bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-079 Analytical Assessment of Abbott’s SigmaSTRONG assays on the Alinity c and ARCHITECT c Systems
Authors: Cox S , James T , Allott K , Ervankai R , Potter G H , Allen G , Lapić I , Komljenović S , Bogić A , Rogić D 
Published: September 2023

Abstract

Introduction
Clinical chemistry assays are responsible for 57% of all core lab testing (1) as a result there is an ever-increasing demand to improve the accuracy and reliability of results in clinical laboratories. Sigma metrics have proven to be powerful tools for quantitatively evaluating clinical assay and instrument performance. The Sigma performance of an assay is calculated from the formula (TEa-Bias)/CV. To address modern clinical laboratory performance requirements Abbott has developed and launched a portfolio of clinical chemistry assays under the brand name Sigma STRONG ™ which claim to achieve world class performance with a Sigma Metric of ≥6 for 86% of products within this portfolio (2). The purpose of this study is to assess these assays against Abbott’s products requirement (PR) for precision and method comparison.

Methods
Assay precision (%CV) studies were performed based on guidance from CLSI EP05-A3 using 2–3 levels of commercially available serum-based control material. Method Comparison (MC) studies were performed based on guidance from CLSI EP09-A3 using the Passing-Bablok regression method. Assays under investigation were assessed for performance on either the Abbott Alinity c or Abbott ARCHITECT c systems.

Results

Conclusion
This study has confirmed the sigma STRONG ™ assays, under assessment, have met Abbott’s product requirement for both precision and method comparison.
A-091 Assessing the Reliability of Creatinine-Estimated Glomerular Filtration Rate in Living Kidney Donor Candidates: Does it Measure up to the Measured Rate?
Authors: Lahorewala S , Yi X , Bertholf R 
Published: September 2023

Abstract

Background
A living donor kidney transplant is the best therapy option for patients with end stage renal disease (ESRD); however, it is associated with an increased risk of ESRD development in the donor. Thorough evaluation of the donor candidate’s kidney function status is essential for the appropriate selection of candidates with minimal risk of post-donation kidney dysfunction.

Methods
Glomerular filtration rate (GFR) values measured by iohexol plasma clearance (mGFR) and estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) creatinine equations (eGFR), with and without the race factor (2009 and 2021 CKD-Epi equations, respectively), were compared in a cohort of 303 kidney donor candidates. GFR values were analyzed using Bland-Altman plots, linear regression, Mann–Whitney U-tests, and p10 and p30 values.

Results
Bland-Altman analysis revealed a lack of agreement between the 2009 and 2021 CKD-Epi eGFR and corresponding mGFR values, with both equations showing a negative bias of 10–11 mL/min/1.73 m2 and indicating an underestimation of creatinine-eGFR. eGFR underestimation was confirmed by Mann Whitney U analysis; median GFR values were significantly lower for both CKD-Epi equations as compared to corresponding iohexol-measured values (2009: 85.86; 2021: 87.29; mGFR: 96.58). Despite the overall underestimation, over 14% of donor candidates with eGFR &gt;90 mL/min/1.73 m2 had an mGFR value &lt;90 mL/min/1.73 m2. Conversely, 36%–38% of donors with normal kidney function of &gt;90 mL/min/1.73 m2 as determined by iohexol-mGFR had corresponding eGFR values &lt;90 mL/min/1.73 m2. eGFR showed a significant but poor correlation with mGFR, with R2 values of 0.2775 and 0.2803, respectively. While the 2021 eGFR equation had better accuracy as compared to the 2009 equation (p30 of 81% vs 76%), it displayed low overall accuracy with a p10 of &lt;43%. Separate analysis of Black donor candidates’ eGFR and mGFR values revealed similar trends as observed for the total cohort. While exclusion of the race factor in the 2021 CKD-Epi equation slightly improved accuracy (p30 of 77% vs 72%), the correlation with mGFR remained poor for both equations (R2: 0.1455 and 0.1377 for the 2009 and 2021 equations, respectively).

