bluuebunny/crossref_metadata_2025_split huggingface dataset:
B-093 Analytical performances of a novel fluorescent immunoassay of anti-Müllerian hormone and establishment of the reference intervals in Chinese children
Authors: Jiang L , Li L , Shen L , Li M , Zhu W , Lu D , Zhou Y 
Published: October 2024

Abstract

Background
Anti-Müllerian Hormone (AMH) plays a important role in children growth and the concentrations change with age as well as gender. This study aimed to evaluate the analytical performances of a novel AMH assay based on the cycle enhanced fluorescence immunoassay (CEFIA) and establish the pediatric reference intervals of AMH

Methods
The experiments on imprecision, sensitivity, linearity, linear range and comparison were carried out to evaluate the analytical performances. Furthermore, the concentrations of serum AMH in 238 females and 346 males aged 0-18 years were measured by the Pylon AMH assays and the reference ranges for ages group were calculated using robust methods.

Results
The repeatability and the within-laboratory imprecision CVs of the assay were 3.7% and 6.4% at at 2.25 ng/mL, and 4.6% and 6.4% at 15.49 ng/mL, respectively. The sensitivity of the assay (LoB =0.05 ng/mL, LoD= 0.1 ng/mL and LoQ= 0.3 ng/mL) was verified. The AMH Pylon assays showed good linearity within the detection range (between 0.1 and 24 ng/ml) and can report up to 480 ng/mL with 20x pre-dilution of samples. The AMH concentrations of serum samples measured by the Pylon assays correlated to those measured by the Elecsys assays. In the males under 18 years old, the AMH levels were high at birth (0-1 month: median 95.10 ng/mL) and continued to increase to a peak between 7 months to one year old (median 158.80 ng/mL) before they started to decrease with age to the lowest level between 15 and 18 years old (median 6.31 ng/mL). On the other side, the serum AMH concentrations in females were low at birth (0-1 month: median 0.20 ng/mL) and increased with age (15-18 years old: median 3.03 ng/mL). The reference intervals were provided for each gender and age groups,respectively.

Conclusions
The Pylon AMH assays showed good analytical performances, and the AMH reference intervals in chinese children determined may provide a basis for the use in clinical diagnosis and treatment of related diseases.
B-095 The level of procalcitonin is a biomarker for differentiation between pathogenic and non-pathogenic bacteria
Authors: Deebukkham S , Pamarapa A , Permsripong N 
Published: October 2024

Abstract

Background
Sepsis is caused by bacteria infected in the bloodstream and the body’s inability to control inflammation. Procalcitonin (PCT) is a biomarker of infection in patients with sepsis, the severity of the infection, and whether the patient is responding to therapy. Thus, diagnostics and early treatment are very important for doctors and patients. In a hospital concerned with sepsis in patients, a doctor ordered a PCT level and hemoculture before treating an antibiotic on a patient whose doctor suspects sepsis. The objective of this study is to compare the PCT level in the blood and hemoculture results in patients.

Methods
In this study, we evaluated the patients who suspected sepsis disease and were admitted to the Uttaradit Hospital, Thailand, between October 2022 and October 2023. The patients were divided into two groups: those with positive hemoculture results (sepsis group) and those with negative hemoculture results (non-sepsis group). The PCT levels in the blood were measured on Alinity ci analyzers and compared between the two groups to determine if there was a significant difference. Additionally, clinical data such as age and gender were collected to assess their potential impact on PCT levels and hemoculture results.

Results
The results of the study showed that the sepsis group had significantly higher PCT levels compared to the non-sepsis group. And the difference in PCT levels between the sepsis and non-sepsis groups was considerably more marked for patients older than 60. Furthermore, there was no significant difference in PCT levels based on gender in either group.

Conclusions
This finding suggests that measuring PCT levels could potentially serve as a diagnostic tool for identifying sepsis in patients. A patient age may be a contributing factor to the severity of sepsis and could potentially be used as a marker for early detection and intervention in older patients. Further research is needed to validate these results and explore the clinical implications of using PCT as a biomarker for sepsis diagnosis.
B-107 Advancing Parasitology Laboratory Quality and Processes Through Artificial Intelligence (AI) and Automation
Authors: Feres M C , Siqueira F S , Pereira C d , de Martino M C , Ramadan-Boscolo D R , de Andrade S S , Tufik S 
Published: October 2024

Abstract

Background
This research emphasizes the profound impact of intestinal parasitic infections on developing countries, particularly in regions such as sub-Saharan Africa, South and Central America, China, and East Asia. With over 1.5 billion people globally affected and 450 million facing serious illness and a mortality rate of 155,000 cases per year, the socio-economic hindrances posed by these infections necessitate innovative approaches for control and eradication. The integration of artificial intelligence (AI) and machine learning (ML) into parasitology, exemplified by the “Automated Diagnosis of Intestinal Parasites” (ADIP), from brazilian Portuguese “Diagnóstico Automatizado de Parasitas Intestinais” (DAPI) system, showcases a paradigm shift. This advanced system, combining simple and complex decision-making mechanisms, demonstrates promising results, achieving high agreement compared to TF-Test (three fecal test).

