Jillian Kodger, Rohit B Sangal, Aldo J Peixoto, Dennis G Moledina, Dustin Miconi, Joe M El-Khoury
{"title":"Creatinine Delta: Improving Critical Call Thresholds for Acute Kidney Injury Detection.","authors":"Jillian Kodger, Rohit B Sangal, Aldo J Peixoto, Dennis G Moledina, Dustin Miconi, Joe M El-Khoury","doi":"10.1093/jalm/jfaf075","DOIUrl":"10.1093/jalm/jfaf075","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1433-1435"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144162750","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}
Christopher DiPasquale, Robert H Christenson, James G Donnelly, Susan A Evans, Alan H B Wu, Eric G Olson, Roy Barr, Nicolas Kosa, Hattie McKenzie, Melissa Abigania, James W Jacobson
{"title":"Equivalence between Capillary Blood and Venous Blood Test Results Using Miniaturized Assays and Novel Collection Methods to Support Routine Bloodwork.","authors":"Christopher DiPasquale, Robert H Christenson, James G Donnelly, Susan A Evans, Alan H B Wu, Eric G Olson, Roy Barr, Nicolas Kosa, Hattie McKenzie, Melissa Abigania, James W Jacobson","doi":"10.1093/jalm/jfaf059","DOIUrl":"10.1093/jalm/jfaf059","url":null,"abstract":"<p><strong>Background: </strong>Capillary blood testing has potential to improve accessibility and adherence for routine tests. Due to historical challenges with sample volume and quality, capillary blood is rarely used for diagnostic testing. These studies provide objective evidence that miniaturized assays and novel capillary collection technologies can enable equivalent results for important panels.</p><p><strong>Methods: </strong>The studies evaluated equivalence of capillary blood testing using miniaturized assays and novel collection methods. We verified the performance of 20 miniaturized assays vs their unmodified versions. We then evaluated specimen equivalence across 39 analytes by comparing samples collected with novel capillary technologies vs samples collected with conventional technologies. For 38 analytes, specimen equivalence was evaluated vs conventional venous samples, and vs conventional capillary samples for 2 analytes with biological gradients (glucose and total CO2).</p><p><strong>Results: </strong>Equivalence of miniaturized assays and novel capillary methods to conventional testing was demonstrated across all analytes. Method comparison of all 20 miniaturized assays highly correlated (Pearson r > 0.95) to unmodified versions of each test. Capillary blood collected with the novel collection procedure produced results equivalent to conventional methods, with 37 analytes performing equivalently to venous serum, glucose to both venous and conventional capillary serum, and total CO2 to conventional capillary serum.</p><p><strong>Conclusions: </strong>Capillary blood can be utilized for routine bloodwork. Issues with sample volume can be overcome by miniaturizing assays without compromising performance. Issues with sample quality can be overcome by novel capillary collection technologies, which additionally enable non-phlebotomist sample collection in a broad scope of healthcare settings.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1090-1104"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144095383","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}
Ranita De, Marballi Basavaraju Deepak, Leo Stephen, Kavitha Lakshmi, Joy Mammen, Eunice Sindhuvi Edison
{"title":"Exploring the Relationship between Extended Red Blood Cell Indices and Platelet Indices in Voluntary Blood Donors.","authors":"Ranita De, Marballi Basavaraju Deepak, Leo Stephen, Kavitha Lakshmi, Joy Mammen, Eunice Sindhuvi Edison","doi":"10.1093/jalm/jfaf078","DOIUrl":"10.1093/jalm/jfaf078","url":null,"abstract":"<p><strong>Background: </strong>As regular blood donors are prone to iron deficiency, the importance of extended red blood cell (eRBC) indices in identifying donors with depleted iron stores was investigated. Thrombocytosis has been well documented in patients affected with iron deficiency anemia. Thus, the significance of eRBC indices in reflecting elevated platelet counts associated with nonanemic iron deficiency was examined in this cohort.</p><p><strong>Methods: </strong>Blood samples were collected in EDTA tubes from consenting donors for analyses of routine hematological and eRBC indices. Serum samples were separated for the estimation of iron parameters.