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ALTEX 2021The use of in vitro assays to inform decision-making requires robust and reproducible results across studies, laboratories, and time. Experiments using positive control...
The use of in vitro assays to inform decision-making requires robust and reproducible results across studies, laboratories, and time. Experiments using positive control materials are an integral component of an assay procedure to demonstrate the extent to which the measurement system is performing as expected. This paper reviews ten characteristics that should be considered when selecting a positive control material for an in vitro assay: 1) the biological mechanism of action, 2) ease of preparation, 3) chemical purity, 4) verifiable physical properties, 5) stability, 6) ability to generate responses spanning the dynamic range of the assay, 7) technical or biological interference, 8) commercial availability, 9) user toxicity, and 10) disposability. Examples and a case study of the monocyte activation test are provided to demonstrate the application of these characteristics for identification and selection of potential positive control materials. Because specific positive control materials are often written into testing standards for in vitro assays, selection of the positive control material based on these characteristics can aid in ensuring the long-term relevance and usability of these standards.
Topics: Biological Assay; Laboratories; Research Design
PubMed: 33637998
DOI: 10.14573/altex.2102111 -
SLAS Technology Oct 2022In most small laboratories, many processes are not yet automated because existing laboratory automation solutions are usually expensive and inflexible to use. Examples...
In most small laboratories, many processes are not yet automated because existing laboratory automation solutions are usually expensive and inflexible to use. Examples of this are autosamplers that are only compatible with one specific laboratory instrument or larger liquid handling stations that are expensive and usually self-contained. A flexible and inexpensive way to automate laboratory processes would be to automate existing laboratory equipment with the help of suitable robotic arms. In this study, we investigate the feasibility of such a strategy based on a low-cost 4-axis robot and freely available software. We used the scripting language AutoIt that automates any Windows-based instrument control software. Using these tools, we automated three fundamentally different laboratory processes: a pipetting process, a use as an autosampler for an atomic absorption spectroscopy instrument, and a more complex process involving the inoculation of bacterial cultures. We also integrated a conventional webcam for 2D barcode recognition. Compared to a trained professional who performed all experiments manually, all setups showed no significant differences in accuracy and precision. In summary, the tested system consisting of a 4-axis robot and freely available software is suitable for flexible automation and has potential for even more complex laboratory processes. Limitations such as a lack of collaboration and speed will be addressed in follow-up studies. The system thus represents a well-suited flexible laboratory automation system for both research and teaching purposes.
Topics: Automation, Laboratory; Laboratories; Robotics; Software
PubMed: 35830957
DOI: 10.1016/j.slast.2022.07.001 -
Clinical Infectious Diseases : An... Dec 2023Capturing Data on Antimicrobial Resistance Patterns and Trends in Use in Regions of Asia (CAPTURA) gained insight into the range of national antimicrobial resistance...
Capturing Data on Antimicrobial Resistance Patterns and Trends in Use in Regions of Asia (CAPTURA) gained insight into the range of national antimicrobial resistance (AMR) stakeholders' long-term visions for AMR surveillance networks. As national AMR networks mature, stakeholders often contemplate adding laboratories to the network to achieve greater representativeness, boost data quantity, or meet other goals. Therefore, stakeholders should carefully select laboratories for expansion based on their goals and several practical criteria. Based on CAPTURA experience, the key criteria a national network may consider when expanding its AMR surveillance network include location, laboratory ownership, access to linked clinical and prescription databases, logistical ease, a laboratory's collaborative spirit, laboratory practices and equipment, laboratory staffing and quality assessments, laboratory methods and specimen types, data cleanliness and completeness, and the quantity of AMR data.
Topics: Humans; Anti-Bacterial Agents; Drug Resistance, Bacterial; Laboratories; Asia
PubMed: 38118012
DOI: 10.1093/cid/ciad548 -
SLAS Technology Feb 2022Increasing the level of automation in pharmaceutical laboratories and production facilities plays a crucial role in delivering medicine to patients. However, the... (Review)
Review
Increasing the level of automation in pharmaceutical laboratories and production facilities plays a crucial role in delivering medicine to patients. However, the particular requirements of this field make it challenging to adapt cutting-edge technologies present in other industries. This article provides an overview of relevant approaches and how they can be utilized in the pharmaceutical industry, especially in development laboratories. Recent advancements include the application of flexible mobile manipulators capable of handling complex tasks. However, integrating devices from many different vendors into an end-to-end automation system is complicated due to the diversity of interfaces. Therefore, various approaches for standardization are considered in this article, and a concept is proposed for taking them a step further. This concept enables a mobile manipulator with a vision system to "learn" the pose of each device and - utilizing a barcode - fetch interface information from a universal cloud database. This information includes control and communication protocol definitions and a representation of robot actions needed to operate the device. In order to define the movements in relation to the device, devices have to feature - besides the barcode - a fiducial marker as standard. The concept will be elaborated following appropriate research activities in follow-up papers.
