bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-101 Is That Unexpected? Education on Handling Real World Complications with Tightly Controlled Analytes During Method Evaluation
Authors: Love S A , Aguanno J , Melchior J , Burnett R , Muldowney T , Von Rotz A , Guerrero A , Pollan M 
Published: October 2024

Abstract

Background
A common activity in clinical laboratories is performance evaluations. Given the importance for a new analyzer being put into clinical use, this exercise typically requires extensive preparation with significant time and resources invested to bring on new instrumentation. During early adoption, studies examined real-world performance and comparability of the Atellica® CI Analyzer (Atellica CI) to clinically used instruments. Precision, linearity, and method comparison (MC) studies, conducted in accordance with CLSI protocols, were completed at several locations installing new instruments to examine the analytical performance of common clinical laboratory assays. This work examines the impact of using only unmodified specimens to verify performance during method comparison for tightly controlled biological analytes like electrolytes and illustrates the impact of the tested sample range on regression analysis.

Methods
Testing was completed using unmodified, de-identified, remnant patient serum specimens. The MC studies for these electrolytes were completed over multiple days using single replicates from at least 40 individual specimens, on two instruments, the Atellica CI and the Dimension® EXL in accordance with CLSI EP09-3A. The effect of sample range on regression was demonstrated through data restriction and inclusion of modified sample results within the data analysis. Data analysis was completed using Analyse-it for Microsoft Excel (version 6.15.4).

Results
Representative method comparison data for sodium, chloride, and potassium found slope differences were more pronounced when sample concentrations were more limited. Individual assay slopes were determined using Deming linear regression model and comparisons between restricted samples show the effects of sample range on regression and correlation parameters.

Conclusions
Understanding the relationship between sample range and regression analysis is helpful to illustrate an important fundamental concept of method comparison. These examples illustrate the importance in covering as much of the analytical measuring interval as possible and the impact on regression analysis when samples are narrowly grouped.
A-104 Study of the matrix effect for thyroglobulin and calcitonin in fine-needle aspiration of cervical nodules
Authors: Canali D , Zampieri G , Bonato C , Francisco G , Sabino C , Oliveira V , Lopes A 
Published: October 2024

Abstract

Background
Analysis of material from fine needle aspiration of cervical thyroglobulin nodules with Beckman Coulter reagents on the ACCESS equipment and Calcitonin using the Siemens reagent on the Immulite equipment. The matrix effect, linearity and the limit of analytical sensitivity were analyzed. This study aims to analyze the correlation between the serum/plasma results described in the suppliers' package inserts with the results obtained with the puncture matrix.

Methods
The performance characteristics were tested according to the laboratory's operating procedures, based on the recommendations of ANVISA RDC 166/2017. Such parameters involved doping, which corresponds to the introduction of a calibrator with a known and traceable value into a pool of puncture material that is known to be negative, in order to analyze the behavior of the results obtained, paying attention to the deviations that may eventually occur due to the interference of the characteristics of the puncture material. puncture. After doping the material, dilutions were performed up to the sensitivity limit of the test, also analyzing the functional sensitivity, where ten replicates of the material were dosed, thus obtaining CV%, mean and Standard Deviation values. The same process was carried out and evaluated using the serum material. During the entire process, the materials received and analyzed were centrifuged and always kept in a refrigerated environment.

Results
The recovery% of the matrix effect study for cervical aspirate puncture showed results within the expected range, ranging from 80% to 120%, as well as the results compared with serum/plasma referenced in the supplier's package insert. The functional sensitivity study for Thyroglobulin showed a CV% of 1.77%, being lower than that recommended by the package insert (2.2%) and for the Calcitonin analyte, the functional sensitivity study showed a CV% of 8.49%, being lower than recommended by the package leaflet (15.7%), in addition to having CV's lower than the 20% recommended by ANVISA. The results obtained with the matrix effect study for serum also showed values between 80% and 120%, both of which agreed.

