bluuebunny/crossref_metadata_2025 huggingface dataset:
Chinese mothers use idioms in shared book reading: A predictor for children’s Chinese vocabulary growth?
Authors: Yang Junyi , Grøver Vibeke , Lawrence Joshua F.
Published: October 2024

Idioms play an important role in language; however, little research has examined idioms in children’s natural language settings. This study explored idioms usage in maternal talk during mother-child shared book reading and its relation to children’s vocabulary development. Thirty-three Chinese children in Norway (aged 3;0–5;5) and their mothers participated. We observed shared reading at the onset of the study and assessed children’s receptive and expressive vocabulary in Chinese three times across one year. Results demonstrated that mothers used an average of 1.8 idioms and explained one-third of the idioms. Maternal idiom usage was correlated with their talk amount and lexical diversity. Individual growth modeling revealed that the number of idioms mothers used predicted the growth of children’s receptive vocabulary in Chinese. We speculate that idiom usage could be an effective and understudied marker of parental linguistic sophistication. This study underscores the importance of idiom exposure in children’s language environment.
Experiential, perceptual, and cognitive individual differences in the development of declarative and automatized phonological vocabulary knowledge
Authors: Saito Kazuya , Uchihara Takumi
Published: October 2024

The present study explores the influence of individual differences in experience, perceptual acuity, and working memory on the development of both declarative and automatized aspects of L2 phonological vocabulary knowledge. A total of 486 Japanese English-as-a-foreign-language (EFL) students took part in two vocabulary tests designed to measure declarative (meaning recognition) and automatized knowledge (lexicosemantic judgement task). Their performance was tied to the quantity and quality of their EFL experience, as well as their scores in auditory processing and working memory. While several significant, modest correlations between experience, aptitude, and vocabulary outcomes were observed, certain predictor variables were uniquely associated with either declarative or automatized vocabulary performance. Specifically, individuals with more extensive, typically language-focused EFL training and greater working memory demonstrated higher levels of declarative knowledge. Conversely, those who pursued extracurricular practice outside the classroom – exposing themselves to auditory materials and/or participating in study-abroad experiences – showed a more automatic execution of vocabulary knowledge.
Monitoring sodium content in processed and ultraprocessed foods in Argentina 2022: compliance with National Legislation and Regional Targets
Authors: Guarnieri Leila , Castronuovo Luciana , Flexner Nadia , Yang Yahan , L’Abbe Mary R , Tiscornia Victoria
Published: October 2024

Objective:

To assess the current Na levels in a variety of processed food groups and categories available in the Argentinean market to monitor compliance with the National Law and to compare the current Na content levels with the updated Pan American Health Organisation (PAHO) regional targets.

Design:

Observational cross-sectional study.

Setting and Participants:

Argentina. Data were collected during March 2022 in the city of Buenos Aires in two of the main supermarket chains. We carried out a systematic survey of pre-packaged food products available in the food supply assessing Na content as reported in nutrition information panels.

Results:

We surveyed 3997 food products, and the Na content of 760 and 2511 of them was compared with the maximum levels according to the Argentinean law and the regional targets, respectively. All food categories presented high variability of Na content. More than 90 % of the products included in the National Sodium Reduction Law were found to be compliant. Food groups with high median Na, such as meat and fish condiments, leavening flour and appetisers are not included in the National Law. In turn, comparisons with PAHO regional targets indicated that more than 50 % of the products were found to exceed the regional targets for Na.

Conclusions:

This evidence suggests that it is imperative to update the National Sodium Reduction Law based on regional public health standards, adding new food groups and setting more stringent legal targets.
Whose war is it anyway? Proportionate reparations in wars of aggression
Authors: Nizami Ameer Arnaaz
Published: October 2024

This article proposes a hybrid legal framework combining jus ad bellum and jus in bello to govern the attribution of State responsibility for reparations at the end of a war of aggression. To this end, the article considers former international mass claims processes and proposes a complementary approach that, on the one hand, acknowledges the role of the aggressor State in waging the war, and on the other, takes a cautionary approach to prevent a disproportionate burden of compensation being imposed on the aggressor State as a form of collective punishment. The consequences of respective violations of the prohibition of the use of force and the law of war are blurred in a war of aggression, resulting in complexities around liability for aggressor States. In response, this article concludes with a nuanced proposal to calculate compensation based on (1) the aggressor party's capacity to comply with jus in bello; (2) the extent of damage caused by the war of aggression, factoring in jus ad bellum considerations if a party is found to be intentionally maximizing destruction; and (3) the incorporation of tort law principles for equitable attribution of responsibility.
Towards common ground: Strategies for effective collaboration between the humanitarian and peacebuilding communities
Authors: Brubaker Rebecca , Bennett Will , Eriksen Hannah Ajelet
Published: October 2024

