bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-150 Extended Pre-Analytical Stability Validation for Coagulation Tests in Brazilian Clinical Laboratory
Authors: Canali D , Fijita A , Sluzula M , Vieira L , Nakatani S , Colombini M , Silva C , Dias C , Lopes A 
Published: October 2024

Abstract

Background
The transport of samples for coagulation tests is a challenge for clinical laboratories, due to their limited stability and short time for processing according to the manufacturer's recommendations. The objective of this study was to evaluate the possibility of extending the stability of samples collected for Prothrombin Time and Activity (PTA), activated Partial Thromboplastin Time (aPTT) and Fibrinogen tests for up to 10 hours at room temperature, in comparison with the stability described in the literature and by the manufacturer of the reagents (4 hours for aPTT, 8 hours for PTA and Fibrinogen). We verified the acceptability of the samples with a longer period between collection and analysis, including its impact on the clinical management

Methods
Four tubes of 3.2% sodium citrate from 40 volunteers were analyzed at times of up to 4 h, 6 h, 8 h and 10 h. The results obtained were compared with the dosage performed within 4 hours (recommended by manufacturer) and the Total Error obtained in the analysis of the samples was evaluated. The tubes remained at controlled room temperature of 15 to 25°C and were centrifuged at 1500 g for 15 minutes. Then, the analyses were performed by coagulometric method.

Results
The results showed safety in the analysis of samples for coagulation tests even within 10 hours after collection at ambient temperature and were within the Maximum Allowable Total Error (Carmen Ricós): 95% of the PTA results (TE 5,3%); 92.2% of aPTT results (TE 4,5%) and 98% of Fibrinogen analyses (TE 13,6%) (Figures 1, 2 and 3). In addition, even the results that exceeded the specified Total Error showed no impact on the clinical decision.

Conclusions
The study demonstrated that there was no significant loss of stability for the analyses of PTA, aPTT and Fibrinogen performed on samples kept at room temperature within 10 hours after collection. Most of the results showed variation within the specified Total Error and all results showed acceptability from a medical point of view
A-158 Multi-site verification and performance of body fluids in-between Horiba Medical Yumizen h2500 with Sysmex XN-10 automated hematology analyzers and manual microscopy for morphology assessment
Authors: Hege M L 
Published: October 2024

Abstract

Background
The analysis of body fluids plays an important role in the diagnosis and management of a wide variety of conditions. As standards for method validation and laboratory developed tests evolve, the body fluids analysis is receiving increased attention from both laboratories and regulatory bodies. We present the evaluated result of the validation and clinical performance accuracy of HORIBA Medical Yumizen H2500 analyzers as compared to SYSMEX XN-10 analyzers and to manual slide microscopy examination as a reference method for differential analysis for body fluids samples.

Methods
Depending on each laboratory collected procedures, synovial samples were collected with Sodium Heparin or K2EDTA or without anticoagulant and the other samples were collected with K2EDTA or without anticoagulant. As recommended, most (94%) of the synovial fluids were treated with the hyaluronidase. For the comparison of Yumizen H2500 versus XN-10 analyzers, the study was performed in 2 US sites and 1 French site collecting 390 samples totally: 138 serous fluids (Ascites, Pleural, Peritoneal, Pericardial), 169 synovial fluids and 83 CSF fluids. Samples were analyzed as soon as possible after collection (with a limit of 24 hours for serous and synovial fluids and 4 hours for CSF) and within 2 hours between both instruments. For the comparison of Yumizen H2500 versus reference method (manual microscopy), the study was performed in 2 US sites collecting 58 samples: 34 serous fluids (Ascites, Pleural, Peritoneal, Pericardial), 12 synovial fluids and 12 CSF fluids. Two qualified morphology examiners made the manual microscopy analysis and the average of the results of the 2 slide readings was used for the analysis.