Conclusions
The results showed excellent performance for material from fine needle aspiration for both Calcitonin and Thyroglobulin, being consistent with the serum data described by the suppliers' package inserts, thus making the reagent usable for the cervical aspirate puncture matrix.
A-105 Cherry-red plasma: unraveling the impact of PV-10 on chemistry assays
Authors: Chen L , Zhang Y , Meng Q 
Published: October 2024

Abstract

Background
The accuracy of clinical laboratory measurements can be compromised by laboratory test interferences. PV-10 (Rose Bengal), a chemotherapy medication used in the treatment of metastatic melanoma, was observed to cause a cherry-red discoloration in plasma. This plasma color change, resembling hemolysis, raises serious concerns about potential interference in clinical laboratory tests. Our study focused on understanding the potential interference of PV-10, particularly the impact on the hemolysis index (H index) and various chemistry assays to ensure result accuracy in cancer treatment.

Methods
To investigate the potential interference of PV-10, pooled normal and high baseline bilirubin plasma samples were spiked with a gradient of PV-10 concentrations (0 to 22 µg/100µL). Samples were analyzed on Roche Cobas 8000 analyzer with H index and all the chemistry assays measured.

Results
The presence of PV-10 in plasma significantly increased the H index, in a dose-dependent manner. Specifically, the H index increased from 14 (control plasma) to 2643 at the highest PV-10 concentration (22 µg/100µL) in pooled plasma. Among all chemistry assays, most of them were not affected by PV-10. However, certain assays like IRON have dose dependent increase with PV-10 concentration. CHO2A (Total Cholesterol), TP (Total Protein), and TRIG (Triglycerides) have shown a consistent increase trend. In contrast, the DBILI values decreased with increasing PV-10 concentrations, from 6.7 mg/dL to 0.2 mg/dL. TBIL levels also demonstrated a gradual decline from 9.6 mg/dL to 8.4 mg/dL as PV-10 concentration increased in pooled high baseline bilirubin plasma.

Conclusions
This study provides insights into the potential interference of PV-10 in clinical chemistry assays. The elevated H index by PV-10 is not attributed to hemolysis. It is imperative for both laboratory professionals and care providers to recognize the implications of PV-10-induced plasma discoloration and its potential interference in laboratory tests.
A-113 Evaluation of Cystatin C Ordering Trends in a Quaternary Care Health System
Authors: Agana B , Ness M , Marzinke M A 
Published: October 2024

Abstract

Background
Cystatin C is an alternative and adjunct kidney biomarker to creatinine in the estimation of glomerular filtration rate (eGFR). The National Kidney Foundation and American Society of Nephrology have called for increased use of cystatin C in the evaluation of kidney function. Our institution brought cystatin C testing in-house in August 2021. The goal of this study was to evaluate the utilization and longitudinal ordering trends of cystatin C within our quaternary care health system.

Methods
Cystatin C is measured on a Roche cobas® c502 using an assay traceable to IFCC-certified reference material. The electronic health record system (Epic) was queried using Epic SlicerDicer to identify ordering trends within our academic medical center between July 2021 and January 2024. The frequency of unique (one-time) cystatin C orders and concomitant orders with creatinine was also conducted. An in-depth analysis and chart review was performed over a one-month period to evaluate ordering locations, underlying clinical conditions, including previous diagnosis of kidney disease, and correlations between cystatin C and creatinine measurements.

Results
Between July 2021 and January 2024, 11,577 tests were performed from 8,415 unique patients. Cystatin C orders remained stable since April 2022, with an average 370 orders (363-378) per month. Eighty percent of cystatin C test requests were accompanied with creatinine testing during the same encounter. In a detailed analysis of a one month period, cystatin C testing was primarily performed in patients with an existing diagnosis of kidney disease (66%) and in the evaluation of renal function in patients with a cancer diagnosis (23%).