In an era marked by growing conflicts, prolonged humanitarian needs and less donor funding, collaboration between the humanitarian and peacebuilding sectors is essential for more effective responses. This paper examines the complexities of fostering such collaboration, emphasizing the importance of integrated multisectoral approaches capable of addressing both immediate necessities and long-term peace and development objectives. While recent initiatives such as the humanitarian–development–peace nexus framework and the United Nations Secretary-General's Agenda for Humanity reflect progress toward integrated approaches, substantial collaborative challenges persist. This paper identifies three key entry points for mutual learning between humanitarian and peace actors. Firstly, it discusses a “peace-responsive” approach to humanitarian activities that proactively contributes to “peace-positive” outcomes. Secondly, it emphasizes the need for the peace sector to learn from humanitarian efforts regarding accountability to affected communities. Thirdly, it underscores the need to understand the normative foundations of each sector and their implications for joint action. Drawing on these insights, the paper offers recommendations for policy-makers and practitioners to help them advance joint approaches to humanitarian assistance and peacebuilding in conflict-affected contexts.
Mineralogical and radiological studies on some Paleozoic yellow ochre deposits in Southwestern Sinai, Egypt
Authors: Abdel-Azeem Marwa M. , Harpy Nareman M. , Alshami Abdalla S. , Maadawy Wael M. El
Published: October 2024

Yellow ochre is the basic material used in the manufacture of yellow oxide (a commercial product). Yellow ochre samples were taken from three different formations in southwestern Sinai: Abu Hamata, Um Bogma, and Abu Zarab. Yellow ochre occasionally exists in Abu Hamata Formation particularly in El Ferah area, associated with Fe–Mn ore in Wadi El Sahu (Um Bogma Formation) and in Himayer area (Abu Zarab Formation). The XRD analysis of the raw material reveals that they are mainly composed of goethite, which is associated with quartz and kaolinite in El Ferah area, hematite, kaolinite and quartz in Himayer area, and kaolinite, gypsum and quartz in Wadi El Sahu. The commercial product is mainly composed of goethite, quartz, and calcite. The heavy mineral investigation shows that some yellow ochre samples contain zircon and rare earth sulfate which may be responsible for the radioactivity of ochre due to their thorium and uranium content. The average values of specific radio-activities of most radionuclides in the samples of Himayer area I and II, and El Sahu I are higher than the respective world averages, while their activities are lower in El Ferah and El Sahu II. Th/U and Ra/U ratios exhibit vigorous changes in physico-chemical conditions during uranium leaching and deposition. Most of the radiological parameters in the ferruginous sediment and commercial product samples from El Ferah, El Sahu II, and Himayer II are lower than the recommended international values but higher than those from Himayer I and El Sahu I samples. The plotted hierarchical cluster analysis (HCA) exhibits that the main contributors for the hazards of these sediments and their commercial product are 238U, 232Th and 226Ra in Himayer I &II, commercial products, and El Ferah area, 232Th and 226Ra in El Sahu II , 232Th, 40K and 226Ra in El Sahu I.
Folded flexure MOEMS for the detection of PSA and hepatitis DNA as biosensor for prostate cancer and viruses
Authors: Bahramian Hossein , Gholinejad Jalal , Yazdanpanah Goharrizi Arash
Published: October 2024

Micro-opto-electro-mechanical systems (MOEMS) biosensors are employed in various applications such as disease monitoring, drug investigation, detection of pollutants, and biological fluid studies. In this paper, a novel MOEMS biosensor based on a differential folded-flexure structure is introduced. The designed device is employed to detect prostate-specific antigen (PSA) protein and Hepatitis DNA. The target molecules cause a mechanical deflection in the folded-flexure; subsequently, the transmitted optical power across the finger, attached to the flexure, is modulated in proportion to the input concentration. Then, a photodiode power sensor measures the modulated optical power, where the output of the sensor is simply a current related to the target molecules’ concentrations. The employed readout circuit operates at a wavelength of λ = 1550 nm with a laser power of 1 µW. The dimensions of the proposed biosensor are considered to be 365 × 340 × 2 μm³, making this sensor small enough and suitable for integration. The designed biosensor provides notable features of mechanical deflection sensitivities of 0.2053 nm/(ng/ml) and 7.2486 nm/nM, optical transmittance sensitivities of 0.535504 × 10−3 1/(ng/ml) and 18.91 × 10−3 1/nM, total output sensitivities of 0.5398 (mA/W)/(ng/ml) and 19.059 (mA/W)/nM, and measurement ranges of 0-1000 ng/ml and 0-28.33 nM for PSA and Hepatitis DNA, respectively. The proposed system is a sensitive and powerful sensor that can play an important role in diagnosing many diseases.
Organic Semiconducting Polymers and Their Post-functionalization for Optoelectronics
Authors: Terayama Kosuke , Michinobu Tsuyoshi
Published: October 2024

The post-functionalization of π-conjugated polymers is an attractive methodology for tuning their optoelectronic properties without the need for complicated synthesis procedures and facing batch-to-batch variability. In this chapter, we summarize and discuss the reaction types used for the post-functionalization of π-conjugated polymers. This will help readers understand the previous research studies and promote the further development of post-functionalized π-conjugated polymers for optoelectronics.
Transformation of the Green Agenda of Russian Energy Companies Under Sanctions
Authors: Gurieva Lira , Baburina Olga
Published: October 2024

Russia is following the global agenda of energy transition and achieving a zero balance of greenhouse gas emissions by 2060. The article examines the impact of economic sanctions on the institutional conditions and factors of reducing the carbon footprint of Russian energy companies. The key conclusions of the research are: 1) economic sanctions act as a limiting factor for the development of Russian raw materials companies; 2) despite high synchronization of Russian legislation with international initiatives and the implementation of large-scale ESG-based projects, under sanctions, the green agenda of Russian energy companies is being significantly transformed: the goal of reducing the carbon footprint remains a priority only for companies with a high level of state participation, but even these companies have made significant adjustments to strategic implementation plans green technologies; 3) maintaining the competitiveness of Russian energy companies in the foreseeable future correlates with the green agenda, therefore, their participation in international projects on the principles of energy transition and national green initiatives will be critically important.
Manifestation of edge spin magnetization in normal metal
Authors: Chiang (Tszyan) Yu. N. , Dzyuba M. O.
Published: October 2024

