bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-110 Analytical Performance Evaluation of Diazo Bilirubin Assays on the Atellica CH Analyzer
Authors: Robinson C , Sinopoli A , Blagovcanin D , Rhea McManus J , Cheek J 
Published: September 2023

Abstract

Background
Measurements of bilirubin are used to evaluate liver function. The two most common methods to measure bilirubin are the diazo method (based on measuring the color of azobilirubin) and the vanadate method (based on chemical oxidation). Advantages and disadvantages of each method are well-documented in the literature. This study was designed to evaluate the analytical performance of two new diazo-based methods: the Atellica® CH Total Bilirubin (D_TBil)* assay and the Atellica CH Direct Bilirubin (D_DBil)* assay on the Atellica CH Analyzer.

Methods
Precision and method comparison (MC) were used as performance indicators for the diazo-based assays. Precision studies were performed according to CLSI EP05-A3. Human serum samples were spiked with either conjugated or unconjugated bilirubin. One aliquot of each sample pool was tested in duplicate in two runs per day &gt;2 h apart for &gt;20 days. MC studies were performed according to CLSI EP09-A3. For total bilirubin comparisons, human serum samples (n = 100) were analyzed using the Atellica CH D_TBil assay and the commercial Dimension® Total Bilirubin (TBI) assay. Direct bilirubin comparisons were performed by analyzing human serum samples (n = 100) using the Atellica CH D_DBil assay and the commercial ADVIA® Chemistry Direct Bilirubin_2 (DBil_2) assay.

Results
Representative precision and MC results for each assay across the indicated sample ranges are listed in the table. Over the two assays tested, repeatability and within-lab %CVs were &lt;2.0% and &lt;3.5%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1.

Conclusion
Evaluation of the Atellica CH D_TBil and D_DBil assays demonstrated good precision and equivalent performance compared to commercially available assays.
A-114 Mas™ Omni·Core™ Controls, Ready-to-use Tube Format
Authors: Adams N , Sunderraj M , Krishnaswami N , Crandall D , Zhang Y , Hu R 
Published: September 2023

Abstract

Background
The Thermo Fisher Scientific™ MAS™ Controls* are assayed controls to monitor assay performance within clinical laboratory settings. The user can compare observed results of controls with their expected ranges as a means of assuring consistent performance of both reagent and instrument.
The objective of developing MAS™ Ready-to-Use Tube Controls is to provide MAS™ controls in a new automation-friendly plastic tube format, as an alternative to the current glass vials. The MAS™ controls contained in the plastic tubes are intended to be used by core labs to be placed directly onto the analyzers, eliminating the need to aliquot into sample cups or other primary tubes.
In this presentation we summarize the results of MAS™ Omni·CORE™ in the new Ready-to-Use Tube Controls configuration.

Methods
The purpose of these studies is to verify material compatibility and acceptable product performance of MAS™ Omni·CORE™ in the new Ready-to-Use Tube Controls configuration.
The controls were also assessed for Fit/Form/Function on various platforms from manufacturers such as Siemens, Roche, Abbott, Ortho Clinical Diagnostics, Thermo Fisher Scientific, and Beckman.

Results
The MAS™ Omni·CORE™ Ready-to-Use Control results demonstrated comparable performance and Fit/Form/Function criterion of the specified platforms.
Torque/Leak, Cap Characterization, and Plastic Interaction studies yielded passing results per protocol criterion. The In-Use (CO2) study demonstrated acceptable “time-on-platform” performance of 9 h in 2–8°C (4 h at 25°C). The Extractables/Leachables study demonstrated passing results for all claimed analytes, with minor exceptions. All light sensitive analytes yielded passing results during the Light Transmission study.

