Testing Standards Research Articles

Considerable interlaboratory variation in PD-L1 positivity forhead and neck squamous cell carcinoma in the Netherlands- A nationwide evaluation study.

Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) are eligible for first-line immune checkpoint inhibition if their tumour is positive for programmed death ligand 1 (PD-L1) determined by the combined positive score (CPS). This nationwide study, using real-world data, investigated the developing PD-L1 testing landscape in the first 3 years after introduction of the test in HNSCC and examined interlaboratory variation in PD-L1 positivity rates. Pathology reports of HNSCC patients mentioning PD-L1 were extracted from the Dutch Pathology Registry (Palga). Tumour and PD-L1 testing characteristics were analysed per year and interlaboratory variation in PD-L1 positivity rates was assessed using funnel plots with 95% confidence limits around the overall mean. A total of 817 PD-L1 tests were reported in 702 patients among 19 laboratories; 85.2% of the tests on histological material were stated to be positive. The national PD-L1 positivity rate differed significantly per year during the study period (79.7-89.9%). The use of the recommended 22C3 antibody increased from 59.9 to 74.3%. A total of 673 PD-L1 tests on histological material from 12 laboratories were analysed to investigate interlaboratory variation. Four (33%) deviated significantly from the national mean of PD-L1-positive cases using CPS ≥ 1 cut-off, while two (17%) deviated significantly for CPS ≥ 20 cut-off. In the first 3 years of PD-L1 assessment in HNSCC, the testing landscape became more uniform. However, interlaboratory variation in PD-L1 positivity rates between Dutch laboratories was substantial. This implies that there is a need for further test standardisation to reduce this variation.

Predicting the odds of chronic wasting disease with Habitat Risk software

Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy that was first detected in captive cervids in Colorado, United States (US) in 1967, but has since spread into free-ranging white-tailed deer (Odocoileus virginianus) across the US and Canada as well as to Scandinavia and South Korea. In some areas, the disease is considered endemic in wild deer populations, and governmental wildlife agencies have employed epidemiological models to understand long-term environmental risk. However, continued rapid spread of CWD into new regions of the continent has underscored the need for extension of these models into broader tools applicable for wide use by wildlife agencies. Additionally, efforts to semi-automate models will facilitate access of technical scientific methods to broader users. We introduce software (Habitat Risk) designed to link a previously published epidemiological model with spatially referenced environmental and disease testing data to enable agency personnel to make up-to-date, localized, data-driven predictions regarding the odds of CWD detection in surrounding areas after an outbreak is discovered. Habitat Risk requires pre-processing publicly available environmental datasets and standardization of disease testing (surveillance) data, after which an autonomous computational workflow terminates in a user interface that displays an interactive map of disease risk. We demonstrated the use of the Habitat Risk software with surveillance data of white-tailed deer from Tennessee, USA.

Estimation of Injury Limits at Vulnerable Impact Locations Along the Forearm Via THUMS AM50 Finite Element Model at Airbag Loading Rates.

Side and frontal airbag deployment represents the main injury mechanism to the upper extremity during automotive collisions. Previous dynamic injury limit research has been limited to testing the forearm at either the assumed most vulnerable location to fracture, the distal 1/3rd, or the midpoint. Studies have varied the surface to which impacts were applied, with no clear consensus on the site of greatest vulnerability. The unpredictability of airbag impact location, especially with altered hand positioning, limits the effectiveness of existing forearm injury limits determined from impacts at only one location. The current study quantified the effect of impacts at alternative locations on injury risk along the forearm using the THUMS FE model. Airbag-level impacts were simulated along the forearm on all four anatomical surfaces. Results showed the distal 1/3rd is not the most vulnerable location (for any side), indicating forearm fracture is not solely driven by area moment of inertia (as previously assumed). The posterior forearm was the weakest, suggesting that current test standards underestimate the fracture risk of the forearm. Linear regression models showed strong correlation between forearm fracture risk and bone geometry (cross-sectional area and area moment of inertia) as well as soft-tissue depth, potentially providing the ability to predict forearm injury tolerances for any location or forearm size. This study demonstrated the forearm's vulnerability to fracture from airbag deployments, indicating the need for safety systems to better address injury mechanisms for the upper limb to effectively protect drivers.

