bluuebunny/crossref_metadata_2025 huggingface dataset:
A-332 Identifying At-Risk Patients Pre-IV Contrast Administration via POCT Creatinine Measurement
Authors: Hawkins R
Published: October 2024

Background

The use of intravenous iodinated contrast in computerized tomography studies is associated with a small risk of acute kidney injury. Pre-existing chronic kidney disease is a recognized factor and assessment of renal function prior to contrast administration is essential. This study assessed the ability of the Abbott iSTAT creatinine assay to correctly identify IV-contrast patient risk using lab-based eGFR as the gold standard.

Methods

This was a retrospective study comparing POCT creatinine (whole blood, Abbott iSTAT enzymatic) and lab creatinine (plasma, Beckman Coulter AU5800 Jaffe) results on simultaneous samples collected in the emergency department. Anonymised data records were extracted from the laboratory database for 2020-2023. IV contrast risk was calculated using eGFR (CKD-EPI 2021) and classified as high risk (HR: eGFR < 30 mL/min/1.73 m2), moderate risk (MR: eGFR 30-59) and low risk (LR: eGFR >=60) as per the Royal Australian and New Zealand College of Radiologists 2018 guidelines, using the Beckman-based eGFR as the gold standard.

Results

132 paired samples patients were available for analysis (61% male, average age 69 y (23-98), 70% Chinese, eGFR (iStat) 3-143, eGFR (Beckman) 3-121 mL/min/1.73 m2). The proportions of Beckman-based eGFR HR:MR:LR cases were 53:39:40. The prevalence of HR/MR cases was 70%. The diagnostic performance of the iSTAT-based eGFR to accurately identify HR/MR patients was: sensitivity 93.5%, specificity 95%, PPV 97.7%, NPV 86.4%, accuracy 93.9%. For different Beckman-derived eGFR categories, the mean difference in eGFR (iSTAT - Beckman), 95% lower limit of agreement (LOA) and upper LOA was: <30 mL/min/1.73 m2: -1.0, -3.2, -1.1; 30-60 mL/min/1.73 m2: 0.9, -13.3, 15.1; >60 mL/min/1.73 m2: 1.6, -16.8, 20.1. Linear regression fit (Passing-Bablok): CKD-EPI Beckman = 1.193 + 0.9773 CKD-EPI iSTAT. Correlation coefficient was 0.981. Kappa for the 3 categories of risk classification was 0.814.

Conclusions

The iSTAT creatinine assay could reliably identify patients at medium/high risk of acute kidney injury following intravenous contrast administration. Performance was best for low and high risk patients with 100% of high risk patients being correctly identified. It is a useful screening test but differences in eGFR of up to 20 mL/min/1.73 m2 may be seen between the Beckman and iSTAT eGFR values at higher levels, meaning numeric eGFR results are not interchangeable.
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

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

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

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

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 > 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

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

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

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

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

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 >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

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.
B-020 Study of Method Intercomparison between Atellica Solution® and CI® Analyzers for T4L, β-HCG Total, and PSA Total
Authors: Ruiz-Alvarez M , Lapeña-Garcia S , Garcia-Valdecasas S , Costales-Lucia T , De La Rubia-Maestu J , Barrionuevo-Gonzalez M
Published: October 2024

Background

Method intercomparison is an essential requirement in Clinical Laboratories before changing a method or instrument to verify the interchangeability of results. After validating a new Siemens device, the CI®, we conducted an intercomparison study with the Atellica Solution® for T4 free (T4L), β-HCG total, and PSA total assays.

Objectives

To check the interchangeability of results between the methods of T4L, β-HCG total, and PSA total, as determined on the Atellica Solution® and CI® analyzers, to evaluate the behavior of both equipment in our laboratory as a single virtual team.

Methods

A total of 120 serum samples from patients with T4L values between 0.41 and 7.5 ng/dL, β-HCG total between 0.5 and 1000 mIU/mL, and PSA total between 0.01 and 78.4 ng/mL were processed on both analyzers. Passing-Bablok regression, Bland-Altman analysis, and Pearson correlation coefficient were used to evaluate the sample size. Results are expressed with a 95% confidence interval. The intercomparison study was conducted using Method Validator Version 1.19.

