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Circulating cell-free microRNAs (cfmiRNA) are an emerging class of biomarkers that have shown great promise in the clinical diagnosis, treatment, and monitoring of several pathological conditions, including cancer. However, validation and clinical implementation of cfmiRNA biomarkers has been hindered by the variability introduced during different or suboptimal specimen collection and handling practices. To address the need for standardization and evidence-based guidance, the National Cancer Institute (NCI) developed a new Biospecimen Evidenced-Based Practices (BEBP) document, entitled "Cell-free miRNA (cfmiRNA): Blood Collection and Processing". The BEBP, the fourth in the document series, contains step-by-step procedural guidelines on blood collection, processing, storage, extraction, and quality assessment that are tailored specifically for cfmiRNA analysis of plasma and serum. The workflow outlined in the BEBP is based on the available literature and recommendations of an expert panel. The BEBP contains the level of detail required for development of evidence-based standard operating procedures (SOPs) as well as the flexibility needed to accomodate (i) discovery- and inquiry-based studies and (ii) the different constraints faced by research labs, industry, clinical and academic institutions to foster widespread implementation. Guidance from the expert panel also included recommendations on study design, validating changes in workflow, and suggested quality thresholds to delineate meaningful changes in cfmiRNA levels. The NCI cfmiRNA: Blood Collection and Processing BEBP is available here as supplementary information as well as through the NCI Biorepositories and Biospecimen Research Branch (BBRB) (https://biospecimens.cancer.gov/resources/bebp.asp).
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MicroRNA Circulante , Neoplasias , Humanos , Reprodutibilidade dos Testes , Manejo de Espécimes/métodos , Biomarcadores , Neoplasias/patologiaRESUMO
BACKGROUND: Microvascular decompression (MVD) is a well-established and effective treatment for primary trigeminal neuralgia (TN). Endoscopy has been implemented to provide a comprehensive view of neurovascular conflict and minimizes the damages of brain retraction during MVD. OBJECTIVES: To preliminarily evaluate the surgical safety and efficacy of fully endoscopic microvascular decompression (EMVD) for primary TN with surgeon performing two-hand manipulation and assistant holding endoscope. METHODS: Retrospective clinical analysis of 189 patients with primary TN underwent EMVD between June 2019 and August 2022 was performed. By analyzing the intraoperative situation, the outcomes of postoperative symptoms and the main complications, we evaluated the reliability and effectivity of the operative technique in the treatment of primary TN. RESULTS: We summarized the standard operating procedure of EMVD for primary TN with surgeon performing two-hand manipulation and assistant holding endoscope. In addition, acicular bipolar electrocoagulation technique was developed to handle venous compression. During the follow-up period, good pain relief was achieved in 178 patients (94.2%) and recurrence of pain was observed in 4 patients (2.1%). Postoperative temporary complications included trigeminal dysesthesias (7 patients, 4.8%), cerebrospinal fluid leak (2 patients, 1.1%), hearing difficulty (3 patient, 1.6%), facial paresis (2 patients, 1.1%) and vertigo (5 patients, 2.7%). There were no cases of intracranial hemorrhage, cerebellar swelling and death. CONCLUSION: This EMVD technique is reliable and effective, and can be used as a routine surgical procedure for primary TN.
