bluuebunny/crossref_metadata_2025_split huggingface dataset:
B-020 Study of Method Intercomparison between Atellica Solution® and CI® Analyzers for T4L, β-HCG Total, and PSA Total
Authors: Ruiz-Alvarez M , Lapeña-Garcia S , Garcia-Valdecasas S , Costales-Lucia T , De La Rubia-Maestu J , Barrionuevo-Gonzalez M 
Published: October 2024

Abstract

Background
Method intercomparison is an essential requirement in Clinical Laboratories before changing a method or instrument to verify the interchangeability of results. After validating a new Siemens device, the CI®, we conducted an intercomparison study with the Atellica Solution® for T4 free (T4L), β-HCG total, and PSA total assays.

Objectives
To check the interchangeability of results between the methods of T4L, β-HCG total, and PSA total, as determined on the Atellica Solution® and CI® analyzers, to evaluate the behavior of both equipment in our laboratory as a single virtual team.

Methods
A total of 120 serum samples from patients with T4L values between 0.41 and 7.5 ng/dL, β-HCG total between 0.5 and 1000 mIU/mL, and PSA total between 0.01 and 78.4 ng/mL were processed on both analyzers. Passing-Bablok regression, Bland-Altman analysis, and Pearson correlation coefficient were used to evaluate the sample size. Results are expressed with a 95% confidence interval. The intercomparison study was conducted using Method Validator Version 1.19.

Results
See table

Conclusions
After evaluating the results, we conclude that the Atellica Solution® and CI® analyzers behave as a single virtual team for the T4L, β-HCG total, and PSA total assays. Although there are systematic errors, they do not exceed the quality specifications established in our laboratory, based on the Total Error allowable according to Biological Variability.
B-028 Result Precision on the New cobas pro integrated solutions cobas ISE neo and cobas c 703 Analytical Units Under Routine-Like Conditions Across Two Sites in Europe
Authors: Thorenz A , Findeisen P , Brandt I , Winnock F , Furrer J 
Published: October 2024

Abstract

Background
The precision of the new cobas® pro integrated solutions cobas® ISE neo and cobas c 703 analytical units (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) was measured under intended use conditions in a routine simulation setting.

Methods
The interaction of hardware, software, assays, and samples was tested at two sites (Aalst, Belgium and Heidelberg, Germany) between October and December 2023. Reproducibility under various stressed routine-like conditions, including provocations, was tested using routine simulation imprecision experiments. To test the interaction of new and existing analytical units under routine conditions, test configurations including commercially available cobas c 503 and cobas e 801 analytical units were used. The first configuration comprised one cobas ISE neo analytical unit, two cobas c 703 analytical units, and one cobas e 801 analytical unit. The second configuration comprised one cobas ISE neo analytical unit, one cobas c 703 analytical unit, one cobas c 503 analytical unit, and one cobas e 801 analytical unit. The precision of batch type measurements was compared with the precision under routine simulated random access conditions. Random access coefficients of variance (CVs) that exceeded 1.5× reference batch CVs, or single measurements deviating by &gt;10% from the batch mean, triggered in-depth analysis of the system components that contributed to the result.

Results
Overall, 56 applications were measured during the reference and random parts of seven routine simulation imprecision runs: six ion selective electrodes (ISE; three serum, three urine), 35 clinical chemistry applications on cobas c 703 (27 serum, eight urine), seven clinical chemistry applications on cobas c 503 (five serum, one urine, one whole blood) and eight immunochemistry (serum) applications. Of six ISE (serum and urine) applications, the mean reference and random CVs were 0.8% and 0.9%, respectively. Of 42 clinical chemistry (serum, urine, and whole blood) applications, the mean reference CV was 0.9% and the mean random CV was 1.0%. Of eight immunochemistry (serum only) applications, mean reference and random CVs were 1.1% and 1.4%, respectively.

Conclusions
The findings from this study demonstrate that the new cobas ISE neo and cobas c 703 analytical units show consistent results over a prolonged time period, with most CVs in this setting below 0.9%. These results also show the successful integration of the new analytical units into the cobas pro integrated solutions, with seamless interaction of existing and analytical units under stressed conditions.
B-047 A Rapid Host-Response Test Supports Antimicrobial Stewardship at a Micro-Hospital Emergency Department
Authors: DuChateau B , Murphy S , Tarr C , Gottlieb T , Spies S 
Published: October 2024

Abstract

Background
The management of patients with suspected infections requires identification of the infectious etiology to determine appropriate use of antibiotics. However, differentiating viral from bacterial infection (and co-infection) is often challenging as clinical presentations can be similar and existing diagnostics sometimes fail to identify a clinically relevant pathogen. A host-response test (MeMed BV®, MMBV) that relies on computational integration of three proteins (TRAIL, IP-10 and CRP) measured from blood or serum has demonstrated high diagnostic performance for differentiating bacterial from viral infections, with a negative predictive value &gt;95% across multiple studies. This report evaluates real-world use of MMBV at a micro-hospital Emergency Department (ED) and associated antibiotic prescribing.