</p><p><strong>Results: </strong>Iron-deficient donors had significantly altered eRBC indices. Among them, reticulocyte hemoglobin equivalent (Ret-He) with a cut-off of ≥32 pg had an area under the receiver operating characteristic curve (AUC) of 0.822 and showed a sensitivity of 72.5% and a specificity of 77.8% (P < 0.001) in detecting iron deficiency. The combination of Ret-He with combined cell index (CCI) (AUC = 0.825; 66% sensitivity, 91.9% specificity) increased sensitivity and specificity to 90.6% and 98.2%, respectively, in detecting donors affected with iron-restricted erythropoiesis. This cohort had increased platelet counts that showed significant association with Ret-He (b = -0.373, P = 0.007), red blood cell hemoglobin equivalent (b = -0.384, P = 0.005), CCI (b = 0.384, P = 0.006), percentage of red blood cells with mean corpuscular hemoglobin < 17 pg (b = 0.494, P < 0.001), and percentage of red blood cells with mean corpuscular volume < 60 fL (b = 0.299, P < 0.05).</p><p><strong>Conclusions: </strong>eRBC indices are useful indicators of nonanemic iron deficiency, which may be enhanced by combining them. A significant relationship between platelet counts and eRBC indices in iron-deficient donors emerges, which has not been explored before.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1119-1132"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144561534","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 Unmeasurable Total Bilirubin in an 80-Year-Old Man.","authors":"Dustin R Bunch","doi":"10.1093/jalm/jfaf102","DOIUrl":"10.1093/jalm/jfaf102","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1418-1419"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144691962","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}
Ingrid Marie Hardang, Jūratė Šaltytė Benth, Morten K Moe, Natalia Kononova, Vidar Søyseth, Gunnar Einvik
{"title":"Hepcidin Isoforms in Chronic Obstructive Pulmonary Disease Compared with the General Population.","authors":"Ingrid Marie Hardang, Jūratė Šaltytė Benth, Morten K Moe, Natalia Kononova, Vidar Søyseth, Gunnar Einvik","doi":"10.1093/jalm/jfaf095","DOIUrl":"10.1093/jalm/jfaf095","url":null,"abstract":"<p><strong>Introduction: </strong>Hepcidin (Hep), a major regulator of iron metabolism, has several isoforms whose biological functions remain unknown. In chronic obstructive pulmonary disease (COPD) several factors, such as inflammation and hypoxemia, stimulate or inhibit Hep production. Our aims were to assess the isoform concentrations in COPD, explore the associations between the isoforms and pathophysiological variables, and assess the effect of initiation of long-term oxygen treatment (LTOT) on Hep concentrations.</p><p><strong>Methods: </strong>The study population constituted 84 patients with COPD and 59 non-COPD participants. Hep isoforms, parameters of inflammation and iron status, and partial pressures of arterial oxygen (pO2) were measured at baseline and at 6-months follow-up in COPD patients. Associations between isoforms and clinical and biochemical characteristics were examined by multivariable tobit regression, while tobit regression with random effects was used to assess whether initiation of LTOT influenced the isoforms.</p><p><strong>Results: </strong>At least one isoform was detected in 96% of the participants, of which Hep25 was the most and Hep22 the least common. All isoforms were associated with C-reactive protein and ferritin. Hep25 and Hep24 were also associated with transferrin saturation, and Hep24 was associated with urine albumin-creatinine ratio. None of the isoforms were associated with hemoglobin, pO2, smoking, or COPD. There was a significant reduction of Hep25 and Hep24 from baseline to follow-up.</p><p><strong>Conclusions: </strong>All isoforms were associated with inflammation, while Hep25 and Hep24 were associated with circulating iron and Hep24 with kidney disease. The concentrations of Hep isoforms were not associated with COPD, nor did initiation of LTOT result in significant changes of isoform concentrations.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1265-1278"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144691963","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":"Recommendations for Methods and Criteria for Evaluating the Imprecision of Leukocyte (WBC) Differential Count (Proportional).","authors":"Changhua Peng","doi":"10.1093/jalm/jfaf104","DOIUrl":"10.1093/jalm/jfaf104","url":null,"abstract":"<p><p>The imprecision coefficient of variation (%CV) of leukocyte (WBC) differential counts (proportion, LDC), the mean proportion of a specific type of white blood cell (%x̅), and the finite number of white blood cells sampled by LDC (n) have a specific functional relationship. The criterion for assessing the imprecision of LDC is based on the %CV, which represents the standard error as a percentage