Inter-laboratory Collaboration Research Articles

Erratum to “Chemsex in France: A national study through interlaboratory collaboration under the auspices of the French Society of Analytical Toxicology (SFTA)” [Toxicologie Analytique et Clinique (2023) 175–197

Erratum to “Chemsex in France: A national study through interlaboratory collaboration under the auspices of the French Society of Analytical Toxicology (SFTA)” [Toxicologie Analytique et Clinique (2023) 175–197

Comparison of Isolated Lymphocyte and Whole Blood-Based CBMN Assays for Radiation Triage

Following a mass-casualty nuclear/radiological event, there will be an important need for rapid and accurate estimation of absorbed dose for biological triage. The cytokinesis-block micronucleus (CBMN) assay is an established and validated cytogenetic biomarker used to assess DNA damage in irradiated peripheral blood lymphocytes. Here, we describe an intercomparison experiment between two biodosimetry laboratories, located at Columbia University (CU) and Health Canada (HC) that performed different variants of the human blood CBMN assay to reconstruct dose in human blood, with CU performing the assay on isolated lymphocytes and using semi-automated scoring whereas HC used the more conventional whole blood assay. Although the micronucleus yields varied significantly between the two assays, the predicted doses closely matched up to 4 Gy – the range from which the HC calibration curve was previously established. These results highlight the importance of a robust calibration curve(s) across a wide age range of donors that match the exposure scenario as closely as possible and that will account for differences in methodology between laboratories. We have seen that at low doses, variability in the results may be attributed to variation in the processing while at higher doses the variation is dominated by inter-individual variation in cell proliferation. This interlaboratory collaboration further highlights the usefulness of the CBMN endpoint to accurately reconstruct absorbed dose in human blood after ionizing radiation exposure.

MOLECULAR DIAGNOSTIC LABORATORY SETUP AND MAINTENANCE FOR SARS-COV-2

Abstract
 Aim: Importance of laboratory diagnosis has come to the spotlight once again with the Covid-19 pandemic caused by Sars-CoV-2 and significant changes have taken place in terms of laboratory operation. A global effort has emerged when all healthcare professionals faced a biological threat. Interlaboratory collaboration and multidisciplinary approach contributed to this effort. This study aims to explain step-by-step establishment of a fully capable laboratory for Sars-CoV-2 diagnosis to support local and global fight for the COVID-19 pandemic.
 Methods: Several precautions were taken, and disaster plans were updated because of the changes in employee health and workload distribution. Some of these are setting up a laboratory from scratch for microorganism diagnostic tests performed in pandemic cases, measures for healthcare workers, personnel assignment planning, changes in the variety and number of tests, innovations in quality standards and the contribution of laboratories to scientific studies.
 Results: XXXXX Molecular Diagnostic Laboratory has become one of the laboratories in Türkiye where Sars-Cov-2 and its mutations have been studied the most with 1,710,856 samples between 01 October 2020 and 01 May 2022 since its establishment and it has become the laboratory with the highest number of equipment and technical personnel in the capital.
 Conclusion: This study summarizes all the phases of XXXXX Molecular Diagnostic Laboratory beginning with its establishment from the scratch and covers all the steps to render this facility fully operational.
 
 Keywords: COVID-19, laboratory disaster planning, laboratory staff, personal protective equipment, Sars-CoV-2

BRCA1 Norway: comparison of classification for BRCA1 germline variants detected in families with suspected hereditary breast and ovarian cancer between different laboratories

Pathogenic germline variants in Breast cancer susceptibility gene 1 (BRCA1) predispose carriers to hereditary breast and ovarian cancer (HBOC). Through genetic testing of patients with suspected HBOC an increasing number of novel BRCA1 variants are discovered. This creates a growing need to determine the clinical significance of these variants through correct classification (class 1–5) according to established guidelines. Here we present a joint collection of all BRCA1 variants of class 2–5 detected in the four diagnostic genetic laboratories in Norway. The overall objective of the study was to generate an overview of all BRCA1 variants in Norway and unveil potential discrepancies in variant interpretation between the hospitals, serving as a quality control at the national level. For a subset of variants, we also assessed the change in classification over a ten-year period with increasing information available. In total, 463 unique BRCA1 variants were detected. Of the 126 variants found in more than one hospital, 70% were interpreted identically, while 30% were not. The differences in interpretation were mainly by one class (class 2/3 or 4/5), except for one larger discrepancy (class 3/5) which could affect the clinical management of patients. After a series of digital meetings between the participating laboratories to disclose the cause of disagreement for all conflicting variants, the discrepancy rate was reduced to 10%. This illustrates that variant interpretation needs to be updated regularly, and that data sharing and improved national inter-laboratory collaboration greatly improves the variant classification and hence increases the accuracy of cancer risk assessment.