Conclusion
The results of this study confirmed that creatinine-eGFR values, regardless of the race factor, differ significantly from iohexol-mGFR. Our data shows that even potential kidney donors with eGFR &gt;90 mL/min/1.73 m2 cannot be presumed to have normal kidney function, while eGFR &lt;90 mL/min/1.73 m2 cannot accurately exclude donor candidates. We conclude that creatinine-eGFR cannot reliably serve as a substitute for mGFR in the context of living donor kidney function evaluation.
A-098 Preliminary Tests of Cell Viability, Proteins and mRNA after Freezing PBMC for the Study of Chronic and Acute Lymphoproliferative Leukemias
Authors: Feres M C , Soares L V , Roz S D , Souza O F , Vicari P , Cabral C C , Ramadan D R , Tufik S , Popi A F 
Published: September 2023

Abstract
The peripheral blood mononuclear cells (PBMC) cryopreserved are widely used in human immunology. However, PBMC, like other cell types, are sensitive to the freezing process. The impact of cryopreservation on T and B cell subsets of PBMC remains a challenge. For human PBMC, some reports have not observed significant changes between fresh and frozen cells in terms of proportions, phenotype and functionality, as well as antigen-specific responses or response to mitogens. Others, however, report that cryopreservation alters the proportions of human PBMC subsets in various immune responses. With the interest of studying chronic and acute lymphoproliferative leukemias (CLL and ALL), the authors’ objective was to test the viability of PBMC cells obtained from patients with CLL and ALL before and after freezing, following a simplified protocol.

Methods
On blood samples collected in EDTA, readings and cell counts were performed. Samples with a suggestive diagnosis of CLL and ALL were selected for the separation of PBMC whose analyzes were performed before and after freezing. The freezing of the PBMC was carried out in several stages and the whole process is carried out with care and in a gradual and simplified way of freezing until reaching the liquid nitrogen phase. Cells were kept frozen in freezing medium (RPMI plus 3% DMSO and 20% fetal bovine serum) for 1 week. Afterwards, staining with Trypan blue and counting in a Neubauer chamber were carried out. Student’s t test for independent variables and a significance level of 5% were considered.

Results
Table 1.

Conclusion
The description of this technique allows its use for analysis of gene expression profile, being able to contribute with the description of the molecular signature of leukemias.
A-101 Assessing Glycemic Control in Potential Blood Donor at the Blood Bank of the University College Hospital, Ibadan, Nigeria
Authors: Ogunleye T D 
Published: September 2023

Abstract

Background
Voluntary blood donation exercise remains one the safest means of sourcing for blood product made available for patients. However, there are several eligibility criteria put in place before a prospective donor can be accepted for donation exercise. One of the eligibility criteria not commonly considered is the glycemic control of a donor. This is because pooly controlled diabetes being treated with insulin or a patent with type 1 Dm is considered unfit for blood donation. This study carried out was to determine gycemic control of the prospective donors by assaying their HBA1C levels before blood donation at the blood bank of the university college hospital, Ibadan, Nigeria.

Methods
Venous blood of the prospective donors was collected during the screening exercise that precedes blood donation to determine eligibility. The blood was for the assay of HBA1C was collected into EDTA bottle and analysed using spectrophometric method. A total number of 184 prospective donors were screened within a period of three weeks. Any result that falls between 4.0%–5.6% was considered normal, 5.7%–6.4% was considered Pre-diabetic while results that are greater than 6.5% were considered diabetic and likely not fit for blood donation.

Results
A total number of 184 apparently healthy young adult between the ages of 19 and 45 years were screened. Out of the 184 prospective donors, 42 (22.8%) of the population were female, the remaining 142 (77.2%) were male. I56 (84.7%) of the population screened had normal gycemic control between 4.0%–5.6% while 20 (15.2%) of the population had a pre-diabetic results (5.7%–6.4%). The reaming 2 (1.1%) prospective donors had poor glycemic control (&gt;6.5%). This suggests that most of the donors had good glycemic control.

