bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-014 Analytical Outlier Occurrence and False Positivity Rate of the Beckman Coulter Access High-sensitivity Cardiac Troponin I Assay
Authors: Noguez J H , Delfin Mendez L , Kulp K , Zhang X , Stempak L 
Published: September 2023

Abstract

Background
Cardiac troponin (cTn) is the preferred biomarker for the diagnosis of acute myocardial infarction due to its high sensitivity and specificity relative to other available cardiac markers. Accurate measurement is therefore paramount to proper risk stratification of patients. Analytical outliers and false positive results have been previously reported on various platforms though the exact cause remains unknown. These false positive test results may pose a risk for the misclassification of patients and lead to adverse clinical outcomes. We evaluated the performance of the Beckman Coulter Access high-sensitivity cTn I method by measuring the occurrence of analytical outliers between duplicate results and the false positivity rate (i.e., fliers).

Methods
We tested 2535 samples from 1879 patients in duplicate on the Beckman Coulter Access hs-cTn I assay. These specimens had initial troponin measurements above the gender-specific 99th percentile of the upper reference limit (URL) cutoff and were immediately aliquoted, re-centrifuged, and re-tested. Non-reproducible results (outliers) were defined as having a concentration difference between the replicates exceeding 10%. Critical outliers were defined as duplicate results with concentrations that differed by greater than 10% from the initial result and the second result was classified in a lower risk stratification category than the original result.

Results
Approximately 12% (305) of the positive samples tested in duplicate had a percent difference that was &gt;10% and therefore did not meet the recommended precision requirements of the assay. Of these specimens, 33 (10.8%) were classified as critical outliers because the repeat test result crossed a critical decision limit threshold. For sixteen samples the risk classification for the patient was downgraded from high (&gt;50 ng/L) to moderate risk (13–50 ng/L (F); 20–50 ng/L (M)). Seventeen false positive results were identified in which the patients were downgraded from the high to low risk category (&lt;13 ng/L (F); &lt;20 ng/L (M)). Nearly 85% of the samples identified as outliers were lithium heparinized plasma.

Conclusion
We evaluated the reproducibility of the Beckman Coulter Access hs-cTn I method across 11 hospitals in an integrated healthcare network to characterize the occurrence of analytical outliers and false positive results. Our data indicated an outlier rate of 12% (305/2535) for positive hs-cTn I results; however, the risk category only changed for 1.3% (33/2535) of positive troponin results upon repeat analysis. Overall the false positivity rate was determined to be &lt;0.1% (n = 55 560).
A-040 Night Shift Work Could Induce Oxidatively Generated Damage to DNA: A Pilot Study
Authors: Zou Y , Ma X , Yu S , Qiu L 
Published: September 2023

Abstract

Background
Currently, specific effects of different night shift modes on human oxidative stress still need to be explored in a realistic cohort study. We aimed to evaluate the effect of night shift on human nucleic acid damage status.

Methods
We recruited 16 healthy volunteers (aged, 33 ± 5 years) working the night shifts at the Department of Laboratory Medicine at Peking Union Medical College Hospital. Their matched serum and urine samples were collected at four time points: before, during (twice), and after the night shift period. The levels of 8-oxo-7,8-dihydroguanosine (8-oxoG) and 8-oxo-7,8-dihydro-2′-deoxyguanosine (8-oxodG), two important nucleic acid damage markers, were accurately determined based on a robust self-established LC-MS/MS method. The Mann–Whitney U or Kruskal-Wallis test was used for comparisons.

Results
The levels of serum 8-oxodG, estimated glomerular filtration rate corrected serum 8-oxodG, and 8-oxodG in serum to urine ratio significantly increased during the night shift period. These levels were significantly higher than at baseline even after 1 month of discontinuing; but no such significant change was found for 8-oxoG. Moreover, 8-oxoG and 8-oxodG levels revealed a significantly positive association with many routine biomarkers such as total bilirubin and urea levels, and significantly negative association with serum lipids such as total cholesterol levels.