Results
Considering all types of body fluids, the H2500/XN results are very well correlated for BFWBC (0.969), BFRBC (0.999), BFMN% (0.912), BFMN# (0.89), BFPN% (0.912), BFPN# (0.97). Similarly, the statistical analysis per body fluids type shows very good correlation. For serous type, all results are higher than 0.876, for synovial type all results are higher than 0.879 and for cerebrospinal fluids type, all results are higher than 0.788. Among all samples, less than 8 samples (&lt;2%) were out of the 95% interval. The comparison Yumizen H2500 versus manual microscopy, all the correlation results (r²) are very good: 0,9705 for Polynuclear and 0,9742 for Mononuclear. The study demonstrated better results of Yumizen H2500 versus manual microscopy than versus XN-10 for BFPN% (0.9705 versus 0.912) and BFMN% (0.9742 versus 0.912). Among 58 samples, only 4 (6.9%) were out of the 95% interval for BFPN% and BFMN%.

Conclusions
The Yumizen H2500 results for body fluid WBC differentiation (Polynuclear and Mononuclear) are very well correlated with the results from manual slide microscopy evaluation. The comparison of the results analyzed on Yumizen H2500 and on XN does not show any significant difference.
A-171 Novel Fluorometric Assay for Pediatric Anti-Factor Xa Testing: Minimizing Bilirubin and Hemolysis Interference in Whole Blood
Authors: Pamula V , Basmajian M , Ullal A , Nichols L , Adhikari S , Moser M , Emani S , Emani S 
Published: October 2024

Abstract

Background
High bilirubin levels are common in pediatric patients and are noted in patients undergoing extracorporeal membrane oxygenation (ECMO). Acute anticoagulation therapy necessitates frequent monitoring of anti-Factor Xa activity (aFXa), and high bilirubin levels cause interference in chromogenic assays. Moreover, large volumes of blood lead to iatrogenic anemia in pediatric and neonatal patients. We developed a fluorescence assay to measure aFXa activity on a near-patient digital microfluidic (DMF) platform using low volume whole blood samples (&lt; 50 μL) and present the results of interference of bilirubin and hemolysis on aFXa activity.

Methods
aFXa assay was performed on a DMF cartridge wherein 50 μL whole blood was loaded into the cartridge which separates plasma droplets through agglutination within the cartridge followed by incubation with a droplet containing exogenous FXa and a fluorogenic substrate. The fluorescence is inversely proportional to the concentration of heparin in the sample. All required reagents for the aFXa assay are dried within the cartridge, allowing for integrated sample preparation and assay automation for point of care use. To test the interference of bilirubin, we spiked into whole blood different concentrations of unconjugated bilirubin, ranging from 0-40 mg/dL. We also tested hemoglobin interference by testing 4 different concentrations of hemolysate (0-1,000 mg/dL) on the aFXa assay. All experiments were performed with 6 replicates of each concentration.

Results
Across each bilirubin concentration, we saw uniform measurements of aFXa activity (see Table). We observed &lt; 5% CV in aFXa activity with 0, 13.33 and 26.67 mg/dL bilirubin levels. All measured unfractionated heparin values for hemolysate interference were &lt;5% CV.

Conclusions
Our interference results suggest that high bilirubin and hemolysate levels do not interfere with our novel aFXa fluorescence assay. Further clinical studies are underway to establish clinical performance.
A-172 Feasibility of PT, aPTT, and Fibrinogen on a Multifunctional Digital Microfluidic Cartridge
Authors: Pamula V , Ceasrine A , Ruddiman C , Caudle B , Ng R 
Published: October 2024

Abstract

Background
Excessive bleeding is prevalent in severe trauma patients, and measurement of multiple coagulation parameters is vital to correcting coagulopathy and improving outcomes. There are no rapid, near-patient technologies that can perform multiple coagulation assays simultaneously on a single consumable. We are developing a point-of-care digital microfluidic (DMF) platform to test three critical coagulation markers: prothrombin time (PT), activated partial thromboplastin time (aPTT), and fibrinogen.

Methods
Five proficiency testing plasma samples were obtained from the College of American Pathologists (CAP) with normal, intermediate, and prolonged response of PT and aPTT, and normal and elevated fibrinogen levels. After loading 10 μL of sample onto the cartridge, autonomous digital microfluidic operations divided the sample into three droplets, which were then combined with reagents for PT, aPTT or fibrinogen. The viscosity of these droplets, measured from the electrical impedance on a toaster-sized instrument, changes at a rate proportional to the amount of coagulation precursors present from which time/activity was calculated.