In paramagnetic metal (Al), the nonlinear behavior of the spin component in the Hall effect was discovered, indicating the role of edge transverse spin magnetization. It is shown how its manifestation is related to the spin precession period and their relaxation length, which weakly depend on the momentum relaxation time.
Flexible construction of demountable superfluid-tight electrical feedthroughs
Authors: Yu Yongle , Zhao Li
Published: October 2024

This work introduces a new and simple design for electrical feedthroughs used in low-temperature experiments. Using readily available materials, one can effortlessly construct reliable electrical lead seals which have been proved superfluid-tight. Compared to the widely used Stycast-type epoxy sealing method in most low-temperature physics groups, our design offers increased flexibility and facilitates easy disassembly, all at a low cost.
Quadratic enrichment of the logarithmic derivative of the zeta function
Authors: Bilu Margaret , Ho Wei , Srinivasan Padmavathi , Vogt Isabel , Wickelgren Kirsten
Published: October 2024

We define an enrichment of the logarithmic derivative of the zeta function of a variety over a finite field to a power series with coefficients in the Grothendieck–Witt group. We show that this enrichment is related to the topology of the real points of a lift. For cellular schemes over a field, we prove a rationality result for this enriched logarithmic derivative of the zeta function as an analogue of part of the Weil conjectures. We also compute several examples, including toric varieties, and show that the enrichment is a motivic measure.
Spectral theory and self-similar blowup in wave equations
Authors: Donninger Roland
Published: October 2024

This is an expository article that describes the spectral-theoretic aspects in the study of the stability of self-similar blowup for nonlinear wave equations. The linearization near a self-similar solution leads to a genuinely nonself-adjoint operator which is difficult to analyze. The main goal of this article is to provide an accessible account of the only known method that is capable of providing sufficient spectral information to complete the stability analysis. The exposition is based on a mini course given at the Summer School on Geometric Dispersive PDEs in Obergurgl, Austria, in September 2022.
A-009 Analytical Characterization of a Novel NT-proBNP Assay on a Central Laboratory Platform
Authors: Christenson R H , Alahapperuma D , Allen B R , Guidi J L , Headden G , Peacock W F , Winden N , Januzzi J L
Published: October 2024

Background

N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) or B-type Natriuretic Peptide (BNP) assay(s) are widely measured with a Class 1, Level of Evidence A recommendation in professional heart failure (HF) guidelines for diagnosis and prognosis. We present the analytical characteristics of the first NT-proBNP assay on Beckman Coulter platforms.

Methods

Measurements were conducted with the Access NT-proBNP assay, a one-step sandwich immunoenzymatic assay using monoclonal capture and detection antibodies, on the DxI 9000 Immunoassay Analyzer with Lithium Heparin (LiHep) plasma samples. Performance was characterized according to CLSI guidelines for: Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity, imprecision (repeatability, reproducibility) and matrix comparison with LiHep, EDTA and serum. Reference intervals (RI) were evaluated in a healthy, adult U.S. population comprised of 675 subjects with 54.6% females, 79.1% White and 15.1% Black individuals. Exclusion criteria included elevated cardiac troponin, abnormal eGFR and cardiac medications. The 97.5th percentile RI upper limit was defined for age-stratified ranges of <50, 50-75, and >75 years old.

Results

Performance was LoB=1.1ng/L; LoD=4.8ng/L; LoQ=4.8ng/L; linearity=35,000ng/L. Repeatability ranged from 1.5%-3.5% and reproducibility from 2.3%-7.9% in seven samples ranging from 38ng/L to 23,848ng/L. Matrix measurement regression (n=68) yielded slopes of 1.00, 1.01; intercepts -0.03 to -2.63; r=0.98. Table 1 shows that NT-proBNP values increase with age and women generally have higher values than men.

Conclusions

The LoB, LoD and LoQ demonstrate highly sensitive low-end characteristics. Repeatability and reproducibility show excellent performance across a wide measurement range. NT-proBNP values are known to be age dependent, and the age-stratified 97.5th percentile RI upper limits were 162 ng/L for <50 years, 311 ng/L for 50-70 years, and 457 ng/L for >75 years. This novel Access NT-proBNP assay offers robust analytical performance as an aid to clinical HF management in acute settings.
A-014 Fifth Generation Troponin T is Unaffected by Extreme Levels of Lipemia and Icterus
Authors: Zakrajsek J A , Zakrajsek J T , Benefit S , McShane A J
Published: October 2024

Background

The tissue specific cardiac isoform of troponin (cTnT) originates exclusively from the myocardium; therefore, it is used as the primary diagnostic biomarker for myocardial infarction. Lipemia, caused by elevated lipoprotein particles, and icterus, caused by elevated bilirubin, are common endogenous interferences that can lead to erroneous results. According to the instructions for use (IFU), recovery is acceptable when bilirubin levels are ≤25 mg/dL (conjugation not specified) and intralipid levels are ≤1500 mg/dL. However, it is common in large hospital settings to observe higher levels for these potential interferents. The purpose of this study was to determine whether 5th generation cTnT results are negatively impacted by extreme levels of lipemia or conjugated or unconjugated bilirubin.