Conclusions
There has been sustained adoption of cystatin C by providers at our institution. The majority of orders have occurred in patients with an underlying renal diagnosis, as well as comorbid or chronic conditions that may affect kidney function.
A-116 Pleural Fluid pH - Are We Collecting and Measuring It Correctly?
Authors: Tan C , Tan S , Chiong S , Yeo C 
Published: October 2024

Abstract

Background
Pleural fluid pH has diagnostic, therapeutic, and prognostic implications in the management of pleural space infections and malignancy. Pleural fluid sample collection, transportation and processing are known for source of pre-analytical error which contribute to inaccuracy of measured pH with clinical implication to patient care. Some clinical practices observed locally include pleural fluid collection in sterile container for ease of other biochemistry analytes measurement in addition to pH. This study aimed to compare the differences in pleural fluid pH and other commonly ordered biochemistry analytes collected using sterile container against heparinized blood gas syringe.

Methods
Total 20 Pleural fluid samples were collected from patient using a procedure called thoracentesis from, with approximately 2 to 3ml of fluid directly transferred into heparinized blood gas syringe as well as in a sterile container. Both samples were then transported to Clinical Biochemistry Laboratory within an hour. Both samples were analyzed on 3 analytical systems; 1) pH on Roche COBAS b221 blood gas analyzer, 2) Glucose, Total Protein, LDH on Beckman AU System and 3) Specific Gravity on Reflectometer. Statistical analysis was performed using Analyze-It software.

Results
pH fluid collected in sterile container demonstrates significant high bias (absolute of 0.4 units or 5%) as compared to sample collected in heparinizes blood gas syringe. Other commonly ordered tests in fluid profile (Glucose, Total Protein, LDH and SG) demonstrate good correlation (Altman-Bland Difference Plot &lt;5%) for pleural fluid collected in sterile container as compared to heparinized syringe.

Conclusions
This positive bias observed is likely attributed to air exposure in pleural fluid collection in sterile container as compared to heparinized syringe. The accuracy of measured pleural pH is critically dependent on the method of sample collection. This study highlights the need for a standardized protocol for pleural pH collection for accurate measurement.
A-120 Analytical and Clinical Verification of the Elecsys® Alzheimer’s Disease Cerebrospinal Fluid Biomarkers pTau/Abeta42 and Total-Tau/Abeta42
Authors: Troike K , Zilka S , Bekris L M , Leverenz J , Khrestian M , DiFilippo F P , Lowe M , Colón-Franco J M 
Published: October 2024

Abstract

Background
Alzheimer’s disease (AD) is the most common form of dementia characterized by amyloid beta (Abeta) plaques and neurofibrillary tau tangles in the brain. Cerebrospinal fluid (CSF) biomarkers Abeta42, total tau (tTau), and phosphorylated tau (pTau181) offer a high degree of sensitivity and specificity in the diagnosis of AD and have utility in monitoring disease progression. AD biomarker ratios, pTau181/Abeta42 and tTau/Abeta42, correlate with amyloid positron emission tomography (PET) imaging, and several assays have received FDA clearance. This study was designed to evaluate the analytical performance and clinical utility of AD-related Abeta and tau biomarkers on the Roche cobas e601.

Methods
Precision studies were performed using Roche PreciControl kits. Intra- and inter-precision samples were tested ten times in a single day or twice a day for ten days, respectively. Five levels of Roche Calcheck material were measured in triplicate for linearity. Method comparison was carried out using 39 samples from the Elecsys CSF Correlation Sample Panel from Roche. Qualitative comparisons to amyloid PET Centiloid scores were performed using 35 CSF samples (n=11 PET negative, n=24 PET positive). CSF samples and PET interpretation were obtained from the Cleveland Clinic Institutional Review Board approved Cleveland Alzheimer's Disease Research Center (CADRC) and Cleveland Clinic Lou Ruvo Center for Brain Health Aging and Neurodegenerative Disease Biobank (LRCBH-Biobank).