Methods
The study is a retrospective analysis of real-world data collected between January and June 2023. MMBV was ordered by providers at a micro-hospital ED in Tucson, AZ at provider discretion as part of routine care. Prescription among cases with MMBV score &lt;35 was analyzed. This cutoff is indicated by the manufacturer to indicate a viral or other non-bacterial etiology. If an antibiotic was prescribed, the authors conducted a chart review to adjudicate whether the prescription was warranted.

Results
Data was evaluated between January and June 2023; 116 MMBV tests were ordered by six providers. Most tests (81.9% (95%CI: ±7.0%)) had an MMBV score &lt;35 (mean score 11.3 with standard deviation 10.8). Among these, 92.6% (95%CI: ±5.3%) of cases with viral results were not prescribed antibiotics. MMBV use increased throughout the study period from 12 tests in the first month to 25 in the last month (r = 0.88; p&lt;0.001). There were seven cases where providers chose to prescribe despite a viral MMBV result. Upon chart review, 2/7 were unwarranted prescriptions.

Conclusions
In the emergency settings, integrating MMBV can effectively guide clinical decision-making, potentially reducing unnecessary antibiotic use. Further research in diverse healthcare settings is needed to validate these findings.
B-057 Evaluating the Use of Unconcentrated Urine for Protein Electrophoresis and Immunofixation: An Alternative Approach for Efficient Analysis
Authors: Rao L V , Wagner J D , Kabawat S E 
Published: October 2024

Abstract

Background
Protein electrophoresis is a widely employed technique for separating and analyzing proteins based on their charge and size. Traditionally, concentrated urine samples have been utilized to enhance protein detection sensitivity. However, this study explores the feasibility of using unconcentrated urine as an alternative sample type for protein electrophoresis (UEL) and immunofixation (UIF) to streamline the analysis process and reduce costs and turnaround time in clinical laboratories. It offers a more efficient and resource-friendly alternative.

Methods
Both UEL and UIF were performed on routinely ordered 80 urine specimens (random or 24 Hr.) for patient management and performed by both concentrated (X40) by Helena and unconcentrated using Sebia (HYDRAGEL 9IF gels using HYDRAGEL BJ dynamic mask procedure. The electrophoretic patterns obtained from unconcentrated urine were compared with those from concentrated urine. Various electrophoretic parameters, including resolution, sensitivity, and reproducibility, were evaluated to determine the reliability of unconcentrated urine in protein electrophoresis. In addition, retrospective analysis was performed before and after implementation on all urine specimens ordered to analyze if there were any differences in the monoclonal band distributions in the population.

Results
All the protein concentrations were correlated well with 95-100% agreement between the methods (Figure 1) clear separation of protein fractions. Serial dilution studies of monoclonal band analyses showed that these bands can be detected at 1.25 mg/dL using an unconcentrated method. Retrospective analysis of patient data before and after the implementation of the new method shows no differences in the identification of monoclonal proteins (Helena [69 of 872 total patients tested (8.0%)] vs. Sebia [90/800 (11.0%)].

Conclusions
These results indicate that unconcentrated urine can be successfully utilized for UEL and UIF with comparable outcomes to traditional concentrated samples. Utilizing unconcentrated urine simplifies the sample preparation process and presents a promising alternative.
B-059 Development and Validation of Multiplex Quantitative Allergy Tests based on Automated Flow Fluorescence Immunoassay Analyzer
Authors: Xue F 
Published: October 2024

Abstract

Background
Serological allergy tests measuring allergen-specific IgE (sIgE) are simpler and safer than skin prick tests, and the results are not influenced by skin condition or human factors. Quantitative detection of sIgE can also aid in evaluating patient allergies and aiding subsequent treatment. Dymind has researched and developed novel quantitative allergy tests based on the automated flow fluorescence immunoassay analyzer system (MF1280), enabling quantitative detection of multiple sIgE in just one test with one sample. Here, we present the performance of tIgE and two specific IgE test kits using the Dymind MF1280 system.