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Cirurgia de Descompressão Microvascular , Neuralgia do Trigêmeo , Humanos , Neuralgia do Trigêmeo/cirurgia , Cirurgia de Descompressão Microvascular/métodos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Estudos Retrospectivos , Adulto , Resultado do Tratamento , Neuroendoscopia/métodos , Complicações Pós-Operatórias/prevenção & controle , Endoscopia/métodos , Idoso de 80 Anos ou maisRESUMO
The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified devices, and post-market surveillance. The IVDR regulates design, manufacture and putting into use of devices, but not medical services using these devices. In the absence of suitable commercial devices, the laboratory can resort to laboratory-developed tests (LDT) for in-house use. Documentary obligations (IVDR Art 5.5), the performance and safety specifications of ANNEX I, and development and manufacture under an ISO 15189-equivalent quality system apply. LDTs serve specific clinical needs, often for low volume niche applications, or correspond to the translational phase of new tests and treatments, often extremely relevant for patient care. As some commercial tests may disappear with the IVDR roll-out, many will require urgent LDT replacement. The workload will also depend on which modifications to commercial tests turns them into an LDT, and on how national legislators and competent authorities (CA) will handle new competences and responsibilities. We discuss appropriate interpretation of ISO 15189 to cover IVDR requirements. Selected cases illustrate LDT implementation covering medical needs with commensurate management of risk emanating from intended use and/or design of devices. Unintended collateral damage of the IVDR comprises loss of non-profitable niche applications, increases of costs and wasted resources, and migration of innovative research to more cost-efficient environments. Taking into account local specifics, the legislative framework should reduce the burden on and associated opportunity costs for the health care system, by making diligent use of existing frameworks.
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Serviços de Laboratório Clínico , Kit de Reagentes para Diagnóstico , Humanos , Kit de Reagentes para Diagnóstico/normas , União Europeia , Serviços de Laboratório Clínico/legislação & jurisprudênciaRESUMO
Intraoral scanning must meet a stringent infection control standard because of contact with the oral mucosa. A preparation protocol is thus presented for increased inquiries about intraoral scanning requirements. Materials required for such a preparation include: a single-use bubble-free gel packet, a gel standoff pad, and a transducer probe cover. Postscan reprocessing of the ultrasound transducer requires high-level disinfection. Examples for proper and improper use are provided as well as limitations of this preparation protocol and recommendations for future development. This guidance meets the current infection control standard and may guide the user to obtain consistent ultrasound image quality.
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Desinfecção , Transdutores , Humanos , Ultrassonografia , Desinfecção/métodos , Contaminação de EquipamentosRESUMO
Potency assays represent crucial experiments at the hub of the comprehensive complexity surrounding cell therapy. Moreover, numerous factors beyond biological and scientific considerations are involved in achieving successful potency assays that fulfil regulatory authority approval for a new advanced therapy medicinal product. Though this can mean a frustratingly long period of discovery and development, progress in cell therapy is nowadays proceeding remarkably quickly, assisted by the potency assay rigorously placing emphasis on the need to critically analyse the key factor/s responsible for the therapeutic mechanism of action. History has shown that it can take many decades for there to be an improved understanding of a mechanism of action. Yet the chasing of precise targets has revolutionised medicine, with no clearer example than approaches to viral pandemics. The centuries involved in the eradication of smallpox have paved the way for an unprecedented pace of vaccine development for the Covid-19 pandemic. Such extraordinary accomplishments foster encouragement that similarly for stem cell-based therapy, our scientific knowledge will continue to improve apace. This chapter focuses on the art of experimentation and discovery, introducing potency assay requisites and numerous factors that can influence potency assay outcomes. A comprehensive understanding of potency assays and their development can hasten the provision of new cell therapies to help resolve burdensome diseases of unmet medical need.
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COVID-19 , Humanos , COVID-19/terapia , Pandemias , Terapia Baseada em Transplante de Células e Tecidos , Transplante de Células-TroncoRESUMO
Many life-threatening diseases remain obscure in their early disease stages. Symptoms appear only at the advanced stage when the survival rate is poor. A non-invasive diagnostic tool may be able to identify disease even at the asymptotic stage and save lives. Volatile metabolites-based diagnostics hold a lot of promise to fulfil this demand. Many experimental techniques are being developed to establish a reliable non-invasive diagnostic tool; however, none of them are yet able to fulfil clinicians' demands. Infrared spectroscopy-based gaseous biofluid analysis demonstrated promising results to fulfil clinicians' expectations. The recent development of the standard operating procedure (SOP), sample measurement, and data analysis techniques for infrared spectroscopy are summarized in this review article. It has also outlined the applicability of infrared spectroscopy to identify the specific biomarkers for diseases such as diabetes, acute gastritis caused by bacterial infection, cerebral palsy, and prostate cancer.
