bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-005 Comparison of Performance of High Sensitive Troponin I (cTNIH) by “Point of care” (POC) and Automated cTNIH Immunoassays in Patients at Low Risk of Heart Attack in a Chilean Emergency Unit; Impact on E.R Department Efficiency
Authors: Ozaki B C , Mix A , Vivanco P 
Published: October 2024

Abstract

Background
Most cases of death from Acute Myocardial Infarction (AMI) occur in the first hours after the manifestation of clinical symptoms, constituting 40 to 65% in the first hour and approximately 80% in the first 24 hours. For the safe, effective, and rapid diagnosis of a patient with suspected AMI, international guidelines recommend that it be done based on clinical symptoms, together with electrocardiogram and analysis of biomarkers in the context of suspected of non-ST-elevation myocardial infarction (NSTEMI). Troponins are the biomarkers of choice with level A level evidence and the ability to perform screening in patients complaining of chest pain and refer it to the correct clinical approach based on the 0h/1h algorithm. To date, the successful clinical implementation of these rapid algorithms is restricted to hospitals working with well-defined workflows and a robust central laboratory structure. The Atellica® vTLi analyzer is based on the chemiluminescence methodology for the quantification of hs-cTnI levels with low sample volume, low complexity, and may enable the rapid management of patients with chest pain and application of 0h/1h algorithm.

Objectives
The aim of the study is to evaluate clinical performance in effectiveness and efficiency of the hs-cTnI Atellica® vTLi point of care test to rule out acute myocardial infarction in subjects with low-risk chest pain established with a validated predictive rule, in an adult-Chilean emergency unit, compared to clinical evaluation and the commonly used ADVIA Centaur® troponin test.

Methods
Descriptive, observational, longitudinal study. Patients over 18 years of age, consulting with acute chest pain of at least one hour from symptom onset and a HEART SCORE less than or equal to 3 points were recruited. A venous blood sample was requested for hs-cTnI analysis by Atellica® vTLi Siemens Healthineers and ADVIA Centaur® Siemens Healthineers. The time difference between sample collection and start of sample analysis; the time difference between sample collection and release of sample results was recorded and the concordance between the two results was determined.

Results
50 subjects were included in the study. The difference between blood sampling and start of sample analysis was 5 minutes with Atellica® vTLi POC and 68 minutes with ADVIA Centaur®. The concordance of hs-cTnI Atellica® vTLi POC and ADVIA Centaur® was 94% for predicting medical discharge and confirmed acute myocardial infarction.

Conclusions
The study findings support the safety and efficiency of the hs-cTnI POC test by providing faster results than central laboratory tests with the same analytical quality, with direct impact on reducing care times in patients consulting for low-risk chest pain.
A-011 Single High-Sensitivity Cardiac Troponin I Compared to High-Sensitivity Cardiac Troponin T Measurement to Rule Out Acute Myocardial Infarction at Low Risk for 30-Day Adverse Events: CONTRAST Study
Authors: Apple F S , Schulz K , Sandoval Y , Smith S , Carlson M , Kohl L , Rischall M , Gelin A , Wagner B , Gray R , Sexter A 
Published: October 2024

Abstract

Background
Cardiac troponin (cTn) is the preferred biomarker for diagnosing myocardial injury and acute myocardial infarction (MI). There are few comparative studies addressing the clinical performance of high-sensitivity (hs)-cTnI and hs-cTnT assays using fresh plasma for early rule out of myocardial infarction (MI) on presentation in patients presenting to emergency departments (ED). This study examined the performance strategies of a derived optimal concentration for a single high-sensitivity cardiac troponin I (hs-cTnI) measurement compared to a derived optimal concentration for a single high-sensitivity cardiac troponin T (hs-cTnT) measurement to rule out acute MI.

Methods
The COmparisoN of high-sensitivity cardiac TRoponin I and T ASsays Trial (CONTRAST) (NCT03214029) is a prospective, observational cohort study of consecutive adult ED patients (n = 2208) undergoing serial cTn measurements as clinically indicated. hs-cTnI (Abbott ARCHITECT) and hs-cTnT (Gen 5, Roche e601) measurements using fresh EDTA plasma were obtained. We determine optimal hs-cTn cutoffs for negative predictive value (NPV) and sensitivity for the diagnosis of acute MI (type 1 and type 2) to allow for a maximum number for early discharges with minimal risk of adverse events (acute MI or cardiac death) at 30 days.