Results

See table

Conclusions

After evaluating the results, we conclude that the Atellica Solution® and CI® analyzers behave as a single virtual team for the T4L, β-HCG total, and PSA total assays. Although there are systematic errors, they do not exceed the quality specifications established in our laboratory, based on the Total Error allowable according to Biological Variability.
B-028 Result Precision on the New cobas pro integrated solutions cobas ISE neo and cobas c 703 Analytical Units Under Routine-Like Conditions Across Two Sites in Europe
Authors: Thorenz A , Findeisen P , Brandt I , Winnock F , Furrer J
Published: October 2024

Background

The precision of the new cobas® pro integrated solutions cobas® ISE neo and cobas c 703 analytical units (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) was measured under intended use conditions in a routine simulation setting.

Methods

The interaction of hardware, software, assays, and samples was tested at two sites (Aalst, Belgium and Heidelberg, Germany) between October and December 2023. Reproducibility under various stressed routine-like conditions, including provocations, was tested using routine simulation imprecision experiments. To test the interaction of new and existing analytical units under routine conditions, test configurations including commercially available cobas c 503 and cobas e 801 analytical units were used. The first configuration comprised one cobas ISE neo analytical unit, two cobas c 703 analytical units, and one cobas e 801 analytical unit. The second configuration comprised one cobas ISE neo analytical unit, one cobas c 703 analytical unit, one cobas c 503 analytical unit, and one cobas e 801 analytical unit. The precision of batch type measurements was compared with the precision under routine simulated random access conditions. Random access coefficients of variance (CVs) that exceeded 1.5× reference batch CVs, or single measurements deviating by >10% from the batch mean, triggered in-depth analysis of the system components that contributed to the result.

Results

Overall, 56 applications were measured during the reference and random parts of seven routine simulation imprecision runs: six ion selective electrodes (ISE; three serum, three urine), 35 clinical chemistry applications on cobas c 703 (27 serum, eight urine), seven clinical chemistry applications on cobas c 503 (five serum, one urine, one whole blood) and eight immunochemistry (serum) applications. Of six ISE (serum and urine) applications, the mean reference and random CVs were 0.8% and 0.9%, respectively. Of 42 clinical chemistry (serum, urine, and whole blood) applications, the mean reference CV was 0.9% and the mean random CV was 1.0%. Of eight immunochemistry (serum only) applications, mean reference and random CVs were 1.1% and 1.4%, respectively.

Conclusions

The findings from this study demonstrate that the new cobas ISE neo and cobas c 703 analytical units show consistent results over a prolonged time period, with most CVs in this setting below 0.9%. These results also show the successful integration of the new analytical units into the cobas pro integrated solutions, with seamless interaction of existing and analytical units under stressed conditions.
B-047 A Rapid Host-Response Test Supports Antimicrobial Stewardship at a Micro-Hospital Emergency Department
Authors: DuChateau B , Murphy S , Tarr C , Gottlieb T , Spies S
Published: October 2024

Background

The management of patients with suspected infections requires identification of the infectious etiology to determine appropriate use of antibiotics. However, differentiating viral from bacterial infection (and co-infection) is often challenging as clinical presentations can be similar and existing diagnostics sometimes fail to identify a clinically relevant pathogen. A host-response test (MeMed BV®, MMBV) that relies on computational integration of three proteins (TRAIL, IP-10 and CRP) measured from blood or serum has demonstrated high diagnostic performance for differentiating bacterial from viral infections, with a negative predictive value >95% across multiple studies. This report evaluates real-world use of MMBV at a micro-hospital Emergency Department (ED) and associated antibiotic prescribing.

Methods

The study is a retrospective analysis of real-world data collected between January and June 2023. MMBV was ordered by providers at a micro-hospital ED in Tucson, AZ at provider discretion as part of routine care. Prescription among cases with MMBV score <35 was analyzed. This cutoff is indicated by the manufacturer to indicate a viral or other non-bacterial etiology. If an antibiotic was prescribed, the authors conducted a chart review to adjudicate whether the prescription was warranted.

Results

Data was evaluated between January and June 2023; 116 MMBV tests were ordered by six providers. Most tests (81.9% (95%CI: ±7.0%)) had an MMBV score <35 (mean score 11.3 with standard deviation 10.8). Among these, 92.6% (95%CI: ±5.3%) of cases with viral results were not prescribed antibiotics. MMBV use increased throughout the study period from 12 tests in the first month to 25 in the last month (r = 0.88; p<0.001). There were seven cases where providers chose to prescribe despite a viral MMBV result. Upon chart review, 2/7 were unwarranted prescriptions.