Methods
Data were extracted through reports from the laboratory information system (LIS) from January-December 2023. TF-test was replaced by ADIP system in October 2023. Data were analyzed using Microsoft Excel software, with a bibliographic survey in national and international repositories.

Results
The parasitology laboratory of AFIP implemented artificial intelligence (AI) with ADIP equipment associated with system LIS automation, automating the analysis of approximately 38,000 monthly stool samples. The ADIP classification, image analysis and subsequent algorithm allowed a reduced examination time, since approximately 90% of samples could be released automatically, optimizing the whole process. In addition, after a three-month period using only ADIP, positivity results increased from 7,63% (TF-test) to 9,53%. Our database is periodically reviewed by specialized professionals who validate positive results, ensuring the security of information obtained by artificial intelligence, bringing efficiency, safety, and quality to the laboratory processes.

Conclusions
Artificial intelligence (AI) in parasite identification and the automated results system promises a bright future. Collaboration between the scientific community and data scientists is crucial to enhance laboratory processes. Through these tools, it is possible to focus on continuous improvements, increased efficiency, and, most importantly, without sacrificing accuracy and result quality. With new technologies associated with the parasitology field, detailed records can be ensured, previously challenging to obtain, showcasing each step from result acquisition to issued report. Process improvement in parasitology brings optimizations, suggesting the potential for team reduction without compromising quality and improving the takt time.
B-113 Beckman Coulter DxI 9000 immunoassay analyzer assay performance meets new CLIA 2024 performance goals with highest proportion of Six Sigma performance amongst all major manufacturers
Authors: Westgard S 
Published: October 2024

Abstract

Background
The Clinical Laboratory Improvement Act (CLIA) proficiency testing (PT) criteria will be updated in July 2024 with some goals tightening by up to 40%. It is assumed, but not known, that all assays and instruments will be able to achieve these goals.
Using these new CLIA 2024 goals, estimates of current instrument group performance from an international proficiency testing (PT) survey have shown significant differences in quality, calling into question which assays can achieve the new CLIA goals. Currently, the highest performing diagnostic instrument achieves only 35.2% 6-Sigma, while the majority of instruments have less than 15% 6-Sigma performance indicating a higher probability of future PT failures.

Methods
Eighteen assays that will be governed by new CLIA 2024 goals were assessed for Sigma metric performance on the DxI 9000 immunoassay analyzer: Alpha Fetoprotein (AFP), Beta hCG, Carcinoembryonic antigen (CEA), Cortisol, Creatine Kinase MB (CK-MB), Estradiol, Ferritin, Folate, Follicle-Stimulating Hormone (FSH), Prolactin, Para-thyroid hormone (PTH), Total Prostate specific antigen (Total PSA), Testosterone, Thyroid Stimulating Hormone (TSH), Total Triiodothyronine (TT3),high sensitivity Troponin I, Total Thyroxine (TT4) and Vitamin B12.
Precision and bias were determined following CLSI EP5 and EP9 guidelines, measured across 3 reagent lots. CLIA 2024 PT criteria provides the allowable total error for the standard Sigma-metric calculation:
Sigma-metric = (TEa - |bias|) / SD
Performance of the other major analyzers was assessed using the methodology introduced in 2006 by Westgard JO and Westgard SA.
The Sigma-metric predicts future problems with PT and potential optimization of QC procedure opportunities, including fewer Westgard Rules, control levels, even reduced QC frequency and materials leading to less cost and time saved.

Results
Half (50%) of the assays on DxI 9000 achieves 6-Sigma, outperforming all other major manufacturers in the market who range from only 5% to 35% 6-Sigma. Further, over 78% of the DxI 9000 performance was 4Sigma and higher. Less than 8% of performance fell below 3-Sigma, which was observed at the extreme ends of the reportable range.