Results
Acute MI occurred in 161 patients (7.3%), including 68 (42.2%) type 1 MI and 93 (57.7%) type 2 MI. For hs-cTnI (&lt;2 ng/L) optimal NPV and sensitivity for adverse events were 99.1% (95% confidence interval 97.7%-99.8%) and 98.2% (CI. 95.4-99.5%). 450 Patients (21%) qualified for early rule out, at a 1.8% miss rate at 30 days. For hs-cTnT (&lt;6 ng/L) optimal NPV and sensitivity for adverse events were 99.2% (CI 98.0%-99.8%) and 98.1% (CI. 95.3-99.5%). 513 Patients (24%) qualified for early rule out, at a 1.9% miss rate at 30 days.

Conclusions
In CONTRAST, a strategy using a single sample hs-cTnI or hs-cTnT alone allows for the early identification of patients unlikely to have acute MI and who are at very low risk for adverse events at 30 days. Minor differences existed between the Abbott ARCHITECT hs-cTnI assay and the Roche e601 hs-cTnT (Gen 5) assay in fresh plasma were found.
A-012 Predictive Value of Baseline Alpha Defensin Level in Patients with Stable Coronary Artery Disease: A Retrospective Single Center Study
Authors: Shapira M , Roguin A , Kobo O , Egbaria D , Amsalem N , Abu Fanne R 
Published: October 2024

Abstract

Background
Inflammation plays a central role in atherogenesis. The major neutrophilic peptide alpha-defensin is a promising evolving risk factor for atherosclerosis. The aim of the present study was to examine the role of alpha-defensin in predicting future major adverse cardiovascular events (MACE) occurrence in fully revascularized patients with stable coronary artery disease (CAD) under optimal medical therapy.

Methods
We retrospectively examined the prognostic value of baseline plasma alpha-defensin levels in predicting MACE occurrence in 174 fully revascularized patients for stable CAD. Demographic, clinical, angiographic, and laboratory data were collected from patients' electronic medical records (EMR). Alpha-defensin levels were measured in samples of EDTA plasma using ELISA kit (HyCult Biotechnology). Other Biochemical parameters were analyzed in serum using COBAS-8000 systems (Roche).

Results
Alpha-defensin levels were 20% higher among demised patients (10,859 pg/ml, IQR [6,920 to 23,320] vs. 9,020 pg/ml, IQR [5,540 to 16,180] pg/ml, P = 0.15). The absolute increase in mortality risk in patients with alpha-defensin levels greater than the median values was 72.5% (P = 0.33). Log-rank analysis proved both recurrent PCI for de novo lesions (14.9% and 2.3%) and the composite of mortality and recurrent PCI for de novo lesions (27.6% vs. 9.2%) were significantly related to alpha-defensin values greater than the median (&gt;9200 pg/ml).

Conclusions
Baseline plasma alpha-defensin is an independent predictor of mortality and recurrent PCI among patients with stable CAD. Alpha-defensin may evolve as a promising factor in cardiovascular risk assessment beyond traditional risk factors. Targeting alpha-defensin to ameliorate MACE occurrence should be addressed in future studies.
A-018 Diagnostic Performance of the Novel Beckman-Coulter NT-proBNP-assay in the Early Diagnosis of Acute Heart Failure
Authors: Hammerer-Lercher A , Maria B , Wussler D , Lopez-Ayala P , Strebel I , Kozhuharov N , Sabti Z , Shrestha S , Prepoudis A , Schäfer I , Mork C , Wildi K , du Fay de Lavallaz J , Koechlin L , Zimmermann T , Nestelberger T , Boeddinghaus J , Breithardt T , Mueller C 
Published: October 2024

Abstract

Background
The diagnostic performance of the novel Beckman Coulter N-terminal pro-B-type natriuretic peptide (NT-proBNP) assay in the early diagnosis of acute heart failure (AHF) is unknown.

Methods
This major unmet clinical need was addressed in a secondary analysis using frozen plasma samples obtained in a prospective diagnostic study, enrolling patients presenting with acute dyspnea to the emergency department (ED). Two independent cardiologists/internists centrally adjudicated the final diagnosis using all individual patient's information. NT-proBNP-Beckman Coulter plasma concentrations were measured blinded and directly compared to NT-proBNP-Elecsys concentrations. Agreement analysis was performed by Bland Altman plot. The primary endpoints were the diagnostic accuracy of both assays using the Area-under-the-Receiver-Operating-Curve and the comparison of the performance for diagnosing AHF using the validated NT-proBNP-Elecsys clinical decision values (&lt;300ng/L for rule-out, age-adjusted &gt;450/900/1800ng/L for rule-in). The secondary endpoint included the application of the recently suggested NT-proBNP-Elecsys clinical decision values for obese patients.