Conclusion
To conclude, the MAS™ Omni·CORE™ Ready-to-Use Controls will contribute to the increased efficiency of core lab workflow by allowing the analyzer(s) to aspirate controls directly from the tube and allow for control storage in an on-board refrigeration unit after use.
*Availability of product in each country depends on local regulatory marketing authorization status.
A-116 Evaluation of Lp(a) Ultra assay for the Immunoturbidimetric Quantitative Determination of Lipoprotein (a) in Human Serum and Plasma With Siemens Healthineers Atellica CH 930 Analyzer
Authors: Cugini A , De Angelis L , Lucini R , Brambilla S 
Published: September 2023

Abstract

Objective
The aim of this study is to evaluate the analytical performances of the Lp(a) Ultra assay for the immunoturbidimetric quantitative determination of lipoprotein (a) in human serum and plasma on Siemens Healthineers Atellica CH 930 Analyzer.

Background
Lipoprotein (a) has been found in artery walls and can have atherogenic effects. Because of its structural similarity to plasminogen, it can also inhibit fibrinolysis and hence acts thrombogenically. High Lp(a) concentrations in serum correlate with premature manifestation of atherosclerosis and strokes. In combination with elevated LDL Cholesterol concentrations, the coronary risk increases approximately six-fold.

Methods
Lp(a) Ultra is a latex immunoassay manufactured by Sentinel Diagnostics and developed to measure Lp(a) levels. If the antigen-antibody reaction takes place between Lp(a) in the sample and the anti-Lp(a) antibodies, which have been adsorbed to latex particles, agglutination occurs. This agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of Lp(a) contained in the sample.

Results
The Limit of Blank LOB (4 samples × 5 replicates × 3 runs) was ≤2.0 mg/dL. The Limit of Detection LOD (4 samples × 5 replicates × 3 runs) was ≤ 3.0 mg/dL. The Limit of Quantitation LOQ (8 dilution levels × 10 replicates × 3 runs) was ≤5.0 mg/dL at %CV lower than 20%. The Intra Assay (5 samples × 20 replicates × 3 runs) gave the following %CVs: 2.4% at 12.1 mg/dL, 0.8% at 30.3 mg/dL, 0.6% at 47.8 mg/dL, 0.5% at 58.8 mg/dL, 1.7% at 87.1 mg/dL. Total precision study (5 samples × 2 runs × 2 replicates × 20 runs) gave the following %CVs: 4.0% at 11.5 mg/dL, 3.6% at 21.7 mg/dL, 3.0% at 32.0 mg/dL, 2.8% at 42.2 mg/dL, 2.3% at 50.7 mg/dL. The test was linear up to 130 mg/dL. Calibration stability was up to 30 days. Reagent on board stability was up to 30 days. This application (y) was compared with the same test applied on Beckman Coulter AU680 Analyzer (x) and gave the following results: using Passing Bablok analysis: y = 0.8 + 1.0x; correlation coefficient (r) = 0.997; using Deming analysis: y = 1.0 + 1.0x; correlation coefficient (r) = 0.997; number of samples = 120. There is not Hook effect/antigen excess up to 600 mg/dL.

Conclusions
Analytical performances of Lp(a) Ultra assay on Siemens Healthineers Atellica CH 930 Analyzer meet the requirements for its use as immunoturbidimetric quantitative determination of lipoprotein (a) in human serum and plasma and make this assay very suitable for the routine measurement of this analyte.
A-118 Evaluation of Mindray Cystatin C Assay
Authors: Bao Y , Hu J , Jiang M , Wang J , Dai J 
Published: September 2023

Abstract

Background
Cystatin C is a low molecular weight non-glycosylated alkaline protein, with a molecular weight of 13kDa. It is formed by all nucleated cells in human at a constant rate. The only pathway of Cystatin C in vivo is excretion through glomerular filtration and absorbed by proximal renal tubular epithelial cells, which was decomposed finally. Therefore, the concentration of Cystatin C in serum is almost not affected by external factors, such as weight, age, gender, etc. Compared with creatinine and urea, it is an ideal endogenous marker for monitoring glomerular filtration function. Currently, the most methods on the market for testing Cystatin C are either latex enhanced immunoturbidimetric method, or immunoturbidimetric method. These methods usually use polyclonal antibodies from different animal species, which are sometime susceptible to the interference from rheumatoid factors reported in the literature, resulting in false positive results. The anti-RF interference ability of this reagent was enhanced by selecting the optimal antibody and optimizing reagent formulation. This study evaluated performances of the Cystatin C assay on Mindray BS-2000M system.