Methods

cTnT interference studies were performed on a cobas e602 (Roche Diagnostics). Low, mid, and high cTnT sample pools at approximate concentrations of 20 ng/L, 100 ng/L, and 1000 ng/L were split into target and control pools. To evaluate the effect of lipemia, target pools were spiked with intralipid solution to achieve a lipemia index (LI) ranging from 1500-2000 (correlates poorly with mg/dL triglycerides). Samples were analyzed in triplicate for cTnT and serum indices. To evaluate the effect of icterus, target pools were spiked with conjugated or unconjugated bilirubin to achieve an icterus index (II) ranging from 30-55 (approximately equal to mg/dL bilirubin). Samples were analyzed in triplicate for cTnT, conjugated and unconjugated bilirubin, and serum indices. Interference was determined by calculating the variance between the average target and corresponding control result.

Results

Conclusions

cTnT has a high lipemia and icterus tolerance with recoveries <10% for all three cTnT concentrations.
A-029 Evaluation of the Analytical Performance of Four Assays Used for Diabetes on the Atellica CI Analyzer
Authors: Frenna J , Maher K , Warnock J , Riverso N , Tyler C , Arrode-Bruses G , Leipold H , Snyder J
Published: October 2024

Background

The Atellica® CI Analyzer is an automated, high-throughput integrated chemistry and immunoassay analyzer utilizing both Atellica® CH and Atellica® IM Assays. This study evaluated the analytical performance of the Atellica IM C-peptide (CpS) and Insulin (IRI) Assays, and the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) and Fructosamine (Fruc) Assays on the Atellica CI Analyzer.

Methods

Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum samples, except for the A1c_E assay using native and contrived human whole blood samples. One aliquot of each sample pool was tested in duplicate in two runs per day ≥2 hours apart on each analyzer for ≥20 days. Precision was evaluated using reagent lot and system combination varying between one to three reagent lots and one to three systems depending on the assay tested. Method comparison (MC) studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum or whole blood (A1c_E) samples were analyzed using the Atellica IM Cps, IRI Assays on the Atellica IM Analyzer, the Atellica CH A1c_E, Fruc Assays on the Atellica CH Analyzer and the four Atellica IM and CH Assays presented on the Atellica CI Analyzer.

Results

Representative precision and MC results for each assay are listed in the table. For the four assays tested, repeatability and within-lab %CVs were <2.8% and <3.2%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1.

Conclusions

Evaluation of the Atellica IM Cps, IRI and Atellica CH A1c_E, Fruc Assays using the Atellica CI Analyzer demonstrated good precision and equivalent performance compared to the same assays on their respective Atellica CH and Atellica IM Analyzers.
A-034 Evaluation of the Analytical Performance of Five Chemistry Assays on the Atellica CI Analyzer
Authors: Lewisch S , Camacho J , Wilkins G , Gupta P , Shalhoub V , Snyder J
Published: October 2024

Background

The Atellica® CI Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer utilizing both Atellica® CH and Atellica® IM assays. This study evaluated the analytical performance of the Atellica® CH Alpha-1-antitrypsin (AAT), Ammonia (AMM), Amylase_2 (AMY_2), Cholinesterase_2 (CHE_2), Lipase (Lip) Assays on the Atellica CI Analyzer.

Methods

The Atellica CI assays use the same reagents and calibrators as the Atellica CH assays. Precision studies were performed according to CLSI EP05-A3 using human urine (AMY_2), serum (AAT, AMY_2, CHE_2, Lip), and plasma (AMM) samples. One aliquot of each sample pool was tested in duplicate in two runs per day for 20 days. MC studies were performed according to CLSI EP09-A3. Samples were analyzed using the Atellica CH and Atellica CI Analyzers.

Results

Across the five assays, repeatability CVs were <5.7% and within-laboratory CVs were <8.2%. Representative precision, and MC results observed for each assay across indicated sample ranges are presented in the table. Slopes determined using the Deming linear regression model were approximately equal to 1.

Conclusions

Atellica CH AAT, AMM, AMY_2, CHE_2, and Lip Assays on the Atellica CI Analyzer demonstrated good precision and equivalent performance to the same assays on the Atellica CH Analyzer.
A-046 Quantification of Corticosteroids and Androgens in Serum, utilizing Waters MassTrak™ Steroid Serum Sets 2 & Sets 3 for Clinical Research
Authors: Moran L , Tobin N , Foley D , Breen N , Davey L
Published: October 2024

Background

Steroid hormones encompass a large class of small molecules that play a central role in metabolic processes, such as the regulation of sexual characteristics, blood pressure, and inflammation. Enzymes that form part of the steroid biosynthetic pathway are pivotal in these metabolic processes, and their dysfunction can be examined through the correct measurement of steroid hormones in a clinical research setting. The availability of lyophilized calibrators and QCs reduces sample preparation time, aids in method harmonization, and assists with metrological traceability in accordance with ISO15189:2022, when used alongside an analytically selective chromatographic method.