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Gastrite , Masculino , Humanos , Espectrofotometria Infravermelho , Biomarcadores/análise , GasesRESUMO
BACKGROUND: The diagnostics of autism spectrum disorder is complex due to missing biological markers and numerous comorbidities. The aim was to assess the role of neuropediatric diagnostics and to develop a standard operating procedure for a targeted assessment. METHOD: All patients presenting to the neuropediatric outpatient clinic at Saarland University Hospital between April 2014 and December 2017 with ICD code F84 pervasive developmental disorders were included. RESULTS: A total of 82 patients were included (male 78%, female 22%; mean age 5.9⯱ 2.9 years, range 2-16 years). The most frequent examination was electroencephalography (EEG) (74/82; 90.2%) with pathological findings in 33.8% (25/74). Based on the history and/or EEG epilepsy was diagnosed in 19.5% (16/82). Magnetic resonance imaging (MRI) was performed in 49/82 (59.8%) patients, 22/49 (44.9%) showed at least 1 cerebral abnormality and definite pathologies could be detected in 63.6% (14/22). A metabolic diagnostic work-up was performed in 44/82 (53.7%) cases and in 5/44 (11.4%) it resulted in a diagnosis or suspicion of a metabolic disease. Genetic testing results were available in 29/82 (35.4%) children and 12/29 (41.4%) showed abnormal results. Delay in motor development was more frequently associated with comorbidities, EEG abnormalities, epilepsy and abnormalities in metabolic and genetic testing. CONCLUSION: Neuropediatric examination in cases of suspected autism should include a detailed history, a thorough neurological examination and an EEG. An MRI, comprehensive metabolic and genetic testing are only recommended if clinically indicated.
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In recent years, various ecotoxicological test guidelines and (technical) guidance documents have been evaluated and updated with regard to their applicability to nanomaterials (NMs). Several of these have currently reached official regulatory status. Ensuring their harmonized implementation with previously recognized methods for ecotoxicity testing of chemicals is a crucial next step towards effective and efficient regulation of NMs. In the present study, we evaluated the feasibility of assessing multigenerational effects in the first generation of offspring derived from exposed Daphnia magna whilst maintaining test conditions in accordance with regulatory test guidelines and guidance documents for NMs. To do so, we integrated the recommendations for ecotoxicological testing of NMs as defined in OECD Guidance Document 317 into an extended long-term D. magna reproduction test method (OECD Test Guideline 211) and assessed effects of two poorly soluble NMs (nTiO2 and nCeO2). Our results show adverse effects on life-history parameters of D. magna exposed to the selected nanomaterials within the range of reported environmental concentrations. We argue that conforming to OECD test guidelines and accompanying guidance for nanomaterials is feasible when performing D. magna reproduction tests and can minimize unnecessary duplication of similar experiments, even when extensions to the standardized test setup are added.
