Journal of Applied Laboratory Medicine最新文献

{"title":"Analytical Characterization and Validation of a Novel Automated Amino-Terminal proB-Type Natriuretic Peptide Assay.","authors":"Robert H Christenson, Dileepa Alahapperuma, Brandon R Allen, Jessica L Guidi, Gary Headden, W Franklin Peacock, Nicole Winden, James L Januzzi","doi":"10.1093/jalm/jfaf012","DOIUrl":"https://doi.org/10.1093/jalm/jfaf012","url":null,"abstract":"<p><strong>Background: </strong>N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurement has class 1, level of evidence A recommendations in heart failure (HF) guidelines for diagnosis and prognosis. Analytical characterization of a novel automated NT-proBNP assay is necessary to examine its fitness for validation in pivotal clinical trials.</p><p><strong>Methods: </strong>The Access NT-proBNP assay is an immunoenzymatic assay using monoclonal capture and detection reagents on the DxI 9000 Immunoassay Analyzer. Clinical and Laboratory Standards Institute guidelines directed limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ), linearity, imprecision, interference, and method comparison studies. Age-specific 97.5th percentile upper reference limits (URLs) were established with 675 healthy US adults that are 54.7% female, 79% White, 15% Black, and 8% Latinx.</p><p><strong>Results: </strong>LoB = 1.1 ng/L; LoD = 4.8 ng/L; LoQ = 4.8 ng/L, linearity = 25 000 ng/L; and no interfering/cross-reacting substances were identified. Repeatability and reproducibility CVs were 1.5% to 3.5% and 2.7% to 7.9%, respectively, at NT-proBNP concentrations from 38 ng/L to 23 848 ng/L. The Passing-Bablock regression equation for method comparison is Beckman Access = 0.92 * Elecsys-1.20 ng/L, r = 0.99. Age-specific 97.5th percentile URLs for the Access NT-proBNP assay are <50 years, 162 ng/L; 50 to 75 years, 311 ng/L; and >75 years, 457 ng/L.</p><p><strong>Conclusions: </strong>A method comparison showed good harmony with an established assay, and analytic parameters demonstrated satisfactory overall performance. Imprecision across the measurement range is <8%. The Access NT-proBNP assay yielded age-specific 97.5th percentile URLs in harmony with the Elecsys reference method. The Access NT-proBNP assay demonstrated robust analytical performance that is fit for the purpose of supporting an NT-proBNP clinical trial for HF diagnosis and prognosis.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Secretoneurin Concentrations Measured with a High-Throughput Assay and Clinical Outcomes in Patients Hospitalized with Acute Dyspnea: Data from the Akershus Cardiac Examination 2 Study.","authors":"Helge Røsjø, Ilde Rugolo, Angelica Gjørven, Arne L Faaren, Frank Frantzen, Geir Christensen, Arne Didrik Høiseth, Anett H Ottesen, Rahul Bhatnagar, Magnus N Lyngbakken, Torbjørn Omland","doi":"10.1093/jalm/jfaf011","DOIUrl":"https://doi.org/10.1093/jalm/jfaf011","url":null,"abstract":"<p><strong>Background: </strong>High-throughput assays are required for novel biomarkers to have clinical potential. Secretoneurin (SN) is a candidate biomarker, and the performance of a new high-throughput SN assay is not known.</p><p><strong>Methods: </strong>We measured SN concentrations with a prototype chemiluminescent immunoassay (CLIA) in 299 patients hospitalized with acute dyspnea. We compared the results with a CE-marked SN enzyme linked immunosorbent assay (ELISA). We adjudicated the cause of dyspnea as heart failure (HF) or non-HF, and we obtained information on all-cause mortality during follow-up.</p><p><strong>Results: </strong>SN concentrations measured with CLIA and ELISA were closely correlated: rho = 0.81, P < 0.001. SN CLIA concentrations were higher in HF patients (n = 129) compared to patients with non-HF-related dyspnea (n = 170): median 51 (quartile 1-3 40-69) vs 41 (32-54) pmol/L, P < 0.001. The area under the curve (AUC) of SN CLIA to diagnose HF was 0.64 (95% CI, 0.58-0.71) and the AUC of N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 0.85 (0.81-0.89). During median 818 days follow-up, 110 patients died (37%). There was a nonlinear association between SN CLIA concentrations and mortality with optimal cutpoint 53 pmol/L. SN CLIA concentrations >53 pmol/L were associated with mortality after adjusting for clinical variables and NT-proBNP and cardiac troponin T concentrations: hazard ratio 1.7 (95% CI, 1.1-2.7), AUC 0.67 (0.61-0.74). We found similar results for SN ELISA for diagnosis and prognosis with AUC 0.63 (0.57-0.70) for the prediction of mortality.</p><p><strong>Conclusion: </strong>The high-throughput SN CLIA correlates with the SN ELISA and provides independent prognostic information over established biomarkers in patients with acute dyspnea.