Test Requirements Research Articles

Challenges and improvements in HER2 scoring and histologic evaluation: insights from a national proficiency testing scheme for breast cancer diagnosis in China

BackgroundIn 2022, our team launched the pioneering national proficiency testing (PT) scheme for the pathological diagnosis of breast cancer, rapidly establishing its credibility throughout China. Aiming to continuously monitor and improve the proficiency of Chinese pathologists in breast pathology, the second round of the PT scheme was initiated in 2023, which will expand the number of participating institutions, and will conduct a nationwide investigation into the interpretation of HER2 0, 1+, and 2+/FISH- categories in China.MethodsThe methodology employed in the current round of PT scheme closely mirrors that of the preceding cycle in 2022, which is designed and implemented according to the “Conformity assessment—General requirements for proficiency testing”(GB/T27043—2012/ISO/IEC 17043:2010). More importantly, we utilized a statistics-based method to generate assigned values to enhance their robustness and credibility.ResultsThe final PT results, published on the website of the National Quality Control Center for Cancer (http://117.133.40.88:3927), showed that all participants passed the testing. However, a few institutions demonstrated systemic biases in scoring HER2 0, 1+, and 2+/FISH- with accuracy levels below 59%, considered unsatisfactory. Especially, the concordance rate for HER2 0 cases was only 78.1%, indicating challenges in distinguishing HER2 0 from low HER2 expression. Meanwhile, areas for histologic type and grade interpretation improvement were also noted.ConclusionsOur PT scheme demonstrated high proficiency in diagnosing breast cancer in China. But it also identified systemic biases in scoring HER2 0, 1+, and 2+/FISH- at some institutions. More importantly, our study highlighted challenges in the evaluation at the extreme lower end of the HER2 staining spectrum, a crucial area for further research. Meanwhile, it also revealed the need for improvements in interpreting histologic types and grades. These findings strengthened the importance of robust quality assurance mechanisms, like the nationwide PT scheme conducted in this study, to maintain high diagnostic standards and identify areas requiring further training and enhancement.

Hattrick of H-deficient phenotypes at a tertiary care health center in India

Abstract: H-deficient phenotypes, commonly known as Bombay blood type, have more inclination to be found in the Indian subcontinent, and conventional gold standard tube techniques are still the recommended method to identify them, provided a strict adherence to testing protocol. There is more to these phenotypes than just the bombay blood type. This brief communication highlights the identification of three H-deficient phenotypes from a single center that adhered to standard operating procedures and basic testing methodologies. It emphasizes the requirement of indirect Coombs test with pooled “O” cells with blood grouping of every sample irrespective of the testing platform and also the H antigen typing on encountering any suspicion. These H-deficient individuals may not be as rare as we assume them to be provided there are reframed testing policies. Although international collaborations and databases like the International Society of Blood Transfusion database have made it easier to record and share knowledge on blood types, a National network and registries of these rare phenotypes are essential to make them available to the general population who actually benefit from them.

Does your equipment pass the test?

Jenny Nixon looks at the UK guidance testing requirements for decontamination equipment.

Research and implementation of a large-bandwidth real-time radar jamming simulator.

The electromagnetic environment faced by modern radar is becoming increasingly complex. One effective means to improve the performance of radar systems is testing in an anti-jamming ability test chamber, where the increased complexity has also led to higher performance requirements for radar jamming simulators. Based on the requirements for modern radar system testing, this paper presents a study of a large-bandwidth real-time radar jamming simulator and describes its overall design architecture; the simulator covers the L-Ku and Ka frequency bands and the instantaneous bandwidth is ≥2GHz, which means that the system is able to simulate 11 interference patterns. Synchronous control of the system is realized in 1ms through use of the reflection memory interrupt mechanism, the synchronous pulse signal mechanism, synchronous timing design, and a real-time control software architecture. An overall design scheme for real-time simulation of a radar target jamming echo is given and baseband signal processing resources are saved through information preprocessing, a large-capacity high-speed storage board is designed to improve the data reading speed, a multiphase filtering structure is used to achieve high sampling rates and save hardware resources, and a high-speed parallel computing method is used to improve computing efficiency; the actual measured baseband signal processing time is less than 500ns. Finally, a measurement platform is built, and the main interference patterns are verified through experimental measurements.