Methods

A quantitative clinical research method utilizing Waters MassTrak Steroid Serum Sets 2 and 3, Cals & QCs and Waters Oasis™ PRiME HLB µElution plate technology for the extraction of testosterone, androstenedione, 17-hydroxyprogesterone (17- OHP), dehydroepiandrosterone sulfate (DHEAS), Cortisol, 11-deoxycortisol and 21-deoxycortisol from human serum samples. Chromatographic separation was performed on an Waters ACQUITY™ UPLC™ I Class Plus (FL-I) System, using an ACQUITY UPLC HSS T3 Column, accompanied by a Xevo™ TQ-S micro Mass Spectrometer.

Results

Accuracy (±6%) and precision (±10%) have been confirmed through comparison to External Quality Assurance (EQA) LC-MS/MS schemes, panels and QC material for all seven steroid hormones. All analytes were assessed at the low, medium and high concentrations for each MassTrak Steroid Serum Set, which yielded excellent results across the range (±10%). Deming and Linear regression analysis were performed. No statistically significant bias was observed for each compound, with a mean method bias of ±1.3% for Set 2 and ±1.0% for Set 3. The clinical research method was shown to be linear for all analytes over the calibration ranges specified, furthermore, calibration lines created using Set 2 and Set 3 were analysed over a five-day period and were linear with a co-efficient of determination of (r2) > 0.999 for all analytes. Analytical sensitivity using Signal:Noise (S/N) of the low calibrator (Calibrator 1) of each set, was >10:1 for each analyte across several analytical runs.

Conclusions

This evaluation has demonstrated that the MassTrak Steroid Serum Calibrator and Quality Control Sets 2 and 3 can provide precise and accurate quantification of steroid hormones in serum. An analytically sensitive and selective clinical research method has been developed for the analysis of testosterone, androstenedione, 17- OHP, DHEAS, cortisol, 11-deoxycortisol and 21-deoxycortisol in serum using Waters I-Class Xevo TQ-S micro system. For Research Use Only. Not for Use in Diagnostic Procedures.
A-140 Reducing cell count bias with the GloCyte® Automated Cell Counter for CSF: an observational study at Loyola University Medical Center
Authors: Maggiore J , Flasher J , Majkut N , Webb D , MacKenzie J
Published: October 2024

Background

Accurate STAT cerebrospinal fluid (CSF) cell counts are critical in supporting diagnoses of meningitis, malignancy, demyelinating disease, and hemorrhage. Limitations of automated analyzers to achieve acceptable linearity for the clinically relevant range has maintained manual CSF cell counting as the preferred method. Manual cell counting, performed with a hemocytometer and bright field microscope, is time-consuming, requires specialized skills and depends on human interpretation. This subjectivity inherently introduces the potential for non-random error in the enumeration of both total nucleated cells (TNC) and red blood cells in CSF by manual methods. The purpose of this study was to evaluate and compare the level of bias inherent in manual determination (TNC) in CSF as compared to the GloCyte Automated Cell Counter.

Methods

Result bias data for CSF specimens processed in the hematology lab at Loyola University Medical Center, a quaternary care 547-bed academic medical center in Maywood, IL, was analyzed for manual cell counting using a Neubauer-improved hemocytometer and GloCyte, an FDA-cleared cell counting device employing fluorescence technology to automate RBC and TNC counts in under 5 minutes, with linearity down to 0 cells/µL. Result bias was determined by defining the “expected result” for both GloCyte and hemocytometer as the initial cell count determined at a 1:5 dilution of a freshly-collected CSF sample and calculating the expected cell count for subsequent serial dilutions of 1:10, 1:20, 1:50, 1:100 for each method. The actual TNC count and the disparity of the actual result from the expected result was recorded as bias.

Results

Data are summarized below in the Table, and indicate a lower bias for GloCyte compared to manual counts across the range of dilutions.

Conclusions

This study demonstrates that GloCyte can be implemented as a means of effectively mitigating the reporting bias of CSF TNC counts performed with a Neubauer-improved hemocytometer.
A-196 Using Aggregated Proficiency Testing Results to Identify Systematic Error
Authors: Astles J R , Kirbiyik U
Published: October 2024

Background

Proficiency testing (PT) should identify systematic errors, which are likely to recur. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) acceptance limits (ALs) include 3SD and concentration limits. We investigated the ability of PT to detect systematic error, especially as affected by the AL type.

Methods

Ungradable, duplicate, and irregular scores were removed from 2008 to 2018 CLIA laboratory PT results. For analytes that had at least 200 events and at least 200 participating laboratories, we calculated the overall sample miss rate, the unsatisfactory event rate, i.e., less than 80, and event rates for Score 100 to 0. We used paired t-tests and the Wilcoxon Signed-Rank test to compare miss rates and unsatisfactory event rates between short- and long-term participants. We used the binomial distribution to model the expected event scores under the assumption that all errors may be independent (random); see Figure. For each analyte and each of the possible PT scores, we compared observed event scores with their expected values as a ratio.

Results

40,596 laboratories produced 15,140,128 event scores for 75 analytes. The distribution of event scores was over-weighted with higher-order event errors (Score 0 - Score 60) compared to the predicted distribution. Miss rates and unsatisfactory rates were significantly higher for short-term laboratories. Plotting the log ratio of observed versus expected rates for event scores showed that the degree of systematic effect increased progressively for each analyte. The magnitude of the effect was less for 3SD ALs.