Results
Classification of samples into normal, intermediate or prolonged categories along with the respective times obtained from the DMF cartridges matched those obtained on the Stago Compact Max instrument (Figure). We also demonstrated separation of plasma from whole blood within the DMF cartridge using agglutinating reagents, enabling an easy-to-use workflow without the need for centrifugation.

Conclusions
Our preliminary results demonstrate that PT, aPTT and fibrinogen can be measured on a single cartridge with performance similar to comparator methods, with a time to result of &lt;15 minutes. To our knowledge, this is the first time these 3 assays have been performed simultaneously on a single consumable and furthermore, this is the first time viscoelastic tests have been performed on a multifunctional instrument that also performs chemistry and molecular tests. Studies are underway to evaluate analytical and clinical performance.
A-173 Evaluation of Artificial Intelligence (AI)-assisted Flow Cytometry Analysis for Plasma Cell Neoplasms
Authors: Yeager T , Lyu Y , Lu Z , Morita M , Wang Z , Fan G 
Published: October 2024

Abstract

Background
Flow cytometry plays a critical role in diagnosing hematologic disorders, yet manual analysis is time-consuming and prone to variability. Significant advancements in artificial intelligence (AI) within healthcare have occurred in recent years. Previously, we developed and evaluated an AI-assisted automated system for diagnosing acute leukemia. This study aims to assess the effectiveness of the AI system in diagnosing plasma cell neoplasms.

Methods
A total of 76 bone marrow samples were analyzed using a panel of antibodies (CD38, CD56, CD138, Kappa, and Lambda) to determine plasma cell percentages and immunophenotype. All samples were used for initial diagnosis of plasma cell neoplasm or therapeutic monitoring. Manual analysis using Kaluza™ software served as the gold standard. The same flow cytometry data was processed by the AI software (DeepFlow™) for comparison. Pearson correlation coefficients were used to compare AI and manual analysis for diagnosis and plasma cell count.

Results
Among the 76 cases, manual analysis identified 57 positive cases for monoclonal plasma cells (36 cases of CD38+/CD138+/Kappa+ and 21 cases of CD38+/CD138+/Lambda+), with 89% showing aberrant CD56 expression. AI identified 49 monoclonal cases, missing 8 cases with low plasma cell levels (&lt;0.07%) or brighter fluorescence. AI accurately matched 97% of immunophenotypes with manual analysis. Pearson correlation coefficients demonstrated excellent correlation (r=1.0) between manual and AI plasma cell percentages. Furthermore, AI has also enhanced laboratory efficiency, reducing analysis time per case from 10 minutes with manual methods to just 3 minutes with AI analysis.

Conclusions
This study shows promise for AI-assisted flow software in diagnosing plasma cell neoplasms. AI has enhanced operational efficiency by reducing the manual processing and analysis time. Further training is needed to improve the identification of variations in fluorescence intensity and low plasma cell levels.
A-174 Comparison of Bleeding Risk Scales in Elderly Patients With Persistent Atrial Fibrillation
Authors: Menendez Mite A R , Camacho F , Vaca R , Valverde A 
Published: October 2024

Abstract

Background
Atrial fibrillation is a significant cause of thromboembolism and sudden death in the world making anticoagulant treatment a cornerstone; however, it is associated with bleeding risk. Currently, there are no studies in Ecuador that support the prognostic validity of the recent bleeding risk scales, as well as the lack of research to discover novel methods that are applicable and more accessible to use within the medical care setting.The Hemorr2hages, ORBIT and ATRIA scores represent a promising approach for those health centers that do not have INR available and consequently cannot measure risk through HASBLED (internationally recommended score). In this way, hemorrhagic events can be prevented in patients with atrial fibrillation with anticoagulant treatment without exception. Our main goal is to compare the predictive bleeding risk scores of 3 scales (Hemorr2hages, ORBIT, ATRIA) versus traditional HASBLED score.