Conclusion
The results of our cohort study suggested that working the night shifts may increase the oxidatively generated damage to DNA even after a month of discontinuing night shift work. Further studies with large-scale cohorts, different night shift modes, and longer follow-up times are needed to clarify the short- and long-term effect of night shifts on DNA damage, and find effective solutions to combat the negative effects.
A-047 Role of the Gut Microbiota in the Efficacy of Dietary Intervention With Flavonoid-Containing Foods in Obesity
Authors: Alqudah S , DeLucia B , Osborn L , Markley R , Bobba V , Hamidi Nia L , Claesen J 
Published: September 2023

Abstract

Background
Flavonoids are an active component of plant-based diets that have been investigated for their beneficial antioxidant properties in high fat diet induced obesity animal models and human intervention trials. Certain bacterial members of the gut microbiota have been reported that transform flavonoids into monophenolic acids. Our goal is to characterize the microbiome link between a flavonoid-rich diet and improved metabolic parameters characteristic of obesity. We hypothesize that flavonoid supplemented diets are most effective in presence of microbiota capable of monophenolic acids formation, and that these bacterial metabolites are a main bioactive compound responsible for the improved metabolic parameters.

Methods
To test our hypothesis, males and females C57BL/6 mice were fed a high fat control diet, or the same diet supplemented with 1% berry extract, or 1% monophenolic acid for 12 weeks. Separate experimental groups received either regular drinking water or antibiotic water to suppress their gut microbial community. We monitored metabolic parameters, including body weight, lean and fat mass, glucose and insulin tolerance, histological assessment of liver cell, quantification of liver injury biomarkers, and transcriptional changes in metabolically active peripheral tissues.

Results
For insulin tolerance test, mice on high fat diet with regular water, or antibiotic water control mice had a comparable increase in insulin resistance, demonstrated by the increase in glucose levels after injecting insulin. Similarly, the groups of mice on high fat diet with 1% monophenolic acid and regular water, or antibiotic water, had improved insulin sensitivity, presented as a decrease in glucose levels after insulin injection. Consistent with our hypothesis, mice on high fat diet supplemented with 1% berry extract had an improved insulin sensitivity, and this effect was dependent on an intact microbiome. This suggests that the gut microbiota are required to metabolize the berry extract to produce bioactive metabolites that improve insulin tolerance. We also observed a significant decrease in fasting blood glucose, an improvement in the expression for genes involved in lipid and glucose metabolism, and a noticeable reduction in hepatic steatosis in both 1% monophenolic acid and 1% berry extract with high fat diet group, compared to the high fat diet control group.

Conclusion
By feeding the mice a flavonoid rich diet, with the presence of an intact gut microbiota, we can improve the metabolic parameters associated with metabolic diseases. Our work will open the door for new benign approaches for treatment, such as dietary flavonoid supplementation with concomitant gut microbial probiotic therapy.
A-059 Evaluation of Free Thyroxin Levels in Patients with Low Thyroxin Binding Globulin Concentrations: Is There Interference in the FT4 Indirect Method?
Authors: Pinheiro M F , Lopes A C , Souza T S , Fontes R , Schrank Y , Perozo A F , Gomes D M , Araujo P B 
Published: September 2023

Abstract

Background
Thyroxine-binding globulin (TBG) is the major carrier of thyroid hormones in serum. Variations in the serum concentration of TBG determine proportional variations in the total serum concentrations of T4 and T3, without implying changes in function, as long as the free fraction remains normal. Several common clinical conditions lead to significant alterations in TBG levels, the most important factor behind low levels being genetic defects. As TBG is encoded by a gene located on the X chromosome, the defects are more easily manifested in males. Differences in FT4 concentrations were observed in sera from subjects with TBG abnormalities, when FT4 are measured by different immunoassays, specially at extremes of TBG concentrations. The objective of this study was to evaluate FT4 levels by indirect method in patients with low TBG concentrations.

Methods
We analyzed blood samples requesting serum TBG, TSH and FT4 levels from patients admitted to a private reference clinical laboratory in Brazil, from January 01, 2017 to December 31, 2022. Anonymized data on laboratory tests was available from a database of the local Laboratory Information System. All the patients included had TSH within the reference range, 0.4–4.3 mUI/mL (ECLIA, Modular, Roche). FT4 was measured by ECLIA (0.7–1.8 ng/dL) and TBG by ICMA, Immulite, Siemens, 13–39 mcg/mL.