Conclusion
As much as a good attention is placed on other eligibility criteria for blood donation attention should also be placed on the glycemic control of donor for the safety of both the donor and the recipients of blood products.
A-112 A Consensus Reference Range for Ionized Magnesium
Authors: Begos D 
Published: September 2023

Abstract

Objective
Ionized magnesium (iMg) is the physiologically active form of the analyte. Despite this, clinical adoption of iMg is infrequent, and there is only one commercially available analyzer that measures iMg. There are now numerous studies that have examined iMg levels in healthy individuals, and this report will summarize their findings and report a consensus reference range.

Relevance
Although reference ranges may vary based on population and location, among other factors, a baseline reference range is an important starting point to introducing a new test to any laboratory.

Methods
A literature search was performed using the search term “ionized magnesium”. Papers with reference ranges for healthy individuals measured by ion-selective electrodes were selected and an attempt was made to establish a reference range for adults and children.

Results
A total of 10 studies were identified, with 422 healthy individuals [1–10]. There were 322 adults and 100 children. Studies looked at venous samples and serum samples. Venous samples were anticoagulated with lithium heparin.Reference ranges for adults and children are shown below: To convert from mg/dL to mmol/L multiply by 0.41. To convert from mg/dL to MEq/L multiply by 1.22.

Conclusions
Although a large-scale study would be helpful in determining a more precise reference range, there is reasonably good agreement among studies evaluating iMg reference ranges in healthy adults and children. Further work to evaluate differences among different age groups, genders, and ethnic groups would be helpful to clinicians and researchers. There has been a call for updating reference ranges for total magnesium, as there is a wide variation in reported ranges [11].
A-125 Analytical Performance of Chemistry Assays Comprising the Basic Metabolic Panel on the Atellica CI 1900 Analyzer
Authors: Bogard A , Gupta P , Kellogg J , Ostolaza-Venegas K , Singh S , 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 utilizing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica CH Urea Nitrogen (UN_c), Creatinine (CREA_2), Enzymatic Creatinine (ECre_3), A-LYTE™ Multisensor (IMT Na K Cl), Carbon Dioxide (CO2_c), Glucose Oxidase (GluO), Glucose Hexokinase_3 (GluH_3), and Calcium_2 (CA_2) assays* on the Atellica CI 1900 Analyzer*.

Methods
The Atellica CI 1900 CH UN_c, CREA_2, ECre_3, IMT Na K Cl, CO2_c, GluO, GluH_3, and CA_2 assays use the same reagents and calibrators as the Atellica CH 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 and Atellica CI 1900 Analyzers.

Results
Representative precision and MC results are listed for each assay in the table. Over the 10 assays tested, repeatability and within-lab %CVs were &lt;5.0% and &lt;6.0%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1.

Conclusion
Evaluation of the Atellica CH UN_c, CREA_2, ECre_3, IMT Na K Cl, CO2_c, GluO, GluH_3, and CA_2 assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica CH Analyzer.
*The products mentioned are not commercially available in all countries. Their future availability cannot be guaranteed.
A-127 Bias and Precision of a NMR-based GFR Estimating Equation in Kidney Transplant Recipients
Authors: Schwäble Santamaría A N , Meeusen J , Lieske J , Scott R J , Robertson A N , Grassi M , Schiffer E 
Published: September 2023

Abstract

Background
An accurate and reliable measurement of glomerular filtration rate (GFR) is essential to monitor for rejection and disease progression post-kidney transplantation. Measured GFR (mGFR) is the current gold standard. However, it has scarce availability at many centers and is labor intensive. Newer estimated GFR (eGFR) methods containing cystatin-C and/or other biomarkers have not been clinically validated in a post-transplant cohort. In this study, we evaluated a new NMR-based GFR (GFRNMR) equation that contains serum creatinine, cystatin C, myoinositol, and valine in post-kidney transplant recipients in a clinical routine setting.