Strive for Measurement, Set New Standards, and Try Not to Be Evil

I consider recent attempts to establish standards, principles, and goals for artificial intelligence (AI) through the lens of educational measurement. Distinctions are made between generative AI and AI-adjacent methods and applications of AI in formative versus summative assessment contexts. While expressing optimism about its possibilities, I caution that the examples of truly generative AI in educational testing have the potential to be overexaggerated, that efforts to establish standards for AI should complement the Standards for Educational and Psychological Testing and focus attention on the issues of fairness and social responsibility, and that scientific advance and transparency in the development and application of AI in educational assessment may be incompatible with the competitive marketplace that is funding this development.

Extraction and characterization of nano-silica particles to enhance mechanical properties of general-purpose unsaturated polyester resin

Abstract Unsaturated polyester resin (UPR) is the most versatile liquid polymer with a wide range of applications in every aspect of the industry but it has low impact strength, low elongation at break, and low toughness. Its mechanical properties can be enhanced with the addition of an optimum percentage of nano-silica fillers by using ASTM polymer test standards, which have been followed by various research groups. For this research, enhanced mechanical properties of the resin have been tested for 0.5, 1, 2, 3, and 4% amount by weight fraction of the nano-silica as fiber nanomaterial. The sugar cane bagasse ash was collected from the Wenji Sugar Factory and extracted with the required size of the particle, which is 10 nm. The ability of extraction is used to manipulate the particle size as the researcher needs. The aim is to determine the enhanced mechanical properties of the UPR by the addition of optimum nano-silica particles. Nanoparticles have the effect of filling porous regions, crack path deflection, and crack bridging capability of the material, which provides good adhesion with the matrix to increase the mechanical properties of composite materials. Experimental result dictates that 0.5% nano-silica addition with 10 nm particle size performs best by enhancing the mechanical properties of composite material up to 30.45% for tensile, 33% for compression, 17.8% for flexural, a slightly 10% improvement for impact test and it shows an overall 27% better performance than the pure UPR. Thermal stability and glass transition temperature were not influenced by the addition of nano-silica.

Experimental study on the effect of cement alkali content on concrete ASR

Conduct alkali silica reaction (ASR) tests on concrete by using cement with different alkali contents and according to different test standards. The influence of cement alkali content on the alkali-silica reaction of concrete was explored, and the effects of different test methods on the results of alkali-silica reaction tests were compared. The results indicate that: the type of cement and the testing method used have no significant impact on the experimental results of the alkali silica reaction. The rate of alkali silica reaction accelerates with the increase of cement alkali content. When the alkali content of cement is greater than 2.0 %, there is no potential harm of alkali silica reaction in the aggregate, which will cause harm of alkali silica reaction. The research conclusion can provide reference for the control value of alkali content in engineering cement.

Comparative Study of the Effects of Treatment Methods on the Tensile Performance of Bamboo

Bamboo is a rapidly replenishing resource that is used as a practical building material in many nations. However, it is not commonly used in the United States or other western nations, in part because building codes and safety standards have not yet included it. The mechanical characteristics of bamboo must be thoroughly comprehended and recorded in order to develop these. Major variables, including age, bamboo species, density, moisture content, post-harvest treatment, and the testing standards used, affects its properties greatly. This work presents a comparative study of the effects of treatment methods on the tensile performance of bamboo. In this research, bamboo samples of size 12x12mm, 14x12mm, 16x12mm and 20x12mm were prepared, some of the samples were treated with epoxy, bitumen emulsion, binding wire and some were treated by combining binding wire and either of epoxy or bitumen emulsion while few were untreated. Tensile strength test was carried out on both samples and the results shows that the tensile strength of bamboo samples was greatly increased in all the treatment methods used. Tensile strength of bamboo is also a function of size, from the research, it was observed that size 20mmx12mm possess higher strength. Hence, it is recommended for construction works, bamboo treated with epoxy has higher strength other treatment methods. However, a combination of binding wire and other treatment techniques give superior strength, epoxy was observed to have demonstrated higher strength than bitumen and binding wire alone.

