bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-280 The Good, the Bad, and the Downright Inappropriate reporting of Gram Positive Resistance Genes in a Proficiency Testing Program
Authors: Mills E , Casey D , Kolehmainen L 
Published: October 2024

Abstract

Background
Molecular technologies can rapidly identify the pathogen, allowing for the correct antimicrobial agent to be used for initial treatment. Many laboratories have implemented molecular technologies to identify the causative agents of infections from various bodily sources. Screening for potential resistance genes to common antimicrobial agents provides high value to clinicians to help guide optimal antimicrobial therapy selection. CLIA ‘88 required proficiency testing for physician office laboratories in 1994. This was in addition to the requirement for hospital and reference laboratories instituted under CLIA ‘67. This study compares the accuracy of laboratory performance for molecular multiplex platforms in the detection of Gram positive resistance genes from gold standard qualified samples in a novel proficiency program.

Methods
American Proficiency Institute, an independent proficiency testing provider, reviewed the reporting of various molecular multiplex systems against simulated patient samples in proficiency samples offered in 2023. Participants were instructed to only report resistance genes their systems were capable of testing for, and ensure they were appropriate for the organism recovered. Failure rates for participants were evaluated against an 80% participant consensus standard for detection of resistance genes.

Results
During the 2023 proficiency year, Gram positive targets were included 14 times in 4 different multiplex programs. Accuracy for correct reporting of resistance genes appropriate for the organism recovered ranged between 71.0%- 100%. Conversely, the number of laboratories reporting resistance genes that were inappropriate for the organism recovered ranged between 2.0% - 67.0%.

Conclusions
Based on the results reported by participants in API’s proficiency event, Molecular Multiplex platforms are accurately identifying Gram positive resistance genes. However, many participants using both FDA approved and LDT systems reported results for resistance genes that were not applicable for the organism recovered. This inaccurate reporting could potentially lead to inappropriate antimicrobial therapies being prescribed.
A-299 Assessment of a new miniaturized line blot system for fully automated serodiagnosis of Borrelia infections
Authors: Sabalza M , Scheper T , Assmann J , Ott A , Schulz A , Meyer W 
Published: October 2024

Abstract

Background
Serodiagnosis of Lyme disease caused by Borrelia burgdorferi commonly affords the combination of a sensitive antibody screening test followed by confirmatory immunoblot analysis. We developed and evaluated a new immunoblot system enabling the multiparametric analysis of anti-Borrelia antibodies by means of miniaturized line blots in a fully automated microplate format.

Methods
The EUROMicroblots Anti-Borrelia (IgG and IgM, EUROIMMUN) are based on diagnostically relevant Borrelia-specific antigens. Diagnostic sensitivity was determined by analyzing 203 pre-characterized samples from patients with Lyme disease stratified by clinical picture and antibiotic treatment. Specificity was assessed using 168 sera from patients clinically diagnosed with rheumatic diseases. The reference range was analyzed using a control panel of 211 (IgG) and 210 (IgM) samples from healthy individuals, comprising 151 (IgG) and 150 (IgM) blood donors as well as 60 pregnant women (IgG, IgM). The Microwell Imager and EUROLineScan software (EUROIMMUN) were used for image acquisition and evaluation.

Results
Depending on the clinical category, the diagnostic sensitivity of the EUROMicroblots ranged from 68.0% in the early phase of infection to 100% (IgG/IgM combined) at a specificity of 86.9% (IgG) and 94.0% (IgM). The analysis of the panel of healthy control subjects revealed a prevalence of 10.9% (IgG) and 2.8% (IgM).

Conclusions
The new EUROMicroblot system enables high-throughput serodiagnosis of Borrelia infections due to the microplate format and automated processing and evaluation. Depending on clinical symptoms and treatment, the assays provide excellent diagnostic sensitivity and specificity for the detection of anti-Borrelia IgG and IgM.
A-301 Evaluation of Second-Generation Visby Medical Sexual Health Point-of-Care Test: Clinical Concordance, Analytical Error Rates, and Result Turnaround Time
Authors: Kelley B , Wockenfus A , Binnicker M , Karon B , Donato L 
Published: October 2024

Abstract

Background
Rapid testing for Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis may be useful for antibiotic stewardship initiatives. Our institution recently implemented the second-generation Visby Medical Sexual Health Test (Visby Gen2) for rapid diagnosis of STIs in our emergency department. Here we (1) compared result concordance of the (Visby Gen2) to the first-generation Visby Medical Sexual Health Click Test (Visby Gen1), (2) compared assay failure rates of the Visby Gen1 to Gen2 tests, and (3) compared result turnaround time (TAT) for clinically ordered rapid STI tests to central laboratory STI results.