Results
357 patients with low TBG levels were evaluated, 220 (62%) men, 137 (38%) women; mean age 35 yrs (19 d to 88 yrs). They were divided in six groups according TBG levels (mcg/mL): &lt;3.5–17 (M 15, F2); 3.5 to 6.0 - 26 (M 20, F 6); 6.1 to 8.0 - 30 (M 25, F 5); 8.1 to 9.9 - 59 ( M 32, F 27); 10.0 to 11.9 - 139 (M 78, F 61); 12.0 to 12.9 - 86 (M 50, F 36). Three patients had FT4 levels above 1.8 (1.85; 1.87 and 1.96) ng/mL, all them male, with TBG levels &lt;3.5; 5.79 and 9.53 ng/mL, respectively.

Conclusion
FT4 Indirect methods are developed taking into account the presence, in the serum, of a thyroxine binding capacity within the normal range, a fact that does not occur in individuals with extreme TBG deficiency. In this study, we found only one slightly elevated FT4 value among 17 patients with TBG values below 3.5 mcg/mL, suggesting little interference of very low TBG levels in this indirect free T4 method.
A-086 Vitamin D and its Variation in a Pandemic Context: Pre-pandemic—Intra-pandemic—Post-pandemic Analysis in the Province of Buenos Aires - Argentina
Authors: Canala P N , Canala M D , Spiccia M , Ghioni G 
Published: September 2023

Abstract

Background
The determination of 25 OH Vitamin D3 is a frequently requested measurement for the purpose of evaluating its deficiency, which would be related to various diseases. The behavior of monthly mean values (X̅) was analyzed in 984 514 patients from Buenos Aires (Argentina) in the period from January 2014 to December 2022, in order to evaluate how seasonality influences and verify the effect of the mandatory isolation due to the SARS-CoV-2 virus pandemic in 2020.

Methodology
We used the Chemiluminescence Assay (QLIA) ADVIA Centaur Vitamin D Total Assay (Siemens) on an Advia Centaur (2014–2020) and Aliniti I 25 OH VITAMINE D3 (Abbott Diagnostics) on an Aliniti I (2020–2022), reference values are Optimal: &gt;30.0 ng/mL, Insufficiency: 20.0–30.0 ng/mL Deficiency: &lt;20.0 ng/mL.

Results

Conclusions
From the analysis of the data, a decrease in the winter months is observed, as already described, caused by less exposure to sunlight. In 2020, it was also observed that due to confinement, there was a slight increase in mean values (26.40 ng/mL (P &lt; .001)), which was the highest of the years analyzed. One hypothesis is that this could be caused by the increased free time of the population resulting in greater exposure to sunlight. At the same time, the insufficiency of Vitamin D3 in the studied population is evident, as only in 2 out of the 108 months analyzed did it slightly exceed the optimal level of 30.0 ng/mL. We believe that it would be important to evaluate the implementation of a Vitamin D3 supplementation policy for the general population and subsequently conduct further studies of this type to verify the effectiveness of such implementation.
A-141 Evaluation of the Novel Blood Coagulation Analyzer S400CF Comparison on Basic Performance and Turnaround Time With the CP 3000
Authors: Abe Y , Uchida K , Munekata S , Kanoh Y 
Published: September 2023

Abstract

Background
Coagulation and fibrinolytic tests are widely used as screening of abnormalities on hemostatic mechanisms, and for thrombosis. Our laboratory routinely receives large number of orders for coagulation and fibrinolytic tests. The monthly average of order is 9700, and these orders are reported as emergency tests. To address the demands, fully automated blood coagulation analyzers that offer a variety of measuring principles such as coagulation time method and photometric method. We have operated three units of the automated blood coagulation CP3000 for eight years. In this eight years, the number of samples in our hospital has been increased. On the other hand, our preparation time before daily set-up has been extended because of the stricter management on quality control to comply with ISO 15189. As a result, we need to do the same procedure on three units and our turnaround time (TAT) has been extended. In November 2021, the blood coagulation analyzer S400CF that offers high throughput and performance was launched. We evaluated basic performance of S400CF and TAT and compared with the CP3000.