Italian-cluster technical solutions for the Quality-Control tests to the pixel-modules of the ATLAS Inner Tracker for High Luminosity LHC

In the era of high-luminosity LHC the instantaneous luminosity will achieve unprecedented levels, leading to the occurrence of up to 200 proton–proton interactions during a typical bunch crossing. In response to the resulting surge in occupancy, bandwidth demand, and radiation damage, the ATLAS Inner Detector is slated for replacement by an all-silicon system known as the Inner Tracker (ITk). The innermost segment of the ITk will be comprised of a pixel detector, featuring an active area spanning approximately 13 square meters. To address evolving requirements related to radiation hardness, power dissipation, and production yield, multiple silicon sensor technologies will be incorporated across the five barrel and end-cap layers. The ITk detector will be built in different laboratories all around the world. Several institutes are actively involved in the ITk project assembling and testing pre-production modules, that have been constructed to assess their production efficiency. Testing sites perform the so-called quality control (QC) tests. The ITk community defines requirements for QC testing both prototypes and modules, and provides common software tools as well as possible technical solutions. Each laboratory must qualify for the QC activity by demonstrating the chosen solutions are compliant with requirements. In this contribution the relevance of the QC procedures will be outlined, focusing on the custom structures and items developed by the Italian laboratories to improve the quality of the tests and to satisfy the requirements imposed by the Collaboration.

Impact of blur on clinical and occupational colour vision test results.

To evaluate whether colour vision normal (CVN) adults pass two Fletcher-Evans (CAM) lantern tests and to investigate the impact of imposed blur on Ishihara, CAM lantern and computerised colour discrimination test (colour assessment and diagnosis test [CAD] and Cambridge colour test [CCT]) results. In a pilot experiment, 20 (16 CVN and 4 colour vision deficient [CVD]) participants with normal VA were tested with the CAM lantern. In the main experiment, the impact of imposed dioptric blur (up to +8.00 D) on visual acuity and the Ishihara test, CAM lantern, CAD and CCT was assessed for 15 CVN participants. CVN participants can fail the CAM lantern, with specificity of 81.25% (aviation mode) and 75% (clinical mode), despite following the test requirements of participants having at least 0.18 logMAR (6/9) in the better eye. With blur, test accuracy was affected. As expected, significant detrimental effects of blur on test results were found for logMAR VA and CAM lantern (aviation) with +1.00 D or higher. Ishihara, CAD and CCT results were not detrimentally affected until +8.00 D. Yellow-blue discrimination was more affected by blur for the CAD than the CCT, which was not explained by the different colour spaces used or vectors tested. False-positive findings on lantern colour vision tests with small apertures are likely to be increased in patients with blur due to uncorrected refractive error or ocular and visual pathway disease. Other colour vision tests with larger stimuli are more robust to blur.

A Systematic Analysis of Read-Across Adaptations in Testing Proposal Evaluations by the European Chemicals Agency.

An important element of the European Union's "Registration, Evaluation, Authorisation and Restriction of Chemicals" (REACH) regulation is the evaluation by the European Chemicals Agency (ECHA) of testing proposals submitted by the registrants to address data gaps in standard REACH information requirements. The registrants may propose adaptations, and ECHA evaluates the reasoning and issues a written decision. Read-across is a common adaptation type, yet it is widely assumed that ECHA often does not agree that the justifications are adequate to waive standard testing requirements. From 2008 to August 2023, a total of 2,630 Testing Proposals were submitted to ECHA; of these, 1,538 had published decisions that were systematically evaluated in this study. Each document was manually reviewed, and information extracted for further analyses. Read-across hypotheses were standardized into 17 assessment elements (AEs); each submission was classified as to the AEs relied upon by the registrants and by ECHA. Data was analyzed for patterns and associations. Testing Proposal Evaluations (TPEs) with adaptations comprised 23% (353) of the total; analogue (168) or group (136) read-across adaptations were most common. Of 304 read-across-containing TPEs, 49% were accepted; the odds of acceptance were significantly greater for group read-across submissions. The data was analyzed by Annex (i.e., tonnage), test guideline study, read-across hypothesis AEs, as well as target and source substance types and their structural similarity. While most ECHA decisions with both positive and negative decisions on whether the proposed read-across was adequate were context-specific, a number of significant associations were identified that influence the odds of acceptance. Overall, this analysis provides an unbiased overview of 15 years of experience with testing proposal-specific read-across adaptations by both registrants and ECHA. These data will inform future submissions as they identify most critical AEs to increase the odds of read-across acceptance.