Total Laboratory Automation in Clinical Microbiology: A Note on Needs, Challenges, and Applications in a Pandemic Scenario

Recently, an increasing number of publications on automation in diagnostic laboratories, especially in microbiology, has illustrated its potential impact on modern medicine by enhancing the overall quality of culture-based microbiology testing. In the context of clinical microbiology, total laboratory automation (TLA) is now defined as automating the testing workflow, which comprises all phases from sample inoculation to outcome analysis. Hence, there is a need to design or implement proper laboratory automation management processes to enhance workflow, reduce analysis time, and deliver high-quality results without delay in treatment initiation. This review-cum-perspective article highlights the need and current advancements in diagnostic microbiology automation that could revolutionize laboratory operations in healthcare settings. Automation of the workflow is a crucial advancement in the recent history of laboratory diagnostics that unites many diagnostic specializations into a single track to increase the effectiveness, administration, standardization, reliability, and safety of lab tests. While clinical chemistry laboratories adopted and deployed laboratory automation decades earlier, the process of implementing them into routine clinical microbiological practices has several bottlenecks and is still a lengthy process and fraught with technical and regulatory challenges. Moreover, due to outbreaks including the COVID-19 pandemic of recent times, testing volumes are increasing, and automation could probably be a great solution for small and mid-sized laboratories. This article lists the TLA remedies and the specimen-processing tools that are presently available. The need and challenges to implementing automation in microbiological laboratories are discussed with a note on applications in pandemic scenarios.

Non-Destructive Testing (NDT) Method for Defect Detection in Glass Fibre Reinforced Plastic/Polymer (GFRP/GRP) Composite Materials Structures: A Review

Various industries are considering metal product in lieu composite materials. Structural engineers appreciate glass fibre reinforced plastic/polymer (GFRP/GRP) because to its high modulus of elasticity, ratio of strength to weight, and corrosion resistance features. It has been discovered that structural engineering defects to be leading cause for the catastrophic consequences. This paper provides an overview of available NDT methods that can be employed to assess the quality of GFRP/GRP composite materials. The most common NDT method used by researchers and practitioners is also discussed, along with the advantages, disadvantages, characteristics, and potential applications of these materials. The review will lead the research using ultrasonic testing as a potential method employing low-frequency transducers with multielement architecture. This study will lead industry players, GFRP/GRP manufacturers, researchers, and NDT practitioners towards the development of technical standards for ultrasonic testing on GFRP/GRP in Malaysia.

Mechanical and Physiochemical Characteristics of Sandcrete Blocks Produced with Sustainable Biomaterials

The quest for sustainable construction materials is rapidly increasing; due to health hazards associated the traditional construction items. This research goal is to investigate how sugarcane bagasse ash (SBA), crushed periwinkle shells (CPS) and cassava starch (CS) incursion affects the engineering performance of sandcrete blocks, and the physiochemical qualities of their leachate. SBA was incorporated at a rate of 5, 10, 15 and 20% as substitution for cement; treated CPS (TCPS) and untreated CPS (UCPS) were add at a rate of 10, 15, 20 and 25% as partial replacement for sand; while 1% CS was added as integrity enhancer. A consistent cement–sand mix ratio of 1:8 and corresponding water–cement (w/c) ratio of 0.55 were employed across all 17 experimental units; and the blocks were cured using the irrigation technique. Likewise, the blocks were subjected to leaching condition (immersion in water) to collect their leachate. Chemical compositions of the SBA, sand, cement, CS and TCPS and UCPS were examined using the x–ray fluorescent technique, while the mechanical and physiochemical parameters of the blocks were studied in harmony with the American Society for Testing and Materials standards. The results obtained revealed that the mechanical and physiochemical qualities of the blocks were dependent on the volume of the bio–materials incorporated into the sandcrete. Furthermore, the findings showed that an environmentally friendly high–strength lightweight sandcrete blocks, meeting international requirement of 3.45 N/mm2 can be produced by incorporating 10% SBA, 15% TCPS and 1% CS into the sandcrete block. The research highlights the possibility of using agricultural waste materials in achieving sustainable materials for the housing industry.