Methods
In the evaluation of basic performance, S400CF (Sekisui Medical) and was used. Correlation was compared with CP3000 (Sekisui Medical). In the comparison of TAT, three units of CP3000 and one unit of S400CF were used and the orders corresponding for the 243 samples that were requested by 7:45 AM–10:08 AM on July 11, 2022 were demonstrated on both analyzers.

Results
Repeatability:C.V.% 2% or less for all items. Between-day precision: C.V. 8% or less for all items. Correlations were PT-% (N = 135): Y = 1.0477 X − 6.40, PT-INR (N = 135): Y = 0.9612 X + 0.046, APTT (N = 124): Y = 1.0150 X + 0.42, Fbg (N = 112): Y = 1.0284 X + 2.4, AT (N = 52): Y = 0.9700 X, FDP (N = 49): Y = 0.9326 X + 0.06, DD (N = 80): Y = 1.0322 X + 0.279, SF (N = 50): Y = 1.0423 X − 1.73. TAT of CP3000 and S400CF were MIN 1 minutes(min.) 41 seconds(sec.), MAX 14 min. 45 sec. and MIN 1 min. 20 sec., MAX 12 min. 27 sec., respectively.

Conclusion
It was indicated that one S400CF has three times or more productivity of CP3000. Therefore, the number of blood coagulation analyzers can be reduced from the current three units. And the total time for quality related process such as calibration and control can be saved.Results were equivalent to current CP3000 or better. It indicates that the quality of our current test can be maintained. S400CF has a capability to connect laboratory automation system that saves the time for placing specimen and improves the working efficiency of laboratory technicians. We concluded S400CF can solve the problems in our current operation in blood coagulation test and can contribute to faster report of high-quality test results.
A-198 Acute Effects of a Single Moderate-intensity Exercise on Omega-3 and Omega-6 Metabolic Pathway Using Whole Blood Lipidomics
Authors: Sakane N , Suganuma A , Sakane S , Fujibayashi M 
Published: September 2023

Abstract

Background
Omega-3 fatty acid supplementation can reduce muscle soreness and maintain muscle function following eccentric exercise-induced muscle damage. However, the relationship between the dietary and biological status of omega-3 fatty acids in rugby players is unknown. This study aimed to examine the relationship between the dietary and biological status of omega-3 fatty acids in university rugby players. We investigated acute effects of a single moderate-intensity exercise on omega-3 and omega-6 metabolic pathway using whole blood lipidomics.

Methods
A cross-sectional study of university rugby players and age-matched sedentary controls was conducted. Diets including omega-3 and omega-6 fatty acids were assessed using a validated brief-type self-administered diet history questionnaire. Whole blood lipidomics analysis was performed using the dried blood spot technique before and after a single training session, namely a 2-h shuttle run, and the omega-3 index (EPA + DHA) was calculated. We categorized rugby players based on the proposed omega-3 index risk zones for cardiovascular disease as follows: high risk, &lt;4%; intermediate risk, 4%–8%; low risk, &gt;8%.

Results
The rugby group (n = 29) had a significantly higher intake of omega-3 and omega-6 fatty acids than the control group (n = 31). The blood omega-6 relative concentration did not differ between the groups; however, the rugby group had lower omega-3 fatty acid levels than the control group (4.4 ± 1.1 vs 6.2 ± 1.8%). Approximately 48% of rugby players had an omega-3 index that was considered high risk, and 52% had that considered intermediate risk. None of the patients had a low-risk omega-3 index. A single training session affected the omega-3 and omega-6 metabolic pathways.

Conclusion
Rugby football players may be deficient in omega-3 fatty acids, despite having a higher omega-3 fatty acid intake than controls. The omega-3 index and lipidomics can be used to profile and monitor rugby players. Further nutritional interventions are required to confirm these issues.
A-244 Performance Comparison of the Alinity i Hepatitis C Core Antigen Assay in Routine Laboratory Testing vs HCV RNA Testing
Authors: Gunsolus I L , Prostko J , Pearce S , Degaga B , Eickstead S , Thapa S , Radman C , Taylor R , Grieshaber J , Richard K , Hoffman A , Pekalska A 
Published: September 2023

Abstract

Background
The elimination of Hepatitis C by 2030 is a goal established by the WHO and other country specific health organizations worldwide. This goal is enabled by the availability of effective treatment regimens. A recent surprise in the US has been the increase in HCV infections during the COVID 19 pandemic, which may be caused by increased needle sharing. HCV Antibody assays have been used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to PCR which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV Core Antigen is a new immunoassay on the Alinity i system. The aim of the study was to evaluate the precision, linearity, and sensitivity of this research use assay in a US-based population.