Methods
In this retrospective cohort study, we assessed chronic persistent atrial fibrillation in 100 patients using the electronic medical records in an outpatient clinic in Guayaquil, Ecuador. We calculated 3 bleeding risk scores for each patient according to the variables measured in each one of them and used those to compare the categories against HASBLED’s. A Pearson correlation index was obtained, and ROC performance curves were made. P value &lt;0.05 was deemed statistically significant.

Results
Of the 100 patients included, 65% were males, and mean age was 75±10.73. We reported only 6% bleeding events during the follow up. According to HASBLED score: 31% were at high risk. In comparison: 40% and 37% were also at high risk in Hemorr2hages and ATRIA scores, respectively. HASBLED was fairly correlated with Hemorr2hages and ATRIA scores (Pearson’s R: 0.617, p:&lt;0.001; R:0.528, p:&lt;0.001, respectively). Only 22% were classified at high risk by the ORBIT score. ROC curve analysis showed ORBIT’s AUC was 0.963, while Hemorr2hages, ATRIA and HASBLED were 0.931, 0.925, and 0.732 (p:&lt;0.001), respectively.

Conclusions
In our sample, ORBIT score was better correlated with bleeding episodes than the other scales. This a promising approach for those health centers that do not count with INR reactive materials available for it to be measured at their laboratories. Further research is needed to accurately analyze whether criterion included in ORBIT score might predict bleeding scores better than HASBLED, Hemorr2hages and ORBIT tools; since the items required to calculate it are more readily accessible.
A-176 Do you have a hemoglobin variant?
Authors: Fan S 
Published: October 2024

Abstract

Background
Hemoglobinopathies are the most common genetically inherited red blood cell disorder. While there are more than 1,000 hemoglobin variants currently identified, the most common ones include hemoglobin S, Hemoglobin C and hemoglobin E. Patients with homozygous variants are usually identified at young age due to symptoms, whereas patients with heterozygous variants (carriers) can be undiagnosed due to clinically benign nature. Although at low risk, extreme conditions such as high-intensity physical activity can lead to serious health issues in sickle cell trait (carriers). Moreover, children from carrier parents may have homozygous conditions that can produce devastating consequences. This study is to find out a rough estimate of patients’ awareness of their own carrier state of a hemoglobin variant in the population of our medical center.

Methods
Hemoglobin A1c (HbA1c) is performed on the BioRad D-100 in our laboratory. It is a HPLC-based technology, similar to the BioRad VARIANT II that performs the hemoglobin variant analysis with the Beta-Thal program. Although HbA1c results are not based of any peaks after A0, any variants, if present, are marked in designated windows. A medical chart review is performed, and if the condition of hemoglobin variant is not mentioned, it is considered as “undiagnosed”, and vise versa.

Results
In the duration of 95 days, a total of 35684 HbA1c samples were analyzed. Of those, 491 samples (1.4%) were marked with hemoglobin variant present. The rest of the samples (98.6%, n=35193) had no hemoglobin variant marked. Of the 491 samples marked with variants, hemoglobin S accounted for 72.5% (n=356), hemoglobin C accounted for 19.1% (n=94), hemoglobin E accounted for 4.9% (n=24), and the rest were marked with various hemoglobinopathies (3.5%, n=17). In any category, vast majority of the patients were “undiagnosed”, ranging from 85% to 100%. Only 8% to 15% of the patients were aware of their hemoglobin variant. There is no difference of awareness in different age groups, either, given that hemoglobin variants are included in the Newborn Screen Program in most states. One patient, at age 55, with hemoglobin C disease (HbCC) was undiagnosed.

Conclusions
Although most patients who are carriers of hemoglobin variants can have a normal life and often go undiagnosed, it still poses risks in specific situations. Sickle cell trait patients are under risks at high-intensity physical activity. Carriers of hemoglobin C and hemoglobin E often have microcytosis but are misled as iron-deficiency anemia. Screening of hemoglobinopathies has become increasingly important in antenatal diagnosis and prevention of hemoglobin disorders.
A-178 Quality Improvement of Cystic Fibrosis-Related Diabetes Screening at a Large Pediatric Center
Authors: Chokkalla A , Tuley P , Kurtca M , Ona H , Ruiz F E , Devaraj S 
Published: October 2024

Abstract

Background
Cystic Fibrosis Foundation guidelines recommend annual diabetes screening by oral glucose tolerance test in pediatric patients with cystic fibrosis starting at the age of 10 years. Adherence to these guidelines proves to be challenging, and the nationwide screening rates are still considered suboptimal. The aim of this study is to assess and improve the screening rates at our large pediatric center.

