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Journal of Clinical Virology : the... Aug 2021In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon... (Review)
Review
In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon (Republican-Indiana) and Diana DeGette, (Democrat-Colorado). The VALID Act attempts to create a new framework for the oversight and regulations of both laboratory-developed testing procedures (commonly known as laboratory-developed tests) and In vitro diagnostic tests by the U.S. Food and Drug Administration. The potential impact of this new law if passed may be significant for clinical laboratories in terms of diagnostic test development and implementation. In this report, we review the background and key information that every clinical virologist should know about the VALID Act.
Topics: Clinical Laboratory Services; Colorado; Diagnostic Tests, Routine; Humans; Laboratories; United States; United States Food and Drug Administration
PubMed: 34243115
DOI: 10.1016/j.jcv.2021.104875 -
Annals of Global Health 2021Antimicrobial resistance (AMR) is a global public health threat. Worse still, there is a paucity of data from low- and middle-income countries to inform rational...
INTRODUCTION
Antimicrobial resistance (AMR) is a global public health threat. Worse still, there is a paucity of data from low- and middle-income countries to inform rational antibiotic use.
OBJECTIVE
Assess the feasibility of setting up microbiology capacity for AMR testing and estimate the cost of setting up microbiology testing capacity at rural district hospitals in Rwanda.
METHODS
Laboratory needs assessments were conducted, and based on identified equipment gaps, appropriate requisitions were processed. Laboratory technicians were trained on microbiology testing processes and open wound samples were collected and cultured at the district hospital (DH) laboratories before being transported to the National Reference Laboratory (NRL) for bacterial identification and antibiotic susceptibility testing. Quality control (QC) assessments were performed at the DHs and NRL. We then estimated the cost of three scenarios for implementing a decentralized microbiology diagnostic testing system.
RESULTS
There was an eight-month delay from the completion of the laboratory needs assessments to the initiation of sample collection due to the regional unavailability of appropriate supplies and equipment. When comparing study samples processed by study laboratory technicians and QC samples processed by other laboratory staff, there was 85.0% test result concordance for samples testing at the DHs and 90.0% concordance at the NRL. The cost for essential equipment and supplies for the three DHs was $245,871. The estimated costs for processing 600 samples ranged from $29,500 to $92,590.
CONCLUSION
There are major gaps in equipment and supply availability needed to conduct basic microbiology assays at rural DHs. Despite these challenges, we demonstrated that it is feasible to establish microbiological testing capacity in Rwandan DHs. Building microbiological testing capacity is essential for improving clinical care, informing rational antibiotics use, and ultimately, contributing to the establishment of robust national antimicrobial stewardship programs in rural Rwanda and comparable settings.
Topics: Anti-Bacterial Agents; Antimicrobial Stewardship; Capacity Building; Drug Resistance, Bacterial; Feasibility Studies; Hospitals, District; Hospitals, Rural; Humans; Laboratories; Laboratories, Hospital; Quality Assurance, Health Care; Rwanda
PubMed: 34430228
DOI: 10.5334/aogh.3416 -
Diagnosis (Berlin, Germany) Mar 2019Following an ordered clinical chemistry plasma/serum test, ideally the venous blood specimen is adequately collected at a health care facility, then swiftly transported... (Review)
Review
Following an ordered clinical chemistry plasma/serum test, ideally the venous blood specimen is adequately collected at a health care facility, then swiftly transported to and readily handled, analyzed and sometimes interpreted at a clinical chemistry laboratory followed by a report of the test result to the ordering physician to finally handle the result. However, often there are practical as well as sample quality reasons for short- or long-term storage of samples before and after analysis. If there are specific storage needs, the preanalytical handling practices are specified in the laboratory's specimen collection instructions for the ordered test analyte. Biobanking of specimens over a very long time prior to analysis includes an often neglected preanalytical challenge for preserved quality of the blood specimen and also involves administrative and additional practical handling aspects (specified in a standard operating procedure - SOP) when demands and considerations from academic, industry, research organizations and authorities are included. This short review highlights some preanalytical aspects of plasma/serum short- and long- term storage that must be considered by clinicians, laboratory staff as well as the researchers.