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Nanoestruturas , Poluentes Químicos da Água , Animais , Daphnia , Ecotoxicologia/métodos , Nanoestruturas/toxicidade , Reprodução , Poluentes Químicos da Água/toxicidadeRESUMO
BACKGROUND: Guideline-based therapy of cardiac arrhythmias is important for many physicians from the beginning of their training. Practical training of the required skills to treat cardiac arrhythmias is useful for acquiring these skills but does not seem sufficient for skill retention. The aim of this study was to compare different retention methods for skills required to treat cardiac arrhythmias with respect to the performance of these skills in an assessment. METHODS: Seventy-one final-year medical students participated in a newly designed workshop to train synchronized cardioversion (SC) and transcutaneous cardiac pacing (TCP) skills in 2020. All participants completed an objective structured clinical examination (OSCE 1) one week after the training. Afterwards, the participants were stratified and randomized into three groups. Nine weeks later, one group received a standard operating procedure (SOP) for the skills, one group participated in a second workshop (SW), and one group received no further intervention (control). Ten weeks after the first training, all groups participated in OSCE 2. RESULTS: The average score of all students in OSCE 1 was 15.6 ± 0.8 points with no significant differences between the three groups. Students in the control group reached a significantly (p < 0.001) lower score in OSCE 2 (-2.0 points, CI: [-2.9;-1.1]) than in OSCE 1. Students in the SOP-group achieved on average the same result in OSCE 2 as in OSCE 1 (0 points, CI: [-0.63;+0.63]). Students who completed a second skills training (SW-group) scored not significantly higher in OSCE 2 compared to OSCE 1 (+0.4 points, CI: [-0.29;+1.12]). The OSCE 2 scores in groups SOP and SW were neither significantly different nor statistically equivalent. CONCLUSIONS: Partial loss of SC and TCP skills acquired in a workshop can be prevented after 10 weeks by reading an SOP as well as by a second workshop one week before the second assessment. Refreshing practical skills with an SOP could provide an effective and inexpensive method for skills retention compared to repeating a training. Further studies need to show whether this effect also exists for other skills and how frequently an SOP should be re-read for appropriate long-term retention of complex skills.
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Estudantes de Medicina , Competência Clínica , Avaliação Educacional/métodos , Cardioversão Elétrica , Humanos , Estudos ProspectivosRESUMO
BACKGROUND: To improve the efficient use of magnetic resonance imaging (MRI) in routine clinical practice, an expert panel has revised the guidelines for its use in the diagnosis and monitoring of multiple sclerosis (MS). OBJECTIVES: The revised guidelines now take into account new developments and relevant advances in knowledge, such as the ongoing debate about safety related to intravenous gadolinium-based contrast agents. The value of spinal cord MRI for diagnostic, prognostic, and surveillance purposes has been re-evaluated. Standardization of brain and spinal cord MRI protocols for diagnosis, assessment of prognosis, and monitoring of therapy, as well as the use of 3D-FLAIR (three-dimensional fluid-attenuated inversion recovery) as the most important sequence in the diagnosis of lesions in the brain have been included, as this allows better interpretation and comparability, e.g., in follow-up assessments.
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Esclerose Múltipla , Encéfalo/diagnóstico por imagem , Encéfalo/patologia , Meios de Contraste , Humanos , Imageamento por Ressonância Magnética/métodos , Esclerose Múltipla/diagnóstico por imagem , Esclerose Múltipla/patologia , Medula EspinalRESUMO
A procedure is presented and discussed that highlights the use of the Nix Pro Color Sensor ("Nix") in digitizing soil colors with applications for forested wetland soils. Informed by our soil color investigations using both the Munsell Soil Color Chart (MSCC) and the Nix in forested wetlands of the northern Virginia area, we crafted a standard operating procedure (SOP), adaptable to various locations and/or soil types, that guides users-regardless of knowledge of soil ecology or familiarity with the Nix-to successfully assess and monitor soil colors at various depths. Our SOP outlines steps for digitally collecting, storing, and sharing soil color data. Through the implementation of this procedure, soil color monitoring can enter the digital age, removing barriers of entry to soil color determination and enhancing individuals' interest in monitoring and understanding of the importance of soil color as an environmental and ecological indicator. With continued refinement and adaptation to intended use, the SOP herein presented has the potential to aid wetland/watershed assessment by providing data on soil colors that can be tracked over time while also encouraging public engagement in environmental monitoring of soils.