Methods
This study evaluated the performance of total IgE (tIgE) and two allergen-specific IgE (sIgE) panels of inhalant and food allergens, inhalant allergen panel including d1 (Dermatophagoides pteronyssinus), d2 (Dermatophagoides farina), i6 (Cockroach), e1 (Cat epithelium), e5 (Dog epithelium), w1(Common ragweed), and food allergen panel including f1 (Egg white), f2 (Cow’s milk), f3 (cod), f23 (Crab), 24 (Shrimp), and f27 (beef). Evaluation criteria included precision, linearity, limit of detection (LOD) and method comparison. As clinical performance of 425 clinical samples collected from 2 hospital laboratory in China was evaluated by both of Dymind allergen IgE MF1280 system and Phadia ImmunoCAP.

Results
The validated linearity of total IgE and sIgE were 2.0-5000.0 IU/mL and 0.1-100.0 IU/mL respectively. The LOD of total IgE and sIgE determined to be 2 IU/mL and 0.1 IU/mL respectively. The precision was evaluated by assaying a low and a high samples of every sIgE assay and the result of d1, d2, i6, e1, e5, w1, f1, f2, f3, f23, f24, f27 were 3.73% / 1.34% (low sample / high sample), 3.26% / 1.95%, 2.18% / 0.87%, 1.31% / 1.40%, 3.63% / 1.13%, 2.84% / 4.76%, 4.50% / 1.53%, 5.97% / 1.64%, 3.46% / 1.11%, 1.58% / 1.73%, 3.77% / 1.28%, 1.78% / 0.96% respectively. The total mean coefficient of measurements was below 7% to ensure high precision in multiplex quantitative analysis. Method comparison of 425 clinical samples between Phadia ImmunoCAP and Dymind allergen IgE showed total concordance rate was over 85% except f2 (over 80%).

Conclusions
The Dymind Allergen-specific IgE test kits on the automated flow fluorescence immunoassay analyzer system provide fast and accurate in vitro diagnostic detection of tIgE and sIgE for aiding diagnostics specific allergens sensitization and treatment for allergy patients, with good precision and excellent agreement compared to ImmunoCAP. The MF1280 system has advantages including random access, fully automated, multiplex quantitative detection of allergen sIgE with reducing assay time, sample consumption and lower costs.
B-133 Uric acid: A description of the values found in adult patients treated during 2022 in a High Complexity Hospital
Authors: Corominas A I , Casal G , Vommaro F , Balconi S , Damiano A 
Published: October 2024

Abstract

Background
An association between uric acid and kidney disease, glucose intolerance, high blood pressure, metabolic syndrome and cardiovascular disease has been recognized. It is the obligation of the Clinical Laboratory to have valid reference intervals (RI) for this marker. Each particular population has genetics and a diet that represents it, which cannot be extrapolated in many cases. The difficulty and high cost of using direct methods for its establishment drive us to use the existing data in our electronic archive retrospectively. Objective: to describe the range of uric acid values in adult outpatients treated at the Posadas Hospital during the year 2022. Evaluate the influence of gender and age range on the observed values.

Methods
A retrospective observational approach was carried out from the System database Laboratory Informatics (SIL), Roche Infinity, from the year 2022. The data corresponding to all adult outpatient patients treated in the service were processed. Analytical System: Roche Cobas 6000, Uricase-Oxidase method. Exclusion criteria: oncology patients, kidney patients, diabetics, hyperglycemic patients, obstetric patients, hormonal patients, treated in wards and referred patients. Outliers excluded by Tukey method. The statistical treatment was carried out with the SPSS 17.0 program.

Results
We worked with 91922 data groups. Hence 12331 of uric acid. After meeting the exclusion criteria: 3899, of which 2289 (3.96 ± 1.05 mg/dl) correspond to women &lt; 50 years , 747 (4.36 ± 1.15 mg/dl at ≥ 50 years and 863 (5.59 ± 1.33 mg/dl) men, all with normal distributions. Applying ANOVA and Student's test it was possible to verify in addition to the described significant difference between sexes, a difference between the 2 age groups of women (p&lt;0.01) which is not equal to that of men in women ≥ 50 years of age.

Conclusions
A more extensive study is necessary to define own reference ranges that enable the early alarm guidelines, especially in the group of women &lt; 50 years of age. This will allow an adequate evaluation of risk and evolution of patients. The application of Indirect Methods will make it possible to exclude values corresponding to underlying pathologies not registered in the SIL.
B-142 Using Big Data Analytics to Measure the Multi-year Consistency of Sigma metrics for Vitros Cardiac 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(R) 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 cardiac assays assessed in the study.