Results

Conclusions
Evaluation of AD biomarkers on the Roche cobas e601 revealed reliable precision and analytical accuracy. The pTau181/Abeta42 and tTau/Abeta42 ratios demonstrated excellent positive agreement when compared to amyloid PET, but poor negative agreement. This may be due to the small sample size of PET-negative patients. Alternatively, as amyloid PET detects neuritic plaque accumulation, the CSF biomarker-positive/PET-negative patients may have early non-neuritic amyloid plaque pathology not detectable by imaging. Overall, this assay is suitable for use and may serve as a valuable tool in AD diagnosis.
A-126 The Role of Lysozyme and Other Inflammatory Markers in Understanding GI Microbiome Changes
Authors: Reynolds D , Gruzdys V , Mortensen J E 
Published: October 2024

Abstract

Background
The role of GI microbiome in gut health, intestinal permeability, and the development of inflammation has been well-established however, few clinical studies assess microbiome (i.e. PCR) and biochemical markers from the same stool collection. Doctor’s Data Inc. (DDI) has been performing a GI microbiome test in conjunction with other stool biochemical markers for the past 3 years, with over 7000 patient samples analyzed. The aim of this study was to analyze GA-map® Probe results for possible correlations with elevated values for fecal calprotectin, lactoferrin, and lysozyme.

Methods
Microbiome characterization The microbiome analysis test used in this study identifies 48 targeted analytes across six phyla using the GA-map® Dysbiosis test (Genetic Analysis AS, Oslo). The test algorithm has been trained and validated using 48 bacterial markers signal intensity obtained from 668 adults, including healthy subjects, patients with IBS and IBD. GA-map® Dysbiosis Analyzer software calculates the degree of dysbiosis (DI) of a given sample, assigning a DI ranging from 1 to 5. DI greater than 2 indicates that the microbiota is deviant from a healthy reference population (“dysbiotic”), while a score of 2 or lower is reported as “normobiotic”. Biochemical marker characterization Each stool sample was analyzed for a suite of biochemical markers - in particular calprotectin, lactoferrin and lysozyme - with the concentration determined using commercially available ELISA kits (ALPCO, Techlab).

Results
Using clinical cut-offs of 100.0 ug/g (calprotectin) and 7.3 ug/g (lactoferrin) the patient data was sorted into cohorts indicating disease state of “Normal”, “Intermediate” and “IBD Likely”, and further differentiated using the lysozyme result. The biochemical marker results were correlated against DI score for each stool sample (Figure 1).

Conclusions
DI score increases as biochemical inflammatory markers increase, with lysozyme as the key differentiating factor between patient cohorts.
A-129 Evaluation of the Analytical Performance of Magnesium and Calcium General Chemistry Assays on the Atellica CI Analyzer
Authors: Carter R H , Varhue W , Gupta P , Shalhoub V , Camacho J , Snyder J 
Published: October 2024

Abstract

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 was designed to evaluate the analytical performance of the Atellica® CH Magnesium (Mg) and Calcium (Ca), Assays on the Atellica CI Analyzer.

Methods
The Atellica CI Mg and Ca assays use the same reagents and calibrators as the Atellica CH assays. Precision studies were performed according to CLSI EP05-A3 using serum and urine samples. One aliquot of each sample pool was tested in duplicate in two runs per day &gt;2 hours apart on each analyzer for 20 days. MC studies were performed according to CLSI EP09-A3. Individual human urine and serum samples were analyzed using the Atellica CH and Atellica CI Analyzers. LoB, LoD, LoQ were determined according to CLSI EP17-A2.

Results
Representative precision and MC results observed across indicated sample ranges are listed for each assay in the table below. Over the two assays tested, repeatability and within-lab %CVs were &lt;4.9%. Overall, slopes determined using the Deming linear regression model were approximately equal to 1. LoB, LoD, LoQ for serum Mg were 0.07 mg/dL (0.03 mmol/L), 0.11 mg/dL (0.05 mmol/L), and 0.50 mg/dL (0.21 mmol/L), and for urine Mg, 0.07 mg/dL (0.03 mmol/L), 0.14 mg/dL (0.06 mmol/L), and 1.00 mg/dL (0.41 mmol/L). LoB and LoD for serum Ca were 0.2 mg/dL (0.05 mmol/L) and 0.3 mg/dL (0.08 mmol/L), and for urine Ca, 0.3 mg/dL (0.08 mmol/L) and 0.5 mg/dL (0.13 mmol/L), respectively. Linearity was demonstrated for both assays.