Gender Reassignment and the Role of the Laboratory in Monitoring Gender-Affirming Hormone Therapy.

Transgender people experience distress due to gender incongruence (i.e., a discrepancy between their gender identity and sex assigned at birth). Gender-affirming hormone treatment (GAHT) is a part of gender reassignment treatment. The therapeutic goals of the treatment are to develop the physical characteristics of the affirmed gender as far as possible. Guidelines have been developed for GAHT, which recommend dosage as well as different formulations of oestrogen and testosterone for treatment. Questions arise about the metabolic side effects of hormone treatment. Establishing reference ranges for common analytes in transgender individuals remains a task for laboratory medicine. It has been suggested once GAHT is commenced, the reference ranges for affirmed gender are reported for red blood cells, haemoglobin and haematocrit. For transgender assigned-female-at-birth (AFAB) people, testosterone concentrations are recommended to be within the reference interval established for cisgender men and for transgender assigned-male-at-birth (AMAB) people, estradiol concentrations are within the reference range for cisgender women. Sex-specific reference ranges are available for certain laboratory tests, and these may be organ (e.g., heart)-specific. Transgender-specific reference ranges may be a requirement for such tests. Laboratories may need to make decisions on how to report other tests in the transgender population, e.g., eGFR. Interpretation of further tests (e.g., reproductive hormones) can be individualized depending on clinical information. Electronic medical record systems require fields for gender identity/biological sex at birth so that laboratory results can be flagged appropriately. In this review, we aim to summarise the current position of the role of the laboratory in the clinical care of the transgender individual. Prior to the review, we will summarise the genetics of sex determination, the aetiology of gender incongruence, and the recommendations for GAHT and monitoring for the transgender population.

Machine Vision-Based Method for Reconstructing the Vehicle Coordinate System in End-of-Line ADAS Calibration

To ensure the accuracy and reliability of Advanced Driver Assistance Systems (ADAS), it is essential to perform offline calibration before the vehicles leave the factory. This paper proposes a method for reconstructing the vehicle coordinate system based on machine vision, which can be applied to the offline calibration of ADAS. Firstly, this study explains the preliminary preparations, such as the selection of feature points and the choice of camera model, combining actual application scenarios and testing requirements. Subsequently, the YOLO model is trained to identify and obtain feature regions, and feature point coordinates are extracted from these regions using template matching and ellipse fitting. Finally, a validation experiment is designed to evaluate the accuracy of this method using metrics such as the vehicle’s lateral and longitudinal offset distances and yaw angle. Experimental results show that, compared to traditional vehicle alignment platforms, this method improves reconstruction accuracy while reducing costs.

Real-World Adherence to a Delirium Screening Test Administered by Nurses and Medical Staff during Routine Patient Care.

Delirium is often the first symptom of incipient acute illness or complications and must therefore be detected promptly. Nevertheless, routine screening for delirium in acute care hospital wards is often inadequate. We recently implemented a simple, user-friendly delirium screening test (RMA) that can be administered during ward rounds and routine nursing care. The test was found to be non-inferior to 4AT in terms of sensitivity and specificity. However, the dominant factors to take into account when assessing the performance of a test added to the routine work of busy acute care hospital wards are ease of administration, real-life amenability and the ability of the staff to adhere to testing requirements. In this study, we evaluated the prevalence of daily RMA tests that were not administered as scheduled and the impact of these omissions on the overall real-world performance of RMA. Using point-in-time assessments of 4AT by an external rater, we found that complete RMA was administered in 88.8% of the days. Physicians omitted significantly more tests than nurses, but their results were more specific for delirium. Omissions reduced the sensitivity and specificity of RMA for delirium (compared to 4AT) from 90.7% to 81.7%, and from 99.2% to 87.8%, respectively. Ideally, the number of omitted RMA tests should be minimized. However, if over 85% of the daily quota of complete tests are administered, the sensitivity and specificity of RMA for diagnosing delirium as soon as it appears remain at acceptable levels.

