Journal of Applied Laboratory Medicine最新文献

{"title":"Simulation-Based Machine Learning as a Benchmarking Tool for the Retrospective Identification of IV Fluid Contamination in Basic Metabolic Panels.","authors":"Nicholas C Spies, Christopher W Farnsworth","doi":"10.1093/jalm/jfag128","DOIUrl":"https://doi.org/10.1093/jalm/jfag128","url":null,"abstract":"<p><strong>Background: </strong>Current laboratory workflows fail to reliably capture intravenous fluid contamination of chemistry results, leading to diagnostic uncertainty and misinformed clinical decisions. These events cause predictable error patterns, but no gold-standard detection method or definition exists, hindering optimization efforts. We sought a scalable detection solution for these errors to guide quality initiatives and research efforts.</p><p><strong>Methods: </strong>We developed an ensemble of LightGBM classifiers to retrospectively identify the typical anomaly-with-resolution pattern seen in contaminated results by simulating contamination from common fluid compositions into authentic patient results. Models were evaluated by cross-validation and manual review, applied to a held-out 1-year validation cohort, and used to benchmark existing delta-check and published detection approaches.</p><p><strong>Results: </strong>Models produced excellent discrimination between real results and simulated contamination. When applied to real-world data, results flagged as contamination consistently exhibited the expected anomaly-with-resolution pattern and were enriched for abnormal and critical results that often exceeded reference change values across multiple analytes. Predicted contamination rates varied substantially by clinical setting, with the highest rates in emergency departments, operating rooms, and intensive care units. The retrospective machine learning ensemble provides a scalable benchmarking tool for evaluating routine laboratory workflows and published rule-based or delta check methods.</p><p><strong>Conclusions: </strong>Simulation-based machine learning provides a scalable, high-fidelity \"silver standard\" for retrospective identification of intravenous fluid contamination. This approach enables robust benchmarking of detection strategies, supports optimization of practical rule-based workflows, and offers actionable insights for laboratory quality improvement and patient safety initiatives.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148799317","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":"Unexplained Quality Control Drift in an Automated Vitamin B12 Immunoassay.","authors":"Pallavi Chincholkar, Gowri Vadivelu, Leslie Lam","doi":"10.1093/jalm/jfag115","DOIUrl":"https://doi.org/10.1093/jalm/jfag115","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148762157","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":"Effect of Adherence to Sodium-Glucose Cotransporter 2 Inhibitors on 1,5-anhydroglucitol.","authors":"Natalie R Daya, Dan Wang, Michael Fang, Scott J Pilla, Justin B Echouffo-Tcheugui, Jennifer P Carson, Christopher W Farnsworth, Lawrence J Appel, Elizabeth Selvin","doi":"10.1093/jalm/jfag116","DOIUrl":"10.1093/jalm/jfag116","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13483307/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148799279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commentary on Unexpected Hyponatremia in a Young Child Receiving Intravenous Immunoglobulin Therapy.","authors":"Ian S Young","doi":"10.1093/jalm/jfag121","DOIUrl":"https://doi.org/10.1093/jalm/jfag121","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148670891","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":"Accessible Prostate-Specific Antigen Testing through Finger-Stick Dried Blood Spots and Routine Laboratory Analyzers.","authors":"Elizabeth M van Vugt, Lotte Hofstee, Leosa R Soels, Michael Y Schakelaar, Wouter M Tiel Groenestege","doi":"10.1093/jalm/jfag119","DOIUrl":"https://doi.org/10.1093/jalm/jfag119","url":null,"abstract":"<p><strong>Background: </strong>Prostate-specific antigen (PSA) is a biomarker used for detection, screening, and follow-up of prostate cancer. Traditional PSA quantification requires venipuncture, which poses challenges in collection, storage, and transportation. Dried blood spot (DBS) technology presents a promising alternative for measuring PSA levels, potentially facilitating telemedicine, and large-scale screening programs.</p><p><strong>Methods: </strong>PSA concentrations were measured in paired capillary finger-stick DBS and venous serum samples from 75 patients using a Siemens immunochemistry analyzer. For DBS samples, PSA was extracted using PBS prior to analysis. Additional validation of stability, hematocrit effects, precision, and limits of blank and quantitation was performed according to corresponding Clinical and Laboratory Standards Institute standards.</p><p><strong>Results: </strong>The DBS PSA assay demonstrated good analytical performance, with total CVs of 4.5% and 6.1% at PSA concentrations of 11.5 µg/L and 3.8 µg/L, respectively. Limit of blank, limit of detection, and limit of quantitation were 0.24 µg/L, 0.28 µg/L, and 0.70 µg/L, respectively. Method comparison showed strong agreement between venous serum and finger-stick DBS (R2 = 0.987) with minimal bias. Stability studies showed that PSA remained stable for up to 31 days between -20°C and +30°C. Hematocrit affected measured PSA concentrations, but results remained within predefined total allowable error limits across 0.25-0.50 L/L. Variations in double spotting, blood volume, and number of spots did not affect PSA concentrations with a consistent trend.</p><p><strong>Conclusions: </strong>PSA can be accurately measured from finger-stick DBS on an automated high-throughput immunochemistry analyzer. This method is less invasive for patients and may facilitate at-home self-sampling supporting (tele)diagnostics, screening, and follow-up.