Results
1400 patients (46% 3women, median age 76 years, BMI 25.9m2/kg, LVEF 53%) had both NT-proBNP measurements on presentation to the ED. Of those 744 (53%) had an adjudicated diagnosis of AHF. The agreement analysis showed overall higher concentrations for the NT-proBNP-Beckman assay. The diagnostic accuracy of both assays was excellent (AUC: 0.915 vs 0.922; P = 0.006, respectively). In the clinical application less patients were ruled-out using the Beckman assay compared to the Elecsys assay (18.7% vs 26.3%) with comparable sensitivities (98.9% vs 98.5%). Regarding rule-in NT-proBNP-Elecsys had a significantly higher specificity (78.8% vs 70.9%) and positive predictive value (83.1% vs 78.7%; both P&lt;0.001; Figure 1). Similar findings were obtained in recently suggested cutoffs for obese patients.

Conclusions
In comparison to established NT-proBNP-Elecsys cutoffs, a derivation of Beckman-specific cutoffs is needed to implement NT-proBNP-Beckman Coulter clinical decision values providing a higher rule-out proportion and an optimal specificity for diagnosing AHF.
A-032 Accuracy of Immunoassay Testosterone Assays in Low Testosterone Patients
Authors: Deebajah M , Patel S , Keating M , Palmer O , Wheeler S E 
Published: October 2024

Abstract

Background
The measurement of testosterone in patients expected to have low testosterone levels can present a challenge to the clinical laboratory for turn-around-time and cost. At our institution send-out for measurement by mass spectrometry (MS) is the current standard in patients for whom we expect low testosterone levels. We aimed to investigate the utility of three immunoassay methodologies as a first line screen for testosterone levels by comparing results to mass spectrometry with an emphasis on specimens with low testosterone levels.

Methods
48 remnant plasma samples each from healthy men and women were aliquoted and stored at -80°C within 24 hours of draw (n=96 total specimens). Samples are remnants from out-patients being drawn for lipid profiles or other tests indicative of an annual wellness visit. Immunoassays were performed at the University of Pittsburgh Medical Center within the CAP accredited clinical laboratories. This study was approved by the University of Pittsburgh Institutional Review Board. The assays assessed were Access® Testosterone, Beckman Coulter (B-TST); Elecsys® Testosterone II, Roche Diagnostics (R-TST); Atellica® IM Testosterone II, Siemens Healthineers (S-TST). MS was sent to ARUP for testosterone analysis. The CDC Hormone Standardization program (HoSt) provides information of the accuracy of testosterone assays for participants. Both the S-TST and ARUP MS assays participate in this program.

Results
Results by MS ranged from 0.07 to 27.31 nmol/L. Correlation between testosterone by MS and immunoassays was strong with R2 &gt;0.95 for all methods (B-TST: R2= 0.9570, y= 0.8588x + 0.9431; R-TST: R2= 0.9797, y= 1.085x + 0.3119; S-TST: R2= 0.9556, y= 1.124x + 0.0917). Assessment of specimens with low concentrations (&lt; 3 nmol/L by MS, n=41) found that correlations were similarly poor between immunoassay methods and highest for B-TST (B-TST: R2= 0.5883, y= 1.259x + 0.3866; R-TST: R2= 0.4460, y= 0.9681x + 0.2760; S-TST: R2= 0.5449, y= 0.6352x + 0.3202). The root mean squared error (RMSE) was also calculated for the low concentration specimens and was significantly lower for S-TST than B-TST or R-TST (B-TST: 0.6708 nmol/L; R-TST: 0.6872 nmol/L; S-TST: 0.3698 nmol/L).

Conclusions
In patients where we expect low testosterone levels, MS continues to be the standard of care and immunoassays do not compare robustly at levels below 3 nmol/L. However, in cases where clinical decision making requires faster turn-around-time screening by immunoassay may be feasible. Clinical laboratories should be aware of the performance of their testosterone immunoassay methodologies at low testosterone concentrations as performance may vary between manufacturers. Manufacturer participation in the CDC HoSt program may provide additional performance information for clinical laboratories. Additional work is needed to assess performance across a larger cohort and additional immunoassay manufacturers.
A-035 Profiling of circulating-microRNAs' signatures in Pre-diabetic versus Diabetic patients
Authors: Rashid G , Abu-Toamih Atamni H , Sultan M 
Published: October 2024

Abstract

Background
MicroRNAs (miRs) are small non-coding RNAs involved in the process of gene regulation, and hence affect various diseases including metabolic pathways in diabetes. Given their key roles, they are promising candidates as potential biomarkers or better understanding of disease etiology. In this study, our aim is to identify miRs signatures of plasma circulating-miRs related to glycemic control, vitamin D deficiency and platelet activation in diabetic, pre-diabetic versus non-diabetic patients.