Methods
A four-year retrospective audit of oral glucose tolerance test completion among pediatric patients with cystic fibrosis of age &gt;10 years who have not yet been diagnosed with diabetes was conducted. A collaborative working group with the cystic fibrosis center was formed to identify the barriers to screening (Figure 1) and formulate a quality improvement plan, which was evaluated for a 9-month period post-intervention. The 3 key interventions included: 1) scheduling annual summer labs for all the eligible patients, 2) best practice advisory to guide providers with oral glucose tolerance test ordering, and 3) a streamlined process for oral glucose tolerance test appointments at the outpatient lab.

Results
The diabetes screening rates determined by oral glucose tolerance test completion at our center showed a gradual decline during the COVID-19 pandemic from 2019 to 2022. Following the implementation of the quality improvement plan during the summer of 2023, there was a marked increase in test ordering compliance by the provider as well as test completion by the patients. Notably, the fractional test completion rate rose from 45% during the pre-intervention phase (January-April, 2023) to 70% during the post-intervention phase (May-September, 2023).

Conclusions
Diabetes screening in pediatric patients with cystic fibrosis can be effectively improved by refining the practices related to patient experience, care coordination and laboratory testing strategies.
A-187 Program for Recognition of Patient Safety Cores in Diagnostic Services
Authors: Dias C , Marques F A , Morales A M , Canali D G , Teixeira M R , Mata L S , d. Melo G , Godoi C T , Quiarato P A , Maximo A C 
Published: October 2024

Abstract

Background
Health services are complex and challenging structures, including diagnostic services. Therefore, it is everyone's responsibility to ensure patient safety. The scope of this study is to present the challenges and opportunities in structuring the Quality Management and Patient Safety System (QM&PS) of a large diagnostic service that culminated in the first laboratory to receive the Patient Safety Core Recognition Seal (NSP), a program established by the partnership of QGA (Quality Global Assurance) and IBSP (Brazilian Institute for Patient Safety).

Methods
The restructuring of the QM&PS began in 2018 and since then, 6 NSPs have been established, distributed across 6 regions of the Brazil, with procedures, regulations, confidentiality agreements, and responsibilities clearly defined. The NSP are multidisciplinary and discuss 13 safety indicators monthly, namely: adverse events, contrast extravasation, falls and faints, reactions to medications, contrasts, and vaccines, immunization errors - vaccine application and exchange, loss of noble samples, technovigilance, and pharmacovigilance. With an engaged and participative Medical Board, the Patient Safety Committee was created in 2020, with the participation of top management and representatives of strategic leaderships to discuss cases of serious adverse events and deaths with systemic outputs and plans. In 2022, we conducted the first Patient Safety Perception Survey, from which we extracted insights to further develop the safety culture. Six working groups were organized focusing on interaction between company committees and programs, institutional communication for sharing information and Patient Safety initiatives in the organization, identification, prevention, and monitoring of incidents, risk management tool for analysis of clarity, application, and relevance of use as support for management and continuing education.

Results
The working groups involved 58 professionals and resulted in 65 implemented actions. Among the main results achieved, we can highlight the implementation of the rapid response flow to SAE (serious adverse event), Just Culture Policy, Disclosure Protocol, Second Victim Care Flow, Safety Rite in Customer Service Units, Patient Safety Trail, Institutional Communication, and the Patient Safety Core Recognition Seal.

Conclusions
Patient Quality and Safety must be part of the institutional pillar, composing the Strategic Objectives to be achieved. It is necessary to engage the organization and rely on the involvement of leadership and physicians. As a large service, our biggest challenges are demonstrating the effectiveness of implemented improvement actions in the face of identified risk modifications, defining strategies to reduce underreporting, and being able to involve all collaborators and operational teams in the safety culture.