Methods
Accuracy was assessed using residual clinical samples in Aptima buffer submitted for routine molecular STI testing (C. trachomatis, N. gonorrhoeae, and T. vaginalis) in the central laboratory on the Panther platform (Hologic). Aptima samples were diluted 1:33 in Visby collection buffer prior to testing on the Visby cartridge. Clinically reported results were used as reference results. Diluted samples with discordant results were re-tested on the reference method and the result from the dilution was used in calculations. Assay failure rates were calculated as the number of failed assays compared to the total assays performed. TAT for rapid and central lab testing was calculated as time of sample received in laboratory to time verified in laboratory information system.

Results
For Visby Gen1 we observed negative concordance of 100% (41/41) for C. trachomatis, 97.5% (39/40) for N. gonorrhoeae, and 97.1% (34/35) for T. vaginalis. Positive concordance was 91.7% (11/12) for C. trachomatis, 100% (11/11) for N. gonorrhoeae, and 100% (17/17) for T. vaginalis. For Visby Gen1 we observed a 10.5% (12/114) cartridge failure rate. For Visby Gen2, we observed negative concordance of 100% (59/59) for C. trachomatis, 100% (63/63) for N. gonorrhoeae, and 100% (55/55) for T. vaginalis while positive concordance was 100% (10/10) for C. trachomatis, 100% (6/6) for N. gonorrhoeae, and 90.9% (10/11) for T. vaginalis. The Visby Gen2 assay displayed a 4.9% (4/81) cartridge failure rate. Six weeks after implementing the Visby Gen2 assay in our ED, rapid STI panel TAT was 0.48 hours on average (n=20). In the central laboratory the average TAT was 22.31 hours (n=7892).

Conclusions
Assay concordance to reference method was similar for Visby Gen1 and Gen2 assays. The cartridge failure rate improved by 46.7% with the Gen2 assay which should decrease the need to repeat testing due to assay failure. Result TAT decreased by 97.8% when comparing rapid Visby results to central laboratory. Therefore, Visby STI testing using the Gen2 assay can provide accuracy and rapid results likely to facilitate more rapid patient management.
A-335 Evaluation of the Next Generation i-STAT® Point of Care Prothrombin Time Test
Authors: Ball S , Hahn S , Kornfeld S F 
Published: October 2024

Abstract

Background
The i-STAT® PTplus cartridge contains a point of care prothrombin time (PT) test. The purpose of this study was to assess the performance of the i-STAT PTplus cartridge compared to other commercially available PT tests namely, Dade® Innovin® on the Sysmex® CS-2500 and the Roche CoaguChek®. The i-STAT® PTplus cartridge is a point of care whole blood test for the determination of prothrombin time. It is used to aid in the monitoring of patients receiving anticoagulant therapy with coumarin derivatives.

Methods
Venous and capillary whole blood specimens were prospectively collected with IRB approved informed consent from 222 subjects undergoing coumarin therapy and from subjects who were not on anticoagulant therapy at three clinical sites to span the reportable range of 0.8 - 8.0 INR. Both venous and capillary whole blood specimens were tested in duplicate on the i-STAT 1 Wireless Analyzer and were tested in singlicate on the Roche CoaguChek® device. Plasma from a citrated venous blood specimen obtained from the same subjects was tested in duplicate on the Sysmex® CS-2500 instrument.

Results
The Passing-Bablok regression results in the table below demonstrate international normalized ratio (INR) in the first replicate of the i-STAT PTplus cartridge versus the first replicate comparative device for venous and capillary whole blood.