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143598112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AI-Augmented Kidney Stone Composition Analysis with Auto-Release Improves Quality, Efficiency, Cost-Effectiveness, and Staff Satisfaction.","authors":"Patrick L Day, Denise Rokke, Laura Schneider, Jillian Abbott, Brenda Holmen, Patrick Johnson, Mikolaj A Wieczorek, Katie L Kunze, Rickey E Carter, Joshua Bornhorst, Paul J Jannetto","doi":"10.1093/jalm/jfae146","DOIUrl":"10.1093/jalm/jfae146","url":null,"abstract":"<p><strong>Background: </strong>We sought to evaluate key performance indicators related to an internally developed and deployed artificial intelligence (AI)-augmented kidney stone composition test system for potential improvements in test quality, efficiency, cost-effectiveness, and staff satisfaction.</p><p><strong>Methods: </strong>We compared quality, efficiency, staff satisfaction, and financial data from the 6 months after the AI-augmented laboratory test system was deployed (test period) with data from the same 6-month period in the previous year (control period) to determine if AI-augmentation improved key performance indicators of this laboratory test.</p><p><strong>Results: </strong>In the 6 months following the deployment (test period) of the AI-augmented kidney stone composition test system, 44 830 kidney stones were analyzed. Of these, 92% of kidney stones were eligible for AI-assisted interpretation. Out of these AI-eligible stones, 45% were able to be auto-released by the AI-augmented test system without human secondary review. Furthermore, the new AI-augmented kidney stone test system resulted in an apparent 40% reduction in incorrect laboratory results. Additionally, the new AI-augmented test system improved laboratory efficiency by 20%, improved staff satisfaction, and reduced the average analysis cost per kidney stone by $0.23.</p><p><strong>Conclusions: </strong>The AI-augmented test system improved test quality, efficiency, cost-effectiveness and staff satisfaction related to this kidney stone composition test.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"305-314"},"PeriodicalIF":1.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142865784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Presumptive Identification of Clinically Significant Hemoglobin Variants Hb E, Hb S, Hb D in Hb A1c Capillary Electrophoresis.","authors":"Ankitha K Puthiyaveettil, Glen S Vaz, Sujay R Prasad, Deepalakshmi D Putchen","doi":"10.1093/jalm/jfae102","DOIUrl":"10.1093/jalm/jfae102","url":null,"abstract":"<p><strong>Background: </strong>The quantitation of glycated hemoglobin (Hb A1c) represents an average blood glucose level for a period of 2 to 3 months for diagnosing, monitoring, and managing diabetes mellitus. Unreliable results are reported when hemoglobin (Hb) variants are present in the sample. Patients are advised to use an alternate method due to the presence of the variant Hb and a reflex test to Hb electrophoresis to obtain precise information about the Hb variant. The present study utilizes x axis values from Hb A1c capillary electrophoresis (CE) to identify clinically significant Hb variants Hb E, S, and D.</p><p><strong>Methods: </strong>Patient samples (n = 60) that showed a variant peak in the Hb A1c test with an x axis value of 190 to 240 were selected for the study. The migration position of the Hb variant (x axis value) and variant percent of the Hb A1c test were compared with the x axis value and variant percent in the Hb electrophoresis test to presumptively identify the variants. The identity of the variants was confirmed using mass spectrometry (MS).</p><p><strong>Results: </strong>Out of 60 samples, 20 samples were identified as Hb E (x axis 225-227), 20 samples were identified as Hb S (x axis 210-214), and 18 samples were identified as Hb D-Punjab (x axis 200-201). Two variants with an x axis value of 194 were identified as an α variant Hb Q India using MS. There is an overall negative shift of the x axis (-1 to -13 units) and a lower variant percent (-0.2% to -8.7%) in Hb A1c CE when compared with Hb electrophoresis.</p><p><strong>Conclusions: </strong>The present study highlights the significance of the x axis value and variant percent to identify clinically significant Hb variants in the Hb A1c CE test.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"406-415"},"PeriodicalIF":1.