Topics: Automation, Laboratory; Humans; Laboratories; Robotic Surgical Procedures; Robotics
PubMed: 35058216
DOI: 10.1016/j.slast.2021.11.003 -
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 -
American Journal of Clinical Pathology Nov 2019To explore challenges explaining the decrease in quality performance and suggest strategies to improve and sustain laboratory quality services.
OBJECTIVES
To explore challenges explaining the decrease in quality performance and suggest strategies to improve and sustain laboratory quality services.
METHODS
Twenty key informants' interviews from laboratory personnel were conducted in five laboratories. Four had previously shown a decrease in quality performance. Interviews were transcribed verbatim and analyzed using inductive thematic analysis.
RESULTS
Two themes emerged: (1) insufficient coordination and follow-up system towards accreditation, where lack of coordination, follow-up, and audits explained the decrease in performance; (2) inadequate resource optimization, where insufficient knowledge in Laboratory Quality Management System (LQMS), ownership by laboratory workforce, and insufficient stakeholders' communication contributed to low-quality performance.
CONCLUSIONS
The coordination, follow-up, and assessments of LQMS, in conjunction with training of laboratory workforce, would establish an institutional culture of continuous quality improvement (CQI) towards accreditation and sustainment of quality health care. To achieve CQI culture, routine gap checking and planning for improvement using a system approach is required.
Topics: Humans; Laboratories; Medical Laboratory Personnel; Quality Improvement; Rwanda
PubMed: 31304959
DOI: 10.1093/ajcp/aqz092 -
The Journal of Molecular Diagnostics :... Oct 2021The coronavirus disease 2019 (COVID-19) response necessitated innovations and a series of regulatory deviations that also affected laboratory-developed tests (LDTs). To... (Review)
Review
Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like.
The coronavirus disease 2019 (COVID-19) response necessitated innovations and a series of regulatory deviations that also affected laboratory-developed tests (LDTs). To examine real-world consequences and specify regulatory paradigm shifts, legislative proposals were aligned on a common timeline with Emergency Use Authorization (EUA) of LDTs and the US Food and Drug Administration (FDA)-orchestrated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) labeling update study. The initial EUA adoption by LDT developers shows that the FDA can have oversight over LDTs. We used efficiency-corrected microcosting of our EUA PCR assay to estimate the national cost of the labeling update study to $0.3 to $1.4 million US dollars. Labeling update study performance data showed lower average detection limits in commercial in vitro diagnostic (IVD) assays versus LDTs (32,000 ± 75,000 versus 71,000 ± 147,000 nucleic acid amplification tests/mL; P = 0.04); however, comparison also shows that FDA review of IVD assays and LDTs did not prevent differences between initial and labeling update performance (IVD assay, P < 0.0001; LDT, P = 0.003). The regulatory shifts re-emphasized that both commercial tests and LDTs rely heavily on laboratory competence and procedures; however, lack of performance data on authorized tests, when clinically implemented, precludes assessment of the benefit related to regulatory review. Temporary regulatory deviations during the pandemic and regulatory science tools (ie, reference material) have generated valuable real-world evidence to inform pending legislation regarding LDT regulation.
Topics: COVID-19 Nucleic Acid Testing; Humans; Laboratories; Limit of Detection; Polymerase Chain Reaction; Time Factors; United States; United States Food and Drug Administration
PubMed: 34538703
DOI: 10.1016/j.jmoldx.2021.07.011 -
JAMA Network Open Oct 2022Blood culturing is a critical diagnostic procedure affecting patient outcomes and antibiotic stewardship. Although there are standards for blood culturing, the process...
IMPORTANCE
Blood culturing is a critical diagnostic procedure affecting patient outcomes and antibiotic stewardship. Although there are standards for blood culturing, the process is not often measured.
OBJECTIVES
To evaluate processes related to the diagnosis of bloodstream infection and compare them with best practices.
DESIGN, SETTING, AND PARTICIPANTS
A quality improvement study using laboratory data from January 1 to June 30, 2019, was conducted in 28 (96.6%) Israeli acute care hospitals. All blood cultures (BCs) performed on samples from adults and children in a period of 147 hospital-months were analyzed. Data analysis was performed from April 12, 2021, to September 9, 2022.