Enhancing logic-based testing with EvoDomain: A search-based domain-oriented test suite generation approach

ContextEffective software testing requires test adequacy criteria. MC/DC, a widely used logic-based testing criterion, struggles to detect domain errors caused by incorrect arithmetic operations. Domain errors occur when test requirement boundaries shift or tilt, causing unpredictable behavior and system crashes. ObjectiveTo address the inadequacy of MC/DC in detecting domain errors, we present EvoDomain, a search-based testing technique. MethodEvoDomain uses a memetic algorithm combining genetic and hill-climbing algorithms, along with the DBSCAN clustering algorithm to select diversified boundary test data. The memetic algorithm is designed to efficiently enhance the search process for covering boundary test data. We compared EvoDomain with two logic-based testing approaches, a domain-oriented test suite generation approach, and random testing. ResultsEvaluations on 30 case studies show EvoDomain increases fault detection by 74.44% over MC/DC and 65.06% over RoRG. Additionally, EvoDomain improves support for different fault types by up to 68.89% for MC/DC and 66.33% for RoRG. Compared to COSMOS, which uses static analysis, EvoDomain improves the convergence effectiveness of identifying feasible subdomains by 32%. It offers high accuracy (0.99-1) and F1-score (0.99-1). EvoDomain finds the subdomains in less than 1/3 the time of Random search. ConclusionEvoDomain effectively generates domain-oriented test suites, enhancing the accuracy and effectiveness of fault detection.

Design of a High-Frame-Rate and Large-Grayscale Simulation Projection System Based on Digital Micromirror Devices

With the increasing acquisition speed of image sensors, it has become necessary to provide image sources with higher frame rates and grayscale in order to meet testing requirements. In the field of semi-physical simulation projection, digital micromirror devices are often chosen for their high resolution, uniformity, response speed, and energy concentration. In this study, we utilized digital micromirror devices to construct a high-frame-rate and large-grayscale simulation projection system. To achieve our experiment goals, we employed two digital micromirror devices. One DMD was used to modulate the light intensity of the light source, while the other generated images with different bit planes. By projecting the target images onto the image sensor, we were able to achieve a frame rate of 1611 hz for the projected 12-bit image. This system meets the requirements for our experiment design and ensures the accurate testing of image sensors.

Target mechanisms of mindfulness-based programmes and practices: a scoping review

QuestionMindfulness-based programmes (MBPs) and practices have demonstrated effects in mental health and well-being, yet questions regarding the target mechanisms that drive change across the population remain unresolved.Study selection and analysisFive...

Assessment of the implementation of risk minimization measures for bosentan: a retrospective study

ABSTRACT Background Bosentan is associated with adverse hepatic effects. To minimize such risk, regulators implemented risk minimization measures (RMMs), including testing for liver injury biomarkers (alanine and aspartate transaminase and bilirubin) prior to therapy initiation and monthly throughout therapy. This study aimed to examine the adherence to hepatic monitoring requirements. Research design and methods This retrospective cohort study collected data about bosentan new-users from the Real-world Evidence Research Network from 2016 to 2022. We ascertained hepatic tests from laboratory files. Adherence to RMM definition was performing the required tests within 90 days before initiation and categorized adherence to monthly testing requirement based on the expected number of tests throughout therapy as low (<50%), moderate (50–74%), and high (≥75%). Results One hundred patients entered the study cohort and 71% were females, with a median age of 25 years. Adherence to testing prior to bosentan initiation was 60%. Adherence to monthly testing was low in the majority of patients (58.2%). Conclusions Adherence to bosentan RMMs relevant to minimizing risk of hepatotoxicity either before starting or throughout therapy was low. Our findings could be used as a baseline for monitoring trends in implementation of RMMs over time or to compare performance of various minimization strategies.

