bluuebunny/crossref_metadata_2025_split huggingface dataset:
B-029 Evaluation of the Analytical Performance of Creatine Kinase, Lactate dehydrogenase L-P, Myoglobin Assays on the Atellica CI Analyzer
Authors: Carter R H , Belth B , Ozgen N , Shalhoub V , Camacho J , Snyder J , Leipold H 
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 Creatine Kinase (CK_L), Lactate dehydrogenase L-P (LDLP), and Atellica IM Myoglobin (MYO) Assays on the Atellica CI Analyzer.

Methods
The Atellica CI assays use the same reagents and calibrators as the Atellica CH and IM assays. Precision studies were performed according to CLSI EP05-A3 using human serum 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 serum samples were analyzed using the Atellica CH, Atellica IM, and Atellica CI Analyzers. LoB, LoD, LoQ were determined according to CLSI EP17-A2.

Results
Representative precision and MC results across indicated sample ranges are listed for each assay in the table. Over the three assays tested, %CVs for repeatability were &lt;2.6% and %CVs for within-lab were &lt;4.5%. Slopes determined using the Deming linear regression model were approximately equal to 1. LoB, LoD, LoQ were 5, 8, and 15 U/L for CK_L; 2, 4, and 11 U/L for LDLP; and 3,00, 6.00, and 6.00 ng/mL (µg/L) for MYO assays, respectively.

Conclusions
Atellica CH CK_L and LDLP, and Atellica IM MYO Assays on the Atellica CI Analyzer demonstrated good precision and equivalent performance to the same assays on Atellica IM and CH Analyzers.
B-030 Performance evaluation of Siemens Atellica® IM Anti-Müllerian Hormone Assay
Authors: Shang E , Agustin H , El-Khoury J , Lee J K , Jones J , Scheidegger M , Abou-Diwan C , Rhea-McManus J , Li J 
Published: October 2024

Abstract

Background
Anti-Müllerian hormone (AMH), a glycoprotein dimer, is produced by ovarian granulosa cells and its levels have been shown to directly correlate to the number of eggs remaining in the ovaries (ovarian reserve). Thus, measurements of AMH are widely used as an aid in the assessment of the ovarian reserve in women presenting to fertility clinics. This study aimed to evaluate the performance of the Siemens Atellica® IM AMH assay and compare it to the Beckman Access AMH assay.

Methods
The Atellica AMH assay is a fully automated chemiluminescent monoclonal sandwich immunoassay, while the Beckman Access AMH assay is also an automated chemiluminescent monoclonal sandwich immunoassay. Precision and linearity were assessed for the Atellica AMH assay using manufacturer-provided standards. Inter-laboratory correlation studies were completed using deidentified patient samples collected from 120 reproductive-age women undergoing fertility outpatient evaluation at Yale New Haven Health. Blood was drawn on the first office visit for fertility workup. AMH values were initially performed at Yale University using the Beckman Access AMH assay. Serum samples were then frozen (-20°C) and shipped on dry ice to the laboratory at the Ohio State University where they were thawed and analyzed using the Siemens Atellica AMH assay. Linear regression was employed for data analysis. Overall percent agreement using an AMH cut-off value of 1.77 ng/mL was calculated. AMH values &gt;1.77 ng/mL were classified as positive and values ≤1.77 were classified as negative.

Results
The Siemens Atellica AMH assay exhibited good performance across the measuring range, with intra-assay and inter-assay coefficients of variation (CVs) ranging from 1.4% to 3.2% and 2.5% to 6.0%, respectively. The assay demonstrated linearity over the four recommended ranges (0.043-24.0 ng/mL) without significant bias observed. The Access and Atellica AMH assays demonstrated good overall agreement of 97% and were well-correlated with a R2 value of 0.9721.

Conclusions
The AMH assay was validated and routinely measured in-house using the Atellica automated assay. The Siemens Atellica AMH assay performs well across its measuring range and shows good agreement with Beckman Access AMH at the AMH cut-off of 1.77 ng/mL.
B-031 A new Ready to use Bio-Rad Quality Control to Streamline Daily Workflow
Authors: Yagoot A M , Khalil H , Alharbi M , Almalayo G , Borai A 
Published: October 2024

Abstract

Background
A comprehensive Quality Management System starts with performing a daily Quality Control (Q.C.) process. The daily Q.C. process monitors the Instrument’s optimal performance and detects shifts and trends. However, the existing traditional daily Q.C. process is not only prone to manual errors, but also time consuming, costly and labor intensive. We evaluated a Bio-Rad InteliQTM Load and go Quality Control that comes in a barcoded tube ready to be loaded. We monitored the workflow efficiency gained in comparison to the traditional quality control material that comes in glass vials.