of the mean. This criterion should fall within the prediction interval limits associated with %x̅ and n. An evaluation of the LDC can be based on the functional relationship among these 3 variables. The %CV is calculated from the other 2. Using this functional model, curve fitting is applied to the LDC imprecision data. Hypothesis testing is performed on the parameters of the fitted curve. This aims to identify and exclude entire experimental datasets that, after undergoing the fitting process, do not follow a binomial distribution. An indicator, CVx50E, which is used to evaluate the imprecision of LDC (CVx50E represents the %CV when %x̅ = 50%), is used to compare with the theoretical imprecision indicator of binomial distribution, CVx50B. Subsequently, those experimental datasets that still do not conform to the binomial distribution after the fitting process are excluded. The imprecision of LDC is reassessed using CVx50E. This comprehensive approach to evaluating LDC imprecision is applicable to various instruments and techniques, such as the manual-visual, digital imaging system, and flow-cytometric methods, as well as other measurement procedures where data follow a binomial distribution. This report provides recommendations on how to establish acceptable imprecision criteria for LDC, identify experimental data that do not conform to binomial distribution, and perform imprecision evaluation. The report contains examples of imprecision evaluation of LDC data from the literature.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1333-1346"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144838137","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":"Disease Associations of Cluster of Differentiation (CD) 5+ Peripheral B Cells in a Diagnostic Flow Cytometry Laboratory.","authors":"Adrian Y S Lee","doi":"10.1093/jalm/jfaf066","DOIUrl":"10.1093/jalm/jfaf066","url":null,"abstract":"<p><strong>Background: </strong>Cluster of differentiation (CD) 5+ B cells comprise approximately 15% of peripheral blood B cells and are commonly encountered in diagnostic flow cytometry. However, their disease associations have not been systematically reviewed before, particularly in non-CD5+ B-cell malignancy cases. The aim of this study was to ascertain the prevalence and clinical associations of nonmalignant-associated peripheral blood CD5+ B cells in the diagnostic flow cytometry laboratory.</p><p><strong>Methods: </strong>Over a period of 3 months, we undertook a single-laboratory cross-sectional study to examine disease associations of CD5+ B cells. B cells were assessed by flow cytometry using our standard B-cell panel. Medical records were reviewed to ascertain disease associations.</p><p><strong>Results: </strong>In the audit period, there were 426 consecutive B-cell panels excluding duplicate patients, CD5+ B-cell malignancies, and B-cell-depleted samples. The highest percentage of CD5+ B cells were noted in patients with autoimmune diseases and was, in general, higher than patients who had infections or other hematological disorders.</p><p><strong>Conclusions: </strong>CD5+ B cells are common in the periphery of patients with a variety of medical conditions and may reflect a degree of B-cell hyperreactivity. It would be important for future studies to examine the functional role and consequences of these B cells, and whether they may hold any prognostic or monitoring value.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1279-1284"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112093","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}
Jacob A Wasylenko, Isolde Seiden-Long, Mireille Kattar, Heather A Paul, Miranda Brun, Mathew Estey, Poonam Reddy, Sean van Diepen, Albert K Y Tsui
{"title":"Verification of a Novel High Sensitivity Troponin I Assay for Implementation in Rural Clinical Laboratories.","authors":"Jacob A Wasylenko, Isolde Seiden-Long, Mireille Kattar, Heather A Paul, Miranda Brun, Mathew Estey, Poonam Reddy, Sean van Diepen, Albert K Y Tsui","doi":"10.1093/jalm/jfaf088","DOIUrl":"10.1093/jalm/jfaf088","url":null,"abstract":"<p><strong>Background: </strong>High sensitivity cardiac troponin (hs-cTn) assays run on instruments suitable for small laboratories are a desirable commodity for rural cardiovascular testing. The Quidel TriageTrue hs-cTnI assay was recently approved as a laboratory test in Canada. This study aimed to verify the analytical performance of this novel hs-cTnI assay and perform a head-to-head comparison with other hs-cTn assays.