Topics: Biological Specimen Banks; Blood Specimen Collection; Humans; Laboratories; Medical Laboratory Personnel; Plasma; Pre-Analytical Phase; Quality Control; Serum; Time Factors
PubMed: 30138113
DOI: 10.1515/dx-2018-0037 -
Journal of Visualized Experiments : JoVE Aug 2018Stable flies, Stomoxys calcitrans, are serious pests of livestock, humans, companion animals and wildlife worldwide. During the last 20+ years, changes in agronomic...
Stable flies, Stomoxys calcitrans, are serious pests of livestock, humans, companion animals and wildlife worldwide. During the last 20+ years, changes in agronomic practices resulted in serious outbreaks of stable flies in several countries. These outbreaks disrupted livestock production and human recreation resulting in public demands for increasing research and management efforts for this pest. A simple and inexpensive procedure for rearing stable flies for laboratory studies is presented. The procedure uses locally available diet components, equipment and supplies. The procedure can be adapted for rearing other muscoid flies including face fly (Musca autumnalis), horn fly (Haematobia irritans), and house fly (Musca domestica). The procedure produces stable fly puparia averaging 12.5 mg and ~35% egg to adult survival. Approximately 3000 flies are produced in each pan.
Topics: Animals; Diptera; Houseflies; Laboratories
PubMed: 30124666
DOI: 10.3791/57341 -
Ground Water Mar 2021This review focuses on investigations of groundwater flow and solute transport in karst aquifers through laboratory scale models (LSMs). In particular, LSMs have been... (Review)
Review
This review focuses on investigations of groundwater flow and solute transport in karst aquifers through laboratory scale models (LSMs). In particular, LSMs have been used to generate new data under different hydraulic and contaminant transport conditions, testing of new approaches for site characterization, and providing new insights into flow and transport processes through complex karst aquifers. Due to the increasing need for LSMs to investigate a wide range of issues, associated with flow and solute migration karst aquifers this review attempts to classify, and introduce a framework for constructing a karst aquifer physical model that is more representative of field conditions. The LSMs are categorized into four groups: sand box, rock block, pipe/fracture network, and pipe-matrix coupling. These groups are compared and their advantages and disadvantages highlighted. The capabilities of such models have been extensively improved by new developments in experimental methods and measurement devices. Newer technologies such as 3D printing, computed tomography scanning, X-rays, nuclear magnetic resonance, novel geophysical techniques, and use of nanomaterials allow for greater flexibilities in conducting experiments. In order for LSMs to be representative of karst aquifers, a few requirements are introduced: (1) the ability to simulate heterogeneous distributions of karst hydraulic parameters, (2) establish Darcian and non-Darcian flow regimes and exchange between the matrix and conduits, (3) placement of adequate sampling points and intervals, and (4) achieving some degree of geometric, kinematic, and dynamic similitude to represent field conditions.
Topics: Groundwater; Laboratories; Models, Theoretical; Research Design; Water Movements
PubMed: 32978959
DOI: 10.1111/gwat.13052 -
Clinical Chemistry and Laboratory... Dec 2018A large body of evidence collected in recent years demonstrates the vulnerability of the extra-analytical phases of the total testing process (TTP) and the need to...
A large body of evidence collected in recent years demonstrates the vulnerability of the extra-analytical phases of the total testing process (TTP) and the need to promote quality and harmonization in each and every step of the testing cycle. Quality indicators (QIs), which play a key role in documenting and improving quality in TTP, are essential requirements for clinical laboratory accreditation. In the last few years, wide consensus has been achieved on the need to adopt universal QIs and common terminology and to harmonize the management procedure concerning their use by adopting a common metric and reporting system. This, in turn, has led to the definition of performance specifications for extra-analytical phases based on the state of the art as indicated by data collected on QIs, particularly by clinical laboratories attending the Model of Quality Indicators program launched by the Working Group "Laboratory Errors and Patient Safety" of the International Federation of Clinical Chemistry and Laboratory Medicine. Harmonization plays a fundamental role defining not only the list of QIs to use but also performance specifications based on the state of the art, thus providing a valuable interlaboratory benchmark and tools for continuous improvement programs.
