{"title":"Tattoos.","authors":"Thomas M Annesley","doi":"10.1093/jalm/jfag015","DOIUrl":"https://doi.org/10.1093/jalm/jfag015","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"11 3","pages":"680-681"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844234","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}
Tyler Cooke, Craig R Soderquist, Mahesh M Mansukhani, Susan J Hsiao
{"title":"Ordering Practices and Utilization of a Next-Generation Sequencing Panel for Myeloproliferative Neoplasms.","authors":"Tyler Cooke, Craig R Soderquist, Mahesh M Mansukhani, Susan J Hsiao","doi":"10.1093/jalm/jfaf197","DOIUrl":"10.1093/jalm/jfaf197","url":null,"abstract":"<p><strong>Background: </strong>JAK2, CALR, and MPL mutations are defining features of myeloproliferative neoplasms (MPNs). Molecular testing for variants in these genes is standard of care in the diagnosis of MPNs. A high reimbursement denial rate led to review of ordering practices and test utilization to identify potential areas for optimization, education, or triage to improve laboratory stewardship.</p><p><strong>Methods: </strong>MPN panel orders placed between January 1, 2023 and December 31, 2023 were analyzed by ordering provider, complete blood count (CBC) values, demographics, test results, and International Classification of Diseases, 10th revision (ICD10) code. Laboratory staff manually review orders prior to testing. Clinical appropriateness was defined as unexplained cytosis or atypical thrombosis.</p><p><strong>Results: </strong>Orders for 257 unique patients were included for analysis. Most orders were placed by hematology/oncology providers (79.0%). Of orders, 72.8% had a cytosis-related ICD10 code, and 11.7% a thrombosis-related ICD10 code. MPN panel results were negative in 76.3% of patients and positive (pathogenic mutations in JAK2/CALR/MPL) in 13.2%. A χ2 test did not show a statistically significant association between ICD10 category and positive results. Of patients with positive results, 79.4% had thrombocytosis on CBC, but 70.6% had normal or low hemoglobin.</p><p><strong>Conclusions: </strong>Orders for our institution's MPN panel are generally appropriate and placed correctly. Our findings do not support additional interventions or clinical decision support, utilizing features such as the patient's CBC values or ICD10 codes, as likely to be of significant benefit. The limited reimbursement remains challenging, but we will continue to engage stakeholders to advocate for continued access.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"569-578"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918878","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}
Zaraith Sanchez Oviol, Eric S Sorensen, Pablo Carmona, Marc S Zumberg, Kristi J Smock, Karen Moser, Dong Chen, Neil S Harris, Maximo J Marin
{"title":"A Diagnostic Journey through a Rare Hemostatic Disorder.","authors":"Zaraith Sanchez Oviol, Eric S Sorensen, Pablo Carmona, Marc S Zumberg, Kristi J Smock, Karen Moser, Dong Chen, Neil S Harris, Maximo J Marin","doi":"10.1093/jalm/jfaf195","DOIUrl":"10.1093/jalm/jfaf195","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"655-660"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147370129","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 Coming Age of Interdependence.","authors":"Paul L Epner, Michael H Kanter","doi":"10.1093/jalm/jfag014","DOIUrl":"10.1093/jalm/jfag014","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"668-672"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147345226","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}
Jesse Albert Canchola, Benjamin Blue La Brot, Daniel Jarem, Sonia Rao
{"title":"Aligning Test and Reference Methods by Simultaneous Correction of Proportional and Constant Bias in Comparative Analysis.","authors":"Jesse Albert Canchola, Benjamin Blue La Brot, Daniel Jarem, Sonia Rao","doi":"10.1093/jalm/jfag025","DOIUrl":"10.1093/jalm/jfag025","url":null,"abstract":"<p><strong>Background: </strong>Biases between test and reference methods, specifically constant and proportional biases, can affect diagnostic accuracy. Conventional methods address these biases separately, limiting precision.</p><p><strong>Methods: </strong>We introduce a unified regression-based correction method for both constant and proportional bias, demonstrated using simulated polymerase chain reaction viral load data. The method applies linear and log-transformed regression adjustments with validation using both regression and Bland-Altman plots.</p><p><strong>Results: </strong>The correction, when plotting the test against the reference, yielded a fitted regression line with slope and intercept confidence intervals containing the ideal values of 1 and 0, respectively, confirming elimination of bias. Residual analysis provided evidence of model linearity assumptions.</p><p><strong>Conclusions: </strong>This unified correction enhances reliability in comparative studies and provides a reproducible foundation for recalibration across diagnostic platforms.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"542-553"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147327586","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}
Ida Boegh Andersen, Anne Lindegaard Christiansen, Maj-Britt Fruekilde, Lene Rosenberg