Surrogate metamodels from digital image correlation for testing high-performance composite vessels

In this work, a workflow has been developed for the generation of surrogate metamodels to predict and evaluate failure with a confidence above 95 % in initial service conditions of high-performance cylindrical vessels manufactured in composites by Roll Wrapping technology. Currently, there is no specific testing standardization for this type of vessel and to fill this gap probabilistic numerical models were developed, performed by the Finite Element Method, fed with the material characteristics obtained experimentally by 2D digital image correlation from flat specimens. From the initial numerical model, a surrogate metamodel was generated by stochastic approximations. Once the metamodels were obtained by robust engineering, an experimental ring-ring tensile test was developed under service conditions and deformations were measured by high-precision 3D digital image correlation. Parametric and robust tests showed that the results of the metamodel did not show statistically significant differences, with errors in the rupture part of less than 2 % with respect to the results obtained in the test, being proposed as a basis for new test procedures.

Appraisal of reclaimed asphalt pavement as coarse aggregates in cement concrete

This systematic literature review evaluates reclaimed asphalt pavement (RAP) in concrete construction, targeting reduced natural aggregate use and lower construction carbon footprint. It comprehensively covers RAP in concrete, including mechanical properties, durability, test methods, mix design, performance, influencing factors, RAP content, processing, admixtures, curing, and environmental aspects. RAP concrete matches traditional concrete mechanically while increasing sustainability through waste reduction. Durability parameters, like permeability, freeze-thaw resistance, and chloride penetration, suggest long-term structural enhancement. Reliable testing methods and standards are vital for RAP in concrete assessment. The review explores RAP in mix design, considering content, gradation, and processing. Admixtures and additives optimize RAP concrete. Curing and environmental conditions influence RAP concrete performance. Gaps indicate a need for long-term studies, understanding mechanisms, specific environmental exploration, standardized testing, and economic assessment. The study recommends future research directions to guide sustainable construction practices.

A Sustainable Solution with Improved Chemical Resilience Using Repurposed Glass Fibers for Sewage Rehabilitation Pipes

This paper introduces a sustainable sewage rehabilitation solution, utilizing repurposed glass fibers for enhanced chemical resilience and environmental conservation. The approach involves dividing a unitary pipe into segments, assembled during commissioning, aiming to reduce installation and transportation costs, particularly in less accessible areas. Each pipe segment comprises a multi-layered glass fiber composite sandwich, joined by an adhesive reinforced with recycled glass fibers. The glass fiber-reinforced plastic (GFRP) pipe features a core of blended sand impregnated with resin, an outer layer for impact resistance, and an inner layer to prevent corrosion. Chemical resilience is assessed through a 10,000 h strain corrosion study exposing both unitary and two-piece circular GFRP pipes to sulfuric acid in a deflected condition. An apparent hoop tensile test evaluates mechanical integrity before and after exposure. The experimental results reveal that the two-piece pipe with a tongue and groove joint (TGJ) with recycled glass fiber adhesive exhibits superior long-term bending stress and failure strain % compared to unitary pipes. This enhancement is attributed to the TGJ’s improved load-bearing capability and chemical resistance. The failure strain % of the two-piece pipe (1.697%) is higher compared to the unitary pipe (1.2613%). The long-term bending stress of the two-piece pipe obtained is 119.94 MPa whereas the unitary pipe reaches 93.48 MPa at the 50-year mark. The cost analysis supports the adoption of the two-piece pipe over unitary pipes due to a 40% reduction in carbon emissions and transportation cost. The novelty lies in the utilization of multi-piece pipes with enhanced chemical resilience, achieved through the incorporation of milled fiberglass reinforcements in the TGJ. Strain corrosion tests take a long time to perform; hence, an accelerated test is needed to improve the current recommended testing standard.