Method
Mindray Cystatin C assay is based on latex immunno-agglutination. Latex nanoparticles were coated with anti-Cystatin C antibody. Reagent of this assay contains R1 buffer and R2 with latex particles coupled with anti-Cystatin C antibodies. The assay starts with R1 and sample incubation for 5 min and then R2 is added. After another 5 min of incubation, agglutination occurs, leading to turbidity increasing. The turbidity is measured at 570 nm. Multi-level (5-point) calibration is used. Cystatin C concentrations are obtained from the calibration curve with signals from the assay with patient samples. Following basic assay performances were evaluated: precision, limit of detection, linearity, method comparison, interference and high dose hook.

Results
The precision study followed EP05-03 protocol. The repeatability and within-lab CVs on the BS-2000M system with 2 QC and 3 patient samples were ranged from 0.9% to 5.3%, respectively. Limit of detection was 0.1 mg/L and linearity was given up to 8.63 mg/L. The assay (y) shows good accuracy when compared with Roche Cystatin C (x) assay on the cobas 701: y = 1.0055x - 0.0268 (r2 = 0.9994, n = 109). The assay showed no significant with bilirubin up to 40 mg/dL, with hemoglobin up to 500 mg/dL, with lipids up to 500 mg/dL, and with rheumatoid factors up to 1200 IU/mL that is about 0.3% out of a total of 55 184 samples collected from our customers in China with RF measurements. No prozone was observed with the assay up to the high cystatin C concentration of 800 mg/L tested.

Conclusion
From this evaluation, we confirmed that Mindray Cystatin C assay can measure serum Cystatin C precisely and accurately, and with good performance against rheumatoid factors interference. It is suitable for use in routine clinical laboratories.
A-122 Fluid Type (STILL) Matters: An Analysis of Quality Control Material Suitability for Measuring Eleven Body Fluid Analytes in the Clinical Laboratory
Authors: Fyffe-Freil R C , Baumann N A , Block D R 
Published: September 2023

Abstract

Background
Measuring the concentration of albumin, amylase, bilirubin, cholesterol, creatinine, glucose, lactate dehydrogenase (LDH), lipase, total protein(TP), triglycerides, and urea nitrogen(UN) in body fluids(BFs) provides important information to aid in clinical decision-making. The range of expected values of these analytes in BFs may not match serum, and the distribution by fluid type is not well described. Quality control (QC) materials are designed to reflect clinically relevant concentrations in blood. Hence, the measuring ranges for assays modified for BF testing vary in suitability. Laboratorians and manufacturers would benefit from understanding the overlap in BF and serum analyte concentrations. The aim of this study was to characterize the range of BF analyte concentrations compared to serum and assess the suitability of QC materials used on these assays.

Methods
A retrospective analysis was performed for the following analytes in BFs with reportable ranges(including maximum dilution factor): albumin = 0.2–12.0 g/dL(×2), amylase = 3–14 000 U/L(×100), bilirubin = 0.1–72.2 mg/dL(×2), cholesterol = 4–8000 mg/dL(×10), creatinine = 0.1–92.0 mg/dL(×4), glucose = 2–3375 mg/dL(×5), LDH = 10–9000 U/L(×10), lipase = 3–300 000 U/L(×1000), TP = 0.2–36.0 g/dL(×3), triglycerides = 4–8850 mg/dL(×10), and UN = 2–300 mg/dL(×3). Chemistry tests were run on a cobas® 6000 c501 (Roche Diagnostics,Indiana). Patient analyte concentration and fluid type results reported between 9/16/2019 and 1/27/2022 at all Mayo Clinic locations were extracted from an institutional database of electronic medical record data. Serum results were included for comparison. Descriptive statistical analyses (median and range) were performed with R (version 4.2.2)/R Studio(version 2022.12.0). QC materials for BF testing were purchased from Bio-Rad (Multilevel Qual, Levels 1 and 3; Hercules, CA, USA). Target concentrations are reported.