Conclusions

In the emergency settings, integrating MMBV can effectively guide clinical decision-making, potentially reducing unnecessary antibiotic use. Further research in diverse healthcare settings is needed to validate these findings.
B-057 Evaluating the Use of Unconcentrated Urine for Protein Electrophoresis and Immunofixation: An Alternative Approach for Efficient Analysis
Authors: Rao L V , Wagner J D , Kabawat S E
Published: October 2024

Background

Protein electrophoresis is a widely employed technique for separating and analyzing proteins based on their charge and size. Traditionally, concentrated urine samples have been utilized to enhance protein detection sensitivity. However, this study explores the feasibility of using unconcentrated urine as an alternative sample type for protein electrophoresis (UEL) and immunofixation (UIF) to streamline the analysis process and reduce costs and turnaround time in clinical laboratories. It offers a more efficient and resource-friendly alternative.

Methods

Both UEL and UIF were performed on routinely ordered 80 urine specimens (random or 24 Hr.) for patient management and performed by both concentrated (X40) by Helena and unconcentrated using Sebia (HYDRAGEL 9IF gels using HYDRAGEL BJ dynamic mask procedure. The electrophoretic patterns obtained from unconcentrated urine were compared with those from concentrated urine. Various electrophoretic parameters, including resolution, sensitivity, and reproducibility, were evaluated to determine the reliability of unconcentrated urine in protein electrophoresis. In addition, retrospective analysis was performed before and after implementation on all urine specimens ordered to analyze if there were any differences in the monoclonal band distributions in the population.

Results

All the protein concentrations were correlated well with 95-100% agreement between the methods (Figure 1) clear separation of protein fractions. Serial dilution studies of monoclonal band analyses showed that these bands can be detected at 1.25 mg/dL using an unconcentrated method. Retrospective analysis of patient data before and after the implementation of the new method shows no differences in the identification of monoclonal proteins (Helena [69 of 872 total patients tested (8.0%)] vs. Sebia [90/800 (11.0%)].

Conclusions

These results indicate that unconcentrated urine can be successfully utilized for UEL and UIF with comparable outcomes to traditional concentrated samples. Utilizing unconcentrated urine simplifies the sample preparation process and presents a promising alternative.
B-059 Development and Validation of Multiplex Quantitative Allergy Tests based on Automated Flow Fluorescence Immunoassay Analyzer
Authors: Xue F
Published: October 2024

Background

Serological allergy tests measuring allergen-specific IgE (sIgE) are simpler and safer than skin prick tests, and the results are not influenced by skin condition or human factors. Quantitative detection of sIgE can also aid in evaluating patient allergies and aiding subsequent treatment. Dymind has researched and developed novel quantitative allergy tests based on the automated flow fluorescence immunoassay analyzer system (MF1280), enabling quantitative detection of multiple sIgE in just one test with one sample. Here, we present the performance of tIgE and two specific IgE test kits using the Dymind MF1280 system.

Methods

This study evaluated the performance of total IgE (tIgE) and two allergen-specific IgE (sIgE) panels of inhalant and food allergens, inhalant allergen panel including d1 (Dermatophagoides pteronyssinus), d2 (Dermatophagoides farina), i6 (Cockroach), e1 (Cat epithelium), e5 (Dog epithelium), w1(Common ragweed), and food allergen panel including f1 (Egg white), f2 (Cow’s milk), f3 (cod), f23 (Crab), 24 (Shrimp), and f27 (beef). Evaluation criteria included precision, linearity, limit of detection (LOD) and method comparison. As clinical performance of 425 clinical samples collected from 2 hospital laboratory in China was evaluated by both of Dymind allergen IgE MF1280 system and Phadia ImmunoCAP.

Results

The validated linearity of total IgE and sIgE were 2.0-5000.0 IU/mL and 0.1-100.0 IU/mL respectively. The LOD of total IgE and sIgE determined to be 2 IU/mL and 0.1 IU/mL respectively. The precision was evaluated by assaying a low and a high samples of every sIgE assay and the result of d1, d2, i6, e1, e5, w1, f1, f2, f3, f23, f24, f27 were 3.73% / 1.34% (low sample / high sample), 3.26% / 1.95%, 2.18% / 0.87%, 1.31% / 1.40%, 3.63% / 1.13%, 2.84% / 4.76%, 4.50% / 1.53%, 5.97% / 1.64%, 3.46% / 1.11%, 1.58% / 1.73%, 3.77% / 1.28%, 1.78% / 0.96% respectively. The total mean coefficient of measurements was below 7% to ensure high precision in multiplex quantitative analysis. Method comparison of 425 clinical samples between Phadia ImmunoCAP and Dymind allergen IgE showed total concordance rate was over 85% except f2 (over 80%).