Comparative analysis of petroleum products from artisanal refineries and standard products

Comparative analysis of petroleum products from artisanal refineries and standard products

Point-of-Care HbA1c in Clinical Practice: Caveats and Considerations for Optimal Use.

Hemoglobin A1c (A1C) is widely used for the diagnosis and management of diabetes. Accurate measurement of A1C is necessary for optimal clinical value. Assay standardization has markedly improved the accuracy and consistency of A1C testing. Devices to measure A1C at point of care (POC) are commercially available, allowing rapid results when the patient is seen. In this review, we describe how standardization of A1C testing was achieved, leading to high-quality results in clinical laboratories. We address the use of POC A1C testing in clinical situations and summarize the advantages and disadvantages of POC A1C testing. We emphasize the importance of considering the limitations of these devices and following correct testing procedures to ensure that accurate A1C results are obtained for optimal care of patients.

Small animal patient preoperative preparation: a review of common antiseptics, comparison studies, and resistance.

This review aims to describe commonly used antiseptics in veterinary medicine including their mechanism of action, spectrum of activity, potential adverse effects, and application techniques. Additionally, it provides a review of the veterinary literature comparing antiseptics, a discussion of effectiveness and efficacy studies, and the potential for increased resistance to biocides and antimicrobials. This review concludes that appropriate selection and use is necessary to prevent the occurrence of surgical site infections, adverse effects, and potential for increasing resistance to antimicrobials. Continued research is needed to fill gaps in the current knowledge such as optimal preparation procedures for various surgical sites, standardization of efficacy and effectiveness testing, and the clinical impact of decreased susceptibility to chlorhexidine and other antiseptics.

Longitudinal normative standards for cognitive tests and composites using harmonized data from two Wisconsin AD-risk-enriched cohorts.

Published norms are typically cross-sectional and often are not sensitive to preclinical cognitive changes due to dementia. We developed and validated demographically adjusted cross-sectional and longitudinal normative standards using harmonized outcomes from two Alzheimer's disease (AD) risk-enriched cohorts. Data from the Wisconsin Registry for Alzheimer's Prevention and the Wisconsin Alzheimer's Disease Research Center were combined. Quantile regression was used to develop unconditional (cross-sectional) and conditional (longitudinal) normative standards for 18 outcomes using data from cognitively unimpaired participants (N=1390; mean follow-up=9.25 years). Validity analyses (N=2456) examined relationships between percentile scores (centiles), consensus-based cognitive statuses, and AD biomarker levels. Unconditional and conditional centiles were lower in those with consensus-based impairment or biomarker positivity. Similarly, quantitative biomarker levels were higher in those whose centiles suggested decline. This study presents normative standards for cognitive measures sensitive to pre-clinical changes. Future directions will investigate potential clinical applications of longitudinal normative standards. Quantile regression was used to construct longitudinal norms for cognitive tests. Poorer percentile scores were related to concurrent diagnosis and Alzheimer's disease biomarkers. A ShinyApp was built to display test scores and norms and flag low performance.

Formulation and Physical Evaluation of Papaya Leaf (Carica papaya L.) Ethyl Acetate Fraction Cream Preparation as Anti Acne Against Propionibacterium acne Bacteria

Acne or acne vulgaris is a disease in the form of inflammation of multiple sebaceous glands caused by the bacteria Propionibacterium acne. Papaya leaves are a plant that can potentially be used as an acne treatment. To determine the antiacne activity of papaya leaf ethyl acetate fraction cream preparations caused by Propionibacterium acne bacteria. The ethyl acetate fraction of papaya leaves are made into a cream preparation with varying concentrations of ten, fifteen, and twenty percent. The results of the cream preparation test met the physical property standards. Still, the viscosity in formulation three did not meet the standards, and formulas two and three did not meet the cream stability test standards. Antibacterial tests show that all formulas have inhibitory power against bacteria. The average inhibition zone results in formula one, formula two, and formula three were 4.99 ± 0.48 mm, 6.85 ± 0.48 mm and 10.12 ± 1.42 mm. Formula One papaya leaf fraction cream fulfills all the physical characteristics of the preparation. All papaya leaf ethyl acetate fraction cream preparations are antibacterial against Propionibacterium acne. So, research can be developed using the ethyl acetate fraction of papaya leaves in various preparations, and activity tests against other bacteria can be carried out.