Methods
Venipuncture for serum collection was performed immediately prior to mGFR measurement with urinary iothalamate clearance in 67 post-kidney transplant recipients. Serum was stored at 4°C and measured by NMR no later than four days after collection. eGFR was assessed using the following equations: i) GFRNMR, ii) CKD-EPI2021Cr (creatinine) and iii) CKD-EPI2021Cr,Cys (creatinine and cystatin-C). Bias was calculated as “eGFR—mGFR” for all equations. The Bootstrap method was employed to assess pairwise significance levels between bias distributions interquartile ranges (IQR), and P-value correction was determined with the Benjamini & Hochberg method. Precision, which was defined as percentage of samples within ±30% and ±15% from the mGFR value (P30 and P15, respectively), was calculated for each equation. Pairwise comparisons were made using McNemar’s Chi-squared and Benjamini & Hochberg correction. Precision was defined as the proportion of eGFR values concordant with mGFR values by CKD clinical stage.

Results
P30 for GFRNMR was significantly higher than CKD-EPI2021 Cr,Cys (97% vs 84%, P &lt; 0.01) and higher than CKD-EPI2021 Cr (88%, P = 0.08). Similarly, P15 for GFRNMR was 63%; higher than for CKD-EPI2021 Cr (54%, P = 0.35) and CKD-EPI2021 Cr,Cys (51%, P = 0.19). Bias IQR for GFRNMR was 9.5 mL/min/1.73 m2 (median bias 2.0 mL/min/1.73 m2); significantly smaller than for CKD-EPI2021 Cr (Bias IQR 15.55 mL/min/1.73 m2, P &lt; 0.05; median bias 1.47 mL/min/1.73 m2), and smaller than CKD-EPI2021 Cr,Cys (Bias IQR 14.4 mL/min/1.73 m2, P = 0.09; median bias 2.3 mL/min/1.73 m2). A broad range of medications such as immune modulators, and comorbidities such as hypertension, thyroid dysfunction, and coronary artery disease, did not interfere with GFRNMR performance.

Conclusion
NMR-based eGFR was less biased, more precise, and more accurate compared to creatinine and cystatin-C CKD-EPI eGFR equations in a post-kidney transplant setting. These findings suggest GFRNMR may more closely resemble mGFR in post-transplant patients and warrants further study on its potential use to improve clinical management in this patient group.
A-129 Analytical Performance Evaluation of Vitamin D, Intact Parathyroid Hormone, and Inorganic Phosphorus on the Atellica CI 1900 Analyzer
Authors: Freeman J , Aleo R , Tyler C , Valdivia B , Rhea-McManus J , Leipold H , Snyder J 
Published: September 2023

Abstract

Background
The Atellica® CI 1900 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 IM Vitamin D (VitD) and Intact Parathyroid Hormone (PTH) and Atellica CH Inorganic Phosphorus (IP) assays* on the Atellica CI 1900 Analyzer*.

Methods
The Atellica CI 1900 VitD, PTH, and IP assays use the same reagents and calibrators as the Atellica IM VitD and PTH and CH IP 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 (VitD and IP) or plasma (PTH) 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. Native and contrived human samples were analyzed using the Atellica IM VitD and PTH assays on both the Atellica IM and Atellica CI 1900 Analyzers. For IP, native and contrived human samples were analyzed using the Atellica CH IP assay on both the Atellica CH and Atellica CI 1900 Analyzers.

Results
Representative precision and MC results for each assay across indicated sample ranges are listed in the table. For the three assays tested, repeatability and within-lab %CVs were &lt;4.5% and &lt;10%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1.

Conclusion
Evaluation of the Atellica IM VitD and PTH and Atellica CH IP assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on their respective Atellica IM and Atellica CH Analyzers.
*The products/features mentioned are not commercially available in all countries. Their future availability cannot be guaranteed.
A-157 Evaluation of Cellular Stability in Bone Marrow for Flow Cytometry Analysis
Authors: Correa Wengerkievicz Lopes A , Sousa I , Muniz Ribeiro Franzon C , Oliveira Martin Wagner A 
Published: September 2023

Abstract

Background
Plasma cells are sensitive and can rapidly deteriorate after sample collection or due to roughhandling. Delayed sample processing remains a common challenge due to logistical limitations.Specialized tests performed in central pathology laboratories are frequently located aconsiderable distance from healthcare providers. According to the Clinical Flow CytometricAnalysis of Neoplastic Hematolymphoid Cells; Approved Guideline-Second Edition, BM samplescollected in EDTA anticoagulant should be analyzed within 12 to 24 h. The objective of thisstudy was to define the stability of a bone marrow (BM) sample within 48 h through theevaluation of the main cell populations with a focus on plasma cells.

