Journal of Applied Laboratory Medicine最新文献

{"title":"Resource-Aware Sample Size Planning for Sustainable Biological Variation Studies.","authors":"Muh Taufiq, Linda Augustien Makalew","doi":"10.1093/jalm/jfag126","DOIUrl":"https://doi.org/10.1093/jalm/jfag126","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148799320","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":"Threshold and Kinetic Differences between Fifth- and Sixth-Generation High-Sensitivity Cardiac Troponin T in Routine Clinical Care Testing.","authors":"Megan Palacio, Lori B Daniels, Nolan R Martin, Spencer Seely, Ronald W McLawhon, Robert L Fitzgerald, Raymond T Suhandynata","doi":"10.1093/jalm/jfag129","DOIUrl":"https://doi.org/10.1093/jalm/jfag129","url":null,"abstract":"<p><strong>Background: </strong>High-sensitivity cardiac troponin assays, such as troponin T (hs-cTnT), underpin the diagnosis and risk stratification of myocardial injury, with interpretation anchored to the 99th percentile upper reference limit (URL). As clinical laboratories transition from fifth-generation (Gen5) to sixth-generation (Gen6) hs-cTnT assays, analytical shifts may alter threshold crossing and timing of elevation near the 99th percentile URL, where clinical classification is highly consequential. However, real-world data describing the impact of this transition remain limited.</p><p><strong>Methods: </strong>In this retrospective paired analysis, residual specimens from patients undergoing hs-cTnT testing were measured using Roche Gen5/Gen6 assays. A total of 3617 paired measurements from 1847 encounters (1737 patients) were analyzed longitudinally. Patient encounters were assessed for time to elevation above the 99th percentile URL; peak concentration; modeled 0-, 1-, and 3-hour pathway classification; and kinetic behavior.</p><p><strong>Results: </strong>Overall concordance between Gen5 and Gen6 was high for classification of hs-cTnT measurements and encounter peak values relative to the 99th percentile URL. Differences concentrated near the 99th percentile URL, where Gen6 crossed this threshold earlier than Gen5 and the converse was infrequent (2.6% vs 0.1%; P = 0.0001). In the modeled 0/1/3-hour rule-out/rule-in pathway, agreement between assays remained, although some encounters differed in classification between rule-out, indeterminate, and abnormal categories. Gen6 also demonstrated larger relative changes during the rising phase and steeper post-peak declines, with apparent elimination more similar to CK-MB than Gen5.</p><p><strong>Conclusions: </strong>Gen5 and Gen6 hs-cTnT assays demonstrate strong overall agreement, although small analytical differences near decision thresholds produce measurable differences in timing of elevation and modeled clinical classification.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148799236","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":"A Molecular Tool Set for Measurement of Lung Cancer-Associated Protein Biomarker CIZ1B-FibA in Human Plasma.","authors":"Susanna F Rose, Joanna F Pearson, Lewis Byrom, Justin F X Ainscough, Dawn Coverley","doi":"10.1093/jalm/jfag124","DOIUrl":"https://doi.org/10.1093/jalm/jfag124","url":null,"abstract":"<p><strong>Background: </strong>CIZ1B is an alternatively spliced protein fragment of the Cyclin-dependent kinase interacting protein 1 (CIP1)-interacting zinc finger protein (CIZ1) complexed with fibrinogen alpha chain (FibA), forming a single parameter protein analyte (CIZ1B-FibA). The CIZ1B blood biomarker has potential to indicate the presence of early-stage lung cancer and could alter clinical practice.</p><p><strong>Methods: </strong>We report configuration and calibration of a sandwich ELISA for measurement of CIZ1B-FibA that uses a new and highly specific CIZ1B exon junction-selective monoclonal antibody to capture the analyte, and an anti-fibrinogen antibody to detect it, in microliter quantities of plasma from lung cancer patients.