Conclusions
The DxI 9000 assay performance is well designed to meet CLIA 2024’s new PT criteria and has the highest prevalence of 6-sigma assay performance observed on market when compared to the top 5 major instrument manufacturers. Assays with Sigma metrics at 4-Sigma and higher are unlikely to face analytical PT difficulties and can be optimized for reduced Westgard Rules, control levels, and potentially even QC frequency.
B-132 Within limits - is my thyroid just plump, or are these reference intervals telling me something?
Authors: Bransfield A , Costelloe S J , Green A D 
Published: October 2024

Abstract

Background
Replacing immunoassay equipment brings challenges in the implementation of reference intervals (RIs). In 2023, Cork University Hospital (CUH) replaced Abbott Architect immunoassay analysers with Beckman Coulter DxI 9000 units. The manufacturer’s recommended reference intervals were applied as the DxI 9000 is new to the market. CUH reports ≈100,000 immunoassay results per month.

Methods
A minimum of 45 adult patient samples were run on the Abbott and Beckman Coulter platforms for each of sixteen analytes as part of method verification following the requirements of ISO 15189 and CLSI. The slope and intercept of the Passing-Bablok regression analyses were used to transform the Abbott RI and the newly modelled RIs compared to those provided by Beckman Coulter.

Results
Conclusions:
While the manufacturer’s RI was adopted initially, the modelled data have shown that for three analytes (PTH, HCG, Free T4) the modelled RI differs significantly from the manufacturer’s. This was judged by how patients would theoretically be classified. For these assays it is necessary to closely monitor patients in the initial three months post-go-live to ensure that the RIs are clinically acceptable. A comprehensive dialogue was undertaken with clinicians before and after the implementation to ensure they were aware of the changes. All modelling was performed on adult patient data. However, CUH has a large paediatric patient cohort, and for this group, the same RI transformations were performed, and discussions were held with paediatric teams. Introducing new platforms and RIs requires careful planning, education and an open dialogue with clinicians to ensure no compromise to patient care. RIs should be reviewed frequently for appropriateness.
B-138 A Harmonization Program Leading to Improved Accuracy and Precision of Hemoglobin A1c (HbA1c) Testing: A Six-Year Multi-Site, Multi-Instrument Review and Comparison
Authors: Meyers W , Amukele T , McCloskey T W , Phalen L E , Swenson C 
Published: October 2024

Abstract

Background
Across four global laboratory locations in North America, Europe, and Asia a quality control system was implemented in the measurement of Hemoglobin A1c (HbA1c). The intent was to improve accuracy and reduce imprecision, both being independent contributors to total analytical performance.

Methods
Quality control (QC) data, created during routine clinical operations, was used for this analysis. Analysis of QC data evaluated bias and precision separately and provided the ability to predict and monitor performance. The in-process harmonization program indicated a change in instrumentation was needed to meet and maintain a more stringent analytical error profile. The instrumentation change allowed for a before and after comparison across platforms.

Results
Use of a harmonized quality control system allowed for the visualization of the role bias and precision play in measurements. Improved performance was confirmed using native matrix samples tested routinely from participation in the National Glycohemoglobin Standardization Program. Independently assessing bias and precision highlighted the cumulative and offsetting effects that challenge quality assessment and risk mitigation. Bias appeared to have both a transient and systematic nature. The transient bias contributed to the overall normal distributive property of the quality data. In contrast, the systematic accumulation of bias appeared to occur slowly, over multiple reagent and calibration cycles. The accumulation of bias occurred in the direction of the assay drift. While precision commonly consumes the largest amount of analytical error within an instrument, the dual (negative and positive) nature of bias similarly affects the harmonization of an instrument group.

Conclusions
Changing the way data is viewed to include assessments of bias improved performance and aided in the identification of opportunities to reduce analytical variances that results in inter- and intra-individual variation. Harmonization of instruments should include methods to assess and describe bias, independent of precision.
B-139 Ai-all inclusive, artificial intelligence cannot outsmart the clinical chemist
Authors: Ibrahim R , Chokkalla A K , Kumar S , Devaraj S 
Published: October 2024

Abstract

Background
The rise of Artificial intelligence (AI) tools and their ability to generate human-like answers in a conversational context has sparked massive interest in people with calls for their application in different areas like healthcare. We evaluated the utility of artificial intelligence-powered language models (Google Bard, ChatGPT 3.5 and GPT-4) compared to trainees and clinical chemists in responding to common laboratory questions in the broad area of Clinical Chemistry.

Methods
35 questions from clinical consultations, real-life case scenarios, and clinical chemistry questions were used to evaluate these AI tools alongside clinical chemistry trainees and clinical chemistry faculties. Responses were scored by a blind participant and scores assigned as either being correct, partially correct, or incorrect. Additionally, responses were ranked based on categories and years of experience.