Methods
We evaluated the new quality control material ready to load on the instrument. This new Q.C. (Bio-Rad InteliQ Assayed Multiqual Control - 3 levels) were processed in parallel with our routine Q.C. (Bio-Rad Assayed Chemistry Lyphocheck vials - 2 levels). We performed the evaluation on Abbott Architect c8000 Chemistry analyzers in our central Laboratory (NGHA-Jeddah). The Q.C. was stored frozen. Before testing it was thawed at room temperature as per the insert instruction. Over a 5 days period, in parallel with our routine quality control, we run the new Q.C. Two times per day for 33 analytes. We monitored the processing time difference between the new and current approaches. We monitored the stability of all the analytes in the tube after Two days and again after Five days. We also monitored the cost effectiveness, labor intensiveness, probability of operator error and the overall improvement in workflow and Turn Around Time.

Results
Over the evaluation period, we observed the following: - Saving 40 minutes in average per week only for chemistry Q.C (time spent in reconstituting, mixing and aliquoting old Q.C) - 100% reduction in waste of plastic consumables such as pipette and plastic tubes. - Save an average of 1.0 ml dead volume in every 5.0 ml old Q.C. vial (20% of the volume, hence saving 20% of the total Q.C. cost). The dead volume wasted due to aliquoting step using the old Q.C. - 100% Eliminated delays caused by operator error such as wrong reconstitution, inadequate mixing and wrong Q.C. aliquoting. Not needed for the InteliQ. - High score of staff satisfaction. - Stability of the 32 analytes was excellent except that of Co2, which deteriorated by 14% after Two days as indicated in the insert package. Co2 day five result deteriorated by 34%.

Conclusions
Bio-Rad InteliQ is easy to use. It saves time and cost. When combined with Unity Q.C. data management solution it can streamline Q.C. workflow, eliminate operator errors, reduce T.A.T. and increase the overall laboratory performance. It may also work optimally with Instruments that have on-board fridge for Q.C.
B-035 Atellica CI Analyzer Sample-to-sample Carryover Performance Evaluation
Authors: Kampfrath T , Diabate D , Maxwell T , Seltmann J , Shalhoub V , Lewisch S , Snyder J 
Published: October 2024

Abstract

Background
Laboratories in many parts of the world are required to demonstrate/confirm the lack of sample carryover on their analyzer under their laboratory conditions using patient populations. Sample carryover occurs when analyte adheres to the probe and/or cuvette and contaminates a subsequent sample or cuvette in the testing sequence of the analyzer. Inadequate washing of the sample aspiration/ dispensing device and cuvette can cause this type of carryover. The Atellica® CI Analyzer uses independent integration and random-access sampling to process chemistry (CH) and immunoassay (IM) tests. The immunoassays performed on the IM portion of the analyzer utilizes a single-use, disposable sample tip and reaction cuvette which reduces sample carryover from IM to CH tests, whereas a reusable probe is used for CH assays—which is washed between sampling. This study evaluated the potential for carryover of CH samples from one sample to the next due to washing protocols on the Atellica® CI Analyzer in four independent real world clinical laboratories.

Methods
Carryover verification was performed as per CLSI GP31-A:2009 and Vericheck protocols. The study was conducted at four sites (UAE, France, Croatia, U.S.) using 2 serum samples prepared in 12 sample containers-9 for low (L) and 3 for high (H) concentrations of analyte. For glucose (GluH_3), UAE, L and H were 63 and 356 mg/dL (3.5 and 19.8 mmol/L), Croatia, 77.4 and 237.5 mg/dL (4.3 and 12.2 mmol/L), and U.S., 101 and 374 mg/dL (5.6 and 20.8 mmol/L). For creatine kinase (CK_L), France, L and H were 40 and 1400 U/L. Samples were tested in a defined sequence: L1, L2, L3, H1, L4, H2, L5, H3, L6, L7, L8, L9 and results analyzed for % carryover. Carryover was defined as average of L4, L5, L6 minus the average of L1, L2, L3, L7, L8, L9 divided by the average of H1, H2, H3.