Conclusions

In an event, PT errors are often dependent. Concentration and 3SD ALs were similarly sensitive to detect systematic error; both were more sensitive than ALs for qualitative or dilution assays. Expressing systematic error using PT data could help to identify remediable analytical issues.
A-204 Commitment to Sustainability From Laboratory Medicine
Authors: Yeoh A C , Saw M Y , Ngabedan R , Jamaluddin F A , Chew Y Y
Published: October 2024

Background

According to McGill University, sustainability means “meeting our needs without compromising the ability of future generations to meet their own needs”. Sustainable environmental practices improve water and air quality, reduce landfills, and increase renewable energy sources in the long term. In response to the growing urgency of global sustainability challenges, the healthcare industry is taking a step forward to reduce its environmental impact. University of Malaya Medical Centre (UMMC) is a government-funded teaching hospital and medical institution, which processes about 3.95 million chemistry and 371,000 immunoassay tests per year. This study aims to evaluate the sustainability aspects of Atellica Solution, focusing on water usage, power consumption, carbon dioxide emissions and plastic waste generations.

Methods

Power and water consumption for the analysers Advia Chemistry 2400 & XPT and Advia Centaur XPT were obtained from Atellica Solution using the year 2022 test volumes and compared with those of Siemens legacy system for the year 2019 test volumes. In addition, the reduction of plastic usage was also assessed for the year 2019 and 2022.

Results

With innovative Atellica Solution replacing Siemens legacy system, the data showed reduction in water and energy consumption by 36.44% and 47.74% respectively, whereas the annual throughput increased by 13.7%. By using Atellica INTELIQ QC management, fewer aliquot tubes were used and thus plastic waste was reduced by 168 kg. These reductions combined to lower CO2 emissions by about 16 tons.

Conclusions

Atellica Solution is designed for high throughput and sustainability, reducing water and energy consumption while also significantly reducing CO2 emissions. Furthermore, it enables faster, streamlined quality control management with Atellica INTELIQ QC management system. UMMC is strongly committed to minimizing laboratories’ environmental footprint and provide better access to care eventually contributing to the well-being of patients.
A-264 Validation of a Novel Real-Time PCR Assay for Identification of Mycobacterium species Isolates Recovered from Clinical Culture
Authors: Harris A B , Jadi R , Urban T J , Le T , Song K , Brochu H N , Iyer L K , Dale S E , Capraro G A , Boles D J
Published: October 2024

Background

Historically, clinical mycobacteriology laboratories used the nucleic acid hybridization-based AccuProbe assay manufactured by Hologic, Inc., to rapidly rule in or rule out Mycobacterium tuberculosis (MTB) and members of the M. avium-intracellulare complex (MAC). The clinical value of this test was in its ability to rapidly rule in/out MTB from positive broth cultures and allow the initiation of appropriate antimicrobial therapy and infection prevention practices. Recent discontinuation of this commercial assay left a gap in testing available for the rapid identification of these organisms, which allowed us to develop an in-house real-time PCR test.

Methods

A replacement assay was developed by Labcorp R & D based on real-time PCR amplification of extracted nucleic acids from positive culture growth. Aliquots from positive AFB VersaTREK broth cultures were heat inactivated, and nucleic acids were extracted using the MagNA Pure 24 (MP24) instrument (Roche). Real-time PCR using published primer probe sets (Rocchetti, et al 2016) was performed on the QuantStudio™ 7 (QS7) instrument (Applied Biosystems®). The assay was designed with three independent primer/probe sequence targets: one for MTB Complex (IS6110), one for MAC (ITS), and one pan-target for the Mycobacterium genus (16s rRNA).

Results

Procedural verification was performed using 100 residual clinical specimens previously identified using the Hologic AccuProbe® assay. Categorical concordance was 97% (97/100). The three discrepant results were identified as MAC positive by PCR; however, these were not identified as MAC on the predicate assay. Analytical sensitivity for the PCR assay was established to be 1,000 CFU/mL for each target. Analytical specificity was assessed in vitro for nine Mycobacterium species, with no cross-reactivity observed. In vitro analysis of target detection in the presence of yeast (Candida glabrata) was also performed, and we saw no inhibition. Analysis of the primer/probe sets for all targets was performed in silico using XploreDB database of microbial genomes, with confirmed 100% matches for both MAC and MTB genomes compared to hundreds of species. By comparison, the PAN-Myco primer set showed decreased performance, having three mismatches (two on forward primer and one on the probe). As this target sequence is used as an Internal Control (IC) this was not problematic for overall assay performance. The assay demonstrated excellent precision (%CV) for each target: MTB = 0.74%, MAC = 1.10%, PAN-Myco = 3.19%.

Conclusions

Utilizing the depth of molecular methodologies available in our laboratories, we developed a rapid method for identification of MAC and MTB from positive broth cultures, which had excellent performance compared to the predicate assay. The PCR ID LDT test is now available and allows testing to continue with no interruption in patient care.
A-346 Evaluating 14-3-3η Detection in Finger Prick Blood Using Lateral Flow Technology: Advancing Clinical Laboratory Diagnostics
Authors: Sidhu N , Stojanovic V , Marotta A
Published: October 2024

Background

The protein 14-3-3η is a critical biomarker in the diagnosis and monitoring of autoimmune rheumatologic disorders, and its early detection is pivotal for patient outcomes. Previous research has established the significance of 14-3-3η as a biomarker, particularly in inflammatory polyarthritis, as well as patients’ and physicians’ interest in near-patient testing. While 14-3-3η is traditionally measured in serum via ELISA, this study explores the innovative use of lateral flow technology (LFT) for its detection in finger prick blood, addressing the urgent need for near-patient testing.This research aims to evaluate the technical and clinical performance of 14-3-3η measurement using LFT in comparison to standard ELISA methods, with an emphasis on its detectability in finger prick blood.