</p><p><strong>Results: </strong>The format is tested across 3 independent sample sets encompassing cancer and control samples, yielding Receiver Operating Characteristic area under curve (ROC AUC) values of 0.82 for Set 1 (n = 48), 0.81 for Set 2 (n = 38), and 0.86 for Set 3 (n = 57), indicating discrimination for individuals with lung cancer including those with stage I or II disease (Set 3). However, comparison of the control plasma samples in each set, which were sourced in 3 countries with site-specific plasma isolation processes, revealed baseline differences indicating a note of caution regarding sensitivity to pre-analytic variables. Application of set-specific thresholds, determined by the maximum Youden Index, returned negative predictive values (NPV) of 95%, 77%, and 97% for Sets 1, 2 and 3, respectively.</p><p><strong>Conclusion: </strong>We describe an affordable and scalable blood test which can measure CIZ1B-FibA and now requires further validation of analytical parameters and investigation of potential biological variables.</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":"148799245","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":"Validation of Rectal Swab Specimens for Sensitive and Specific Carbapenemase Gene Detection in Pediatric Patients.","authors":"Majie C Foster, Kailee Cummings, Shannon L Morris, Elizabeth J Nazarian, Kimberlee A Musser","doi":"10.1093/jalm/jfag127","DOIUrl":"https://doi.org/10.1093/jalm/jfag127","url":null,"abstract":"<p><strong>Background: </strong>To reduce the spread of carbapenem-resistant gram-negative bacteria, the Centers for Disease Control recommends rectal and perirectal swab surveillance using the Cepheid Xpert® Carba-R Assay. An expressed limitation of the assay is lack of validation data for patients <21 years. To address this limitation, an in-house validation was performed using pediatric stool specimens from patients <21 years.</p><p><strong>Methods: </strong>Pediatric validation of the Cepheid Copan Dual Swab Collection Device and Xpert® Carba-R Assay was performed using pooled stool specimens from 17 patients ages <1 to 21 years, spiked with Escherichia coli, Acinetobacter baumannii, Klebsiella pneumoniae, Enterobacter cloacae, and Pseudomonas aeruginosa harboring β-lactamase mechanisms (Klebsiella pneumoniae carbapenemase, New Delhi metallo-β-lactamase, oxacillinase-48-like carbapenemase, Verona integron-encoded metallo-β-lactamase, and imipenemase). Validation was supported by molecular and culture analysis of 747 pediatric clinical specimens.</p><p><strong>Results: </strong>Pediatric stool-spiked rectal swabs produced Cepheid Carba-R results with 100% accuracy (SD < 1; CV < 4%) and excellent precision (SD < 1, CV < 4%). Clinical carbapenemase surveillance of >24 000 rectal specimens screened by the Carba-R assay (2018-2024) showed lower carbapenemase-detected percent positivity in patients ages 0 to 20 years (3.0%-4.2%) compared with adults ages 21 to >65 (7.8%-12.7%) (χ2, P < 0.00001). No significant age-group differences were observed in the ability to isolate detected β-lactamase mechanisms from patient specimens.</p><p><strong>Conclusion: </strong>The Cepheid Copan Dual Swab Collection Device with the Xpert® Carba-R Assay is a valid method for rapid (<1 h) screening of carbapenemase-producing organisms (β-lactamase mechanisms: Klebsiella pneumoniae carbapenemase, New Delhi metallo-β-lactamase, oxacillinase-48-like carbapenemase, Verona integron-encoded metallo-β-lactamase, and imipenemase) in pediatric patients.</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":"148799270","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 an Automated Lipoprotein(a) Assay on a Third-Party Automated Analyzer: Validation, Method Comparison, and Clinical Impact of Formula-Based Mass-to-Molar Conversion.","authors":"Nerea Sainz-Pastor, Silvia Camos Anguila, Miriam Albéniz Abaigar, Ana Molina, Helena Castellà, Marc Delgado, José Luis Bedini, Rebeca Muñoz, Emilio Ortega, Naira Rico","doi":"10.1093/jalm/jfag122","DOIUrl":"https://doi.org/10.1093/jalm/jfag122","url":null,"abstract":"<p><strong>Background: </strong>Lipoprotein(a) [Lp(a)] is an independent, genetically determined cardiovascular risk factor. Although consensus recommends reporting Lp(a) in molar units using assays with minimized apolipoprotein(a) [apo(a)] isoform size-related bias, some laboratories still use mass units with conversion formulas of uncertain reliability. This study describes the first adaptation and validation of the Roche Tina-quant® Lp(a) Gen.2 assay [TQ-Lp(a)] on the Atellica Solution platform, including method comparison and evaluation of formula-based mass-to-molar conversion.