Results
Of the 35 questions asked, all human participants performed better than the AI tools. The Senior Chemistry Faculty demonstrated superior accuracy with 100% of correct responses compared to 71.4, 82.9% and 90.5% of correct responses from the residents, fellows and junior chemistry faculty. Both Google Bard and ChatGPT 3.5 generated 60% correct responses while GPT-4 generated 71.4% correct responses respectively. Of the sub-categories examined, both Google Bard and GPT-4 did not achieve 100% accuracy in any subcategory while ChatGPT 3.5 achieved 100% accuracy in endocrinology. GPT-4 outperformed both Google Bard and ChatGPT 3.5 but performed poorly to human participants when both partially correct and incorrect indices were considered.

Conclusions
We evaluated the performance of the popular AI-tools in answering clinical chemistry questions compared to responses given by individuals specially trained in the field of laboratory medicine. Despite advances in AI-powered language models, they cannot replace a trained pathologist in answering clinical chemistry questions. Caution should be observed by people, especially those not trained in clinical chemistry, to interpret test results using these tools.
B-143 Using Big Data Analytics to Measure the Multi-year Consistency of Sigma Metrics for Vitros Oncology Assays
Authors: Miller J 
Published: October 2024

Abstract

Background
Sigma metrics assess lab quality by incorporating precision, accuracy and total error allowed (TEa). Sigma metrics report quality on a 0-6 scale, with 6 representing World-Class quality. Due to logistical constraints, Sigma metrics are often calculated with limitations such as a small number of analyzers, single reagent lot or short duration. QuidelOrtho developed a novel approach using big data analytics for the objective, automated calculation of Sigma metrics across thousands of Vitros analyzers running in real lab conditions. This approach was previously used to report the Sigma metric performance for 115 assays using data from 2022. Of particular interest is the consistency of quality levels for Vitros oncology assays assessed in the study. The aim of this analysis was to examine Sigma metrics for Vitros oncology assays and compare Sigma metrics to data from 2022.

Methods
The methods follow the previous approach using the same Python algorithm to extract worldwide QC data from Jan. to Nov. 2023 (inclusive). A QC fluid lot from the study period was selected for each analyte to align with the fluid level reported in the 2022 study, which was based on medical relevance. Metrics were calculated for each set of QC data that originated from a single analyzer, reagent lot and calibration curve; the median Sigma metric is reported in the Results. Proficiency testing limits were utilized as TEa limits where available, with preference to CLIA 2024 limits.

Results
The following assays reported Sigma metrics as &gt;6 using both 2022 and 2023 data: alpha-fetoprotein, cancer antigen 125, carcinoembryonic antigen, prostate-specific antigen (PSA), free PSA, IgA, and IgG. Assays with higher metrics using 2023 data: cancer antigen 19-9 (5.0 vs &gt;6) and IgM (5.3 vs &gt;6). Assays with lower metrics using 2023 data: cancer antigen 15-3 (4.8 vs 4.4).

Conclusions
Vitros oncology assays report similar performance for 2022 and 2023. All Vitros oncology assays assessed report Sigma metrics of 4 or greater, indicating they achieve results within the corresponding allowable error.
B-158 Association between multiple heavy metals exposure and blood lipid levels: evidence from a cross-sectional study of Korean adults
Authors: Park H , Choi K , Kim H , Kim C , Lee M , Lee K 
Published: October 2024

Abstract

Background
Metals are ubiquitous in our environment and enter human body via various pathways, such as air, soil, food, water, etc. Increasing studies have found that metals are important risk factors in developing dyslipidemia. However, there is no consensus regarding the effects of co-exposure to multiple metals on blood lipid levels. We investigated both the joint and individual effects of this metal mixture exposure on human blood lipid levels.

Methods
Blood concentrations of four human toxic metals (Pb, Cs, Hg, and Cd) in 2,798 general populations from Korea were simultaneously determined as a measure of exposure. Weighted quantile sum (WQS) regression and Bayesian kernel machine regression (BKMR) were used to estimate associations of four blood metals and metals mixture with lipid profiles, including total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C).

Results
The mean age of the overall study population was 41.2 ± 9.85 years, and 66.9% were men. The prevalence of overweight or obesity, diabetes, and hypertension in the population was 62.5, 6.8, and 13.9%, respectively. In the multivariable linear regression model, the blood Cs was positively associated with TC and LDL-C(p &lt; 0.05, all), and the blood Pb was positively associated with serum TG (p &lt; 0.05, all). Also, the blood Cd was positively associated with serum HDL-C (p &lt; 0.05, all). We did not identify any other obvious interaction between metals on the lipid profiles using a bivariate exposure-response function in BKMR.

Conclusions
Our finding suggests that combined exposure to this metal mixture may affect human blood lipid levels. Therefore, reducing exposure to heavy metals, such as Cs and Pb, should be a priority for the general population. However, future studies with a larger number of heavy metals are still needed to focus on the detrimental effects of single metals on lipid profiles as well as to identify key components.