Methods

This study included two phases of testing involving patient serum and spiked whole blood. In the serum phase, 53 samples (19 NEG, ≤0.19 ng/mL, and 34 POS, 0.27 to 28 ng/mL 14-3-3η) were tested using LFT. LFT results were compared to JOINTstat® ELISA measurements for concordance. For whole blood, recombinant 14-3-3η and ELISA-positive serum samples were spiked into whole blood at increasing concentrations (0.4 to 3.2 ng/mL) and tested with LFT. Concordance criteria included visual inspection of test and control lines, with results captured and analyzed using a reference key card. The study was extended to assess 14-3-3η levels in consented patients with 22 matched finger prick and venous serum samples​​.

Results

In serum testing, LFT demonstrated 100% positivity in detecting 14-3-3η for POS samples. Among NEG samples, 85% tested negative, with 15% positive, indicating a strong concordance between LFT and ELISA. The LFT's ability to semi-quantitatively measure 14-3-3η was confirmed by a significant Kruskal-Wallis test (p<0.0001) across four intensity groups. In whole blood testing, LFT correctly identified all samples spiked at concentrations ≥0.5 ng/mL. The Spearman correlation showed a strong and significant association (r=0.96 to 0.98, p=0.001) between LFT test line intensity and spiked 14-3-3η levels. Finally, the equivalence testing for finger prick and venous serum samples affirmed the LFT’s reliability, with a strong correlation (p<0.0001), underscoring its potential for near-patient testing​​.

Conclusions

The study validates LFT as a reliable and semi-quantitative method for detecting 14-3-3η in finger prick blood, demonstrating strong concordance with traditional ELISA measurements. The findings support the feasibility of LFT in near-patient testing for early detection, prognosis, and monitoring of autoimmune diseases, paving the way for enhanced patient accessibility. Future research will focus on integrating this technology into routine clinical care and examining its impact on patient management and outcomes.
B-045 Evaluation of the Analytical Performance of Three Sepsis Related Assays on the Atellica CI Analyzer
Authors: Frenna J , Lee H , Tyler C , Arrode-Bruses G , Leipold H , Snyder J
Published: October 2024

Background

The Atellica® CI Analyzer is an automated, high-throughput integrated chemistry and immunoassay analyzer utilizing both Atellica® CH and Atellica® IM Assays. This study evaluated the analytical performance of the Atellica IM BRAHMS Procalcitonin (PCT) Assay, and the Atellica CH Revised C-Reactive Protein (RCRP) and Lactate_3 (Lac_3) Assays on the Atellica CI Analyzer.

Methods

Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum (PCT, RCRP) or plasma and cerebrospinal fluid (Lac_3) samples. One aliquot of each sample pool was tested in duplicate in two runs per day ≥2 hours apart on each analyzer for ≥20 days. Precision studies were evaluated with one to three lots of reagent on one to two systems. Method comparison (MC) studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum (PCT, RCRP) or plasma and cerebrospinal fluid (Lac_3) samples were analyzed using the Atellica IM PCT Assay on the Atellica IM Analyzer, the Atellica CH RCRP, Lac_3 Assays on the Atellica CH Analyzer and all three Atellica IM and CH Assays listed above on the Atellica CI Analyzer.

Results

Representative precision and MC results for each assay are listed in the table. For the three assays tested, repeatability and within-lab %CVs were <1.4% and <8.9%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1.

Conclusions

Evaluation of the Atellica IM PCT and Atellica CH RCRP, Lac_3 Assays using the Atellica CI Analyzer demonstrated good precision and equivalent performance compared to the same assays on their respective Atellica CH and Atellica IM Analyzers.
B-110 Descriptive Analysis of Multiple Myeloma Participants in the NIH All of Us Research Program Cohort: Insights into Demographics Disparities
Authors: Houze T A , Azuine R E , Mack N , McClain J , Lunt C , Denny J C
Published: October 2024

Background

Multiple Myeloma (MM) is a complex hematological malignancy characterized by significant heterogeneity in participant characteristics and treatment responses. The All of Us Research Program seeks to enroll 1 million diverse participants who share multiple sources of data, providing unique opportunities for research. A comprehensive descriptive analysis of MM participants within Electronic Health Records (EHR) databases can provide valuable insights into the disease's epidemiology, participant demographics, comorbidities, and treatment outcomes.

Objective

Using AI/ML predictive analytics, this study conducted a detailed descriptive analysis of MM participants’ EHR data in the All of Us Research Program cohort, which is enrolling 1 million diverse participants who share multiple sources of data.

Methods

We extracted data for participants diagnosed with MM from an extensive EHR database. The analysis included participant demographics (age, gender, race, ethnicity), diagnostic laboratory tests (SPEP, UPEP, CBC, renal function), comorbidities (renal impairment, bone disease, anemia, cardiovascular diseases), treatment details (chemotherapy, stem cell transplantation), and genetic markers (cytogenetic abnormalities).

Results

The analysis revealed diverse demographic patterns and a wide range of comorbidities associated with MM (Table 1).

