Journal of Applied Laboratory Medicine最新文献

{"title":"Stability of Hemolytic, Lipemic, and Icteric Indices in Blood Samples Transported by Drone: A Focused Report.","authors":"Noel Stierlin, Andreas Hemmerle, Harald Renz, Lorenz Risch, Martin Risch","doi":"10.1093/jalm/jfaf009","DOIUrl":"https://doi.org/10.1093/jalm/jfaf009","url":null,"abstract":"<p><strong>Background: </strong>Maintaining blood sample integrity is essential for accurate laboratory diagnostics. The hemolytic, lipemic, and icteric (HIL) indices are critical markers of sample quality, detecting common preanalytical interferences such as hemolysis, lipemia, and icterus. Drone technology offers a novel transport method for medical logistics, particularly in remote or underserved regions. This study assessed the stability of HIL indices in blood samples transported by drone.</p><p><strong>Methods: </strong>Twenty-five samples each of serum, EDTA whole blood, lithium-heparin plasma, and citrate plasma were collected from healthy volunteers using standard venipuncture techniques. Serum samples were collected in gel separator tubes. Samples were transported unprocessed using a rotor-type hybrid drone (Jedsy Glider) over a 25-kilometer route. Temperature and vibration were monitored during flight using data loggers and accelerometers. HIL indices were measured preflight and postflight using a Roche Cobas 6000 system. Paired t-tests assessed significant changes (P < 0.05).</p><p><strong>Results: </strong>No statistically significant differences were observed in the HIL indices preflight and postflight for all blood sample types. For serum samples, the hemolytic index decreased slightly from 9.60 to 9.45 (P = 0.19), with negligible changes in lipemic and icteric indices. Similar stability was observed for EDTA whole blood, lithium-heparin plasma, and citrate plasma.</p><p><strong>Conclusions: </strong>Drone transport is a viable alternative for blood sample logistics, preserving HIL index stability across various sample types. These findings underscore the potential of drones to enhance healthcare logistics in remote or underserved environments.</p><p><strong>Research ethics: </strong>This study was conducted as a quality assurance project for the Institute of Clinical Chemistry at Dr. Risch, Buchs, Switzerland. The Ethics Committee Ostschweiz reviewed the study under BASEC-ID Req-2024-01510 and determined that it does not fall within the scope of the Swiss Human Research Act and therefore does not require formal ethics committee approval. This determination was based on the project's designation as a quality assurance initiative rather than a human research study. As per the committee's guidance, data protection and confidentiality were strictly maintained throughout the study, ensuring compliance with all relevant legal and institutional requirements.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664968","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":"Can Hb A1c Be Greater Than 100%? A Case of Homozygous Hemoglobin J-Iran.","authors":"Maximo J Marin, Shruti S Vaghasia, Molly W Mandernach, Neil S Harris","doi":"10.1093/jalm/jfaf014","DOIUrl":"10.1093/jalm/jfaf014","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143665026","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":"Commentary on Persistently Suppressed Thyroid-Stimulating Hormone without Overt Symptoms.","authors":"Heather A Nelson","doi":"10.1093/jalm/jfaf018","DOIUrl":"https://doi.org/10.1093/jalm/jfaf018","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143651357","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":"Persistently Suppressed TSH without Overt Symptoms.","authors":"William Butler, Rebecca G Ramesh, Benjamin Cooperberg, Daniel S Herman","doi":"10.1093/jalm/jfae160","DOIUrl":"10.1093/jalm/jfae160","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143651358","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":"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}