Results
No significant carryover was observed at any site. Carryover % for UAE, France, Croatia, and U.S was 0.500%, -0.085%, -0.095%, and -0.095%, respectively.

Conclusions
When using high positive samples at concentrations at or greater than the upper limit of the clinical range, negligible CH sample carryover was found from the Atellica CI Analyzers in four independent real world clinical laboratory settings.
B-037 Zeon original coating technology COP microplates for cell imaging
Authors: Ishigami T , Adachi S , Funayama S , Kotagiri K , Ichimura N 
Published: October 2024

Abstract

Background
Zeon has developed high quality microplate made of Cyclo Olefin Polymer (COP) and special coat reagent for cell culture for Aurora microplates. The new 96 well-microplates have best-in-class properties for analysis of cultured cells can reduce the background of fluorescence images absolutely and excellent bottom flatness for observation of target. This enables to obtain high-precision data for cell analysis. Also, we developed Zeon original coating (ZOC) reagent specialized for COP surface. It is suitable for various cells including neurons derived from human induced pluripotent stem cells (iPSC), primary cells, general cell lines, and so on. ZOC coated COP microplates (ZOC plates) are fully-precoated and ready-to-use.

Methods
We evaluated the following points regarding ZOC plates. The cells used were derived from human iPSC.
[1. Storage stability] ZOC plates were stored at room temperature for a long time. After that, cardiomyocyte cells were cultured for 3 days on the plates. The cell adhesion and beat rate were evaluated.
[2. Neurite extension] Dopaminergic neurons were cultured for 14 days, then the neurite extension was evaluated. For comparison, a conventional poly-D-lysine* (PDL) coating was used.
[3. Lot-to-lot variation] COP microplates coated with different lots of ZOC reagents were prepared. Glutamatergic neurons were cultured for 14 days on those plates, then the neurite extension and cell morphology were evaluated. *The typical coating reagent applied for neuronal culture.

Results
[1.] ZOC plates stored over 12 months at room temperature showed excellent cell adhesion, and the beat rate was equivalent to prepared just before use.
[2.] ZOC plates tended to extend neurites more than PDL coated plates.
[3.] No variation between lots was observed on ZOC plates regarding the neurite extension and cell morphology.

Conclusions
We suggest applying the combination of high accuracy for cell imaging using COP microplates and high performance for cell culture using ZOC can provide high precision data at bioassay research. This would be a significant value for development of drug screening processes at pharmaceutical company.
B-048 Proposal of a new monitoring algorythm for patients with a HIV positive result with the Elecsys HIV DUO test
Authors: Castro Menendez J A , Leal Leyva Y Y , Garcia Gil A 
Published: October 2024

Abstract

Background
Worldwide HIV infections remain a public health problem, contributing significantly to morbidity. In Mexico we have had a progressive adaptation to the HIV epidemic providing free therapy and testing (4th generation tests) for the whole population in anbulatory centers for HIV/AIDS prevention and medical care. During 2022 Mexico reported 12,374 new cases. In the last decade there has been an increasing interest in the identification of patients HIV positives subgroups, based on disease progression and serological features. To date, 6 generations of tests for HIV detection have been developed, strongly reducing the window period for a positive result. Elecsys HIV Duo is a 5th generation immunological test that provides in a separate manner an antibody and antigen results for HIV detection. These results show a better insight of the serologycal status reducing the window period post infection. By using these tests we want to provide an early detection of new cases that gives a better prognosis for the patient and propose a new monitoring for patients with a positive antigen result but that have not yet produced antibodies. Such algorythm is currently lacking in the Mexican public health services.

Methods
A retrospective statystical analysis of HIV results of samples procesed with the Elecsys HIV DUO test during the january-april 2023 period in the National Reference Center of Salud Digna correlated with western blot results.

Results
The study population was 6405 patients, 6340 (98.98%) had a negative result in the test and 65 (1.02%) a positive test. Based in antibody/antigen results we categorized the positives results in three grupos: Group 1 Ab positive/Ag negative (16), group 2 Ab positive/Ag positive (32) and group 3 Ab negative/Ag positive (7). When correlated with the WB results all the patients from group 1 and 2 had a positive result while all patients in group 3 had a negative result.