Conclusions
This study demonstrates that the i-STAT® PTplus cartridge has good agreement to both laboratory and point of care commercially available PT tests when tested with venous and capillary whole blood from subjects not on anticoagulant therapy and subjects receiving coumarin therapy. The studies were funded by Abbott Laboratories.
A-340 Analysis of OrganOx Liver Perfusate at the Point-of-Care on the Abbott iSTAT and Nova Glucometer to Support Clinical Evaluations of Donor Livers Prior to Transplantation
Authors: Doe B , Gant-Kanegusuku A , Maggiore J 
Published: October 2024

Abstract

Background
The recently FDA-approved OrganOx Metra normothermic perfusion system for maintaining donor livers under physiologic conditions prior to transplantation comes equipped with a limited onboard blood gas analyzer for monitoring pO2, pCO2 and temperature. In clinical practice, however, additional biomarkers are used to assess the functional performance of the donor liver, including perfusate lactate clearance and glucose utilization. Liver perfusate contains a mixture of packed red blood cells, albumin, heparin, antibiotic, and solutions of amino acids and electrolytes and bile salts to support metabolic function, and is a specimen type that is not approved by the FDA. Implementation of the OrganOx Metra at Loyola University Medical Center (LUMC), a quaternary care transplant center, led to the validation of liver perfusate for the evaluation of glucose and lactate at the point-of-care (POC) using the Nova STATStrip Glucometer and Abbott iSTAT CG4 cartridge, respectively.

Methods
Lactate was measured on the Abbott iStat CG4 cartridge, and glucose which was measured using the Nova STATStrip Glucometer. Recovery studies were performed by mixing liver perfusate (non-centrifuged, n=16 independent specimen) with heparinized whole blood.

Results
The average recovery for the evaluation of lactate was 100% (range = 78 to 122%), and the average recovery for glucose was 109% (range = 93 to 112%).

Conclusions
Recovery studies evaluating matrix effect for the analysis of lactate (Abbott iSTAT, CG4) and glucose (Nova STATStrip) in liver perfusate indicate that the matrix of the perfusate does not affect the analytical accuracy, as compared to heparinized whole blood, the FDA-approved specimen type. Measurement of the OrganOx liver perfusate for lactate and glucose on these POC devices demonstrates reliable assessments to guide transplant teams in evaluating the viability of donor livers.
A-344 Delivering better and timely diagnosis for critical patients: POC clinical performance versus Central Laboratory assays in key cardiac markers
Authors: Aldunate J , Montecinos C , Gárate J , Vial M 
Published: October 2024

Abstract

Background
Cardiac markers are often used in critical settings, such as emergency department and coronary units. Clinica Redsalud Santiago implemented a reference Cardiovascular center to improve patient length of stay and clinical output, supported by diverse procedures and opportune diagnosis. Our aim was to implement POC devices for measuring key Cardiac Markers. Here we validated clinically and analytically the performance of POC devices versus Central Laboratory results for Troponin I, hs Troponin I, BNP and NT-proBNP markers.

Methods
Forty-nine patients admitted at emergency department were included in the study. Forty samples were obtained from male patients (69.7±9.8 years) and 9 from female patients (67.8±3.9 years). Samples were drawn and processed in parallel using Triage SOB panel, hsTroponin I and NT-proBNP tests, and the other samples were analyzed in a VITROS system, using Troponin I ES, hs Troponin I and NT-proBNP.

Results
Clinical agreement was assessed for different methodologies, using kappa values. Almost perfect agreement was achieved for Troponin I and NT-proBNP between Triage and VITROS systems (Figure 1). For harmonization results reporting purposes, regression fits and Bland-Altman plots were analyzed for both assays (data not shown). Hs Troponin methods did not show a good linear correlation fit, but it improves significantly on quadratic regression. For NT-proBNP methods, a good linear correlation was achieved. In both comparisons, major differences were observed for high values, while those values near to cut-off or low-to-mid in pathological range were comparable.

Conclusions
Timely decisions are important but is difficult to find perfect solutions for end-to-end needs. We identified two key cardiac biomarkers used routinely in emergency department and coronary care that can be harmonized for clinicians, in terms of quality and traceability. Based upon results, we can expect value discrepancies between different methodologies, hence the need for creating proper guidance for supporting key decisions for clinicians.
A-365 Rapid HIV testing and confirmation reflex testing integration in Laboratory Information System (LIS) using a point-of-care glucometer
Authors: Leung E K , Gabra M I , Mendoza R , Lee C , Xiao Y 
Published: October 2024

Abstract

Background
Point-of-care (POC) rapid testing for HIV antigen/antibody has aided in the rapid determination of HIV infection and initiating post-prophylaxis treatment. However, the molecular confirmation test needed to confirm positive POC HIV results is a send-out test at Children’s Hospital Los Angeles (CHLA). A 2021 internal POC survey identified 4.5% of positive screening test results that were missed or ordered the inappropriate confirmation test due to manual order entry errors.