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148664639","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":"Unexpected Hyponatremia in a Young Child Receiving Intravenous Immunoglobulin Therapy.","authors":"Alexander L Kolb, Aglaia E Morlock, Mark D Kellogg","doi":"10.1093/jalm/jfag091","DOIUrl":"https://doi.org/10.1093/jalm/jfag091","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148664626","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":"The Doctor of Clinical Laboratory Science in Practice: A Survey of Workforce Roles, Responsibilities, and Integration.","authors":"Melody B Nelson, LaShanta Brice, Kacy Peterson, Kris L Sullivan, Christina C Pierre","doi":"10.1093/jalm/jfag118","DOIUrl":"https://doi.org/10.1093/jalm/jfag118","url":null,"abstract":"<p><strong>Background: </strong>The Doctor of Clinical Laboratory Science (DCLS) is a novel advanced-practice doctoral degree that was established in 2014 to equip medical laboratory scientists for integrative practice roles within clinical healthcare teams (e.g., diagnosticians, consultants, directors). The goal of this study was to comprehensively review the professional trajectories of DCLS graduates from 3 programs in the United States. Further, the study sought to understand the professional society resources needed by DCLS practitioners to support career development.</p><p><strong>Methods: </strong>This study employed a cross-sectional survey design to characterize the educational background, professional roles, practice settings, and career trajectory of DCLS graduates. The survey was developed by the Association for Diagnostics & Laboratory Medicine (ADLM) DCLS Task Force.</p><p><strong>Results: </strong>A total of 41 DCLS alumni completed the survey. Most respondents held roles in education (39%), as laboratory administrative directors (29.2%), or as medical laboratory directors (24.4%). Respondents were largely specialized in hematology and coagulation (46.3%; n = 19) and clinical chemistry and toxicology (43.9%; n = 18). Most respondents expressed interest in board certification, and nine were board-certified by the National Registry of Certified Chemists (NRCC). Respondents expressed interest in advocacy for broader recognition and understanding of DCLS skill sets.</p><p><strong>Conclusions: </strong>DCLS graduates hold a variety of roles within the clinical laboratory across various clinical pathology subspecialties. Most DCLS graduates function in clinical oversight, administrative leadership capacities, and education. Graduates expressed interest in increased recognition of DCLS roles and a broader awareness of DCLS skill sets across the laboratory medicine community.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148621837","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 Two Ion-Exchange HPLC Methods for HbA1c Quantitation.","authors":"Darren L Latzig, Paula Zwiefelhofer, Ian L Gunsolus","doi":"10.1093/jalm/jfag112","DOIUrl":"https://doi.org/10.1093/jalm/jfag112","url":null,"abstract":"<p><strong>Background: </strong>This study characterized the analytical performance of the Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (GR01), the newest-generation hemoglobin A1c (HbA1c) analyzer from Tosoh, relative to the predicate Tosoh HLC-723G8 glycohemoglobin analyzer (G8).</p><p><strong>Methods: </strong>Performance of the GR01 was assessed through precision, linearity, method comparison, and variant interference studies in whole blood and hemolysate. The G8 was the comparator method for all studies. Variant interference studies included specimens with heterozygous hemoglobin variants C, D, E, and S, as well as elevations of hemoglobin A2. Interference studies for elevated hemoglobin F were also conducted using cord blood.</p><p><strong>Results: </strong>Total imprecision for the GR01 at HbA1c concentrations ranging from 5.0% to 12.0% (31-108 mmol/mol) was approximately 1% CV, meeting common acceptance limits applied to HbA1c clinical testing and method certification. Linearity studies also met acceptance criteria, with an average of 0.1% bias from the expected HbA1c concentration across the analytical measurement range. All paired GR01 and G8 HbA1c measurements in nonvariant specimens showed relative differences less than 5%; mean differences (in %HbA1c units) were 0.03% in whole blood (SD 0.07%) and 0.02% HbA1c in hemolysate (SD 0.07%). Across all variants, the mean difference between GR01 and G8 measurements was 0.1% (SD 0.25%).</p><p><strong>Conclusions: </strong>The GR01 showed excellent correlation with the predicate G8, including in specimens containing high concentrations of common heterozygous hemoglobin variants, exceeding variant levels of 30% to 40%. Relative bias between the methods near medical decision points of 6.5% and 8.0% (48 and 64 mmol/mol, respectively) achieved the ±5% criterion used by the National Glycohemoglobin Standardization Program.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148608345","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 New Insights into Unexpected Enzymatic Creatinine Assay Interference: A Case of Acetaminophen Toxicity.","authors":"Preejith P Vachali, Adam J McShane","doi":"10.1093/jalm/jfag120","DOIUrl":"https://doi.org/10.1093/jalm/jfag120","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148608399","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":"New Insights into Unexpected Enzymatic Creatinine Assay Interference: A Case of Acetaminophen Toxicity.","authors":"Chelsea B Swartchick, Christopher L Rosemark, Darci R Block, Nikola A Baumann, Brooke M Katzman","doi":"10.1093/jalm/jfag111","DOIUrl":"https://doi.org/10.1093/jalm/jfag111","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148608393","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}