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Solo , Áreas Alagadas , Cor , Monitoramento Ambiental/métodos , Florestas , HumanosRESUMO
Native mass spectrometry (nMS) is a rapidly growing method for the characterization of large proteins and protein complexes, preserving "native" non-covalent inter- and intramolecular interactions. Direct infusion of purified analytes into a mass spectrometer represents the standard approach for conducting nMS experiments. Alternatively, CZE can be performed under native conditions, providing high separation performance while consuming trace amounts of sample material. Here, we provide standard operating procedures for acquiring high-quality data using CZE in native mode coupled online to various Orbitrap mass spectrometers via a commercial sheathless interface, covering a wide range of analytes from 30-800 kDa. Using a standard protein mix, the influence of various CZE method parameters were evaluated, such as BGE/conductive liquid composition and separation voltage. Additionally, a universal approach for the optimization of fragmentation settings in the context of protein subunit and metalloenzyme characterization is discussed in detail for model analytes. A short section is dedicated to troubleshooting of the nCZE-MS setup. This study is aimed to help normalize nCZE-MS practices to enhance the CE community and provide a resource for the production of reproducible and high-quality data.
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Espectrometria de Massas , Eletroforese Capilar , Proteínas , Espectrometria de Massas por Ionização por ElectrosprayRESUMO
The survival of the severely injured is dependent on the rapid and efficient prehospital treatment. Despite all efforts over the last decades and despite an improved network of rescue helicopters, the time delay between the accident event and admission to the trauma room could not be reduced. A certain proportion of the severely injured need induction of anesthesia even before arrival in hospital (typically as rapid sequence induction, RSI). Due to the medical and technical progress in video laryngoscopy as well as in the means of air rescue used in German-speaking countries, under certain conditions the possibility to carry out induction of anesthesia and airway management in the cabin of the rescue helicopter, i.e. during the transportation, seems to be a possible option to reduce the prehospital time. The aspects dealt with in this article are elementary for a safe execution. A procedure that has been tried and trusted for some time is presented as an example; however, the in-cabin RSI should only be carried out by pretrained teams using a clear standard operating procedure.
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Resgate Aéreo , Anestesia , Serviços Médicos de Emergência , Humanos , Intubação Intratraqueal , Indução e Intubação de Sequência RápidaRESUMO
BACKGROUND: The working group for palliative medicine within the Comprehensive Cancer Center (CCC) network funded by the German Cancer Aid in Germany has developed and published 14 Standard Operating Procedures (SOPs) for palliative care in CCCs. This study analyzed to what extent these SOPs have been implemented in the clinical routine in the CCC network one year after their publication. METHODS: An online-based survey on the implementation status, limitations in daily practice and further themes was conducted between April and July 2018. In total, 125 health professionals in specialized palliative care from all 16 CCC locations were invited to participate. The data were analyzed descriptively using SPSS. RESULTS: The response rate was 52.8%. More than half of the respondents (57.6%) knew about the free availability of SOPs on the CCC network website. The extent to which each SOP was being used actively in practice by the survey respondents ranged from a low of 22.7% (for the "Fatigue" SOP) to a highest of 48.5% (for the "Palliative Sedation" and "Respiratory Distress" SOPs). The respondents became aware of the SOP through recommendations from colleagues, team meetings or from the head of the department. The SOPs "Respiratory distress of an adult palliative patient" and "Palliative sedation" were perceived as the most practically oriented and understandable. Barriers to use SOPs were mainly limited time resources and lack of knowledge of existence and availability. CONCLUSIONS: In practice, better knowledge about the SOPs and at the same time increased use can be achieved through systematic training or discussion of SOPs in regular team meetings. There is a need to take measures to optimize the implementation in clinical practice.