{"title":"GFAP/UCH-L1 Assay for mTBI: Preanalytical Factors and Levels in Healthy Individuals-A Study on Danish Adults.","authors":"Ida Boegh Andersen, Anne Lindegaard Christiansen, Maj-Britt Fruekilde, Lene Rosenberg","doi":"10.1093/jalm/jfag021","DOIUrl":"10.1093/jalm/jfag021","url":null,"abstract":"<p><strong>Background: </strong>Ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) have been evaluated as an alternative to S100 calcium binding protein B (S100B), which is mentioned in the Scandinavian guideline for managing mild traumatic brain injury (mTBI). Preanalytical, analytical and diagnostic performance of GFAP/UCH-L1 must be assessed before clinical use.</p><p><strong>Methods: </strong>GFAP/UCH-L1 were quantified using the TBI assay on Abbott Alinity. Precision was estimated using internal quality controls, and matrix effects were evaluated using serum and plasma from 30 outpatients. Repeatability and stability at different conditions (25, 4, -20, and -80°C) were evaluated on serum and plasma. GFAP and UCH-L1 serum levels in 30 healthy individuals were determined and compared to S100B levels.</p><p><strong>Results: </strong>Inter-instrumental precision was ≤4.2% for both biomarkers. Random outliers were observed for UCH-L1 in plasma, where 5 measurements deviated >25%. Acceptable storage stability was found for GFAP and UCH-L1. All healthy individuals had GFAP values within the manufacturer's reference interval (6.6 to 70.9 ng/L) and two exceeded the upper limit for UCH-L1 (44.7 to 226.8 ng/L). Four healthy individuals (13%) had GFAP results above cutoff without S100B exceeding its cutoff, while one individual had values of S100B above cutoff but GFAP below cutoff.</p><p><strong>Conclusions: </strong>The analytical precision and storage conditions of GFAP/UCH-L1 were satisfactory. Serum and plasma can be used for measurement of GFAP, whereas UCH-L1 measurement in plasma is not advised until further evaluations are conducted. The manufacturer's upper reference limits may not be suitable for our population. Thorough research on cutoff values is necessary.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"446-459"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147460573","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}
Rebekah Goldblatt, Florencia Monge, Cory Hansen, Melissa M Budelier
{"title":"Tacrolimus Assay Comparison: Analytical and Operational Considerations for Immunoassay vs Mass Spectrometry Testing in a High Volume Clinical Laboratory.","authors":"Rebekah Goldblatt, Florencia Monge, Cory Hansen, Melissa M Budelier","doi":"10.1093/jalm/jfaf199","DOIUrl":"10.1093/jalm/jfaf199","url":null,"abstract":"<p><strong>Background: </strong>Tacrolimus therapeutic drug monitoring is a routine and critical assay for managing transplant patients. Tacrolimus can be measured from whole blood samples via liquid chromatography-tandem mass spectrometry (LC-MS/MS) or immunoassay (IA). LC-MS/MS provides accurate parent drug quantification with minimal metabolite interference but requires expensive analyzers, highly trained staff, and is often a very manual process. Immunoassays offer faster, simpler workflows, but historically have been prone to significant cross-reaction with the drug's metabolites or other therapeutic drugs, leading to a falsely elevated result. Newer immunoassays show promising improvements in specificity.</p><p><strong>Methods: </strong>Using 73 residual patient samples, we compared our in-house LC-MS/MS tacrolimus assay to the Roche Elecsys® tacrolimus electrochemiluminescence immunoassay on the cobas® e801 analyzer. Comparative analysis was done with Deming regression and Bland-Altman comparison. Linearity, within-individual imprecision, and total imprecision post immunoassay implementation were also evaluated, along with changes and improvements to workflow and turnaround times (TAT).</p><p><strong>Results: </strong>The Roche Elecsys tacrolimus assay correlated well with our LC-MS/MS method (Deming regression equation: y = 1.004x + 0.4848). The bias was 0.52 ng/mL (an average of 8.1%) as determined by Bland-Altman comparison. When switching to the immunoassay we observed a 42%-51% improvement in TAT across the median, 75th percentile, and 90th percentile.</p><p><strong>Conclusions: </strong>We observed excellent correlation between the Roche Elecsys tacrolimus assay on an e801 analyzer vs our in-house LC-MS/MS assay, with good precision and linearity across reportable ranges. Changing from mass spectrometry to tacrolimus immunoassay substantially improved our TAT and workflow.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"531-541"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918924","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}
Melissa M Budelier, Nilda E Fink, Joesph R Wiencek
{"title":"Ethics through the Years: The Evolution of Ethical Guidelines for ADLM.","authors":"Melissa M Budelier, Nilda E Fink, Joesph R Wiencek","doi":"10.1093/jalm/jfag023","DOIUrl":"https://doi.org/10.1093/jalm/jfag023","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"11 3","pages":"673-676"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844148","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":"Correction to: Equivalence between Capillary Blood and Venous Blood Test Results Using Miniaturized Assays and Novel Collection Methods to Support Routine Bloodwork.","authors":"","doi":"10.1093/jalm/jfag002","DOIUrl":"10.1093/jalm/jfag002","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"685"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146214523","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":"Small But Mighty: A Brief Commentary on How Small Clinical Laboratories Can Thrive in a Competitive Industry.","authors":"Alaa Koleilat","doi":"10.1093/jalm/jfag008","DOIUrl":"https://doi.org/10.1093/jalm/jfag008","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"11 3","pages":"677-678"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844215","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}