Interlaboratory collaboration to determine the performance of the Randox food diagnostics biochip array technology for the simultaneous quantitative detection of seven mycotoxins in feed

An inter-laboratory collaborative study was performed to evaluate the performance of the Biochip Array Technology (BAT) Myco 7 method. The Myco 7 Array is a method which simultaneously and quantitatively detects 20 mycotoxins including aflatoxins B1, B2, G1 and G2, ochratoxin A, deoxynivalenol, zearalenone, fumonisin B1, B2 and B3 and T-2 and HT-2 toxin. The BAT Myco 7 method was collaboratively evaluated by nine government and private Association of American Feed Control Officials (AAFCO) laboratories. Samples were analysed in a proficiency testing round format. Seventeen blind samples were analysed on the same equipment using Myco 7 kits. 99% of the results fell within an acceptable Z-score range of -2|<Z<|+2. Deoxynivalenol had a 100% Z-score pass rate, while a 99% pass was recorded for aflatoxins, zearalenone, ochratoxin A and fumonisins. T-2 toxin had a 97% Z-score pass rate. HorRat analysis for reproducibility used a range of 0.3<|HorRat|≤2. The target was met for deoxynivalenol, zearalenone, T-2 and HT-2 toxin, and aflatoxins B1, B2, G1 and G2 assays. Fumonisins and ochratoxin A assays had a 93% and 94% pass, respectively. The reproducibility co-efficiency of variation was between 16 and 20% meeting set criterion of <40% and is, therefore, fit-for-purpose for use in the AAFCO control programs for mycotoxins.

Remote Evaluation of Short Videos Captured by Static Telecytological Applications for Obtaining Expert Opinions

Over the last decade, cytopathology laboratories wishing to achieve an automated and seamless workflow process, to diminish turnaround times and to improve their diagnostic accuracy have successfully adopted information technologies and automation. New types of cameras and microscopes, connected to computers, have made possible image capture and transmission (telecytology). New innovative information technologies, including e-health and telemedical applications, constitute a valuable tool for interlaboratory collaboration and quality improvement. New applications are expected to enhance the opportunities for improvement in the field of cytological data management and sharing. In this article, we emphasize on the possible use of short videos captured by static telecytology applications in a modern cytopathology laboratory wishing to establish an effective interlaboratory comparison system and obtain expert opinions in diagnostically challenging cases from distant consultants with well recognized diagnostic competence and experience in the field of thyroid cytology.

An interlaboratory collaboration to determine consensus 231Pa/235U model ages of a uranium certified reference material for nuclear forensics

Application of the 231Pa/235U radiochronometer for nuclear forensic investigations is challenged by a lack of certified reference materials with 231Pa/235U model purification dates. The Japan Atomic Energy Agency, Los Alamos National Laboratory, and Lawrence Livermore National Laboratory completed an interlaboratory study measuring 231Pa/235U model ages of New Brunswick Laboratory CRM U100. Results from independent laboratories were combined to calculate a consensus 231Pa/235U model purification date for CRM U100 of March 26, 1959 ± 237 days. This 231Pa/235U consensus date for CRM U100 may be used by the nuclear forensic community for quality control of 231Pa/235U radiochronometry measurements of unknown materials.

Design of a joint research data platform: A use case for severity assessment.

Severity assessment in animal models is a data-driven process. We therefore present a use case for building a repository for interlaboratory collaboration with the potential of uploading specific content, making group announcements and internal prepublication discussions. We clearly show that it is possible to offer such a structure with minimal effort and a basic understanding of web-based services, also taking into account the human factor in individual data collection. The FOR2591 Online Repository serves as a blueprint for other groups, so that one day not only will data sharing among consortium members be improved but the transition from the private to the persistent domain will also be easier.