Results

Conclusion
BF median (range) concentrations are similar or higher for bilirubin, creatinine, glucose, lipase, and UN. Serum QC material is likely appropriate for these assays in BFs. BF median(range) concentrations are lower for albumin, cholesterol, TP, and triglycerides suggesting that serum QC material may not be well suited for BFs. The need for extended dilutions may impact BF amylase and lipase.
A-124 Evaluation of the Analytical Performance of 10 General Chemistry Assays on the Atellica® CI 1900 Analyzer
Authors: Kolewe K , Micklitsch C , Ostolaza-Venegas K , Pham T , Tyler C , Varhue W , Arrode-Bruses G , Rhea-McManus J , Snyder J 
Published: September 2023

Abstract

Background
The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer employing both Atellica chemistry and Atellica immuno assays. This study was designed to evaluate the analytical performance of the Atellica CH Alkaline Phosphatase concentrated (ALP_2c), Direct Bilirubin 2 (DBil_2), Total Bilirubin_2 (TBil_2), Albumin (Alb), Albumin BCP (AlbP), Total Protein II (TP), Aspartate Aminotransferase (AST), Aspartate Aminotransferase P5P (ASTPLc), Alanine Aminotransferase (ALT), and Alanine Aminotransferase P5P (ALTPLc) assays* on the Atellica CI 1900 Analyzer.

Methods
The Atellica CI 1900 ALP_2c, DBil_2, TBil_2, Alb, AlbP, TP, AST, ASTPLc, ALT, and ALTPLc assays use the same reagents and calibrators as the Atellica Chemistry assays. Precision and method comparison (MC) were used as performance indicators for the Atellica CI 1900 Analyzer. Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum samples. One aliquot of each sample pool was tested in duplicate in two runs per day &gt;2 h apart on each analyzer for &gt;20 days. MC studies were performed according to CLSI EP09-A3. Individual native and contrived human serum samples were analyzed using the Atellica CH assays on both the Atellica® CH 930 and Atellica CI 1900 Analyzers.

Results
Representative precision and MC results are listed for each assay in the table below. For the nine assays tested, repeatability and within-lab %CVs were &lt;6.0% and &lt;9.0%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1.

Conclusion
Evaluation of the Atellica CH ALP_2c, DBil_2, TBil_2, Alb, AlbP, TP, AST, ASTPLc, ALT, and ALTPLc assays using the Atellica CI 1900 Analyzer demonstrated acceptable precision and equivalent performance compared to the same assays on the Atellica CH 930 Analyzer.
*The products mentioned are not commercially available in all countries. Their future availability cannot be guaranteed.
A-126 Evaluation of NMR-based GFR Estimation in Dosing of High-dose Methotrexate
Authors: Schwäble Santamaría A N , Einhell S , Robertson A N , Grassi M , Pukrop T , Schiffer E 
Published: September 2023

Abstract

Background
The cytotoxic agent methotrexate (MTX) is mainly used in oncology and rheumatology. MTX is 80%–90% excreted unchanged in the urine, thus, impaired renal excretion because of kidney disease leads to accumulation and prolonged exposure, with a consequent increased risk of myelosuppressive and other toxic adverse effects. Direct kidney damage from MTX crystal precipitation and tubular injury may also occur. Therefore, precise and accurate measurement of renal function prior to MTX administration is of paramount importance to determine accurate dosing and to minimize such adverse risks. Commonly used estimated glomerular filtration rate (eGFR) equations perform poorly in patients with cachexia and at later stages of life—the typical oncology patient. Here we evaluate the feasibility of applying the recently introduced nuclear magnetic resonance (NMR)-based GFR equation (GFRNMR) using creatinine, cystatin C, myo-inositol, and valine, in oncology patients receiving high-dose MTX.