Conclusions
Actually Mexican public health services do not have access to 5th generation HIV tests like the Elecsys HIV DUO test, therefore, public health profesional are not qualified to interprete these results and do not have a stated algorythm for patientes belonging to group 3. Therefore and based in our results we suggest 5th generation test (or superior if available) and propose a new patient monitoring algorythm with a molecular confirmatory test for viral detection. This proposal is strongly supported by the fact the we have a population that have not generated antibodys during the first weeks of post infection and will test negative in a serologycal confirmatory test like WB. Screening for patients in early infection stages is important because if we provide early therapy which may lead to infection reversal or a less impact in C4+ T cells numbers. Studies like this provide information for the generation of public politics in benefit of the population.
B-060 Prevalence of CCD and profilins antibodies in a seasonal allergy study
Authors: De Haro T , De Haro Romero T , González Cejudo T 
Published: October 2024

Abstract

Background
Allergen sources are complex and heterogeneous mixtures of proteins, which may contain from innocuous IgE-binding structures such as CCDs (cross-reactive carbohydrate determinants), which are not associated with symptoms, to a panallergen such as profilin, which is associated with multiple sensitizations to pollen and pollen-food-latex syndromes. CCDs are present in many plant and animal allergens and cause strong cross-reactivity due to the high similarity of their structure. They complicate the interpretation of positive in vitro diagnostic results because they do not associate symptomatology and, thats why, the determination of specific IgE antibodies against CCDs can provide useful information when positive IgE results are not consistent with the clinical picture. Profilins are ubiquitous proteins present in all eukaryotic cells and identified as allergens in pollen, latex and plant foods. The highly conserved structure explains the cross-reactivity of IgE antibodies against plant profilins and their designation as panallergens. As a panallergen, profilin is associated with multiple pollen sensitization and pollen-food-latex syndromes that the allergist must be aware of for accurate diagnosis and successful treatment of allergic diseases. We intend to evaluate the prevalence of these two markers with a new diagnostic tool, since profilins and CCDs are the substances most likely to cause in vitro cross-reactivity.

Methods
In our study 8,242 adults who presented rhinoconjunctivitis and visited their primary care center were included. The samples were analyzed in serum samples which were routinely processed in our laboratory with the EUROLINE Mediterranean Inhalation 2 (IgE) assay from Euroimmun® from February to July 2023, according to the manufacturer’s protocols. Patients with specific IgE levels ≥ 0.35 kU/L were identified as sensitized to allergen.

Results
A total of 8,242 patients were enrolled in this study, 5,173 women and 3,069 men, ranging in age from 15 to 65 years. Of these, 279 patients (3.39%) had antibodies against CCD, 570 (6.92%) antibodies against profilins and 183 (2.22%) had both. A higher prevalence of these antibodies was observed in men (CCD, n = 168, 5.47%; Profilins, n = 308, 10.04%) than in women (CCD, n = 111, 2.15%; Profilins, n = 262, 5.06%). Both markers were more frequently found in the presence of specific IgE antibodies to grass and weed pollens.

Conclusions
The possibility of detecting the presence of IgE antibodies against CCD and panallergenic profilins is useful to detect cross-reactivity in vitro, which could explain the differences found between laboratory results and patients' symptoms, helping the allergist to make a diagnosis with greater certainty and accuracy.
B-063 Changes in nonalcoholic fatty liver disease and M2BPGi due to lifestyle intervention in primary healthcare
Authors: Nah E , Choi Y , Park J 
Published: October 2024

Abstract

Background
A healthy lifestyle is the most important method for managing nonalcoholic fatty liver disease (NAFLD). Mac-2-binding protein glycosylated isomer (M2BPGi) has been suggested as a biomarker for NAFLD. This study aimed to determine the efficacy of personalized lifestyle interventions on NAFLD remission.

Methods
This single-arm intervention study recruited participants with NAFLD who underwent health checkups at seven health-promotion centers in five South Korean cities. Fatty liver diagnosis was based on ultrasonography (US). The 109 individuals were recruited for personalized lifestyle interventions of hypocaloric diets and exercise. The participants attended the lifestyle intervention programs once per month for the first 3 months, and once every 3 months for the subsequent 6 months. And phone-based self-monitoring were also provided monthly during the 3-month follow-up period. The primary outcome was NAFLD remission at month 12 as measured on US and magnetic resonance elastography. The secondary outcomes were the changes in metabolic factors and M2BPGi.