A versatile macro-based neurohistological image analysis suite for ImageJ focused on automated and standardized user interaction and reproducible data output

BackgroundThe development and increasing adoption of advanced microscopy imaging technologies, including high resolution, multi-dimensional digital photography and multiple fluorescence channel acquisition, as well as the availability of inexpensive terabyte-capacity storage, have enabled research laboratories to pursue neurohistological imaging experiments involving multiple neurochemical probes and experimental conditions covering a variety of brain regions. Analyzing and processing the resulting datasets, composed of hundreds of micrographs, presents challenges in ensuring accuracy and reproducibility under demanding time and training constraints. New methodThe ‘Custom Macros’ plugin suite for ImageJ automates and systematizes user interaction in neurohistological image analysis tasks, including region selection and thresholding, point/object counts, area measurement, batch filter processing, and data review. Written in the accessible ImageJ macro language, the plugin implements a user login-based data storage framework and facilitates inter-laboratory collaboration over cloud file server clients. ResultsA macro-based interface approach integrates dozens of novel operations, software interactions, algorithm calls, and background tasks into individual shortcut commands. Every completed procedure generates image, region, and calibrated measurement records that are saved in a standardized folder structure. Comparisons with existing methodsPlugin installation adds startup access to a persistent interface layer of extensive and streamlined functionality that is generalizable to a variety of neurohistological contexts, thus providing an efficient and reliable alternative to the use of analysis software in an unstructured, provisional manner that necessitates repeated menu and plugin interaction. ConclusionsOur free/open-source software provides researchers a straightforward solution to addressing daunting usability and data oversight issues, ultimately making efficient, accessible, and reproducible image analysis methodology attainable for many laboratories.

Sampling and pre-treatment effects on the quantification of (nano)silver and selected trace elements in surface water - Application in a Dutch case study

Detection and quantification of trace elements in aqueous samples is crucial in terms of environmental monitoring and risk assessment for (heavy) metals in the environment. Silver (Ag) in its nanoparticulate form is commonly used as antimicrobial additive in consumer products and pharmaceuticals. Since released dissolved Ag species act as the actual antimicrobial agent, Ag nanomaterials are supposed to pose risks to the environment by a release of dissolved species. Unfortunately, no standard protocols exist yet to gain reliable information about the presence and distribution of nanomaterials in the environment. Therefore, we present an interlaboratory collaboration involving three laboratories to quantify silver, silver based nanoparticles (Ag-b-NPs) and a wide range of relevant trace elements after different sample pre-treatments for profiling surface water of a Dutch channel. Besides quantification of the elements, different sample pretreatments like acidification, with or without filtration, and their effect on the measurable elemental content were studied. Total Ag and Ag-b-NPs were quantified at lower ng L−1 range in the channel water whereas reasonable differences depending on the pre-treatment were identified; Ba, As, Pb, Co, Cr, Cu, Ni and Zn were detected at μg L−1 range and Na, K, Mg, Ca and Fe at mg L−1 range. Significant sample pre-treatment effects were observed for the elements Cr, Cu, Fe, Pb and Zn, which is very likely due to the existence of particulate species. Measured concentrations were well comparable among the three laboratories underpinning method validity and correctness allowing for a comprehensive, reliable risk assessment for nanomaterials in the environment.

Marine Microalgae: Promising Source for New Bioactive Compounds.

The study of marine natural products for their bioactive potential has gained strength in recent years. Oceans harbor a vast variety of organisms that offer a biological and chemical diversity with metabolic abilities unrivalled in terrestrial systems, which makes them an attractive target for bioprospecting as an almost untapped resource of biotechnological applications. Among them, there is no doubt that microalgae could become genuine “cell factories” for the biological synthesis of bioactive substances. Thus, in the course of inter-laboratory collaboration sponsored by the European Union (7th FP) into the MAREX Project focused on the discovery of novel bioactive compounds of marine origin for the European industry, a bioprospecting study on 33 microalgae strains was carried out. The strains were cultured at laboratory scale. Two extracts were prepared for each one (biomass and cell free culture medium) and, thus, screened to provide information on the antimicrobial, the anti-proliferative, and the apoptotic potential of the studied extracts. The outcome of this study provides additional scientific data for the selection of Alexandrium tamarensis WE, Gambierdiscus australes, Prorocentrum arenarium, Prorocentrum hoffmannianum, and Prorocentrum reticulatum (Pr-3) for further investigation and offers support for the continued research of new potential drugs for human therapeutics from cultured microalgae.