Conclusions

The analysis demonstrated marked disparities in MM prevalence among African Americans and “More than one race,” revealing social and medical disparities. Implications: By understanding the diverse profiles of MM participants, stakeholders can more effectively address disparities in healthcare outcomes (1).

Reference:

1. Zeng, C., Schlueter, D. J., Tran, T. C., Babbar, A., Cassini, T., Bastarache, L. A., & Denny, J. C. (2024). Comparison of phenomic profiles in the All of Us Research Program against the US general population and the UK Biobank. Journal of the American Medical Informatics Association. Retrieved from, https://doi.org/10.1093/jamia/ocad260
B-164 Comparison of Analytical Performance of Two Processing Methods for Measurement of Zinc and Copper on Triple Quadrupole Inductively Coupled Plasma Mass Spectrometer
Authors: Oyelakin-Ogunbileje J O , Dahal R A , Zimmerman M K
Published: October 2024

Background

Copper (Cu) and zinc (Zn) are essential cofactors of enzymes involved in several metabolic processes required for the development of tissue structures and immune response, especially in pediatrics and pregnant women. Triple quadrupole inductively coupled plasma mass spectrometer (ICP-QQQ) enables simultaneous precise quantification of multiple elements with high throughput, sensitivity, and specificity. Samples are introduced into ICP-QQQ as a liquid and converted to fine aerosol with the help of a nebulizer and spray chamber. The precision and sensitivity of measured metals are dependent on the sample preparation thus, this study focuses on comparing the analytical performances between two sample preparations: 0.5% nitric acid (HNO3) as the only diluent (Diluent A) versus a combination of 0.5% HNO3 along with 1% ethanol, 0.5% Ammonium hydroxide, 0.02% TritonX-100, and 0.1% HNO3 (Diluent B) for Cu and Zn metal analysis in serum using ICP-QQQ.

Methods

Twenty deidentified randomly selected patient serum samples were prepared with either diluent A or diluent B and analyzed by ICP-QQQ (Agilent 8900). Data were analyzed using EP Evaluator. Bland-Altman analysis was used to determine the agreement between the two sample preparations. Deming regression analysis was used to determine other analytical performances, such as the proportional and constant bias of Zn and Cu concentration.

Results

There was a bias of -4.8 and -3.0 between the two sample preparation methods when analyzing Cu and Zn, respectively. The mean of Cu-Diluent B versus Cu—Diluent A was 125.2 ± 28.3 µg/dL and 120.4 ± 29.8 µg/dL, respectively, with a slope of 1.070. Conversely, the Zn comparison study shows a lower slope (0.769) with a mean of 71.0 ± 20.5 and 68.0 ± 16.1 µg/dL for Zn-Diluent B and Zn-Diluent A, respectively.

Conclusions

Samples prepared with nitric acid solution only (Diluent A) appeared to show negative bias compared to Diluent B solution containing triton-X for both metals. However, the bias is within the total allowable error for zinc and copper. Importantly, Zn-sample analysis with diluent A (HNO3 only) shows a 23% proportional bias, which is absent with copper sample analysis. A larger study is needed to further compare several methods of sample preparation in ICP-QQQ analysis while leveraging simple preparation without compromising analytical sensitivity. Overall, this study shows that both methods of sample preparation can be effectively used in the ICP-QQQ analysis of serum copper and zinc.
B-178 A Sensitive LC-MS/MS Assay for Total Testosterone Quantification
Authors: Cao W , Wolken J K , Peterson M M , Challoner K E , Jin Z
Published: October 2024

Background

Total testosterone immunoassay is a commonly ordered test for the diagnosis of gonadal disorders. However, immunoassays suffer from low specificity and sensitivity, which leads to inaccuracy especially in the low concentration range (< 100 ng/dL). As a result, commercial testosterone immunoassays have difficulties to accurately measure total testosterone levels for women, children, and hypogonadal men. LC-MS/MS has emerged as the method of choice for the accurate quantitation of steroid hormones. We presented here a sensitive laboratory-developed total testosterone assay, which was validated on two LC-MS/MS instruments.

Methods

An internal standard containing [2,3,4-13C3]-testosterone was added to each sample. The spiked serum sample was loaded on a supported liquid extraction (SLE) cartridge and eluted using methylene chloride. The elute was dried down under nitrogen and reconstituted in sample reconstitution buffer. Chromatographic separation was achieved using a Restek Ultra C18, 50 x 2.1 mm, 3µm analytical column and a total run time of each sample was 5 minutes. The assay was validated on two triple quadrupole mass spectrometers, API 6500 and API 4500. Results were compared with those of a reference laboratory.

Results

The assay was linear in the range of 1 to 1200 ng/dL for total testosterone and the AMR was set at 2-1200 ng/dL. The interday and intraday imprecision were less than 8%. Split sample comparison to a reference laboratory demonstrated acceptable accuracy with the slope of 1.053 and correlation coefficient (R2) of 0.991. The limit of detection (LOD) was 0.2 ng/dL and the limit of quantitation (LOQ) was 0.5 ng/dL. Results obtained from two instruments agreed well with the slope of 0.996 and the R2 of 0.999. No carryover or interferences was observed for this assay.

Conclusions

A LC-MS/MS based method was developed and validated for measuring total testosterone levels for female and children. This sensitive and specific assay will improve the diagnosis of hypogonadism and monitoring of testosterone-suppressing treatment.