</p><p><strong>Methods: </strong>A total of 126 serum samples were analyzed using 3 approaches: Roche TQ-Lp(a) as the molar comparator method, adapted Atellica-TQ-Lp(a), and native Siemens Lp(a) on Atellica CH, which reports results in mg/dL. Siemens mass-based results were converted to nmol/L using the manufacturer's equation. Analytical performance was assessed according to Spanish Society of Laboratory Medicine recommendations. Method comparison included Passing-Bablok regression, Bland-Altman, and Cohen κ at clinically relevant thresholds.</p><p><strong>Results: </strong>Atellica-TQ-Lp(a) demonstrated acceptable precision (CV <6%), excellent linearity (r = 0.99), and adequate sensitivity (limit of quantification, 8 nmol/L). No relevant interference was observed, and stability was maintained for 4 days under refrigerated and frozen conditions. Agreement with the comparator method was high (slope, 0.99; intercept, 3.9 nmol/L; r = 0.99), with minimal constant bias and high categorical concordance (weighted κ = 0.98). In contrast, formula-derived values showed proportional bias (slope, 1.27), moderate agreement (weighted κ = 0.78), and frequent upward reclassification at ≥125 nmol/L.</p><p><strong>Conclusions: </strong>The Roche Tina-quant® Lp(a) Gen.2 assay can be implemented on Atellica CH to report Lp(a) in nmol/L with high analytical comparability to the Roche/cobas implementation. Fixed mg/dL-to-nmol/L conversion formulas introduce systematic bias and clinically relevant misclassification.</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":"148799328","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":"Increased False Positives vs Increased Interference Flags: Comparison of 2 Ethyl Glucuronide Immunoassays.","authors":"Alexandria N Jackson, Sara P Wyness, Sonia L La'ulu, Jessica M Boyd, Kamisha L Johnson-Davis","doi":"10.1093/jalm/jfag114","DOIUrl":"https://doi.org/10.1093/jalm/jfag114","url":null,"abstract":"<p><strong>Background: </strong>Screening for alcohol use in a population to treat pain and substance use disorders is important for monitoring adherence to treatment plans. Urine screening for ethanol exposure by immunoassay can provide a cost-effective testing option, with a faster turnaround time to result in comparison to LC-MS/MS. The purpose of this study was to compare two ethyl glucuronide (EtG) immunoassays to determine which method would be better suited for our laboratory work flow and patient population.</p><p><strong>Methods: </strong>Two EtG immunoassays were evaluated to assess false-positive results and interference flags for alcohol biomarker testing. The EtG enzyme immunoassays were verified and put into use for patient testing during 2 separate timeframes.</p><p><strong>Results: </strong>Both assays compared qualitatively well to LC-MS/MS for positive EtG (>500 ng/mL) patient samples. In our patient population, the ARK EtG assay had a presumptive positivity rate of 13.81%, a false-positive rate of 1.35%, and an interference rate of 0.45%. The Immunalysis assay had a 9.87% presumptive positivity rate, a false-positive rate of 0.15%, and a 2.86% interference rate.</p><p><strong>Conclusions: </strong>Selecting an assay for the laboratory requires understanding the strengths and limitations of the method. For our work flow, our lab chose the assay with more interferences, since our work flow reflexes presumptive positive immunoassay results and interferences to confirmation by mass spectrometry. For labs that use an immunoassay screen-only approach, selecting an immunoassay that generates a higher rate of interference flags could make result interpretation difficult for the client and raise concerns for specimen adulteration.</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":"148799264","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":"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}