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142376164","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of Integrated Clinical Pharmacogenomics Testing at an Academic Medical Center.","authors":"Claire E Knezevic, James M Stevenson, Jonathan Merran, Isabel Snyder, Grant Restorick, Christopher Waters, Mark A Marzinke","doi":"10.1093/jalm/jfae128","DOIUrl":"10.1093/jalm/jfae128","url":null,"abstract":"<p><strong>Background: </strong>Pharmacogenomics has demonstrated benefits for clinical care, including a reduction in adverse events and cost savings. However, barriers in expanded implementation of pharmacogenomics testing include prolonged turnaround times and integration of results into the electronic health record with clinical decision support. A clinical workflow was developed and implemented to facilitate in-house result generation and incorporation into the electronic health record at a large academic medical center.</p><p><strong>Methods: </strong>An 11-gene actionable pharmacogenomics panel was developed and validated using a QuantStudio 12K Flex platform. Allelic results were exported to a custom driver and rules engine, and result messages, which included a diplotype and predicted metabolic phenotype, were sent to the electronic health record; an electronic consultation (eConsult) service was integrated into the workflow. Postimplementation monitoring was performed to evaluate the frequency of actionable results and turnaround times.</p><p><strong>Results: </strong>The actionable pharmacogenomics panel covered 39 alleles across 11 genes. Metabolic phenotypes were resulted alongside gene diplotypes, and clinician-facing phenotype summaries (Genomic Indicators) were presented in the electronic health record. Postimplementation, 8 clinical areas have utilized pharmacogenomics testing, with 56% of orders occurring in the outpatient setting; 22.1% of requests included at least one actionable pharmacogene, and 67% of orders were associated with a pre- or postresult electronic consultation. Mean turnaround time from sample collection to result was 4.6 days.</p><p><strong>Conclusions: </strong>A pharmacogenomics pipeline was successfully operationalized at a quaternary academic medical center, with direct integration of results into the electronic health record, clinical decision support, and eConsult services.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"259-273"},"PeriodicalIF":1.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142830394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Algorithm for the Identification of Hemoglobin Wayne Interference on Hb A1c Measurement Using Intact Hemoglobin Protein Mass Spectrometry Analysis.","authors":"Yu Zi Zheng, Adam J McShane, Sihe Wang, Sarah Ondrejka, Jessica M Colón-Franco","doi":"10.1093/jalm/jfae109","DOIUrl":"10.1093/jalm/jfae109","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"522-525"},"PeriodicalIF":1.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preanalytical Sedimentation Effects on Hematological Tests.","authors":"Kenneth Gard, Ian L Gunsolus","doi":"10.1093/jalm/jfae148","DOIUrl":"10.1093/jalm/jfae148","url":null,"abstract":"<p><strong>Introduction: </strong>Specimens suspected of errors related to low hemoglobin or changes in hemoglobin beyond that of clinically explained variations during hospital stays are frequently redrawn under the auspices that they are contaminated. When lack of an indwelling IV eliminates contamination as a possibility, evaluation of the specimen between the time of collection and testing should occur.</p><p><strong>Methods: </strong>As part of a quality improvement project, we investigated the impact of sedimentation on collected blood specimens not immediately transferred to their respective tubes from a syringe. Each syringe of blood was allowed to stand in a vertical position on the transfer device. After 10 min, each syringe was divided into a bottom half and top half into fresh blood tubes, with half of the samples inverted prior to division. Samples were then analyzed for complete blood count.</p><p><strong>Results: </strong>These results indicate that implementing an inversion of collected specimens prior to transferring will effectively eliminate variations related to sedimentation of blood.</p><p><strong>Conclusions: </strong>Results highlight the importance of specimen handling after collection, including appropriate mixing to avoid erroneous results caused by erythrocyte sedimentation. Mixing syringes before transferring blood to collection tubes ensures a uniform sample and accurate result.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"455-458"},"PeriodicalIF":1.