Stability of organic solar cells with PCDTBT donor polymer: An interlaboratory study

Abstract

Разработка отраслевого стандартного образца специфической активности эритропоэтина

Основываясь на рекомендациях ВОЗ и разработанных принципах стандартизации эритропоэтинов, в качестве материала для кандидата в стандартный образец выбрана одна из фармацевтических субстанций эпоэтина альфа, внесенных в Государственный реестр лекарственных средств. По результатам контроля производителя выбранная фармацевтическая субстанция соответствовала требованиям нормативной документации, дополнительный контроль подлинности методом капиллярного зонного электрофореза показал присутствие 8 изоформ, что соответствует требованиям Европейской фармакопеи. Разработаны условия получения отраслевого стандартного образца в лиофилизированной форме. Аттестацию отраслевого стандартного образца провели в межлабораторных исследованиях, значение аттестованной характеристики — специфической активности — составило 2400 ME в 1 ампуле, доверительный интервал от 94,5 до 105,8 %. Изучение стабильности разработанного отраслевого стандартного образца позволило установить срок годности 5 лет при температуре хранения –20 °C с возможностью его продления по результатам мониторинга стабильности.

Comparative Indoor and Outdoor Degradation of Organic Photovoltaic Cells via Inter-laboratory Collaboration.

We report on the degradation of organic photovoltaic (OPV) cells in both indoor and outdoor environments. Eight different research groups contributed state of the art OPV cells to be studied at Pomona College. Power conversion efficiency and fill factor were determined from IV curves collected at regular intervals over six to eight months. Similarly prepared devices were measured indoors, outdoors, and after dark storage. Device architectures are compared. Cells kept indoors performed better than outdoors due to the lack of temperature and humidity extremes. Encapsulated cells performed better due to the minimal oxidation. Some devices showed steady aging but many failed catastrophically due to corrosion of electrodes not active device layers. Degradation of cells kept in dark storage was minimal over periods up to one year.

Reproducible automated phosphopeptide enrichment using magnetic TiO2 and Ti-IMAC.

Reproducible, comprehensive phosphopeptide enrichment is essential for studying phosphorylation-regulated processes. Here, we describe the application of hyper-porous magnetic TiO2 and Ti-IMAC microspheres for uniform automated phosphopeptide enrichment. Combining magnetic microspheres with a magnetic particle-handling robot enables rapid (45 min), reproducible (r2 ≥ 0.80) and high-fidelity (>90% purity) phosphopeptide purification in a 96-well format. Automated phosphopeptide enrichment demonstrates reproducible synthetic phosphopeptide recovery across 2 orders of magnitude, “well-to-well” quantitative reproducibility indistinguishable to internal SILAC standards, and robust “plate-to-plate” reproducibility across 5 days of independent enrichments. As a result, automated phosphopeptide enrichment enables statistical analysis of label-free phosphoproteomic samples in a high-throughput manner. This technique uses commercially available, off-the-shelf components and can be easily adopted by any laboratory interested in phosphoproteomic analysis. We provide a free downloadable automated phosphopeptide enrichment program to facilitate uniform interlaboratory collaboration and exchange of phosphoproteomic data sets.

Web based tools for visualizing imaging data and development of XNATView, a zero footprint image viewer.

Advances in web technologies now allow direct visualization of imaging data sets without necessitating the download of large file sets or the installation of software. This allows centralization of file storage and facilitates image review and analysis. XNATView is a light framework recently developed in our lab to visualize DICOM images stored in The Extensible Neuroimaging Archive Toolkit (XNAT). It consists of a PyXNAT-based framework to wrap around the REST application programming interface (API) and query the data in XNAT. XNATView was developed to simplify quality assurance, help organize imaging data, and facilitate data sharing for intra- and inter-laboratory collaborations. Its zero-footprint design allows the user to connect to XNAT from a web browser, navigate through projects, experiments, and subjects, and view DICOM images with accompanying metadata all within a single viewing instance.