Methods
Nineteen bone marrow samples (without the use of preservative medium) were evaluated at 0, 24 h and 48 h, collected in EDTA anticoagulant and stored at 4°C before processing. To definethe stability of the samples, the MFI (mean fluorescence intensity) was evaluated. The samplepreparation protocol was performed based on the monoclonal gammopathy screening panel attime 0 (CD38 FITC, CD138V500; CD45V450; CD19PECY7, CD56PE, CD27PERCP and KAPPA APCand LAMBDAAPCH7), and at times 24 h and 48 h it was performed a panel with anchor markers (CD45V450, CD19PEcy7, CD38FITC, CD138V500, CD56PE), acquisition in FACS CANTO II and FACSLyric equipment and data analysis performed with Infinicyt software. To assess the impact ofsample storage and the MFIs of individual markers, positive reference populations wereanalyzed using the antigen CD38 for plasma cells, CD19 for B lymphocytes, CD56 for NK cells andCD45 for other populations. Statistical analysis was performed using the Paired t-test,considering statistically significant results those with P &lt; 0.05.

Results
In the present study, the evaluation at 24 and 48 h showed that the populations ofgranulocytes, B lymphocytes and plasma cells did not present a significant difference betweenthe evaluated times. The monocyte population showed a decrease of P &lt; 0.05 in the time 48 h an in the first 24 h it remains stable. In NK cells, despite P &lt; 0.05 between 0–24 h and 0–48 h, it can be observed that between 24 h–48 h the population remained stable.

Conclusion
Evaluating these results, based on the cell type of interest, different delays are acceptable.Despite the greater sensitivity of plasma cells, it was concluded that the evaluation of CD38 asan anchor marker for plasma cells can be used in up to 48 h without significant change inthe MFI evaluation for analysis of this cell with this marker. The differences found in NK lymphoidcell may be due to methodological problems, considering that the analyzed panel is not ideal forevaluating this population. Therefore, it is necessary to carry out more detailed studies for othertypes of cell populations.
A-164 Key Performance Indicators (KPIs) Can be Polluted by Add-on Tests
Authors: Ellison T , Fraser D , Cane P , James D 
Published: September 2023

Abstract

Background
Key Performance Indicators (KPIs) are a measurement of service performance which are measured frequently and can demonstrate the clinical effectiveness of services. We undertook a review of a subset of KPIs following feedback from clinicians in the emergency department that was at odds to our reported KPIs. Our reported KPIs suggested that we were not meeting the turnaround times (TATs) required (1 h from receipt in the laboratory to result availability), however the view of the clinicians was that we were achieving the KPIs needed to manage their patients. We undertook an exercise to quantify the impact of add-on tests to our published KPIs as our laboratory information systems are not able to discriminate tests that are added on at a later time from those that go though as a first pass.

Methods
We reviewed all data (February 2022) for 4 common tests requested in the Emergency Department at King’s College NHS Foundation Hospital: amylase, CRP, paracetamol and high sensitivity troponin. Through a laborious process, we reviewed all records where a test had been added on to compare the turnaround time (TAT) for tests that pass through the first time and those that are added on so that we could quantify the impact of add-ons.

Results
In the month of February 2022, we processed 754 amylase, 4014 CRP, 121 paracetamol and 1414 high sensitivity troponin tests. The highest proportion of add-on tests was experienced with troponin (9.7%), amylase (9.4%) and paracetamol (8.3%). The lowest percentage of add-on tests was CRP (1.9%). Figures to be presented will demonstrate the impact of add-on tests as compared to those that go through as a first pass yield in whisker box plot format, non-truncated.

Conclusion
Add-on tests were polluting the KPIs that we were reporting. The service was delivering a TAT that the clinicians required, however our legacy internal reporting systems were not able to discern the date/time of add-on from that of the receipt of the tube into CSR or strip out the add-ons from the KPI reports and hence the negative impact that they have on reporting.