Analysis of different detection methods for pulmonary tuberculosis

Tuberculosis is classified as a chronic respiratory disease with its pathogen being Mycobacterium tuberculosis (MTB). It poses a significant health threat due to its highly contagious nature and is difficulty in treatment. Various methods are employed to test for tuberculosis, including pathological, immunological and molecular biological tests. Each test has its unique principles and all are different in effects, and are widely used in clinical practice. In this research, principles, development and effects of each type of tests in testing pulmonary tuberculosis will be explored respectively. Additionally, the review will provide insights into the optimization of tuberculosis testing by comparing and contrasting different testing methods. Pathological tests represent the most traditional approach to testing for tuberculosis. Bacterial culture, a pathological test, is the gold standard of tuberculosis test. Nevertheless, it suffers from a long detection time. Meanwhile, immunological tests and molecular biological tests benefits from a fast detection, while the accuracy of the tests can be influenced by multiple factors. Thus, it will accelerate the detection speed while enhancing the precision to combine three different kinds of tests in clinical practice.

Abstract 325: Validation of Aventa FusionPlus: An LDT NGS assay for comprehensive cancer genomic profiling

Abstract Next-generation sequencing (NGS) assays play a pivotal role in illuminating the genomic landscape of cancer by providing insights into gene regulation and biomarker detection for the purpose of guiding therapeutic decisions to advance personalized medicine. We validated the Aventa FusionPlus Test, a Laboratory-Developed Test (LDT) that integrates HiC technology to enhance detection of actionable gene fusions and rearrangements in solid tumors, including those that are missed by current standard of care tests. This is a DNA-based test that is robust to DNA degradation in FFPE specimens, in contrast with RNA-seq and long-read technologies. The test utilizes the Element Biosciences AVITI sequencing platform to achieve high quality sequencing data at low cost per sample. The Aventa FusionPlus test enables gene-level detection of structural variants near or within 361 medically actionable or diagnostically relevant cancer genes. The 3D structure and long-range linkages captured by the test amplify the signal counts for each rearrangement. The test integrates the Arima-HiC+ FFPE sample prep and the Arima Library Prep Kit workflow. After dewaxing and rehydrating the FFPE tissue, the chromatinized DNA is fragmented and the fragmented ends are filled in with a biotinylated nucleotide. Next, spatially proximal fragmented ends of DNA are ligated, capturing the 3D structure of the genome. The proximally-ligated DNA is then purified and further fragmented, and the biotinylated ligation fragments are enriched. DNA libraries are prepared from these enriched fragments and sequenced in “paired-end” mode. Genes involved in genomic rearrangements were detected using the Arima-SV pipeline along with manual curation. The test achieved robust detection of structural variants, with accuracy of 98.8% relative to reference methods. FFPE tumor specimens from 10 different tissue types and a wide range of tumor content (20%-100%) were included. No correlation between tumor cellularity and sensitivity was observed, suggesting that samples with as low as 20% tumor cellularity can be tested. When comparing to RNA-based and other targeted reference methods, we found additional fusions nearby oncogenes missed by these reference methods. As an example, in a breast cancer case, a fusion of genomic regions neighboring BRAF and MYC oncogenes on chromosomes 7 and 8 respectively, was missed by the reference method but was successfully detected by the Aventa FusionPlus test. The Aventa FusionPlus test is a highly sensitive, specific, and accurate method for comprehensive cancer genomic profiling. The enhanced understanding of gene fusions and rearrangements positions the test as a valuable tool for clinical decision-making in oncology. Citation Format: Shadi Melnyk, Jon Belton, Sofia Nomikou, Katelyn Powell, Daniel Heiney, Roy Khalife, Damien Jones, Anthony Schmitt, Catherine Wilson, Melissa Won, Anthony Magliocco, Chris Roberts. Validation of Aventa FusionPlus: An LDT NGS assay for comprehensive cancer genomic profiling [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 325.