bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-099 Assessment of Stability of Routine Clinical Biochemical Results in 24-h Urine Specimen Under Conditions Simulating Various Preanalytical Variables
Authors: Chae H , Jang H , Cha K , Oh E 
Published: September 2023

Abstract

Background
The preanalytical phase has long been recognized as a source of substantial variability for 24-h urine samples. Hence, we examined the stability of analyte concentrations of 14 clinical biochemistry parameters commonly requested in a 24-h urine sample. The effects of various preanalytical variables simulating preexamination processes of the testing process were assessed.

Methods
We aimed to examine the effect of time delay in sample processing (up to 7 days), storage temperature (at 4 °C and room temperature), storage container (24-h urine bag, styrofoam box), and the effect of addition of toluene as preservative. The effect of the variables on clinical biochemistry parameters (uric acid, calcium, amylase, LDH, total protein, urea nitrogen, magnesium, phophorus, glucose, creatinine, sodium, potassium, chloride, and micro-albumin) in 24-h urine samples were assessed.

Results
Most of the analytes (uric acid, calcium, amylase, total protein, urea nitrogen, magnesium, creatinine, sodium, chloride, and micro-albumin) showed values not significantly different (≤± 5%) from baseline after 7 days of storage regardless of the storage temperature or addition of preservative. Three analytes were stable ≤24-h: phosphorus and glucose were stable up to 24-h and potassium up to 4-h. The addition of toluene had significant positive interference with LDH measurements.

Conclusion
According to our results, major analytes (uric acid, calcium, amylase, total protein, urea nitrogen, magnesium, creatinine, sodium, chloride, and micro-albumin) were stable up to 7 days in ambient storage conditions and toluene as a preservative was not necessary. However, a few analytes (phosphate, glucose, and potassium) were much more unstable and allowed ≤24-h or ≤4-h of storage in ambient or refrigerated conditions.
A-117 Performance Evaluation of five Sentinel Diagnostics’ Assays on Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer
Authors: Cugini A , O’Meara D , Di Gennaro F , Di Rocco N , Assalini C , Lucini R , Brambilla S 
Published: September 2023

Abstract

Objective
The aim of this study is to evaluate the analytical performances of the following Sentinel Diagnostics’ assays: ACE Liquid, Lp(a) Ultra, Pancreatic Amylase, Lipase NG, Albumin BCP on the Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer.

Methods
Performance evaluation included Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity, intra assay precision, inter assay precision, calibration stability, on board reagent stability and instrument correlation, following the current CLSI guidelines protocols. Analytical Measuring Range (AMR) was defined through linearity and sensitivity.

Results
Summary of the analytical performances for all the assays tested is reported in table below.

Conclusions
All assays showed good results for the parameters tested on the Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer making these kits very suitable for a routine measurement of these analytes.
A-120 Performance Evaluation of Three Sentinel Diagnostics’ Assays on Roche Cobas c 303 Analytical Unit
Authors: De Lorenzis M , Di Gennaro F , Valdambrini M , 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 following Sentinel Diagnostics’ assays: Total Bile Acid Liquid, Copper, Aldolase, on Roche cobas c 303 analytical unit.

Methods
Performance evaluation included Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity, intra assay precision, inter assay precision, on board reagent stability, prozone effect, instrument correlation following the current CLSI guidelines protocols. Data were evaluated using Microsoft Excel statistical tool Analyse-it. Analytical Measuring Range (AMR) was defined through linearity and sensitivity.

Results
Summary of the analytical performances for all the assays tested is reported in table below.

Conclusion
All assays showed good results for all the parameters tested on Roche cobas c 303 analytical unit making these kits very suitable for a routine measurement of these analytes.
A-121 Performance evaluation of two Sentinel Diagnostics’ assays on Roche cobas c 503 analytical unit
Authors: De Lorenzis M , Di Gennaro F , 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 following Sentinel Diagnostics’ assays: Zinc, Total Bile Acid Liquid on Roche cobas c 503 analytical unit.

Background
Zinc is a component of metalloenzymes involved in nucleic acid and protein synthesis, therefore it is a necessary complement for cell replication. Acute zinc deficiency can result in skin lesions, irritability, loss of hair, growth retardation. Also impaired immunological function is associated with zinc insufficiency. Total Bile Acids (TBA) are metabolized in the liver and hence serve as a marker for liver function. Serum TBA are increased in patients with acute hepatitis, chronic hepatitis, liver sclerosis and liver cancer.

Methods
Performance evaluation included Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity, intra assay precision, inter assay precision, calibration stability, on board reagent stability, and instrument correlation following the current CLSI guidelines protocols. Data were evaluated using Microsoft Excel statistical tool Analyse-it. Analytical Measuring Range (AMR) was defined through linearity and sensitivity.

Results
Summary of the analytical performances for both the assays tested is reported in table below.

Conclusions
Both assays showed good results for all the parameters tested on Roche cobas c 503 analytical unit making these kits very suitable for a routine measurement of these analytes.
A-142 Comparison of Alinity c Hemoglobin A1c Immunoassay with Premier Hb9210 Automated HPLC Assay: Very Few Patients May be Outside Reportable Range Using Alinity c.
Authors: Walton A 
Published: September 2023

Abstract

Background
Hemoglobin A1c (HbA1c; glycosylated hemoglobin) is used for diagnosis and monitoring of patients with diabetes. In the clinical laboratory both immunoassays and high-performance liquid chromatography (HPLC) based tests are available for such measurement. We use Premier Hb9210 analyzer (HPLC method; Trinity Biotech, Jamestown, NY) for measuring HBA1c in whole blood. As our laboratory is transitioning to Abbott chemistry systems, we compared HbA1c values obtained by the Alinity c and Premier Hb9210.

Methods
The Premier Hb9210 analyzer is based on boronate affinity high performance liquid chromatography with output in 66 sec. The analytical measurement range is 3.8 to 18.5% although values as low as 2% can be reported by the analyzer but result may not be accurate. The Alinity c Hemoglobin A1c assay measures both total hemoglobin and HbA1c (enzymatic assay) in whole blood and then calculates %HbA1c. The analytical measurement range of this assay is 4 to 14% of HbA1c. Specimens cannot be diluted for Alinity c HbA1c measurement.

Results
Alinity c HbA1c has excellent total precision (0.4% at HbA1c of 5.1% and 0.25% at Hb A1c of 9.4%). In contrast, Premier HB9210 has total precision of 1.89% at HbA1c of 5.5% and 1.81% at HbA1c of 8.4%. However, analytical measurement range of Premier HB9219 is slightly wider compared Alinity c assay. Plotting HbA1c results obtained by the Premier Hb9210 analyzer in the x-axis and the corresponding values obtained by the Alinity c assay, we observed the following regression equation: y = 0.9499 x + 0.1108 ( n = 50, 0.99). The 95% confidence interval of the slope was 0.9241 to 0.9757. Rarely, we get specimen where HbA1c is between 3.8 and 4.0% (42 specimens out of 52 803 between 2/7/22 to 2/7/23; 0.08%) or above 14% (174 specimens out of 52 802; same period; 0.33%) and these specimens would not produce any result with Alinity c assay. We recently observed HbA1c result of 2.4 % in a sickle cell patient (reported as &lt;3.8% per our lab policy).

Discussion
Our result indicates that HbA1c immunoassay on the Alinity c analyzer showed values comparable to HPLC method. However, for very few patients HbA1c may exceed 14% due to uncontrollable diabetes. Because specimen cannot be diluted, real value could not be measured using Alinity c but can be measured by the HPLC method.

Conclusions
We conclude that HbA1c assay on the Alinity c analyzer is a viable alternative to HPLC for measuring HbA1c in clinical laboratory. However, for very few patients (sickle cell trait, uncontrolled diabetes), HbA1c may be outside the range of Alinity c, requiring HPLC analysis.
A-146 A Review of RDW-CV and RDW-SD Measurements in Patients With Iron Deficiency Anemia in an Acute Care Hospital in Singapore
Authors: Chen Z , Ilagan F , Heng P , Prasad V 
Published: September 2023

Abstract

Background
Red Cell Distribution Width (RDW) is a routinely available parameter on automated haematology analysers. This parameter is often used to help in the diagnosis of iron deficiency anaemia. RDW quantitatively measures the degree of anisocytosis of the red blood cells. The more common way of reporting RDW is RDW-CV, which is based on the coefficient of variation of the red blood cell distribution volume and is calculated using mean red cell volume. RDW can also be presented as RDW-SD, which is a direct measurement of the width of the red blood cell distribution curve and is not influenced by mean red cell volume. Conventionally, laboratories report RDW-CV as part of the red blood cell indices in full blood count (FBC) reports. However, it has been proposed that RDW-SD is a better indicator of iron deficiency anaemia compared to RDW-CV. The authors seek to review and assess the clinical utility of both RDW measurements in patients with iron deficiency anaemia in an acute care hospital in Singapore.

Methods
RDW data of samples from 271 unique individuals from Sysmex XN-9000 (Sysmex, Japan) automated haematology analysers over a period of two months were reviewed. These individuals were selected as they had plasma iron measured in the same blood collection. The individuals were sorted into two groups based on the plasma iron measurement: with iron deficiency (80%) and without iron deficiency (20%). The correlation of RDW-CV and RDW-SD with the plasma iron concentration of the individuals was studied. The RDW-CV reference range used were established for the local population by an in-house reference range validation study while that of the RDW-SD is from a recent Participant Summary Report for a College of American Pathologists (CAP) Hematology Automated Differential survey (FH9-B 2022). The sensitivity, specificity, predictive values, and overall efficiency of RDW-CV and RDW-SD were calculated and compared using the data collected.

Results
The sensitivity and specificity of RDW-CV in detecting iron deficiency anaemia are 45.2% and 68.5%. The positive and negative predictive values for RDW-CV are 85.2% and 23.7% respectively. The sensitivity and specificity of RDW-SD in detecting iron deficiency are 33.2% and 64.8%. The positive and negative predictive value of RDW-SD are 79.1% and 19.4% respectively. The overall efficiency of RDW-CV is 49.8%, significantly higher than 39.4% of RDW-SD.

Conclusion
This retrospective study suggested that RDW-CV is still a better blood cell index than RDW-SD in the differential diagnosis of iron deficiency anaemia in a predominantly Asian population. However, the use of RDW-SD reference range that is appropriate for the local population may improve the clinical utility of the RDW-SD.
A-160 Factor VIII Chromogenic Low Activity Sample Analysis in a Low Calibration Curve Model
Authors: de Paula R F , Ramos G R , Yanquen M , Borella C , Perez C M 
Published: September 2023

Abstract

Background
Adequate laboratorial diagnostics of hemophilia is essential and could be done by chromogenic and one-stage assays based on APTT methodologies. Adverse effects of medications became less severe recently, but it remains important to be aware of to ensure that treatment is effective and ensure the best possible conditions for affected individuals. Classification of hemophilia according to FVIII activity: mild 25%–5%; moderate, 5%–1% and severe &lt;1%. For new therapies such as emicizumab and some drugs with an extended half-life, the World Federation of Hemophilia recommends the use of a chromogenic assay of FVIII containing bovine FX for monitoring factor FVIII activity. Objetive: evaluate the applicability of a low calibration curve (LCC) in the chromogenic factor VIII (FVIII-Chr) assay by standardizing the dilution of the standard (calibrator) and thus ensuring the accuracy of the analyses in the lower values like severe hemophilia range.

Methods
The samples were obtained from H&H LAB SAS, which guarantees all requirements. Sysmex® CS 2100i Siemens Healthineers. Calibration was performed with Standard Human Plasma (SHP), together with FVIII-Chr. Quality Control (QC); the accuracy of the LCC was checked.

Results
Preparation of the LCC: SHP reconstitution, followed by 1:10 dilution between the SHP and the plasma deficient in FVIII. The curve was named FVIII-Chr Low. QC was performed through pathological control (PC) with 2 dilutions: 1) identical to the formation of the low curve, i.e., dilution 1:10 (2.3%–3.9%). 2) dilution 1:30 (0.2%–2%) to accommodate the range of activity comprising severe hemophilia. The values found confirms the curve’s quality.

Discussion
This study sought to develop a way to detect FVIII activities &lt;1.5% in a reproductive manner, even with a reduced “N” number of samples for severe state. The chromogenic test presents a limit of detection for the optical density of D.O. 0.0080 reporting &lt;0,3% FVIII-Chr activity, which is very close to the most diluted point of the LCC.

Conclusion
QC performance with PC 1/10 and 1/30 showed excellent reproducibility. With the protocol FVIII Low and LCC (SHP + PDF) it is possible to obtain results of FVIII-Chr &lt;1.0% compatible patients with severe hemophilia clinical condition.
A-165 Test Harmonisation Is a Key Enabler of Pathology Transformation
Authors: Ellison T , Cane P , MacFarlane C , James D 
Published: September 2023

Abstract

Background
In April 2021 a new joint venture was formed to deliver and transform services across South East London. Two large NHS Foundation Trusts (Guy’s and St Thomas’, and King’s College hospitals) partnered with SYNLAB who are specialist pathology providers, bringing extensive global experience and expertise in setting up, transforming and running diagnostic services. The Trusts had been working in partnership for many years but were operating in numerous areas as two separate entities. There was duplication of services and tests, with different analytical platforms and very different ways of working, which led to variations in resulting and reporting. Our aim was to establish a single consolidated service, with a harmonised test catalogue, facilitating the provision of consistent results regardless of the origin of sample, and to have a single governance framework to drive improved accountability and optimisation of resources. Our view was that test harmonisation was essential to enable the deployment of a common core Laboratory Information Management System (LIMS) from the 24 legacy systems, and that the harmonisation process should be clinically led.

Method
We established forums (through a series of workshops) for comprehensive engagement and dialogue to allow key clinical leads from all services to meet and agree the path forward. After extensive collaborative engagement, a new model was created with a single “Strategic Clinical Lead” with pan-site responsibility appointed for each service from the existing senior clinical staff. The Strategic Clinical Lead works with their colleagues to drive consensus, seeking wide stakeholder engagement from end service users as required.

Results
From an initial repertoire of circa 7100 tests, test harmonisation has resulted in a 25% reduction, and in some services such as Virology, we identified 31% duplication in tests. The establishment of the new clinical model has resulted in improved efficiency and better use of resources including staffing as well as a reduction of variation of services. Importantly, test harmonisation is essential to move samples seamlessly in a hub and spoke model. The implementation of a single common core LIMS this year will significantly improve business continuity by facilitating seamless transfer of work between sites.

Conclusion
Extensive clinical engagement is key to transforming pathology services. The benefits of consolidation include an overall reduction in process variation leading to improved standardisation and therefore enhanced patient safety as a result of consistency in result reporting. We established a framework and new clinical model which has resulted in improved links between staff across all sites who are working collaboratively on the new target operating model (hub and spokes) which will be live in April 2024.
A-166 Severity of Harm Category Designation Survey Results
Authors: Peltier L , Van Aelst S , Peeters B , Raimbourg J , Yundt-Pacheco J 
Published: September 2023

Abstract

Background
ISO document 14971-Application of Risk Management to Medical Devices and CLSI document EP23-Laboratory Quality Control Based on Risk Management use a Severity of Harm model to designate maximum acceptable probability of patient harm (risk) based on the severity of the consequence to the patient.
When designing a risk managed quality control program for the clinical diagnostic laboratory, the starting point is to select Severity of Harm categories for each analyte being tested. As each Severity of Harm Category (Negligible,Minor,Serious,Critical,Catastrophic) can be mapped to a corresponding maximum acceptable probability of patient harm from erroneous results (0.01,0.001,0.0001, 0.00001,0.000001). The laboratory can then design quality control strategies that have a predicted probability of patient harm below this maximum for a risk managed quality control program.
Unfortunately, there is little guidance on setting Severity of Harm designations, and they are by nature, subjective. To remedy this, we conducted a survey of laboratory professionals, asking them to rate the Severity of Harm for 20 analytes.

Method
An international Severity of Harm survey was conducted to solicit Severity of Harm designations for analytes in the clinical diagnostic laboratory. 261 respondents from 42 countries answered the question: “How would you rate the severity of patient harm if a clinician would interpret incorrect reported results from these analytes in the most unfavorable situation?”.
The available ratings were described as:

Results

Conclusion
While Severity of Harm designations are specific to the local clinical system, guidance can be provided by collecting the opinion of a wide variety of clinical laboratory professionals. This provides support for the clinical diagnostic community in building risk managed quality control programs.
A-175 Objective Indexes for Comparing Platelet Usage Among Peer Hospitals During the COVID-19 Pandemic
Authors: Tu Y , Hsueh Y , Cheng Y , Lin T , Chiueh T 
Published: September 2023

Abstract

Background
Besides hospital size, clinical diagnosis and severity of patients’ cases determine the total platelet transfusions of each hospital. Therefore, the appropriateness of platelet usage could not be simply compared with the total units of platelet usage among hospitals of different sizes. This study aimed to establish objective indexes that can appropriately reflect the differences in platelet usage in various hospitals.

Methods
We used three objective indexes X, Y, and Z to compare the appropriateness of platelet transfusions among different hospitals. Instead of considering various factors such as hospital size, patient population, and disease diagnosis individually, three indexes were generated by dividing the annual total units of platelet usage by total annual reimbursement, the total number of admissions, and the average total reimbursement per admission for each hospital, respectively.

Results
Total units of platelet usage were only directly related to the sizes of hospitals. New indexes X and Y alleviated the hospital size-dependent difference. Index Y was considered a better option than index X, as its value fluctuated less during the COVID-19 pandemic. Index Z was adjusted with the average total reimbursement per admission, and its results showed that more patients of higher disease complexity did not result in more platelet usage during the COVID-19 pandemic.

Conclusion
These three objective indexes are suitable for peer comparison and monitoring the platelet usage of hospitals irrespective of their size.
A-179 Implementation of an Electronic Competency Evaluation System for Point of Care Testing
Authors: Sanchez N , Coughlin V , Okulewicz A , Urena C , Mauriello M , Chen D 
Published: September 2023

Abstract

Background
Management of training and competency evaluation for point of care testing personnel is essential to hospital operations. Typically, documentation for training and competency of point of care operators is a paper based manual process and managed by the POCT team. The responsibilities include maintaining these records for the duration of employment and thereafter and retrieving records for regulatory inspections. It is a challenge for any POCT team in a hospital system with a high volume of operators. In an effort to streamline this process, an electronic training and competency format for the operators of point of care glucose meter was developed and implemented in our hospital system.

Method
Initial training and competency requires in person delivery which must capture specific elements of competency and must be traceable to the trainer and trainee. Leveraging a survey based online training platform (Qualtrics) as the repository of the training record, the paper based training checklist was converted to an online format accessed via QR (Quick Response) code. Delivery of the training is performed by a certified trainer or preceptor under observation. The training checklist and competency quiz are documented directly in Qualtrics capturing all of the data required for traceability. The evaluation record of each new trainee is available to the POCT Team in real time.

Results
The online format of initial training and competency was validated by comparing the paper based version to the electronic version. Functionality of the electronic version was confirmed and accuracy of the checklist answers were validated. This electronic format was implemented for initial operator training and evaluation in January 2023. Over 150 trainees have successfully completed the electronic training checklist and competency quiz.

Discussion and Conclusion
The implementation of an electronic evaluation tool for operators of point of care blood glucose testing has streamlined the process of documentation management in a secure, reliable and transparent way. It also helps to standardize the training process and minimize errors related to a manual process. These documents are readily available and can be retrieved upon request. The implementation of the electronic training evaluation system through Qualtrics coupled with our existing electronic re-certification process will allow us to transition to a fully paperless evaluation/documentation workflow.