The GRS/GRC from the Perspective of a Graduate Student and First Time Attendee

The networking and collaborative opportunities afforded to the attendees of the Ocean and Human Health Gordon Research Seminar (GRS) and the Gordon Research Conference (GRC) are vast and great. The GRS/GRC, in particular, has the capability of facilitating interlaboratory and interdisciplinary collaborations. The following article highlights the benefits associated with attending the GRS/GRC as a graduate student and first time attendee.

Biosafety Level-4 laboratories in Europe: opportunities for public health, diagnostics, and research.

Summary of Findings and NextSteps The experience with the existing BSL-4laboratorynetworks[2]hasbeenvaluableinfacilitating information and resource shar-ing, scientific exchange and training, andorganizing external quality control assays;the result of the 2-day conference held in2010 [7] was a consensus on some key issuesthat have represented a new starting pointfor the future of the fight against HIDs: N Sustainability. Limitations in fund-ing together with the risk of prolifer-ation of new facilities in Europe andNorth America pose the question oftheir long-term sustainability. Resourc-es need to be identified for themaintenance of their diagnostic capa-bility, training, and research. In par-ticular, funding should be provided tocontinue the implementation of inter-laboratory collaboration, including co-ordinated quality control assays,training,andprofessionaldevelopment. N Biosafety and Biosecurity. A bet-ter interaction between biosafety pro-fessionals and researchers should beencouraged, as well as the adoption ofpolicies and practices that are evi-dence-based. A consensus should befound to allow the exchange of valu-able samples or reagents betweendesignated high containment facilities,and formal agreements addressingsecurity issues should be establishedbetween European countries to allowthe exchange of researchers, and togrant access to BSL-4 laboratories toscientists from countries where thereare no such facilities.

Relationship of human-associated microbial source tracking markers with Enterococci in Gulf of Mexico waters

Human and ecosystem health can be damaged by fecal contamination of recreational waters. Microbial source tracking (MST) can be used to specifically detect domestic sewage containing human waste, thereby informing both risk assessment and remediation strategies. Previously, an inter-laboratory collaboration developed standardized PCR methods for a bacterial, an archaeal, and a viral indicator of human sewage. Here we present results for two subsequent years of field testing in fresh and salt water by five laboratories across the U.S. Gulf Coast (two in Florida and one each in Mississippi, Louisiana and Texas) using common standard operating procedures (SOPs) developed previously. Culturable enterococci were enumerated by membrane filtration, and PCR was used to detect three MST markers targeting domestic sewage: human-associated Bacteroides (HF183), Methanobrevibacter smithii and human polyomaviruses BK and JC (HPyVs). Detection of sewage markers in surface waters was significantly associated with higher enterococci levels and with exceedance of the recreational water quality standard in four or three regions, respectively. Sewage markers were frequently co-detected in single samples, e.g., M. smithii and HF183 were co-detected in 81% of Louisiana samples, and HPyVs and M. smithii were co-detected in over 40% of southwest Florida and Mississippi samples. This study demonstrates the robustness and inter-laboratory transferability of these three markers for the detection of pollution from domestic sewage in the waters impacting the Gulf of Mexico over a coastal range of over 1000 miles.

Antiangiogenic therapy—evolving view based on clinical trial results

Antiangiogenic therapies that target VEGF or its receptors have become a mainstay of cancer therapy in multiple malignancies. However, the clinical efficacy of these agents is less than originally anticipated and, in most settings, requires the addition of cytotoxic chemotherapy suggesting that, as for other targeted therapies, VEGF inhibitors will require selection of patient subpopulations to achieve maximal clinical benefit. Without the identification and use of predictive biomarkers for VEGF-targeted agents, and other agents that target the vasculature, further improvements in current clinical outcomes are unlikely. Exciting new data presented in 2011 at the ESMO conference showed that retrospective evaluation of plasma concentrations of VEGF-A predicted progression-free survival and/or overall survival benefit from bevacizumab in phase III trials in certain tumour types; prospective evaluation of the assay is required. This endeavour should be followed by further biomarker research, requiring inter-laboratory collaboration and high-quality, adequately powered clinical trials.