Methods
We investigated the use of the NOVA StatStrip glucometer to record and transmit the results of the HIV 1/2 antigen/antibody test into the laboratory information system (LIS) through QML Telcor middleware. A new test entry was developed on the NOVA StatStrip glucometer and an automatic reflex rule was developed to allow the appropriate confirmation test to be automatically ordered to circumvent issues with manual order entry.

Results
The reflex rule was validated using the Abbott HIV 1/2 antigen/antibody test and results were recorded on the NOVA StatStrip glucometer. A positive result for HIV ½ antibodies would automatically order the confirmatory HIV 1/2 Ab differentiation test. A positive result for the HIV 1/2 p24 antigen would automatically order the HIV-1 RNA molecular test. If the POC HIV 1/2 test is positive for both antibodies and the antigen, both confirmatory tests will be automatically ordered. All confirmation test orders were successfully submitted through the LIS without errors.

Conclusions
POC testing using the HIV 1/2 antigen/antibody lateral flow immunoassay allows for rapid bedside or clinic screening for fast treatment response. Our laboratory demonstrated the effective use of glucometers to transmit, auto reflex to order confirmatory tests, and post results to the LIS, thus, reducing errors associated with manual send-out order entries.
B-023 Workflow evaluation of the new Siemens Atellica CI Analyzer
Authors: Rhea-McManus J , Abd Alla M , Barrionuevo-González M , Crneković K , Elkhodary H , Findeisen P , Kraft M , Lapeña García S , Mickeler S , Ruffing U , Ruiz-Alvarez M , Diabate D 
Published: October 2024

Abstract

Background
The Atellica® CI Analyzer, Model 1900 is an integrated clinical chemistry and immunoassay analyzer that has the same user interface, general workflow, and planned test menu to that of the larger Atellica® Solution. Atellica CI Analyzer also shares the same reagents and consumables as the Atellica Solution. The purpose of this study was to evaluate workflow performance of the Atellica CI Analyzer in a routine-like clinical laboratory setting.

Methods
The study was conducted at four international laboratory facilities over a four-month period. Basic throughput of the Atellica CI Analyzer was evaluated at each site by testing quality control (QC) and remnant anonymized patient samples using an 8:2 mixture of chemistry (ion selective electrolytes [IMT], clinical chemistry analytes) and immunochemistry assays. Additionally, the impact of interrupting routine testing for STAT high-sensitivity cardiac troponin samples was also evaluated. Daily, weekly, and monthly maintenance activities were observed, and data collected through direct observations, time and motion studies, and system run logs.

Results
The Atellica CI Analyzer aspirated patient samples in as little as two minutes (mins) with the time to first result for the mixed assay worklist ranging from 1 to 12 mins from the time of first barcode read. Across the four sites, the time to last result for the mixed assay worklist (average n=495 test results per site) ranged from 52 to 65 mins. The average turn around time (TAT) for high-sensitivity troponin was 9 mins from barcode read. Daily maintenance and QC activities for the Atellica CI Analyzer are comprised of both automated and manual activities. The average daily maintenance hands-on time was 3.6 min, ranging from 1.6 to 6.4 mins across the four sites. Daily QC preparation required &lt;5 mins of hands-on time. The total average hands-on time to complete weekly maintenance for the Atellica CI Analyzer was 7.5 min.

Conclusions
The Atellica CI Analyzer demonstrated consistent system performance across all four study sites. Implementation of the Atellica CI Analyzer has the potential to increase laboratory efficiency given the minimal hands-on time required for daily and weekly maintenance activities and short TATs.
B-034 Performance Evaluation of the Total Bile Acids (TBA) Assay on Mindray BS-2800M Analyzer
Authors: Dai J , Cheng W , Jiang M , Wang J 
Published: October 2024

Abstract

Background
Bile acids (BA) are synthesized in the liver and secreted into bile. The function of BA is to promote absorption of lipids including fat-soluble vitamins. During liver diseases such as viral hepatitis and liver injury by hepatotoxic drugs, and cholestasis condition, BA secretion to bile is impaired, causing serum BA level to rise. Therefore, the determination of serum BA can be used as a sensitive indicator of liver function. TBA reagent contains NADH that requires pH ≥ 9 to be stable that is usually difficult to be maintained during reagent opened and stored on the analyzer. Meanwhile, 3α-Hydroxysteroid Dehydrogenase (3α-HSD) is required for the reaction. 3α-HSD is sensitive to pH condition. Minor changes in pH results in significant changes of enzyme activity. We formulated our TBA reagent with prolonged stability when reagent is onboard on the analyzer. This study evaluated the performance of the new Mindray TBA assay on Mindray BS-2800M.