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Institutos de Câncer/normas , Neoplasias/terapia , Cuidados Paliativos/métodos , Adulto , Institutos de Câncer/organização & administração , Feminino , Alemanha , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Avaliação de Programas e Projetos de Saúde/métodos , Padrão de Cuidado/tendências , Inquéritos e QuestionáriosRESUMO
Standard operating procedures (SOP) are increasingly required on farms participating in animal welfare assurance programs, such as the Dairy Farmers of Canada's proAction initiative and the National Dairy FARM Program in the United States. However, little is known about the use of SOP on farms and who is involved in their development. Literature from other industries shows the importance of including advisors when developing SOP. Despite veterinarians being viewed by many farmers as trusted sources of information, little is known about their involvement in SOP development. The aim of this study was to better understand: (1) what advice from researchers and veterinarians is considered when developing an SOP and (2) what factors affect advice adherence. Participants in this study were farmers (n = 9) from 6 dairy farms in the Fraser Valley region of British Columbia, Canada and their herd veterinarians (n = 5). Structured and semi-structured interviews and participant observation were undertaken from April to December 2018, and the resulting data were analyzed using thematic analysis. In relation to the first aim, we identified 3 main themes: (1) the purpose of the SOP, (2) developing an SOP, and (3) accountability and tracking of procedures. For the second aim, 5 themes emerged: (1) feasibility of the advice, (2) resources required, (3) priority of the advice, (4) other actors involved, and (5) the importance of data. Collectively, these findings suggest that a farm-specific SOP that actively tracks procedures is most beneficial, and that advice adherence is context dependent.
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Indústria de Laticínios/métodos , Fazendeiros , Bem-Estar do Animal , Animais , Colúmbia Britânica , Fazendas , Feminino , Humanos , Masculino , Médicos VeterináriosRESUMO
Coronavirus disease 2019 (COVID-19) is a respiratory syndrome caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and emerged in Wuhan, China, in late 2019. It resulted in a worldwide pandemic, and spread through community transmission in the Republic of Korea (ROK). In the ROK, SARS-CoV-2 is categorized as a first-degree infectious disease of the legal communicable disease present. The Korean Society for Legal Medicine (KSLM) is the sole official academic association of forensic professionals in the ROK. As such, this society has played an important role in forensic medicine and science in the ROK. Therefore, KSLM suggests a standard operating procedure for the postmortem inspection in a focus on COVID-19. This article includes the background of this suggested standard operation procedure, basic principles for postmortem inspections of individuals suggested of having an infectious disease, and specific procedures according to the probability level of SARS-CoV-2 infection.
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Autopsia , Betacoronavirus , Infecções por Coronavirus/patologia , Medicina Legal , Pneumonia Viral/patologia , COVID-19 , Infecções por Coronavirus/diagnóstico , Humanos , Eliminação de Resíduos de Serviços de Saúde , Pandemias , Pneumonia Viral/diagnóstico , Guias de Prática Clínica como Assunto , Publicações , República da Coreia , SARS-CoV-2RESUMO
By law the Standing Committee on Vaccination (STIKO) has the mandate to develop recommendations for carrying out vaccinations and other measures of specific prophylaxis of communicable diseases. Currently, the committee has 18 members who meet 3 times per year to discuss and vote on recommendations. The secretariat of STIKO is located at the Immunization Unit of the Robert Koch Institute (RKI). In 2011 the STIKO adopted a new standard operating procedure (SOP) for the development of evidence-based vaccination recommendations. Using methods of evidence-based medicine, the respective STIKO working group, comprised of STIKO members, RKI staff and external experts, develops a draft recommendation on which the commission votes. After conclusion of the external consultation procedure the vaccination recommendation is considered by the Federal Joint Committee and in the case of a positive vote, is incorporated into the guidelines for protective vaccination and therefore becomes a mandatory service of the statutory health insurance. This article provides an overview on the organization and modes of functioning of the STIKO.
