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Biochemia Medica Feb 2021Calculating the sample size in scientific studies is one of the critical issues as regards the scientific contribution of the study. The sample size critically affects...
Calculating the sample size in scientific studies is one of the critical issues as regards the scientific contribution of the study. The sample size critically affects the hypothesis and the study design, and there is no straightforward way of calculating the effective sample size for reaching an accurate conclusion. Use of a statistically incorrect sample size may lead to inadequate results in both clinical and laboratory studies as well as resulting in time loss, cost, and ethical problems. This review holds two main aims. The first aim is to explain the importance of sample size and its relationship to effect size (ES) and statistical significance. The second aim is to assist researchers planning to perform sample size estimations by suggesting and elucidating available alternative software, guidelines and references that will serve different scientific purposes.
Topics: Data Interpretation, Statistical; Laboratories; Models, Theoretical; Sample Size; Software
PubMed: 33380887
DOI: 10.11613/BM.2021.010502 -
Clinical Microbiology Reviews Jun 2021Patient care and public health require timely, reliable laboratory testing. However, clinical laboratory professionals rarely know whether patient specimens contain... (Review)
Review
Patient care and public health require timely, reliable laboratory testing. However, clinical laboratory professionals rarely know whether patient specimens contain infectious agents, making ensuring biosafety while performing testing procedures challenging. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola outbreak, where concerns about biosafety resulted in delayed diagnoses and contributed to patient deaths. This review is a collaboration between subject matter experts from large and small laboratories and the federal government to evaluate the capability of clinical laboratories to manage biosafety risks and safely test patient specimens. We discuss the complexity of clinical laboratories, including anatomic pathology, and describe how applying current biosafety guidance may be difficult as these guidelines, largely based on practices in research laboratories, do not always correspond to the unique clinical laboratory environments and their specialized equipment and processes. We retrospectively describe the biosafety gaps and opportunities for improvement in the areas of risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; equipment and instrumentation safety; disinfection practices; personal protective equipment; waste management; laboratory personnel training and competency assessment; accreditation processes; and ethical guidance. Also addressed are the unique biosafety challenges successfully handled by a Texas community hospital clinical laboratory that performed testing for patients with Ebola without a formal biocontainment unit. The gaps in knowledge and practices identified in previous and ongoing outbreaks demonstrate the need for collaborative, comprehensive solutions to improve clinical laboratory biosafety and to better combat future emerging infectious disease outbreaks.
Topics: Clinical Laboratory Services; Containment of Biohazards; Disease Outbreaks; Humans; Laboratories; Retrospective Studies
PubMed: 34105993
DOI: 10.1128/CMR.00126-18 -
Journal of Virology Aug 2021Starting work in a virology research laboratory as a new technician, graduate student, or postdoc can be complex, intimidating, confusing, and stressful. From laboratory...
Starting work in a virology research laboratory as a new technician, graduate student, or postdoc can be complex, intimidating, confusing, and stressful. From laboratory logistics to elemental expectations to scientific specifics, there is much to learn. To help new laboratory members adjust and excel, a series of guidelines for working and thriving in a virology laboratory is presented. While guidelines may be most helpful for new laboratory members, everyone, including principal investigators, is encouraged to use a set of published guidelines as a resource to maximize the time and efforts of all laboratory members. The topics covered here are safety, wellness, balance, teamwork, integrity, reading, research, writing, speaking, and timelines.
Topics: Guidelines as Topic; Humans; Laboratories; Research Design; Research Personnel; Virology
PubMed: 34319158
DOI: 10.1128/JVI.01112-21 -
ALTEX 2022Good Cell and Tissue Culture Practice (GCCP) 2.0 is an updated guidance document from GCCP 1.0 (published by ECVAM in 2005), which was developed for practical use in the...
Good Cell and Tissue Culture Practice (GCCP) 2.0 is an updated guidance document from GCCP 1.0 (published by ECVAM in 2005), which was developed for practical use in the laboratory to assure the reproducibility of in vitro (cell-based) work. The update in the guidance was essential as cell models have advanced dramatically to more complex culture systems and need more comprehensive quality management to ensure reproducibility and high-quality scientific data. This document describes six main principles to consider when performing cell culture including characterization and maintenance of essential characteristics, quality management, documentation and reporting, safety, education and training, and ethics. The document does not intend to impose detailed procedures but to describe potential quality issues. It is foreseen that the document will require further updates as the science and technologies evolve over time.
Topics: Animals; Animal Testing Alternatives; Cell Culture Techniques; Laboratories; Reproducibility of Results
PubMed: 34882777
DOI: 10.14573/altex.2111011 -
Clinical Chemistry and Laboratory... Apr 2023Lot-to-lot verification is an integral component for monitoring the long-term stability of a measurement procedure. The practice is challenged by the resource... (Review)
Review
Lot-to-lot verification is an integral component for monitoring the long-term stability of a measurement procedure. The practice is challenged by the resource requirements as well as uncertainty surrounding experimental design and statistical analysis that is optimal for individual laboratories, although guidance is becoming increasingly available. Collaborative verification efforts as well as application of patient-based monitoring are likely to further improve identification of any differences in performance in a relatively timely manner. Appropriate follow up actions of failed lot-to-lot verification is required and must balance potential disruptions to clinical services provided by the laboratory. Manufacturers need to increase transparency surrounding release criteria and work closer with laboratory professionals to ensure acceptable reagent lots are released to end users. A tripartite collaboration between regulatory bodies, manufacturers, and laboratory medicine professional bodies is key to developing a balanced system where regulatory, manufacturing, and clinical requirements of laboratory testing are met, to minimize differences between reagent lots and ensure patient safety. has served as a fertile platform for advancing the discussion and practice of lot-to-lot verification in the past 60 years and will continue to be an advocate of this important topic for many more years to come.
