Consortium member sites, and a Krios and Glacios at eBIC for Industry, regarding site evaluation and selection for high-resolution cryo-EM microscopes, the installation process, scheduling, the operation and maintenance of the microscopes and preparation laboratories, and image processing.