MAIN OUTCOMES AND MEASURES
True pathogen detection rate, contamination rate, proportion of adults with blood cultures performed, proportion of adult culturing episodes with only 1 set or bottle used, and median time of steps from sample collection to pathogen identification.
RESULTS
The data set consisted of 348 987 BC bottles. Bloodstream infection was detected in a median of 6.7% (IQR, 5.8%-8.2%) of adult culturing episodes and 1.1% (IQR, 0.7%-1.9%) of pediatric episodes. Eleven of 27 hospitals (40.7%) with adult patients met the standard of a contamination rate of less than 3% and only 2 hospitals (7.4%) met the more stringent standard of less than or equal to 1% contamination rate. The percentage of adults with blood cultures ranged from 2.7% to 29.0% (mean [SD], 15.7% [6.0%]). There was an association between sampling rate and pathogen detection until BCs were performed in 17% of adult admissions. The percentage of solitary BCs ranged from 47.8% to 94.4%. An estimated 1745 of 7436 (23.5%) adult bloodstream infections went undetected because solitary BCs were performed, anaerobic bottles were not used, or BCs were not performed. Median processing time was 51.2 (IQR, 33.9-78.0) hours, 3 times the optimal time: 4.4 (IQR, 1.7-12.5) hours for the preanalytical stage, 15.9 (IQR, 10.2-23.6) hours from incubation to growth detection, 4.5 (IQR, 1.5-10.7) hours from detection to Gram stain, and 30.9 (IQR, 22.0-41.9) hours from detection to isolate identification. An 8.6-hour delay was related to off-hours operating of laboratories.
CONCLUSIONS AND RELEVANCE
The findings of this study suggest that the multistep process of blood culturing is not managed comprehensively in Israel, leading to poor clinical practices and delayed results.
Topics: Adult; Humans; Child; Blood Culture; Israel; Bacteremia; Laboratories; Sepsis
PubMed: 36282502
DOI: 10.1001/jamanetworkopen.2022.38309 -
Journal of Environmental Management May 2023Assessing the ecotoxicological risk of marine sediments is now a critical factor in deciding how to treat dredged material in harbor and coastal areas. Although...
Assessing the ecotoxicological risk of marine sediments is now a critical factor in deciding how to treat dredged material in harbor and coastal areas. Although ecotoxicological analyses are routinely required by some regulatory agencies in Europe, laboratory skills necessary to perform them are often underestimated. According to the Italian Ministerial decree No. 173/2016, ecotoxicological tests are performed on the solid phase and elutriates, and the classification of sediment quality is defined using the "Weight of Evidence" (WOE) approach. However, the decree does not provide adequate information regarding the preparation techniques and laboratory skills. As result, a wide variability among laboratories occurs. An error in the classification of ecotoxicological risk has a negative impact on the whole environmental quality and/or the economy and management of the interested area. Thus, the main aim of this study was to determine if such variability can affect the ecotoxicological outcomes of tested species and WOE associated classification, producing different options for the management of dredged sediments. Four different sediment types were selected to assess the ecotoxicological responses and their changes as a function of variability of the following factors: a) the storage time laps (STL) for both the solid phase and the elutriates; b) the methods used to prepare the elutriates (centrifugation vs. filtration), and the conservation method used for the elutriates (freshly prepared vs. freezing). Results suggest a wide variability of ecotoxicological responses among the four sediment samples here considered, differentiated according to chemical pollution, grain-size texture, and macronutrient contents. The storage time laps significantly affect the physicochemical parameters and the ecotoxicity of both the solid phase test and elutriates. For the elutriates preparation, centrifugation is preferred to filtration to preserve a better representation of sediment heterogeneity. Freezing of elutriates does not seem to show any significant effects on the toxicity. Findings allow to define a weighted schedule of the storage time of sediments and elutriates useful for laboratories to scale analytical priority and strategies related to different sediment types.
Topics: Geologic Sediments; Water Pollutants, Chemical; Artifacts; Laboratories; Ecotoxicology; Environmental Monitoring
PubMed: 36796195
DOI: 10.1016/j.jenvman.2023.117483 -
Biochemia Medica Oct 2023Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory... (Review)
Review
Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the Laboratory Evaluation and Analytical Performance Characteristics (LEAP) checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.
Topics: Humans; Checklist; Laboratories; Clinical Laboratory Services
PubMed: 37841772
DOI: 10.11613/BM.2023.030505