Topics: Accreditation; Humans; Laboratories; Outcome Assessment, Health Care; Quality Indicators, Health Care
PubMed: 29252191
DOI: 10.1515/cclm-2017-0964 -
Annals of Laboratory Medicine Sep 2022Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is increasingly utilized in clinical laboratories because it has advantages in terms of specificity and... (Review)
Review
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is increasingly utilized in clinical laboratories because it has advantages in terms of specificity and sensitivity over other analytical technologies. These advantages come with additional responsibilities and challenges given that many assays and platforms are not provided to laboratories as a single kit or device. The skills, staff, and assays used in LC-MS/MS are internally developed by the laboratory, with relatively few exceptions. Hence, a laboratory that deploys LC-MS/MS assays must be conscientious of the practices and procedures adopted to overcome the challenges associated with the technology. This review discusses the post-development landscape of LC-MS/MS assays, including validation, quality assurance, operations, and troubleshooting. The content knowledge of LC-MS/MS users is quite broad and deep and spans multiple scientific fields, including biology, clinical chemistry, chromatography, engineering, and MS. However, there are no formal academic programs or specific literature to train laboratory staff on the fundamentals of LC-MS/MS beyond the reports on method development. Therefore, depending on their experience level, some readers may be familiar with aspects of the laboratory practices described herein, while others may be not. This review endeavors to assemble aspects of LC-MS/MS operations in the clinical laboratory to provide a framework for the thoughtful development and execution of LC-MS/MS applications.
Topics: Chromatography, Liquid; Clinical Laboratory Services; Humans; Laboratories; Laboratories, Clinical; Tandem Mass Spectrometry
PubMed: 35470272
DOI: 10.3343/alm.2022.42.5.531 -
Science & Justice : Journal of the... May 2023Laboratory work is essential in forensic science degree courses. They provide students with an opportunity to put theory into practice, as well as develop relevant...
Laboratory work is essential in forensic science degree courses. They provide students with an opportunity to put theory into practice, as well as develop relevant professional laboratory skills through a case-based learning framework. Traditional laboratory instruction involves the use of a written laboratory script or manual that details the laboratory procedures and techniques for an experiment. Occasionally, instructors may provide a brief in-person demonstration of a critical aspect of the experimental procedure during the session. Since the coronavirus pandemic, the use of virtual laboratory (vLab) resources, such as video demonstrations, in teaching science practical skills has increased. These resources may be used alone or in combination with in-person laboratory sessions in a flipped learning model. Previous research has shown that vLab resources could enhance students' knowledge, confidence, and experience inside the laboratory. This study aimed to explore the perceptions and attitudes of forensic science students toward the use of a vLab module. Three videos were created in which procedures for carrying out presumptive tests, screening exhibits, and recording examinations were demonstrated. Seven undergraduate students enrolled at different stages of a forensic science degree programme were introduced to the vLab module and interviewed using a semi-structured interview approach. Through a thematic synthesis of the interview transcripts, we found that the implementation of an inclusive vLab module could enhance students' knowledge, confidence, and independence in carrying out forensic science laboratory procedures.
Topics: Laboratories; Forensic Sciences
PubMed: 37169454
DOI: 10.1016/j.scijus.2023.02.002 -
Clinical Chemistry and Laboratory... Dec 2020
Topics: European Union; Humans; Laboratories; Medical Device Legislation; Reagent Kits, Diagnostic
PubMed: 33554564
DOI: 10.1515/cclm-2020-1775 -
Biochemistry and Molecular Biology... Jul 2021Student preparation has been shown to be of appreciable importance to student success in laboratory components of science courses. To promote student engagement prior to...
Student preparation has been shown to be of appreciable importance to student success in laboratory components of science courses. To promote student engagement prior to each laboratory session, technique and content videos, online assessments, and additional methods aiming to decrease cognitive load have been put into effect. Edpuzzle allows for instructors to effectively combine all of these components on a free, user-friendly, cloud-based platform. To improve student experience and performance in the introductory Biochemistry laboratory, Edpuzzle videos were incorporated into the curriculum. Ten videos were created and assigned to students on the platform. The platform allowed students to view the videos at their own pace and provided immediate feedback from assessments embedded within the videos. Student perceptions of Edpuzzle were favorable and the platform helped to promote student engagement in the material prior to the laboratory session which resulted in improvements in the Biochemistry lab experience. Edpuzzle has shown to be a highly effective tool for student engagement in the Biochemistry laboratory and can be utilized in other undergraduate laboratories as a replacement for existing pre-laboratory preparation methods.
Topics: Biochemistry; Computer-Assisted Instruction; Curriculum; Educational Measurement; Female; Humans; Laboratories; Male; Students; Teaching; Video Recording
PubMed: 33666326
DOI: 10.1002/bmb.21494