Conclusions
Atellica CH Mg and Ca Assays on the Atellica CI Analyzer demonstrated good precision and equivalent performance to the same assays on the Atellica CH Analyzer.
A-130 Intercomparison of Methods between Atellica Solution® and CI® Analyzers for Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
Authors: Barrionuevo-Gonzalez M , Lapeña-Garcia S , Garcia-Valdecasas S , Costales-Lucia T , De La Rubia-Maestu J , Ruiz-Alvarez M 
Published: October 2024

Abstract

Background
Objectives: To verify that the results of ALT and AST measured by the Atellica Solution® analyzer (and the new CI® analyzer (Siemens Healthineers) are interchangeable.

Methods
For each assay, 40 patient samples were selected, covering the entire measurement range, and analyzed by both instruments. To determine the degree of agreement between the instruments, Bland Altman analysis of mean differences and Passing Bablok regression were performed. Statistics are expressed with their 95% confidence intervals (CI). The evaluation of results was carried out using the statistical program Method Validator.

Results
ALT: In Bland-Altman analysis, no constant systematic error was found as the 95% confidence interval of the mean difference includes zero. Similarly, in Passing Bablok regression analysis, the confidence interval of the intercept includes zero. No systematic proportional differences were observed based on the slope, as the 95% confidence interval includes the value one. AST: In both Bland-Altman and Passing Bablok regression analyses, a constant systematic error was detected as the 95% confidence interval of the observed mean difference Bland-Altman and the 95% confidence interval of the intercept of the regression line do not include zero. A slight systematic proportional difference was also observed based on the slope, as the 95% confidence interval does not include one.

Conclusions
Based on the observed data, we can conclude that the Atellica Solution® and CI® analyzers are interchangeable for the ALT assay. There are constant systematic differences and a slight proportional systematic error for the AST assay, which should be re-evaluated after a new calibration of the method. It is noteworthy that this variation in the data is more pronounced for high AST values, not being clinically significant differences at these concentrations; nor as pronounced in clinical decision values. Therefore, we can conclude that the Atellica Solution® and CI® analyzers are interchangeable for AST.
A-143 Comparative Evaluation of K2EDTA Performance in Multinational Vacutainers: A Case Study of “DBO” by Schraubg and “BD” by Becton, Dickinson
Authors: Patel T , Patel K , Raj D , Bapu R 
Published: October 2024

Abstract

Background
This research paper presents a thorough comparison of the anticoagulant properties of K2EDTA in two multinational vacutainer brands, “DBO” by Schraubg and “BD” by Becton, Dickinson, with a specific focus on critical hematological parameters. The study encompassed the analysis of 50 samples, spanning a wide range of values from 60 fl to 110 fl, evaluating key parameters such as Hemoglobin (Hb), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), and Red Blood Cell (RBC) count.

Methods
Peripheral blood samples were gathered from 50 outpatient participants using the specified tubes. The samples underwent assessment for six hematological analytes, including RBC Count, hemoglobin, HCT, MCV, MCH, and MCHC. Comparative analysis was performed using the paired t-test. Differences exceeding the total allowable error were considered clinically significant. To assess stability, initial results were compared with those obtained from samples preserved for a duration of 2 hours

Results
Our findings indicate that the use of “DBO” vacutainers resulted in slightly higher values for Hb, HCT, MCV, MCHC, and RBC count compared to the “BD” vacutainers. Notably, the statistical significance was observed in MCV, HCT, and MCHC across nearly all samples, while Hb and RBC parameters showed no significant changes. Given the crucial role of K2EDTA as an anticoagulant in maintaining the hypotonicity of Red Blood Cells (RBCs), ensuring accurate hematological analyses is imperative.

Conclusions
Although the T-value for Hemoglobin did not exhibit statistical significance, the study identified notable differences in Hematocrit (HCT) and Mean Corpuscular Volume (MCV). This underscores the importance of selecting the appropriate vacutainer brand to ensure reliability and accuracy in hematological measurements, particularly when assessing MCV, where even slight variations can carry clinical implications. The results underscore the necessity for clinicians and laboratories to carefully consider the choice of vacutainers based on their specific requirements and the critical nature of the hematological parameters under analysis.