Results
The 108 individuals (62 males and 46 females; age 51.1±12.4 years, mean±standard deviation) were finally analyzed after the 12month intervention. Body mass index, waist circumference (WC), blood pressure, blood lipids (total cholesterol, triglycerides, and HDL-C), and fasting blood sugar levels were improved relative to baseline (all P&lt;0.05). Fatty liver at or above the moderate grade according to US was decreased at month 12 relative to baseline (67.6% vs 50.9%) (P=0.002). M2BPGi levels decreased during the 12-month study period (P&lt;0.001). M2BPGi levels were moderately correlated with hepatic fat fraction by magnetic resonance imaging (r=0.33, P=0.05). WC (OR=0.82, 95% CI=0.67-1.00, P=0.05) and HDL-C (OR=1.17, 95% CI=1.03-1.32, P=0.014) were associated with remission of fatty liver in the multivariate analysis.

Conclusions
The personalized lifestyle intervention was effective in improving fatty liver and metabolic factors, but not hepatic stiffness, in NAFLD.
B-067 Human IgE Monoclonal Antibodies as Unique Tools for Allergy Diagnostics
Authors: Filep S , Reid Black K , Smith B , Bermingham M , Pomes A , Chapman M 
Published: October 2024

Abstract

Background
Current blood-based tests for allergy diagnosis rely on human sera or plasma as the source of IgE antibody for method validation and calibration. Obtaining human samples with sufficiently high levels of IgE presents challenges for researchers and diagnostic companies. Here, we present a unique panel of allergen-specific human IgE monoclonal antibodies (mAb) that target inhalant, food and alpha-gal allergens and offer novel approaches for investigation of IgE responses and standardization of allergy diagnostic reagents and methods.

Methods
Human IgE mAb (n=30) targeting inhalant allergens from dust mite, cat and dog; food allergens from peanut, egg, milk, walnut and cashew, and galactose-α-1,3-galactose, were generated from B cells from symptomatic allergic patients with rhinitis, asthma, atopic dermatitis or red meat allergy using hybridoma technology. Total and allergen-specific IgE were quantified by ImmunoCAP (whole allergen ImmunoCAP were also performed). Allergen binding profiles and mAb titers were determined by two-site immunoassay (ELISA). Antibody purity was assessed using SDS-PAGE and Western Blot.

Results
SDS-PAGE showed single heavy and light chain bands under reducing conditions. Antibody recognition of target allergens was confirmed by Western Blot. Allergen-specific IgE mAb concentrations for inhalant allergens ranged: 9,000-37,000 kU/L for dust mite (n=3), 2,100-53,000 kU/L for cat (n=4), 5,300-21,000 for dog (n=2). Food allergens ranged: 16,300-49,400 kU/L for peanut (n=14), 15,700-81,000 for egg (n=2), 41,600 for milk (n=1), 7,100 for walnut (n=1) and 37,000 for cashew (n=1). Alpha-gal IgE monoclonals (n=2) ranged in concentration from 15,700-81,000 kU/L. The ratios of specific IgE to total IgE measured by ImmunoCAP vary by allergen and by individual human IgE mAb. Ratios for the inhalant mAb ranged from 0.04-1.05, for the food mAb the ratios ranged from 0.33-0.99. The two alpha-gal mAb showed relatively lower specific IgE levels (average ratio was 0.14; range=0.08-0.20).

Conclusions
Monoclonal IgE antibodies derived from patients presenting with allergic symptoms may provide a reliable replacement for human sera to investigate allergic disease. IgE mAb to inhalant and food allergens, and to the alpha-gal carbohydrate epitope, provide unique diagnostic markers and will offer improved accuracy for assessing patient allergy by standardizing diagnostic reagents and methods. Crystal structures of several of the human IgE mAb epitopes have recently been reported (Pomés et al, J Allergy Clin Immunol, 2024). The current panel of human IgE mAb can be expanded to include additional allergen targets, which may lead to the development of improved allergy therapeutics.