Methods
The methods follow the previous approach using the same Python algorithm to extract 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: apolipoprotein A1, apolipoprotein B, CK-MB, dLDL, LDH, myoglobin, NT-proBNP, and triglycerides. Assays with higher metrics using 2023 data: CK (5.2 vs 5.5), dHDL (5.8 vs &gt;6), hsTnI (4.1 vs 4.3), and NT-proBNP2 (4.2 vs &gt;6). Assays with lower metrics using 2023 data: cholesterol (5.8 vs. 5.3) and homocysteine (&gt;6 vs 5.9). CKMB2 (&gt;6) is a newer assay that did not have metrics reported in 2022. Vitros cardiac assays report metrics within 0.5 Sigma of the 2022 metrics. An exception is NT-proBNP2, which changed from 4.2 to &gt;6. However, the 2023 analysis has almost double the number of Vitros analyzers (51 vs 90), representing new use of NT-proBNP2.

Conclusions
Vitros cardiac assays report consistent metrics when using 2023 data compared to 2022. All Vitros cardiac assays assessed report Sigma metrics of 4 or greater, indicating they achieve results within the corresponding allowable error.
B-144 Sigma Metrics for Vitros Reproductive Endocrinology Assays Across Multiple Fluid Levels
Authors: Miller J 
Published: October 2024

Abstract

Background
Sigma metrics assess laboratory quality by incorporating precision, accuracy and total error allowed (TEa). Sigma metrics report quality on a scale of 0 to 6, with 6 representing the World-Class quality. QuidelOrtho developed a novel approach using big data analytics for the objective and automated calculation of Sigma metrics across thousands of Vitros® Analyzers running in real laboratory conditions. This approach was previously used to report the Sigma metric performance for 115 assays using data from 2022. A limitation of that study is the metrics were reported for a single fluid that was selected for medical relevance. However, reproductive endocrinology assays have complex medical utilization and there is a benefit to understanding Sigma metrics at multiple levels. The aim of this poster is to provide additional data on the Sigma metrics for reproductive endocrinology assays.

Methods
The methods follow the previous approach using the same Python algorithm to extract QC data from Jan. to Aug. 2022 (inclusive). Up to seven QC fluid lots were selected for each analyte. 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
Sigma metrics are reported for multiple fluids for the following assays: estradiol, follicular stimulating hormone, luteinizing hormone, progesterone, prolactin, testosterone, human chorionic gonadotropin, and thyroid stimulating hormone. All fluids examined report Sigma metrics greater than 4, which is considered “Good” performance. An exception is luteinizing hormone which has Sigma metrics = 1.9 at the lowest reported concentration.

Conclusions
Vitros reproductive endocrinology assays report strong Sigma metrics across multiple concentrations, indicating they are highly capable of achieving results within the allowable error.
B-148 Bacer: decentralized isotope dilution method with lab blinding for blood alcohol content
Authors: Nie M , Li X , Xiong W , Zou X , Zheng B 
Published: October 2024

Abstract

Background
In legal medicine, the determination Blood Alcohol Content (BAC) usually faced the problems of insufficient sample size, ethanol degradation and impossible double check. In addition, the integrity of laboratory may also be questioned. To this end, we developed a decentralized solution based on isotope dilution method.

Methods
Patented deuterated ethanol vacuum tube was used in field as regular type, weight of blood was record to BACer terminal. Arbitrary amount of sample(ca.0.1-1.0g) was pipetted to GC sample vial and sealed tightly, then heated more than 2min at 70°C, 10µL headspace sample was injected into GC-MS. Blinded lab uploaded peak area ratio of ethanol/deuterated ethanol(mz31/33) to BACer to calculate the final BAC.

Results
Regression between peak area ratios of ethanol/deuterated ethanol showed good linearity in the range of 0.10-5.0 (R2&gt;0.999). Regression equation of different instruments were proved good consistency with slopes ranged from 1.03 to 1.07, and the LOD and LOQ were around 0.01mg/g and 0.05mg/g, 3-level recoveries between 97%-101% with RSD less than 1%. During the 6-month stability test at 4°C and normal temperature, the blood sample test results maintained good stability. The proposed method was applied to 2021 CNAS proficiency testing (2021SF-CNAS002) organized by China Academy of Forensic Sciences with satisfactory results. The comparison with Chinese standard method SF/Z JD0107001-2010 yielded good agreement with Passing&Bablok test (P&gt;0.10). The expanded uncertainty estimated by Monte-carlo method was less than 3%.

Conclusions
This proposed method showed the possibility of decentralized determination of BAC with lab blinding, the separation of on-site sampling data and laboratory testing also provided the possibility of integrity of results. It also provided a possible solution for the scenarios where the storage condition of blood collection is poor, or the cross check is required. But good chromatographic separation and operation are compulsive due to the possibility of interference in IDMS.