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142956607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of 2 Sets of Immunoassays Used in Modified 2-Tiered Testing Algorithms for the Diagnosis of Lyme Disease.","authors":"Michael E Walsh, Daniel J Sietsma, Isabella W Martin, Lynn A Brunelle","doi":"10.1093/jalm/jfae127","DOIUrl":"10.1093/jalm/jfae127","url":null,"abstract":"<p><strong>Background: </strong>Since 2019, modified 2-tiered testing (MTTT) algorithms have been available for the diagnosis of Lyme disease. MTTTs replaced the standard algorithms that utilized enzyme immunoassays and immunoblots with sequential enzyme immunoassays that detect different antigens.</p><p><strong>Methods: </strong>We compared the performance of serological assays from ZEUS Scientific Inc. and DiaSorin Inc. that are used for the diagnosis of Lyme disease. Serological results were compared with clinical information gathered by chart review.</p><p><strong>Results: </strong>Percent positive agreement (PPA) and percent negative agreement (PNA) for total immunoglobulin G (IgG)/immunoglogulin M (IgM) (n = 120) were 64% (95% confidence interval 54% to 73%) and 100% (87% to 100%), respectively. PPA and PNA for IgG (n = 93) were 91% (80% to 97%) and 66% (52% to 78%), respectively. PPA and PNA for IgM (n = 93) were 75% (62% to 85%) and 95% (82% to 99%), respectively. Fewer positive total IgG/IgM results confirmed positive for either IgG or IgM for ZEUS compared to DiaSorin. Overall MTTT algorithm interpretation was concordant in 58% (55/95) of samples, and concordance improved when the results were limited to IgM in patients with symptom duration <30 days. Treatment with antibiotics was most strongly associated with IgM positivity.</p><p><strong>Conclusions: </strong>This analysis highlights differences in the performance characteristics between commercially available diagnostic assays for Lyme disease. Our data suggest that the DiaSorin assays would result in fewer positive total IgG/IgM tests, decreasing the required number of confirmatory IgG and IgM tests. This would potentially lead to fewer patients treated with antibiotics.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"370-379"},"PeriodicalIF":1.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-Sensitivity and Conventional Cardiac Troponin-I Assays in AL Amyloidosis.","authors":"Maura C Dodge, Tatiana Prokaeva, Lisa Mendelson, Tracy Joshi, Vaishali Sanchorawala, Yachana Kataria","doi":"10.1093/jalm/jfae111","DOIUrl":"10.1093/jalm/jfae111","url":null,"abstract":"<p><strong>Background: </strong>Circulating cardiac troponin-I (cTnI) plays a crucial role in biomarker staging systems, offering important information for prognostification and risk stratification of patients with AL amyloidosis. High-sensitivity cTnI (HS-cTnI) assays have been introduced in practice; however, the data on the concordance between conventional and HS-cTnI and the utility of HS-cTnI in cardiac biomarker staging are lacking.</p><p><strong>Methods: </strong>Seventy-eight consecutive patients with AL amyloidosis who were prospectively evaluated at the Boston University Amyloidosis Center from October 2022 through March 2023 were included. cTnI was measured using the Abbott Architect cTnI chemiluminescent microparticle immunoassay (CMIA) and HS-cTnI using the Abbott Alinity HS-cTnI CMIA assay. Assay results were compared by Deming regression and Bland-Altman analyses, and cardiac biomarker stages were assigned and compared using both assay results.</p><p><strong>Results: </strong>Median cTnI and HS-cTnI concentrations were 13.0 and 7.0 ng/L, respectively. Bland-Altman analysis demonstrated a negative bias with HS-cTnI results (mean percent difference between assays: -49.8%) and the greatest variance occurring below 50 ng/L. Deming regression supported this negative discordance (slope, 0.66; intercept, -1.9). The use of HS-cTnI assay downgraded cardiac biomarker staging assignments from stage IIIA to stage II (n = 3) and from stage IIIB to stage II (n = 1).</p><p><strong>Conclusions: </strong>Overall agreement was demonstrated; however, a negative bias for HS-cTnI assay was noted at low concentrations. The application of the conventional cTnI threshold of >100 ng/L to HS-cTnI-based Boston University cardiac staging showed a trend toward downgraded staging assignments. The prognostic utility of HS-cTnI assay in biomarker staging warrants further investigation in patients with AL amyloidosis.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"315-324"},"PeriodicalIF":1.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the Clinical Significance of the MCM6 c.-14011C/T Polymorphism in Lactose Intolerance: Insights from a Case Series.","authors":"Stine B Bruun, Jonna S Madsen, Pernille M Bøttger","doi":"10.1093/jalm/jfae138","DOIUrl":"10.1093/jalm/jfae138","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"514-517"},"PeriodicalIF":1.8,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142824681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}