Methods
TBA assay was based on the method with coupled Thio-NAD and NADH reaction for BA. The R1 contains Thio-NAD. The R2 contains NADH and 3α-HSD. R1 is incubated with serum sample containing BA for 5 min at 37°C and R2 is then added. During further incubation in the presence of Thio-NAD, 3α-HSD converts BA to 3-ketosteroids and Thio-NADH. The reaction is reversible, and 3α-HSD can convert 3-keto steroids and Thio-NADH to BA and Thio-NAD. In the presence of excess NADH, enzyme cycling occurs efficiently and the rate of formation of Thio-NADH is determined by measuring specific change of absorbance at 412 nm. Two-point-line calibration is used by this assay. The TBA concentrations for the test samples are obtained by the absorbances of test samples from the calibration line. The performances of precision, linearity, onboard stability, interference (hemolysis, lipid and bilirubin), correlation are evaluated following CLSI protocols.

Results
The precision study was run according to EP05A3 with two commercial controls (about 21 and 36μmol/L) and two serum sample pools(about 9.9 and 24.2 μmol/L)on the Mindray BS-2800M system. The repeatability and within-lab CVs ranged from 0.74% to 1.97%, respectively. The linearity of the assay was determined as from 2.0 μmol/L to 180 μmol/L. The reagent onboard stability is for 28 days without recalibration that is superior to TBA reagents from other manufacturers. The interference of hemolysis, lipid and bilirubin are with less than ±10% impact with hemolysate Hemoglobin up to 500 mg/dL, Intralipids up to 500 mg/dL, and Conjugated bilirubin up to 30 mg/dL, Unconjugated bilirubin up to 30mg/dL. This assay (Y) also correlated well with SEKISUI TBA assay (x), (Y = 0.9965X + 0.2694, r= 0.9993).

Conclusions
From this evaluation, we concluded that Mindray TBA assay can measure serum TBA precisely and accurately with good performances, especially for onboard stability. It is suitable for use in routine clinical laboratories.
B-039 Evaluating Inter-Analytic Module Immunoassay Carryover
Authors: Spiesman A M , Spriggs A , Légaré W , McShane A J 
Published: October 2024

Abstract

Background
Integrated analytical systems contain both clinical chemistry analyzers and immunoassay analyzers. Immunoassays can be assigned high priority based on potential sample carryover from sample probes used in clinical chemistry analyzers. The priority designation, assigned by the vendor, determines if the immunoassay test (disposable pipette) is sampled prior to the clinical chemistry test (non-disposable pipette). However, in a modern-day core chemistry laboratory, add-on testing is prevalent. High priority assignment by analytical systems is only effective when a specimen’s tests are analyzed concurrently and doesn’t account for an add-on of any high priority immunoassays. Evaluation of carryover for high priority immunoassays on clinical chemistry analyzers provides insight on if there is clinical impact of allowing add-on testing of these analytes.

Methods
Intact human chorionic gonadotropin + β-subunit (HCG-BETA, Roche Diagnostics, cobas e602), Procalcitonin (PCT, Roche Diagnostics, cobas e602), and Elecsys Total Prostate-specific Antigen (TPSA, Roche Diagnostics, cobas e602) were the high priority immunoassays evaluated for carryover. High and low target pools were separated into aliquots and baselines for each pool established. High sampling volume assays to potentially generate carryover on the clinical chemistry analyzers were determined to be Sodium (Na, Roche Diagnostics, cobas ISE), Unsaturated Iron-Binding Capacity (UIBC, Roche Diagnostics, cobas c702), and Ammonia (NH3L2, Roche Diagnostics, cobas c502). The ordering sequence of high pool to low pool was then assayed in triplicate on each clinical chemistry analyzer. After potential carryover had been generated, the low pool was again assayed for the immunoassays to evaluate if carryover had occurred and if the carryover exceeded the analyte’s allowable error. Statistical analysis was then performed utilizing Microsoft Excel.

Results

Conclusions
Add-on testing should be restricted for β-HCG and TPSA as a previous clinical chemistry analysis could lead to an errant add-on result due to carryover. PCT is unaffected by previous clinical chemistry analysis.