Conclusions

The Dymind Allergen-specific IgE test kits on the automated flow fluorescence immunoassay analyzer system provide fast and accurate in vitro diagnostic detection of tIgE and sIgE for aiding diagnostics specific allergens sensitization and treatment for allergy patients, with good precision and excellent agreement compared to ImmunoCAP. The MF1280 system has advantages including random access, fully automated, multiplex quantitative detection of allergen sIgE with reducing assay time, sample consumption and lower costs.
B-133 Uric acid: A description of the values found in adult patients treated during 2022 in a High Complexity Hospital
Authors: Corominas A I , Casal G , Vommaro F , Balconi S , Damiano A
Published: October 2024

Background

An association between uric acid and kidney disease, glucose intolerance, high blood pressure, metabolic syndrome and cardiovascular disease has been recognized. It is the obligation of the Clinical Laboratory to have valid reference intervals (RI) for this marker. Each particular population has genetics and a diet that represents it, which cannot be extrapolated in many cases. The difficulty and high cost of using direct methods for its establishment drive us to use the existing data in our electronic archive retrospectively. Objective: to describe the range of uric acid values in adult outpatients treated at the Posadas Hospital during the year 2022. Evaluate the influence of gender and age range on the observed values.

Methods

A retrospective observational approach was carried out from the System database Laboratory Informatics (SIL), Roche Infinity, from the year 2022. The data corresponding to all adult outpatient patients treated in the service were processed. Analytical System: Roche Cobas 6000, Uricase-Oxidase method. Exclusion criteria: oncology patients, kidney patients, diabetics, hyperglycemic patients, obstetric patients, hormonal patients, treated in wards and referred patients. Outliers excluded by Tukey method. The statistical treatment was carried out with the SPSS 17.0 program.

Results

We worked with 91922 data groups. Hence 12331 of uric acid. After meeting the exclusion criteria: 3899, of which 2289 (3.96 ± 1.05 mg/dl) correspond to women < 50 years , 747 (4.36 ± 1.15 mg/dl at ≥ 50 years and 863 (5.59 ± 1.33 mg/dl) men, all with normal distributions. Applying ANOVA and Student's test it was possible to verify in addition to the described significant difference between sexes, a difference between the 2 age groups of women (p<0.01) which is not equal to that of men in women ≥ 50 years of age.

Conclusions

A more extensive study is necessary to define own reference ranges that enable the early alarm guidelines, especially in the group of women < 50 years of age. This will allow an adequate evaluation of risk and evolution of patients. The application of Indirect Methods will make it possible to exclude values corresponding to underlying pathologies not registered in the SIL.
B-142 Using Big Data Analytics to Measure the Multi-year Consistency of Sigma metrics for Vitros Cardiac Assays
Authors: Miller J
Published: October 2024

Background

Sigma metrics assess lab quality by incorporating precision, accuracy and total error allowed (TEa). Sigma metrics report quality on a 0-6 scale, with 6 representing World-Class quality. Due to logistical constraints, Sigma metrics are often calculated with limitations such as a small number of analyzers, single reagent lot or short duration. QuidelOrtho developed a novel approach using big data analytics for the objective, automated calculation of Sigma metrics across thousands of Vitros(R) analyzers running in real lab conditions. This approach was previously used to report the Sigma metric performance for 115 assays using data from 2022. Of particular interest is the consistency of quality levels for Vitros cardiac assays assessed in the study.

Methods

The methods follow the previous approach using the same Python algorithm to extract QC data from Jan. to Nov. 2023 (inclusive). A QC fluid lot from the study period was selected for each analyte to align with the fluid level reported in the 2022 study, which was based on medical relevance. Metrics were calculated for each set of QC data that originated from a single analyzer, reagent lot and calibration curve; the median Sigma metric is reported in the Results. Proficiency testing limits were utilized as TEa limits where available, with preference to CLIA 2024 limits.

Results

The following assays reported Sigma metrics as >6 using both 2022 and 2023 data: apolipoprotein A1, apolipoprotein B, CK-MB, dLDL, LDH, myoglobin, NT-proBNP, and triglycerides. Assays with higher metrics using 2023 data: CK (5.2 vs 5.5), dHDL (5.8 vs >6), hsTnI (4.1 vs 4.3), and NT-proBNP2 (4.2 vs >6). Assays with lower metrics using 2023 data: cholesterol (5.8 vs. 5.3) and homocysteine (>6 vs 5.9). CKMB2 (>6) is a newer assay that did not have metrics reported in 2022. Vitros cardiac assays report metrics within 0.5 Sigma of the 2022 metrics. An exception is NT-proBNP2, which changed from 4.2 to >6. However, the 2023 analysis has almost double the number of Vitros analyzers (51 vs 90), representing new use of NT-proBNP2.