Methods
Plasma samples were collected from 24 patients (both sexes) in total (eight non-diabetic (ND) control, twelve diabetic (DM), and four pre-diabetic (PD)), classified based on their glycemic control (HbA1c levels). miRs were extracted using the miRNeasy Serum/Plasma Advanced kit of Qiagen, run and analyzed on Next Generation Sequencing (NGS).

Results
Differential expression analysis revealed miRs expression variations between diabetic to pre-diabetic and non-diabetic groups. Expression levels of 131 miRs varied significantly between DM to ND group (92 down- and 39 up- regulated), and 141 miRs in PD compared to ND (97 down- and 39 up- regulated). Although DM and PD had similar differential expression, three miRs (has-miR4776-5p, -6778-3p, and 5002-3p) were over-expressed in PD with very low p-value. Differential expression comparisons accounting sex were performed showing significant differences between males to females that will be presented here.

Conclusions
Our findings supports the important involvement of circulating miRs in the regulation of glucose homeostasis and pathogenesis of diabetes.Further investigation of candidate miRs could identify promising new biomarkers for the early diagnosis and prevention of Diabetes and related health complications.
A-039 Parathyroid Hormone and Vitamin D Follow an Inversely Correlated Serum Level
Authors: Islam S , Swift T , Sorce J , Hashim I A 
Published: October 2024

Abstract

Background
Parathyroid hormone (PTH) is a polypeptide responsible for regulating the physiological level of serum calcium through a complex homeostatic process closely associated with bone metabolism. In response to a decreased serum concentration of calcium, PTH level is increased leading to the elevation of calcium via bone resorption. Furthermore, Vitamin D (Vit-D) is a critical component of the endocrine system that also contributes to calcium homeostasis. Vit-D increases the level of serum calcium by stimulating intestinal absorption and renal reabsorption. Vit-D impacts the serum level of PTH by two distinct mechanisms. First indirectly, an increase in serum concentration of calcium, caused by Vit-D-mediated intestinal absorption and renal reabsorption disengages the process of PTH release through interaction with calcium-sensing receptors on parathyroid cells. Secondly, Vit-D directly interacts with parathyroid cells resulting in a reduced expression of PTH. Taken together, Vit-D is assumed to negatively impact the serum level of PTH. This study examined the homeostatic correlation between the circulating concentrations of Vit-D and PTH.

Methods
Retrospective serum concentrations of PTH and Vit-D were retrieved from the biochemical profiles of hospitalized and ambulatory patients who presented to or admitted at the tertiary care level hospital of University of Texas Southwestern Medical Center during the period between July-to-September of 2021. Correlation analysis between Vit-D and PTH was performed using GraphPad-PRISM-version-8.

Results
A total of 163 corresponding serum Vit-D and PTH values were obtained. Vit-D and PTH values displayed an inverse correlation (Figure 1). Pearson r values for linear and logarithmic trendlines (-0.6745 and -0.785, respectively) demonstrated a negative correlation between Vit-D and PTH.

Conclusions
Measuring Vit-D and PTH levels are critically important for assessing the homeostatic status of calcium. PTH level maintains an inverse relationship with Vit-D. Therefore, therapeutic targeting of Vit-D or PTH would mutually affect their concentration eventually reflected in calcium homeostasis.
A-040 Association of GATA-4 and Platelet Derived Growth Factor-B in Metabolic (Dysfunction) Associated Fatty Liver Disease
Authors: J H , Arulselvi S , Shalimar D , Vikram N K , Pandey S , Meena S , Prakash S 
Published: October 2024

Abstract

Background
Metabolic (dysfunction) associated fatty liver disease is a global concern as its prevalence is rising steeply ranging from 38.7% to 50.7%. MAFLD is a multifaceted burden of diseases such as diabetes, obesity, and cardio-metabolic diseases. It is the leading cause of hepatocellular carcinoma. GATA-4 is a zinc finger transcription factor located in liver sinusoidal endothelial cells and plays a critical role in liver regeneration. Platelet-derived growth factor-B (PDGF-B) plays a role in the profibrogenic trans-differentiation of Hepatic stellate cells and is actively involved in the development of hepatic fibrosis. Therefore, the study hypothesized that GATA-4 and PDGF-B are dysregulated and involved in the progression of MAFLD. Thus, the study aimed to assess the association of GATA 4 and PDGF-B in MAFLD, disease control, and healthy control.