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Imunização , Vacinação , Medicina Baseada em Evidências , Alemanha , Guias como Assunto , Humanos , Programas de Imunização , Esquemas de Imunização , Vacinação/normasRESUMO
AIM AND BACKGROUND: To assess the use of hypofractionated (HG-RT) versus normofractionated radiation therapy (NF-RT) in Breast Cancer in German speaking countries. MATERIALS AND METHODS: Between July 2017 and August 2017, an email-based survey was sent to all 1408 physicians that are members of the German Society of Radiation Oncology (DEGRO). The survey was completed by 180 physicians including 10 private practice owners and 52 heads of departments. The majority (82.1%) of the participants had >15 years of experience in radiation therapy (RT). RESULTS: The majority (83.9%) of the heads of the departments agreed on using the normofractionated regimen of RT as standard treatment for breast cancer. Several physicians were skeptical about HF-RT with 6.5% of the heads refusing to use HF-RT. 40.3% of the departments had not seen the new German guidelines suggesting HF-RT as the standard treatment for all patients as positive or merely adopted a neutral position toward the guidelines (33.9%). The main points of criticism were increased side effects, an impaired toxicity profile and insufficient data. Most departments (46.8%) that perform HF-RT do so in an individual based manner. CONCLUSIONS: HF-RT remains controversial in German speaking countries. Our data shows that NF-RT remains the predominant method of treatment. HF-RT is only used in a defined group of patients as most German physicians agree that particular patients, especially those at higher risk of RT late effects, may benefit from a less intense, extended fractionation schedule.
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Particle size distribution and stability are key attributes for the evaluation of the safety and efficacy profile of medical nanoparticles (Med-NPs). Measuring particle average size and particle size distribution is a challenging task which requires the combination of orthogonal high-resolution sizing techniques, especially in complex biological media. Unfortunately, despite its limitations, due to its accessibility, low cost, and easy handling, batch mode dynamic light scattering (DLS) is still very often used as the only approach to measure particle size distribution in the nanomedicine field. In this work the use of asymmetric flow field flow fractionation coupled to multiangle light scattering and dynamic light scattering detectors (AF4-MALS-DLS) was evaluated as an alternative to batch mode DLS to measure the physical properties of lipid-based nanoparticles. A robust standard operating procedure (SOPs) developed by the Nanomedicine Characterization Laboratory (EUNCL) was presented and tested to assess size stability, batch to batch consistency, and the behavior of the lipid-based nanoparticles in plasma. Orthogonal sizing techniques, such as transmission electron microscopy (TEM) and particle tracking analysis (PTA) measurements, were performed to support the results. While batch mode DLS could be applied as a fast and simple method to provide a preliminary insight into the integrity and polydispersity of samples, it was unsuitable to resolve small modifications of the particle size distribution. The introduction of nanoparticle sorting by field-flow fractionation coupled to online DLS and MALS allowed assessment of batch to batch variability and changes in the size of the lipid nanoparticles induced by the interaction with serum proteins, which are critical for quality control and regulatory aspects. In conclusion, if a robust SOP is followed, AF4-MALS-DLS is a powerful method for the preclinical characterization of lipid-based nanoparticles.
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Fracionamento por Campo e Fluxo/métodos , Lipídeos/química , Nanopartículas/química , Difusão Dinâmica da Luz , Microscopia Eletrônica de Transmissão , Nanopartículas/ultraestrutura , Tamanho da Partícula , Espalhamento de RadiaçãoRESUMO
Optimization of work processes and personnel compliance becomes progressively essential to ensure high process and product quality on dairy farms with an increasingly nonfamily work force. Standard operating procedures (SOP) are important to minimize variation. In addition to having a set of protocols and SOP, regular training of employees is indispensable to reduce procedural drift. A total of 243 farm owners, employees, and veterinarians from 35 farms were invited to take 3 microlearning lessons for colostrum management and provide feedback in an embedded survey. The overall response rate was 48%, and almost all participants accessed the SOP within the course (i.e., 92, 90, and 96% in the first, second, and third course, respectively). Overall, 59% (22/37) launched the course in their leisure time and 80% stated that they were convinced to work more accurately after having taken the course. Most employees underestimated the time spent in the course (76%), accessed background information (89%), or provided feedback (55%). These observations are indicative of high engagement. Overall, 78% of employees felt more confident in correct task completion after the training.