Meeting the challenge of mitigating Li-ion battery fires for aviation

The aviation industry faces a pressing challenge in reducing its environmental footprint, especially with the projected growth in global passenger traffic. Electrification and more-electric aircraft, particularly through Lithium-ion Battery (LiB) systems, offers a promising pathway to reduce emissions but introduces significant safety concerns, particularly regarding thermal runaway (TR) events. This prospective paper examines the unique challenges posed by aviation environments for developing safe LiB systems. It discusses multifaceted mitigation approaches, integrating fire containment structures with advanced thermal management and fire protection technologies. Various cooling technologies and fire suppression agents are explored for their effectiveness in extinguishing LiB fires and mitigating thermal runaway propagation. Integrated LiB suppression systems are proposed to combine fire containment, suppression, and thermal management functionalities for achieving the demanding specific energy density levels that will be required. Scaling safe LiB pack solutions for commercial aviation requires coordinated efforts among regulators, original equipment manufacturers (OEMs), engineers, and researchers to establish standardized design criteria, develop validated modeling tools, and establish rigorous certification testing requirements. In conclusion, addressing the safety concerns of large LiB packs in aircraft applications requires a holistic, integrated approach. This paper provides insights into current research, identifies key challenges, and outlines future directions for advancing LiB safety in aviation.

Experimental study of mechanical properties of deep-sea hydrate-bearing sediments under multi-field coupling conditions

To ensure the long-term safety of hydrate-bearing sediments (HBSs) in the deep sea, it is necessary to conduct a comprehensive study of the mechanical properties of HBSs, which is closely related to the safe extraction of natural gas hydrates (NGH). In this study, a HBSs preparation method was proposed preparing HBSs artificially to meet the test requirement. A series of triaxial shear tests were carried out by the self-developed HBSs multi-field coupling intelligent triaxial test device to analyze the effects of different hydrate saturation and NaCl concentration on the mechanical properties of HBSs. The results show that HBSs have elastic-plastic properties under multi-field coupling conditions, and the stress-strain curves show a strain-hardening trend. Hydrate saturation affects the shear strength of hydrate-bearing sediment critically. When the hydrate saturation is Sh>35 %, the cohesion and internal friction angle is directly proportional to the hydrate saturation. When the NaCl concentration is low, the cohesion of HBSs is more affected by the NaCl concentration, and the shear strength and yield strength are proportional to NaCl concentration. When NaCl concentration is high, the internal friction angle of HBSs is more affected by NaCl concentration and the shear strength is inversely proportional to NaCl concentration. Under the condition of multi-field coupling, the influence of each factor on the mechanical properties of HBSs has an upper limit, which is not a purely linear relationship.

PENGARUH MEDIA BIG BOOK TERHADAP PERKEMBANGAN KOSAKATA BAHASA INGGRIS SISWA KELAS I SD NEGERI 040443 KABANJAHE

The study aims to determine the development of English vocabulary of children aged 6-7 years through Big Book media on students in class I of SD Negeri 040443 Kabanjahe. This study uses an experimental research method because it will look for the effect of certain treatments. The type of research is the Quasi Experiment. The quasi-experimental research design used in this research is the Nonequivalent control group design. In this design there are two groups used, namely the experimental group and the control group. The population used in this research was all class I138students at SD Negeri 040443 Kabanjahe, totaling 40 children, with the sample being classes B1 and B2 determined by purposive sampling. Data collection techniques by conducting observations, questions, and answers (interviews), and taking physical evidence such as photographs (documents), and RPPH. Before being used, the instrument was tested for validity and reliability. Validity testing with the Corrected Item Total Correlation technique and reliability testing with Cronbach Alpha's technique. All calculations use the help of the SPSS program version 18.0 for windows. Furthermore, to meet the requirements of the hypothesis test, normality calculations were carried out with the Kolmogorov-Smirnov test and homogeneity calculations with the Lavene Statistic test on both samples (class B1 and class B2). Data analysis techniques were carried out with descriptive statistics and continued with inferential statistics using the t-test or t-test, with the formula paired sample t-test and a significance value of α = 0.05 (5%). Based on the results of the study, it was concluded that the use of Big Book media in the English learning process on vocabulary proved to have a significant effect on the development of children's English vocabulary in the experimental group in class B1. The level of vocabulary development of children who were given treatment was higher compared to the group of children who were not given treatment, in the experimental group and the control group there was a "quite significant" difference. Based on calculations carried out with the help of the SPSS version 18.0 for Windows program, it is known that the value of t in the SPSS output after the paired samples T-test analysis was -5.315. Where in the t value there is a minus sign (-) which is a sign that there is a difference between the two groups. Therefore, the presence of this minus sign indicates a signal that there is a difference between the two groups (experimental and control).