Methods
80 subjects were recruited after exclusion criteria from Gastroenterology and Medicine OPD at AIIMS, New Delhi, and divided into 3 groups: Group 1 (healthy control)-20, Group 2 (disease control)-20, and Group 3 (MAFLD)-40. Institutional ethical committee approval was obtained. The demographic and anthropometric details, blood investigations, Non-invasive scores (AST/ALT ratio, APRI & FIB-4), and Transient elastography findings were illustrated in all the groups. The correlation between the GATA-4, PDGF-B, and platelet indices (MPV, P-LCR, PDW, and PCT) was done. STATA version 15 software was used for statistical analysis.

Results
GATA 4 was significantly decreased (p&lt;0.001) and PDGF-B (p&lt;0.001) was significantly increased in MAFLD subjects compared to healthy controls. However, no significant correlation was observed between GATA-4 and PDGF-B with platelet indices (P-LCR, PCT, and PDW). In contrast, mean platelet volume (MPV) was statistically significant (p&lt;0.001) but it was clinically insignificant between the study groups. Similarly, HOMA-IR and GATA-4 did not show any significant correlation among MAFLD. However, CAP, LSM parameters of Transient elastography, APRI, and FIB-4 scores were statistically significant (p&lt;0.001) in MAFLD when compared to healthy control. AUROC of non-invasive scores were found with weak discrimination and clinically not robust to distinguish the fibrosis grading.

Conclusions
GATA-4 and PDGF-B could be potential biomarkers, as no drugs are available so far to fill the global gap. However, pharmacological aspects need to be formulated for the treatment of MAFLD.
A-051 Validation and Implementation of the Stanbio Beta-Hydroxybutyrate Assay on Roche c502 Analyzer
Authors: Nogier K , Kalra J , Lu S , Wu F 
Published: October 2024

Abstract

Background
β-hydroxybutyrate (βOHB) serves as a crucial biomarker in assessing, managing, and monitoring ketosis in various clinical scenarios, such as diabetic ketoacidosis and instances of alcohol abuse combined with starvation. This study aimed to validate a βOHB assay (Stanbio Laboratory) conducted on a Roche Cobas c502 analyzer and establish performance specifications. Additionally, we conducted a method comparison for three assays: Randox D-3-Hydroxybutyrate (Ranbut) assay on Roche c501 analyzer, Abbott Freestyle Precision B-Ketone strip point-of-care test, and the Stanbio Laboratory β-Hydroxybutyrate LiquiColor assay on Roche c502 analyzer.

Methods
Precision, linearity, limit of quantification (LOQ), method comparison, and sample stability were determined according to Clinical and Laboratory Standards Institute (CLSI) guidelines, using commercial quality control materials (Randox Multisera) and residual patient samples (Lithium heparin anti-coagulated plasma). The reference interval was verified by residual samples from 20 healthy individuals (normal blood glucose, HbA1c, liver enzymes, and lipid panel results). Statistical analysis was performed by EP-Evaluator (v12).

Results
Intra-assay and total coefficient of variation (CV) were determined as 0% and 2.4% at 0.3 and 1.21 mmol/L, respectively. The linearity range of the assay was verified from 0.0 to 9.0 mmol/L. Using CV &lt; 20% as criteria, the functional sensitivity (LOQ) was 0.10 mmol/L at least. Lithium heparin anti-coagulated plasma specimens were stable for 24 hours at room temperature or seven days at 4 - 8 ̊C. The manufacturer’s reference interval was verified as 0.00 - 0.40 mmol/L. The Stanbio βOHB assay on the Roche c502 analyzer demonstrated a strong agreement with the Randox D-3-Hydroxybutyrate assay on the Roche c501 analyzer with a slope of 1.053 (95% CI: 1.037, 1.070) and intercept of -0.005 (95% CI: -0.068, 0.059) (coefficient correlation R = 0.9992). A positive bias was observed compared to the Abbott Freestyle Precision B-Ketone strip POC test (mean bias = + 0.50 mmol/L; slope = 1.630, 95% CI: 1.404, 1.857; R = 0.9184), and this discrepancy occurred particularly at βOHB &gt; 5.5 mmol/L measured by Abbott method.

Conclusions
The Standbio βOHB assay exhibited excellent precision and linearity across a brand range of concentrations. This assay strongly agrees with the Randox assay run on a similar instrument but discordance with Abbott’s POCT method at high βOHB concentration. Overall, the validated method provides a reliable and efficient means for measuring βOHB levels on a Roche chemistry analyzer, facilitating accurate diagnosis and monitoring of ketosis-related conditions in clinical settings.