Journal of Applied Laboratory Medicine最新文献

Cardiac Troponin Thresholds in Children and Young Adults: A Multi-Center Cohort Study. 儿童和年轻人心肌肌钙蛋白阈值：一项多中心队列研究。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfaf205

Alexander J F Thurston, Eirik Å Røys, Ragnhild Røysland, Øyvind Skadberg, Fabienne Decrue, Dorien M Kimenai, Nicholas L Mills, Kristin M Aakre

{"title":"Cardiac Troponin Thresholds in Children and Young Adults: A Multi-Center Cohort Study.","authors":"Alexander J F Thurston, Eirik Å Røys, Ragnhild Røysland, Øyvind Skadberg, Fabienne Decrue, Dorien M Kimenai, Nicholas L Mills, Kristin M Aakre","doi":"10.1093/jalm/jfaf205","DOIUrl":"10.1093/jalm/jfaf205","url":null,"abstract":"Background: The role of high-sensitivity cardiac troponin (cTn) assays for children and young adults is uncertain, and no guidance is available on diagnostic thresholds. This study evaluates the effect of applying pediatric compared to adult upper reference limits (URLs) for cTn.Methods: We carried out a retrospective multicenter international cohort study of consecutive children and young adults (1 day to 18 years) undergoing cTn I or T testing at 4 tertiary care hospitals in Norway and Scotland, United Kingdom, from 2013 to 2023. Myocardial injury was classified using the adult sex-specific 99th percentile URL, a pediatric sex-specific 99th percentile, and a pediatric sex-specific 97.5th percentile. Diagnoses of myocarditis were obtained from the Norwegian Patient Register and the Scottish Morbidity Record.Results: In total, 9833 (46.6% female) children and young adults underwent cTn testing. Applying the adult sex-specific 99th percentile, 1771 (18.0% [95% CI, 17.3%-18.8%]) had myocardial injury compared with 1762 (17.9% [95% CI, 17.2%-18.7%]) using a pediatric 99th percentile. In contrast, applying a pediatric sex-specific 97.5th percentile would identify 2261 (23.0% [95% CI, 22.2%-23.8%]) with myocardial injury (a 28% relative increase). Infants had a higher frequency of myocardial injury than those 1-18 years old (1035/1104; 93.8% [95% CI, 92.2%-95.1%] vs 1226/8729; 14.0% [95% CI, 13.3%-14.8%] using pediatric sex-specific 97.5th percentile, P < 0.001). Testing for cTn increased over the study period (τ = 0.42, P < 0.001).Conclusions: The use of pediatric-specific 97.5th percentile URLs for cTn would increase classification of myocardial injury in children and young adults. The clinical implications of this are uncertain and require further study given cTn testing has increased over the last decade.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"554-568"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13141673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146012740","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}

引用次数: 0

Comparison of a Reformulated Automated Vitamin D Assay, Its Predecessor, and 2 Contemporary Formulations. 一个重新配制的自动维生素D测定法，它的前身，和2个当代配方的比较。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfaf196

K Aaron Geno, Yasel F Alvarez, Jacqueline A Hubbard, Robert D Nerenz, Ravinder J Singh

{"title":"Comparison of a Reformulated Automated Vitamin D Assay, Its Predecessor, and 2 Contemporary Formulations.","authors":"K Aaron Geno, Yasel F Alvarez, Jacqueline A Hubbard, Robert D Nerenz, Ravinder J Singh","doi":"10.1093/jalm/jfaf196","DOIUrl":"10.1093/jalm/jfaf196","url":null,"abstract":"Background: Historically, 25-hydroxyvitamin D (25OHD) assays have under- or over-recovered 25-hydroxyvitamin D2 (25OHD2), but assay manufacturers have modified their reagents to address this problem. In this study, we compared the second- and third-generation Roche assays as well as two contemporary offerings from Diasorin and Beckman against liquid chromatography-tandem mass spectrometry (LC-MS/MS).Methods: We identified 50 remnant serum samples with 25OHD concentrations from across the analytical range of the second-generation Roche assay. To increase 25OHD2 representation, we identified 25 additional samples from individuals prescribed high-dose vitamin D2 supplements. We tested samples on Roche assays and circulated to laboratories performing Beckman and Diasorin 25OHD assays. We tested samples by LC-MS/MS to obtain concentrations for 25OHD2 and 25-hydroxyvitamin D3.Results: Mean overall bias for each assay was 5.1 ng/mL or less against the LC-MS/MS measurement; mean proportional bias was 8.7% to 12.1%. Some individual specimens had much larger bias. 25OHD2 was under-recovered on average, but the bias for the third-generation Roche assay represents a significant improvement over the previous assay, and mean bias for current generation assays was no worse than -3.2 ng/mL. In most cases, clinical classification by automated assay values agreed with clinical classification by LC-MS/MS; where present, disagreements occurred near classification thresholds.Conclusions: Automated 25OHD assays continue to improve, and 25OHD2 recovery no longer appears to be a significant concern for the assays evaluated here. All assays evaluated were adequate for clinical classification of vitamin D nutritional status and are suitable for routine use, including in patients prescribed high-dose vitamin D2.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"592-598"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146012790","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}

引用次数: 0

Evaluation of Serum Kappa Free Light Chain Reference Interval Using a New Stabilized Calibrator. 用一种新型稳定校准器评价血清游离Kappa轻链参考区间。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfaf208

Derek Waggoner, Katie Thoren, Robert Maynard, Kwaku Twum, Nichole Korpi-Steiner

{"title":"Evaluation of Serum Kappa Free Light Chain Reference Interval Using a New Stabilized Calibrator.","authors":"Derek Waggoner, Katie Thoren, Robert Maynard, