bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-339 Timely Audits and Open Communications are key to Improved Device Result Transmission and Reduction of Potential Errors at the Point of Care
Authors: Doe B , Dumaraog S D , Gant-Kanegusuku A , Maggiore J 
Published: October 2024

Abstract

Background
The Point of Care (POC) department was notified by an end user in the cardiac catheterization laboratory (Cath Lab) of i-STAT activated clotting time (ACT) results not transmitting to a patient's chart. Subsequent audits determined that this failed transmission was due to a delay in properly docking of the i-STAT into its downloader. Upon a broader and more thorough investigation, it became clear that this was a systemic issue among und-users of all i-STAT ACT testing for heparin dosage monitoring, as many cases went without transmission to patient electronic medical records (EMR). Not only did this present patient safety concerns related to the lack of documentation of test performance, it led to an approximate $67,000 loss in charge capture over the course of 2 calendar years. Here, we describe the steps taken to implement process improvements in order to ensure patient results are charted in a timely fashion.

Methods
The first step in rectifying this issue was initiating dialogue between POC and the Cath Lab. Laboratory and nursing leadership and all i-STAT ACT superusers were made aware of this reoccurring issue and the negative effects it could have on patient care. Escalation through these administrative channels of the associated risks to patient care facilitated more effective communication of the expectation that i-STATS need to be docked immediately after completion of each case. It was also reiterated to our end users to be mindful of receiving a successful acknowledgment message to ensure that test results were being sent to the EMR. The next course of action was for POC to increase the frequency of Cath Lab audits. If i-STATs in high volume areas were found to have not transmitted data to our POCT middleware (Abbott RALS) in the prior 4 days, the cause was investigated. Several investigations proved fruitful in identifying issues related to i-STAT docking stations that affected communication with the LIS, which were swiftly corrected as to not impede Cath Lab workflow.

Results
Marked improvement in documentation of patient results was noted in 2023. Total result transmission failures on i-STATS in Cath Lab were reduced from 12% (2021) and 9% (2022) to 1% (2023). This not only represents hundreds of patient tests that were successfully charted, but a year over year charge capture increase of approximately $30,000.

Conclusions
This project shows that open lines of communication to patient care areas combined with timely audits by POC Coordinators can have tremendous benefits on patient care at little to no additional institutional cost. Periodic POC quality assurance should include review of successful connectivity for interfaced test systems to ensure all testing performed is documented to the EMR.
A-353 Lay User testing of Rapid Multiplexed HIV/TP test
Authors: Jones K D , Bauer N 
Published: October 2024

Abstract

Background
Palladium Diagnostics had developed a rapid, multiplexed POC assay for Syphilis and HIV for fingerstick whole blood. To increase potential patient engagement and simplify sample collection it was decided to expand the sample type from fingerstick whole blood to saliva without changing the test time or performance. Additionally, the test was designed to have a lower carbon footprint by using a bioplastic (environmentally friendly foam) for structural components rather than injection molded parts as are commonly used in other assays. The assay was run both by professional users in a lab setting and lay users in the field.

Methods
A flow through rapid assay was produced and tested both by professional users in a lab setting using library sample and by lay users in a field setting using self collected samples.

Results
The results are shown in table 1, the assay performance was broadly similar for both whole blood and saliva, however the saliva dataset was much smaller for the professional use setting. The human factor analysis from the lay user field studies showed that they preferred the saliva collection procedure however for a small subset of subjects it proved difficult to collect sufficient sample for testing. For subjects who were able to collect adequate sample the results corresponded well between the device and lab-based ELISA.

Conclusions
The lay user experience validated test design and function and proved the usability in the field.
A-357 Evaluation of a home kit for lay user collection, centrifugation, and refrigeration of capillary blood specimens
Authors: Iacovetti G , Tokunaga N , Peevler M , Ragar J , Sommer G J , Schaff U Y 
Published: October 2024

Abstract

Background
While solutions enabling at-home self-collection of capillary blood samples are maturing, many analytes require blood separation and controlled shipping temperatures for stable analysis in centralized laboratories. Here we present results of a pilot lay user study evaluating usability and specimen quality of at-home blood collection with centrifugation and refrigerated shipping of capillary serum specimens.

Methods
N=45 consented subjects were mailed kits including supplies for a capillary blood self-collection using a Tasso+™ device, a Labcorp TrueTherm™ reusable shipper containing a temperature tracker, a Labcorp TrueSpin™ battery-powered centrifuge, written instructions, and a usability survey. Subjects independently followed the instructions for blood collection, separation, and thermal protection and returned the kits to Labcorp via overnight shipping. Received kits were evaluated for correct return, volume of blood collected, volume of serum, visual hemolysis, and temperature throughout shipment.

Results
Of the n=45 consented subjects, 39 subjects returned the kits, one subject unsuccessfully attempted to collect blood two times, and the remaining five subjects did not return the kits. Primary analysis parameters are outlined in Table 1.

Conclusions
Untrained subjects were able to collect their own capillary blood samples, process them, and ship them using the investigational home collection kits. While kit return can be a challenge with home collection, the vast majority of subjects were able to return a testable sample. Combining blood separation prior to shipment using the Labcorp TrueSpin centrifuge and temperature control with the reusable Labcorp TrueTherm device successfully protected samples from hemolysis. These results indicate that such kits are a promising at-home blood collection method and may increase test accuracy and menu availability for sensitive analytes.
B-001 Serum 25-hydroxyvitamin D and C-3 epimer concentrations throughout gestation in a bovine dairy herd
Authors: Buchweitz J P , Velasquez Rivertte S , Zyskowski J A , Abuelo Sebio A 
Published: October 2024

Abstract

Background
Serum 25-hydroxyvitamin D (25(OH)D) serves as an indicator of vitamin D status in most animal species. The recent identification of its C-3 epimer, 3-epi-25-hydroxyvitamin D3 (3-epi-25(OH)D3) remains diagnostically confounding. The appearance of this epimer in blood serum has been reported for both pregnant women and infants; however, because of its recent discovery, its physiologic role, biochemical regulation, and overall biologic importance have yet to be fully elucidated. Given its prevalence in pregnant women, it was hypothesized that 3-epi-25(OH)D3 may serve as a novel predictive biomarker of pregnancy in animals.

Methods
In the current study, we validated an LC-MS/MS method to measure the mono-hydroxyvitamin D metabolites 25-hydroxyvitamin D2 (25(OH)D2), 25-hydroxyvitamin D3 (25(OH)D3), and 3-epi-25(OH)D3, in bovine serum. Serum was collected from dairy cows at six stages of pregnancy (n=60 (10 per group), pre-breeding heifers, 30-40 days pregnant, 70-90 days, 120-180 days, 210-260 days, and 30-45 days post-calving). The 25(OH)D metabolites were extracted from serum by supported liquid extraction (SLE) and the eluate was derivatized with 2-Nitrosopyridine. Derivatized samples were introduced to the LC-MS/MS, ionized by electrospray ionization in positive-ion mode, and detected and quantified by multiple-reaction monitoring.

Results
The LC-MS/MS method was linear in the concentration range of 0.25 ng/mL to 100 ng/mL with an r2 &gt; 0.99 for each analyte. 3-epi-25(OH)D3 and total serum 25(OH)D concentrations were calculated for each stage of pregnancy. Pre-bred heifers had serum 25(OH)D concentrations ranging from 65 - 85 ng/mL with trends toward non-significant increases with mean values approaching 100 ng/mL during pregnancy. Interestingly, 3-epi-25(OH)D3 remained near baseline (1.3 - 1.9 ng/mL) for the first 90 days and elevated 3- to 4-fold thereafter.

Conclusions
This study confirms that epimerization of 25(OH)D3 is a conserved biochemical process across species. While not predictive of pregnancy itself, the increase in circulating 3-epi-25(OH)D3 concentrations was consistent with mid- to late-gestational increases in estrogen concentration observed for dairy cattle. Future studies will explore the potential link between increases in gestational estrogen and epimerization.
B-009 Verification of Result Interchangeability Between Two Analyzers in the Determination of Uric Acid and Urea
Authors: Garcia-Valdecasas S , Lapeña-Garcia S , Ruiz-Alvarez M , Costales-Lucia T , Sanchez-Fuertes J , Barrionuevo-Gonzalez M 
Published: October 2024

Abstract

Background
Uric acid and urea are two parameters widely used in the diagnosis and management of renal pathology. In our laboratory, they are determined using Atellica Solution® analyzers (Siemens Healthineers). After validating a new Siemens equipment, Atellica CI®, it is essential to ensure result interchangeability in our laboratory accredited by ISO 15189:2012.

Objectives
evaluate the interchangeability of results for uric acid and urea measured by Atellica Solution® and CI® analyzers.

Methods
A total of 40 serum samples from patients with uric acid values between 1.3 and 15.2 mg/dL, and another 40 serum samples from patients with urea values between 7 and 142 mg/dL were processed in parallel. Statistical analysis of the results was performed using Passing-Bablok regression and Bland Altman mean difference analysis with Method Validator Version 1.19. Results are expressed with their 95% confidence interval.

Results
Uric Acid: After analyzing Bland-Altman differences, a statistically significant slight systematic error was found, as the 95% CI does not include 0, with slightly higher results in CI 1900®. Regarding Passing-Bablok regression analysis, there were no systematic errors of constant type (since the 95% CI of the intercept includes 0) but a discreet significant proportional systematic error was observed (the confidence interval of the slope does not include 1).Urea: In Bland-Altman analysis, a discreet systematic error was observed as the 95% CI of the mean difference does not include the null value. Regarding Passing-Bablok regression analysis, there were no systematic errors of constant type (since the 95% CI of the intercept includes 0) or proportional type (since the 95% CI of the slope includes 1), indicating interchangeability between both analyzers.

Conclusions
The results obtained by both Atellica Solution® and CI® analyzers for uric acid and urea assays are interchangeable since the statistically significant differences observed can be considered analytically and clinically insignificant.
B-011 Intermethod Comparison Verification between Atellica Solution® and CI® Analyzers for Amylase and Glucose Methods
Authors: Garcia-Valdecasas S , Lapeña-Garcia S , Ruiz-Alvarez M , Fernandez-Verduras Y , Costales-Lucia T , De La Rubia-Maestu J , Barrionuevo-Gonzalez M 
Published: October 2024

Abstract

Background
The objective of this study is to verify if the results of the Amylase and Glucose methods, measured by two different analyzers: Atellica Solution® and CI® (Siemens Healthineers), are interchangeable.

Methods
To carry out the intermethod comparison study of the Amylase and Glucose methods, 40 patient samples were selected for each assay, with concentrations across the entire measurement range. Statistical analysis was performed using Method Validator v.19 software, through Bland-Altman mean difference analysis and Passing-Bablok regression. Statistics are expressed with their 95% confidence intervals (CI).

Results
AMYLASE: After analyzing the Bland-Altman differences, a statistically significant systematic error was found, as the mean difference between the results obtained by Atellica Solution® and CI® was 28.1 with a 95% CI that does not include the null value, with higher results in CI®. Regarding the Passing Bablok analysis, systematic differences, both proportional and constant, were observed as the confidence interval of the intercept does not include the zero value, and that of the slope does not include the value 1.GLUCOSE: After Bland-Altman analysis, a systematic error was found, as the mean difference between the results obtained by Atellica Solution® and CI® was 2.1, with slightly higher results in CI®. Regarding the Passing Bablok analysis, there were no systematic differences of constant type since the confidence interval of the intercept includes the zero value, and a slight proportional systematic error based on the slope as its 95% CI does not include the value 1.

Conclusions
After evaluating the results, it is concluded that the Atellica Solution® and CI® analyzers are not interchangeable for the Amylase assay, so new reference values should be established. For the Glucose assay, both analyzers are interchangeable as the observed difference does not exceed our quality specification.
B-012 Total Laboratory Automation: Assessing Serum Bicarbonate Stability Under Conditions Experienced Using the Roche Diagnostics Cobas Connection Module
Authors: Nicklas M A , Baumann N A , Leonard L M , Rossini L A , Block D R 
Published: October 2024

Abstract

Background
Bicarbonate stability in serum depends on time, exposure to air, temperature, tube size and sample volume. With implementation of Cobas Connection Module (CCM) automation, the workflow for bicarbonate measurement needed to be re-evaluated. The aim of this study was to determine bicarbonate stability in filled 3.5 mL and 5 mL serum-separator tubes (SSTs) and capped and uncapped aliquot tubes on the CCM automation.

Methods
Bicarbonate was measured on a Cobas c701 (Roche Diagnostics) at various time points. SSTs (n=8) were centrifuged 6 min at 1649g ∼30 min post-collection. Serum was aliquoted (1 mL) into capped or uncapped tubes and kept ambient (15-25°C) on the CCM track for 0, 60, 90, 150, 180, 240 and 300 minutes (n=2 per time point). Primary SSTs (5mL n=4, and 3.5mL n=5) were uncapped on the CCM track and bicarbonate measured at baseline and 30 minute intervals through 6.5 hours. An absolute difference of +/- 4 mmol/L from baseline was considered acceptable.

Results
Bicarbonate concentrations decrease with time at rates dependent on whether the aliquot tube is capped or uncapped or the SST is 3.5 mL or 5 mL (Figure 1).Figure 1.Average decrease in bicarbonate concentration with time for capped aliquot tubes (black square), uncapped aliquot tubes (red circle), 3.5 mL serum separator tube (blue up triangle), 5 mL serum separator tube (green down triangle). Bars represent +/- 1SD.

Conclusions
Bicarbonate in serum is stable for testing for 2.5 hours in uncapped 1 mL aliquot tubes, 3.5 hours in capped 1 mL aliquot tubes, 3.5 hours in uncapped full 3.5 mL SST tubes and 6 hours in uncapped full 5 mL SST tubes at ambient temperatures (15-25°C). Bicarbonate testing can be accommodated by total laboratory automation but processes such as add-ons and retesting must be done with caution.
B-013 Improving the Workflow of Blood and Coagulation Tests in clinical laboratory through the Utilization of Laboratory Automation Track Systems
Authors: Yang M , Hsieh H , LEE C 
Published: October 2024

Abstract

Background
The Laboratory Automation Track System (TLA) is an automated system designed for executing highly repetitive tasks within a laboratory, commonly applied in biochemical and immunological testing systems. It aims to reduce human errors in specimen handling, enhance the overall process quality, and provide better Turnaround Time (TAT) from specimen collection to result reporting. For the first time in our laboratory, we have integrated the blood and coagulation systems with TLA. Consequently, we seek to evaluate the differences in the testing workflow and reporting efficiency of the blood and coagulation systems after being connected to TLA.

Methods
Abbott GLP systems Track was the TLA system for connecting with blood and coagulation systems. Two Sysmex XN-9100 fully automatic hematology systems and two Sysmex CS-5100 fully automatic coagulation analyzers were developed for blood and coagulation system, respectively. TUNYEN Laboratory Information System was established for Laboratory information system (LIS).

Results
Through the analysis of quality indicators and integration with intelligent information systems, improvements have been made, including the reduction of blood collection tube usage, efficient manpower utilization management, tracking of specimen progress and achievement of timely reporting rates.(1)Approximately 2,915 blood collection test tubes are saved every month, with a converted cost of 0.15 USD per tube, and a total saving of 437 USD. And reduce the carbon emissions of 32 kgCO2e, comply with the spirit of ESG sustainable development.(2)The TLA no longer requires staff to collect and deliver specimens as in the past,reducing staff and enhancing work efficiency.One of manpower was saved and new inspection items were developed.(3)Tracking of specimen progress:The laboratory has set up a specimen tracking system to monitor the specimen delivery location and provide timely response to the clinical status.The one-hour TAT for blood and coagulation increased from 82.0% and 76.9% before improvement to 91.8% and 93.3% after improvement respectively.