Methods
A series of residual sera from patients scheduled to receive high-dose MTX infusion for oncological indications were collected from two sites: n = 52 sera from the University Hospital Regensburg (Regensburg, Germany), at four time points (t0h, t24h, t42h, and t48h), and n = 10 cross-sectionally from the Mayo Clinic (MN). Standard drug-monitoring trough levels were used as a reference. Serum was prepared and NMR-measured in five replicates for all samples. GFRNMR was compared with the current standard GFR equations: i) CKD-EPI2021Cr (creatinine) and ii) CKD-EPI2021CrCys (creatinine and cystatin-C). Coefficient of determination for linear regression, kappa coefficient for categorical regression and bootstrapped confidence intervals were calculated.

Results
MTX was shown not to increase the GFRNMR failure rate or affect the intra-assay precision of GFRNMR. When monitoring eGFR during high-dose MTX treatment, MTX affected GFR according to the RIFLE criteria for AKI in 13 cycles in 9 patients; 1/13 were classified as ‘risk’ (creatinine increased 1.5-fold) and 1/13 were classified as ‘injury’ (creatinine increased 2.0-fold). Using MTX clearance as a surrogate for measured GFR, GFRNMR was shown to reflect the MTX plasma clearance constant k more accurately (using a fitting function c = c0*e−kt) with r = 0.758 (95% CI 0.36–0.92, P = 0.004) compared to CKD-EPI2021Cr (r = 0.401, 95%CI −0.19–0.78, P = 0.176) and CKD-EPI2021CrCyc (r = 0.632, 95% CI 0.12–0.88).

Conclusion
The robustness of GFRNMR test results is not affected by HD-MTX treatment. Compared to standard eGFR equations, GFRNMR is more closely associated with MTX renal clearance rates and may therefore be a novel method to improve the accuracy of MTX dosing in the future.
A-137 Performance Evaluation of an Automatic, Rapid and Non-Westergren Based Method for Erythrocyte Sedimentation Rate Measurement
Authors: Hsiang-Ling H , Fang-Yu W , Hao-Ru L 
Published: September 2023

Abstract
The erythrocyte sedimentation rate (ESR) is widely used for the assessment of acute or chronic inflammation, especially for rheumatoid diseases. The gold standard for determining ESR is the Westergren method, which measures the distance in millimeters that red blood cells fall in one hour. However, this method needs to be performed manually, which increases the biohazard risk to laboratory personnel, and the results are often influenced by many preanalytical and analytical factors. Several automated ESR analyzers with different methodologies are now available to provide faster results directly from whole blood anticoagulated with K3EDTA. In this study, we evaluated the performance of an automatic ESR analyzer, Alifax TEST1, and compared it with that of another automatic analyzer, Diesse Cube 30 touch, and also the Westergren method. TEST1 extrapolates the ESR values by measuring the kinetics of red cells aggregation in 20 s, while Cube 30 is a modified Westergren method that could obtain the results in 20 min. A total of 75 clinical samples were analyzed for ESR using the three methods. The hematocrit (Hct) and C-reactive protein (CRP) values were also analyzed. The Spearman correlation coefficient between TEST1 and Westergren methods was 0.90 (P &lt; 0.0001) with a mean difference of -5.45; the correlation between Cube 30 and Westergren methods was 0.80 (P &lt; 0.0001) with a mean difference of 10.74; the correlation between TEST1 and Cube 30 was 0.69 (P &lt; 0.0001) with a mean difference of -15.9. The precision values (CV %) of TEST1 in low-, medium- and high-level controls were 2.71%, 1.21% and 1.05% for inter-assay, and 3.70%, 1.66% and 0.86% for intra-assay. The normal range of TEST1 was also established by analyzing ESR values of 125 healthy individuals where it is 0–15 mm/hr for men ≤50years old, 0–20 mm/hr for men &gt; 50 years old and for women ≤50 years old, and 0–30 mm/hr for women &gt; 50years old. The ESR values obtained from the three methods all significantly correlated with plasma CRP levels. However, the ESR values from Cube 30 and Westergren methods negatively correlated with Hct values, while that from TEST1 did not. The present study demonstrates that 1) TEST1 has a better correlation and a lower difference to the Westergren method compared to Cube 30, suggesting that TEST1, the automatic, rapid and non-Westergren based method is an effective assay for clinical practice; 2) the Westergren based methods are more easily influenced by Hct; 3) the large mean difference between TEST1 and Cube 30 highlights a need for harmonization of the ESR values obtained from different automatic analyzers, especially when it is applied to monitor the disease activity score (DAS28) in rheumatoid arthritis patients.
A-139 Investigating the Utility of Reticulocyte Hemoglobin Equivalent for Diagnosis of Iron Deficiency Anemia
Authors: Lee H , Wang F , Ho H 
Published: September 2023