</p><p><strong>Methods: </strong>A precision study was performed for 5-6 days with 5 replicates daily using quality control (QC) materials and patient plasma pools corresponding to the clinical decision thresholds. Linearity was assessed based on preparation of patient plasma pools at target troponin concentrations spanning the analytical measuring range. Fresh samples from coronary intensive care unit patients and healthy volunteers were used for head-to-head comparison of the TriageTrue hs-cTnI assay against several hs-cTnI (Beckman Access and Siemens Atellica) and hs-cTnT (Roche Cobas e801) assays. Assay-specific overall 99th percentile upper reference limits (URL) were used to assess analytical concordance. Risk reclassification was analytically assessed by comparing the decision cutpoints using the 2023 European Society of Cardiology (ESC) 0/1 h algorithm for the different hs-cTn assays.</p><p><strong>Results: </strong>QC and patient samples demonstrated a coefficient of variation (CV) <10% near the overall 99th percentile URL. TriageTrue hs-cTnI assay has a >90% analytical concordance at the 99th percentile URL and <10% risk reclassification compared to the Beckman Access and Siemens Atellica hs-cTnI assays.</p><p><strong>Conclusions: </strong>The novel TriageTrue hs-cTnI assay had comparable analytical performance as other hs-cTnI assays and can be considered in lower volume health care delivery settings with limited laboratory space.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1254-1264"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144691979","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}
Alan H B Wu, Jerrold H Levy, W Franklin Peacock, Ramzy Rimawi, Manuel Sanchez Luna, Christopher Farnsworth, Hugo Stiegler, Robert H Christenson
{"title":"Handling Hemolytic Blood Samples from High-Risk Clinical Areas: A Call to Action.","authors":"Alan H B Wu, Jerrold H Levy, W Franklin Peacock, Ramzy Rimawi, Manuel Sanchez Luna, Christopher Farnsworth, Hugo Stiegler, Robert H Christenson","doi":"10.1093/jalm/jfaf082","DOIUrl":"10.1093/jalm/jfaf082","url":null,"abstract":"<p><strong>Background: </strong>Spectrophotometric testing to detect sample hemolysis is available from central laboratory chemistry analyzers. While the cause and preventative measures are known, hemolysis continues to be a common preanalytical error, especially for specimens collected from the emergency department (ED) and intensive care units (ICUs) where point-of-care analyzers are commonly used for whole blood electrolyte testing. Recently, these analyzers have employed technology to detect hemolysis directly on whole blood samples.</p><p><strong>Methods: </strong>Experienced laboratorians and physicians from the clinical laboratory, ED, adult and neonatal ICUs provide a summary of the medical importance of in vitro hemolysis. Causes for in vivo hemolysis are summarized as it is indistinguishable from in vitro hemolysis from routine laboratory analysis. The detection of hemolysis by clinical laboratories is discussed from the American and European perspectives.</p><p><strong>Results: </strong>In vivo hemolysis can occur due to genetic abnormalities, hemoglobinopathies that cause red cell lysis, and mechanical circulatory support. There are many causes of in vitro hemolysis. Patients in the ED and ICU are particularly vulnerable to erroneous laboratory data such as potassium. Incorrectly treated patients can lead to significant medical consequences. Within the clinical laboratory, there are recommendations made by accrediting bodies, but none are mandatory, and the implementation of the hemolysis index testing is not universal.</p><p><strong>Conclusions: </strong>Recommendations have been authored regarding the need for education for prevention, performance of hemolysis detection testing, defining levels of hemolysis reporting, periodic monitoring of hemolysis detection performance, and laboratory reporting practices for high and normal potassium test results.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1347-1361"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144709381","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}
Jenny Yeuk Ki Cheng, L Y Lois Choy, Risa Ozaki, Alice Pik Shan Kong, Teresa Kam Chi Tsui
{"title":"A Pregnant Woman with Severe Gestational Hypertriglyceridemia: Why?","authors":"Jenny Yeuk Ki Cheng, L Y Lois Choy, Risa Ozaki, Alice Pik Shan Kong, Teresa Kam Chi Tsui","doi":"10.1093/jalm/jfaf071","DOIUrl":"10.1093/jalm/jfaf071","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1392-1396"},"PeriodicalIF":1.9,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144545376","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}