Conclusions
The implementation of Laboratory Automation Track Systems (TLA) leads to a reduction in medical errors and specimen sample volume, while also enhancing accuracy and precision, thereby improving the safety of laboratory staff. Although the introduction of TLA may require an initial investment, it brings the benefits of automation, offering ease and efficiency to laboratory processes.
B-016 Evaluation of pyridoxamine phosphate (PAMP) for AST/ALT reagents with recombinant human apoenzymes
Authors: Oba T , Miyachi M , Taketani Y , Mizuguchi M 
Published: October 2024

Abstract

Background
ApoAST/ALT, which have lost a coenzyme such as pyridoxal phosphate (PALP), are normally present at low levels in serum. To form the holoenzyme, IFCC recommends adding PALP into AST/ALT reagents. However, commercial reagents often do not use PALP due to its instability. In recent years, pyridoxamine phosphate (PAMP), a more stable coenzyme, has been marketed. However, the differences in holo formation ability and reagent stability between their coenzymes are not well understood. In this study, we focused on the preparation of PAMP and recombinant human ApoAST/ALT (rhApoAST/ALT), followed by fundamental investigations into their use as AST/ALT reagents.

Methods
PAMP was synthesized from pyridoxamine through an enzymatic reaction using pyridoxal kinase. The reaction product was purified to achieve a purity of &gt;99% in HPLC. rhApoAST/ALT were expressed in Escherichia coli and purified with chromatography. AST/ALT assay was performed on a Hitachi 7180 automatic analyzer. PALP reagents for AST/ALT were designed to correspond with the final concentration of the IFCC method. PAMP reagents were prepared with PAMP instead of PALP. To evaluate the holo formation ability of PALP and PAMP reagents, we measured a dilution series of rhApoAST/ALT. To assess stability, the reagents were stored at 11°C for 3 months and then measured same. The reagents were subjected to content analysis by HPLC.

Results
Similar results were shown between coenzymes in the evaluation of holo formation ability, and high correlations were observed. As for the stability test, the values of PALP reagents decreased after 3 months, while the values of PAMP reagents did not. Content analysis showed that a spontaneous transamination occurred in PALP reagents. These results were observed at both AST and ALT reagents.

Conclusions
In AST/ALT reagents, both PAMP and PALP can activate apoenzymes. While PAMP is stable, PALP causes a decrease in reagent performance due to a spontaneous transamination.
B-018 Design and Development of MASTM Diabetes Max Controls, Ready-to-Use Plastic Tube Format
Authors: Nagaraj M , Crandall D , Kasprisin M , Adams N , Shah J , Qureshi A , Hu R 
Published: October 2024

Abstract

Background
The Thermo Scientific™ MAS™ Controls are assayed controls to monitor assay performance within clinical laboratory settings. The user can compare observed results of controls with their expected ranges as a means of assuring consistent performance of both reagent and instrument. The objective of developing MAS™ Ready-to-Use Tube Controls is to provide MAS™ controls in a new automation-friendly plastic tube format, as an alternative to the current glass vials. Diabetes Max Control is the first MAS™ product designed and developed in this ready-to-use format to be placed directly on the analyzer. The new format will increase efficiency and allow for on-board refrigerated storage, and it is expected to reduce material loss and contamination. It contains Hemoglobin A1c formulated in whole blood matrix to mimic patient specimens. In this presentation we summarize the Feasibility, Development, Verification, and Validation results of MAS™ Diabetes Max Controls.

Methods
The performance was assessed by conducting the following studies for MAS™ Diabetes Max Tube Controls. The analyte Hemoglobin A1c was measured in functional studies to evaluate and verify the product performance. Other studies were also designed and performed to assess the product usability.

Results
MAS™ Diabetes Max Control results demonstrated comparable performance and Fit/Form/Function criterion on specified platforms, particularly the TOSOH™ platform. All feasibility studies provided very promising results passing per protocol criterion. Design Verification and Validation studies ensured product integrity and passed specifications for proposed claims. Process Validation is in progress with data being collected for both Value Assignments and Real Time Stability.

Conclusions
MAS™ Diabetes Max Controls provided in ready-to-use tubes met the design specification criteria. We believe that MAS™ Diabetes Max Controls will contribute to the increased efficiency of core lab workflow by allowing the analyzer(s) to aspirate controls directly from the tube and allow for control storage in an on-board refrigeration unit.