Abstract

Background
Iron deficiency anemia (IDA) is one of the most common leading global health problems, which could cause extreme fatigue, chest pain, headache, and even neurodevelopment deterioration in children. Traditionally, assessing serum ferritin, transferrin, and iron are the tools to diagnose IDA. However, a high false-positive rate of these conventional biomarkers might be observed due to inflammation, infection, or malignancy. Reticulocyte hemoglobin equivalent (RET-He) is a new parameter that reflects the recent functional availability of iron for erythropoiesis, with the advantage of real-time results as part of automated reticulocyte analysis. The present study, therefore, aimed to investigate the utility of RET-He for the diagnosis of patients with IDA.

Methods
This retrospective study collected laboratory data from patients with both serum ferritin and reticulocyte results from January 2022 through December 2022, and excluded the high white blood cell count (WBC &gt; 9380 cells/μL) and high C-reaction protein (CRP &gt; 0.5 mg/dL). RET-He was measured by Sysmex XN-10 or XN-20 automated hematology analyzer (Sysmex, Kobe, Japan). Serum ferritin was measured by Roche Cobas e801 (Roche Diagnostics, Mannheim, Germany). Iron and total iron binding capacity (TIBC) were measured by Roche Cobas c702 (Roche Diagnostics, Mannheim, Germany). Anemia was defined as hemoglobin concentration &lt;13 g/dL for men and &lt; 12 g/dL for women. Iron deficiency was defined as serum ferritin &lt;15 μg/L. Student T-tests and Pearson correlation were performed, and P-values less than 0.05 were considered statistically significant. Statistical analyses were performed with SPSS software (Version 22.0).

Results
A total of 2208 patient data were enrolled in this study and were classified into the IDA, iron deficiency, anemia, and control groups according to ferritin level and hemoglobin concentration. The RET-He were 20.6, 27.7, 30.4, and 32.3 pg in the IDA, iron deficiency, anemia, and control groups, respectively. The IDA group showed significantly lower RET-He levels than the control group (P &lt; 0.001). By Pearson correlation analysis, the RET-He showed a weak positive correlation with ferritin and hemoglobin (r = 0.236, 0.274), moderate positive correlation with iron (r = 0.354), and moderate negative correlation with TIBC (r = −0.369). In addition, the average turn-around time (received-reported) of RET-He was 16.4 min, which was shorter than other biochemical markers such as ferritin, iron, and TIBC (57.7, 34.2, 34.4 min).

Conclusion
The RET-He could be an assessment of the iron actually used for the biosynthesis of hemoglobin and as a useful and rapid tool for diagnosing and monitoring iron deficiency anemia.