Image analysis as a geometry- and integrity-independent tool for predicting strength of cemented tailings backfill using slag-based binder

Compressive strength is a crucial indicator for assessing the stability of the cemented tailings backfill (CTB) matrix. The stringent requirements of traditional non-destructive testing (NDT) methods (e.g., ultrasonic pulse velocity and electrical resistivity) regarding the geometry, section flatness, and integrity of the core sample severely limit their use in the in-situ measurement of CTB strength. Therefore, this study proposes a novel NDT technique for assessing the in-situ strength of CTB made from ground granulated blast furnace slag (slag) by means of image analysis. Strength tests and image analysis are carried out in 258 specimens maintained at different solid concentrations (71−79 %), binder contents (6−14 %), activator ratios (from 28:2–20:10) and curing temperatures (5−40℃). In addition, microscopic investigations are carried out to clarify the underlying mechanisms contributing to the macroscopic features. Increasing solid content, desulfurized gypsum to calcium carbide slag (DG/CS) ratio, and curing temperature results in increases in UCS of 87.9−199.9 %, 171.3−421.2 %, and 27.5−173.8 %, respectively. The strength-enhancing effect of increasing the curing temperature diminishes with time, from 173.8 % at 3 days to 27.5 % at 28 days. Strength initially rises and then abruptly decreases as binder content rises. The grayscale value generally has an opposite trend to strength, but the former is less sensitive to changes in influencing factors. An obvious exponential relationship is found between strength and grayscale for all specimens (R2 = 0.92). Compared with traditional NDT methods, the application of image analysis is not restricted to the shape, size, and integrity of CTB and therefore provides a faster, easier, and less costly tool for the quality evaluation of field CTB matrix.

Microcontroller-based integrated data logging system for solar air heater performance assessment

ABSTRACT Efficiency curves for assessing solar air heater (SAH) performance are determined by measuring different parameters under certain operating conditions recommended by different test standards such as American Society of Heating, Refrigerating and Air-Conditioning Engineers. In this work, development and testing of a low cost integrated datalogging system for tracing efficiency curves are presented. Pyranometer (CMP11) and temperatures sensors (DS18B20) are integrated with microcontroller (AT89S52) for continuous data recording at desired time interval. Switching devices are integrated to automatically control operations of electric heater for maintaining inlet air stream temperature as per testing requirements. Using the system, efficiency curves of a 1.46 m2 SAH installed in Tezpur University, India, are determined at two mass flow rates of air. Results are comparable with published literatures revealing negative slope (energy loss component, F R U L ) and positive intercept (energy absorption component, F R (τα) n ) of efficiency curves. SAH shows better performance at lower mass flow rate of air (0.0235 kg/m2-s), with F R U L as 13.5 W/m2-K compared to operation at 0.0430 kg/m2-s mass flow rate of air where slope increases by around 23% with same intercept. Higher slopes of the SAH demonstrate its highest sensitivity to prevailing wind compared to three previously published designs. Present study shows that the integrated system can replace individual traditional measuring instruments for respective parameters like solar irradiance and temperatures as well as additional control equipment required to maintain desired test conditions. Further development of the system can lead to a modular and portable efficiency curve tracer for SAH performance assessment.

Understanding and Testing Iceberg Algorithmic Trading Strategy

As Technology has advanced in recent times, it also has impacted the Trading requirements that modern day traders have. Trading now is not a simple Buy and Sell of a Security, but it is way complex involving complex mathematical algorithms programmed to execute Trades at much faster rates and using different trading strategies, also called Algorithmic Trading strategies. Traders’ selection of algorithmic strategy/ order types is a critical decision that significantly influences the execution quality and outcome of trades. In this Paper, we will specifically study one of the commonly used Algorithmic strategy/ order type called Iceberg Order. We will try to understand why Iceberg Orders are required, how they are executed with the help of different examples and what Testing should be done to ensure we deploy a Defect free Iceberg Order Strategy to production. A small issue in execution of trading strategy can result in big losses to the company, regulatory fines and reputational loss. So, Test Scenarios to be considered and testing requirements for Iceberg Orders should consider different scenarios which will be discussed in detail in this paper.