Topics: Humans; Quality Control; Reagent Kits, Diagnostic; Chemistry, Clinical; Laboratories
PubMed: 36420533
DOI: 10.1515/cclm-2022-1126 -
Journal of the American College of... Jan 2021
Topics: Cardiac Catheterization; Cardiology; Echocardiography; Functional Laterality; Humans; Laboratories; Motor Skills
PubMed: 33413946
DOI: 10.1016/j.jacc.2020.11.042 -
BMC Genomics Jun 2023The last decade has seen advancements in sequencing technologies and laboratory preparation protocols for ancient DNA (aDNA) that have rapidly been applied in multiple...
The last decade has seen advancements in sequencing technologies and laboratory preparation protocols for ancient DNA (aDNA) that have rapidly been applied in multiple research areas thus enabling large-scale scientific research. Future research could also refine our understanding of the evolution of humans, non-human animals, plants, invertebrate specimens, and microorganisms.
Topics: Animals; DNA, Ancient; Sequence Analysis, DNA; Plants; Laboratories
PubMed: 37291482
DOI: 10.1186/s12864-023-09396-0 -
Fertility and Sterility Jan 2022Delivery of fertility treatment involves both teamwork within a discipline as well as teaming across multiple work areas, such as nursing, administrative, laboratory,... (Review)
Review
Delivery of fertility treatment involves both teamwork within a discipline as well as teaming across multiple work areas, such as nursing, administrative, laboratory, and clinical. In contrast to small autonomous centers, the in vitro fertilization (IVF) laboratory team in large clinics must function both as a team with many members and a constellation of teams to deliver seamless, safe, and effective patient-centered care. Although this review primarily focuses on teamwork within the IVF laboratory, which comprises clinical laboratory scientists and embryologists who perform both diagnostic and therapeutic procedures, it also discusses the laboratory's wider role with other teams of the IVF clinic, and the role of teaming (the ad hoc creation of multidisciplinary teams) to function highly and address critical issues.
Topics: Female; Fertilization in Vitro; Humans; Interdisciplinary Communication; Laboratories; Male; Patient Care Team; Patient-Centered Care; Pregnancy; Reproductive Medicine
PubMed: 34763833
DOI: 10.1016/j.fertnstert.2021.09.031 -
BMC Bioinformatics Sep 2022The recent global focus on big data in medicine has been associated with the rise of artificial intelligence (AI) in diagnosis and decision-making following recent... (Review)
Review
The recent global focus on big data in medicine has been associated with the rise of artificial intelligence (AI) in diagnosis and decision-making following recent advances in computer technology. Up to now, AI has been applied to various aspects of medicine, including disease diagnosis, surveillance, treatment, predicting future risk, targeted interventions and understanding of the disease. There have been plenty of successful examples in medicine of using big data, such as radiology and pathology, ophthalmology cardiology and surgery. Combining medicine and AI has become a powerful tool to change health care, and even to change the nature of disease screening in clinical diagnosis. As all we know, clinical laboratories produce large amounts of testing data every day and the clinical laboratory data combined with AI may establish a new diagnosis and treatment has attracted wide attention. At present, a new concept of radiomics has been created for imaging data combined with AI, but a new definition of clinical laboratory data combined with AI has lacked so that many studies in this field cannot be accurately classified. Therefore, we propose a new concept of clinical laboratory omics (Clinlabomics) by combining clinical laboratory medicine and AI. Clinlabomics can use high-throughput methods to extract large amounts of feature data from blood, body fluids, secretions, excreta, and cast clinical laboratory test data. Then using the data statistics, machine learning, and other methods to read more undiscovered information. In this review, we have summarized the application of clinical laboratory data combined with AI in medical fields. Undeniable, the application of Clinlabomics is a method that can assist many fields of medicine but still requires further validation in a multi-center environment and laboratory.
Topics: Artificial Intelligence; Big Data; Data Mining; Laboratories, Clinical; Machine Learning
PubMed: 36153474
DOI: 10.1186/s12859-022-04926-1 -
Clinical Chemistry and Laboratory... Aug 2020The definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher-order (reference)... (Review)
Review
The definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher-order (reference) methods and/or materials, together with a clinically acceptable level of measurement uncertainty (MU), are fundamental requirements to produce accurate and equivalent laboratory results. The MU associated with each step of the traceability chain should be governed to obtain a final combined MU on clinical samples fulfilling the requested performance specifications. MU is useful for a number of reasons: (a) for giving objective information about the quality of individual laboratory performance; (b) for serving as a management tool for the medical laboratory and in vitro diagnostics (IVD) manufacturers, forcing them to investigate and eventually fix the identified problems; (c) for helping those manufacturers that produce superior products and measuring systems to demonstrate the superiority of those products; (d) for identifying analytes that need analytical improvement for their clinical use and ask IVD manufacturers to work for improving the quality of assay performance and (e) for abandoning assays with demonstrated insufficient quality. Accordingly, the MU should not be considered a parameter to be calculated by medical laboratories just to fulfill accreditation standards, but it must become a key quality indicator to describe both the performance of an IVD measuring system and the laboratory itself.
Topics: Biological Assay; Humans; Laboratories; Quality Control; Reference Standards; Uncertainty
PubMed: 32126011
DOI: 10.1515/cclm-2019-1336