Methods
Alinity i assay HCV Ab is an automated chemiluminescent immunoassay built to measure total antibody to the virus. Similarly, the Alinity i HCV Core Ag is a research use only automated chemiluminescent immunoassay for detection of HCV Core antigen in human plasma and serum. Precision (repeatability, and reproducibility) was determined over 3 days (4–10 replicates/day) using control material consisting of a negative human plasma control, and positive controls made with recombinant core Ag in buffer. Linearity was evaluated by preparing 4 dilutions of a remnant specimen with detectable HCV RNA viral load. Clinical sensitivity was determined using 90 remnant specimens with positive HCV Ab results. Specimens were confirmed positive for Hepatitis C via HCV RNA quantitation using the Aptima HCV Quant Dx transcription-mediated amplification (TMA) assay on the Panther System. Correlation between the HCV Ag assay and TMA was evaluated using specimens submitted for either Hepatitis C infection screening and monitoring of known infection.

Results
The repeatability of the HCV Ag assay ranged between 3.7% and 11.1% CV depending on the sample S/CO level tested. Dilution recovery averaged 98.2% (range 90.2%–107.3%) and a plot of HCV Ag concentration vs dilution factor showed a correlation coefficient R = 0.998 The Hepatitis C core antigen assay had a correlation coefficient R = 0.92 with the TMA. The HCV assay demonstrated a clinical sensitivity of 96.7% vs TMA.

Conclusion
The performance characteristics of the Alinity i HCV Core Ag assay highlight an opportunity to speed time to treatment by reflexing on the same instrument from HCV Ab to Ag and confirming effectiveness of treatment.
A-273 Multicenter Assessment of the Accuracy of MIC Results for Piperacillin/Tazobactam with MicroScan Dried Gram-Negative MIC Panels using CLSI Breakpoints
Authors: Chipman A , Omai G , Harrington A , Traczewski M , DesJarlais S , Beasley D , Diaz J , Brookman R , Hastey C , Chau J 
Published: September 2023

Abstract

Background
MIC data from MicroScan Dried Gram-negative MIC (MSDGN) Panels with piperacillin/tazobactam were evaluated with CLSI-M100-ED32 breakpoints for Acinetobacter, Enterobacterales, Other-Non-Enterobacterales, and proposed CLSI breakpoints for Pseudomonas aeruginosa from a multicenter clinical study. MIC results were compared to results obtained with CLSI frozen broth microdilution panels.

Materials/Methods
The study included a total of 683 clinical isolates tested using Prompt and turbidity during efficacy and challenge phases. MSDGN panels were evaluated at three clinical sites, comparing MIC values obtained using MSDGN panels to MICs utilizing CLSI reference panel. MSDGN panels were incubated at 35 ± 1°C and read on WalkAway System, autoSCAN-4 instrument, and read visually at 16–20 h. Frozen reference panels were prepared according to CLSI methodology, incubated for 16–20 h for Enterobacterales, Other Non-Enterobacterales, and Pseudomonas aeruginosa and for 20–24 h for Acinetobacter and read visually. CLSI breakpoints(mg/L) used for interpretation of MIC results were: ≤16/4 S, 32/4–64/4 I, ≥128/4 R for Acinetobacter and Other Non Enterobacterales, ≤8/4 S, 16/4 SDD, ≥32/4 R for Enterobacterales, and ≤16/4 S, 32/4 I, &gt;64/4 R for Pseudomonas aeruginosa.

Results
When compared to frozen reference panel results, essential and categorical agreements for all isolates tested are as follows with these recommendations: Due to elevated major error rates for S. marcescens and WalkAway reads with Prompt, results should be confirmed visually prior to reporting. Due to performance with P. rettgeri and S. liquefaciens complex, do not report drug, therapy, or MIC.

Conclusion
Piperacillin/tazobactam MIC results for gram-negative clinical isolates obtained with the MSDGN panel correlate with MICs obtained using frozen reference panels with updated CLSI interpretive criteria.