Conclusions

Vitros cardiac assays report consistent metrics when using 2023 data compared to 2022. All Vitros cardiac assays assessed report Sigma metrics of 4 or greater, indicating they achieve results within the corresponding allowable error.
B-144 Sigma Metrics for Vitros Reproductive Endocrinology Assays Across Multiple Fluid Levels
Authors: Miller J
Published: October 2024

Background

Sigma metrics assess laboratory quality by incorporating precision, accuracy and total error allowed (TEa). Sigma metrics report quality on a scale of 0 to 6, with 6 representing the World-Class quality. QuidelOrtho developed a novel approach using big data analytics for the objective and automated calculation of Sigma metrics across thousands of Vitros® Analyzers running in real laboratory conditions. This approach was previously used to report the Sigma metric performance for 115 assays using data from 2022. A limitation of that study is the metrics were reported for a single fluid that was selected for medical relevance. However, reproductive endocrinology assays have complex medical utilization and there is a benefit to understanding Sigma metrics at multiple levels. The aim of this poster is to provide additional data on the Sigma metrics for reproductive endocrinology assays.

Methods

The methods follow the previous approach using the same Python algorithm to extract QC data from Jan. to Aug. 2022 (inclusive). Up to seven QC fluid lots were selected for each analyte. Metrics were calculated for each set of QC data that originated from a single analyzer, reagent lot and calibration curve; the median Sigma metric is reported in the Results. Proficiency testing limits were utilized as TEa limits where available, with preference to CLIA 2024 limits.

Results

Sigma metrics are reported for multiple fluids for the following assays: estradiol, follicular stimulating hormone, luteinizing hormone, progesterone, prolactin, testosterone, human chorionic gonadotropin, and thyroid stimulating hormone. All fluids examined report Sigma metrics greater than 4, which is considered “Good” performance. An exception is luteinizing hormone which has Sigma metrics = 1.9 at the lowest reported concentration.

Conclusions

Vitros reproductive endocrinology assays report strong Sigma metrics across multiple concentrations, indicating they are highly capable of achieving results within the allowable error.
B-148 Bacer: decentralized isotope dilution method with lab blinding for blood alcohol content
Authors: Nie M , Li X , Xiong W , Zou X , Zheng B
Published: October 2024

Background

In legal medicine, the determination Blood Alcohol Content (BAC) usually faced the problems of insufficient sample size, ethanol degradation and impossible double check. In addition, the integrity of laboratory may also be questioned. To this end, we developed a decentralized solution based on isotope dilution method.

Methods

Patented deuterated ethanol vacuum tube was used in field as regular type, weight of blood was record to BACer terminal. Arbitrary amount of sample(ca.0.1-1.0g) was pipetted to GC sample vial and sealed tightly, then heated more than 2min at 70°C, 10µL headspace sample was injected into GC-MS. Blinded lab uploaded peak area ratio of ethanol/deuterated ethanol(mz31/33) to BACer to calculate the final BAC.

Results

Regression between peak area ratios of ethanol/deuterated ethanol showed good linearity in the range of 0.10-5.0 (R2>0.999). Regression equation of different instruments were proved good consistency with slopes ranged from 1.03 to 1.07, and the LOD and LOQ were around 0.01mg/g and 0.05mg/g, 3-level recoveries between 97%-101% with RSD less than 1%. During the 6-month stability test at 4°C and normal temperature, the blood sample test results maintained good stability. The proposed method was applied to 2021 CNAS proficiency testing (2021SF-CNAS002) organized by China Academy of Forensic Sciences with satisfactory results. The comparison with Chinese standard method SF/Z JD0107001-2010 yielded good agreement with Passing&Bablok test (P>0.10). The expanded uncertainty estimated by Monte-carlo method was less than 3%.

Conclusions

This proposed method showed the possibility of decentralized determination of BAC with lab blinding, the separation of on-site sampling data and laboratory testing also provided the possibility of integrity of results. It also provided a possible solution for the scenarios where the storage condition of blood collection is poor, or the cross check is required. But good chromatographic separation and operation are compulsive due to the possibility of interference in IDMS.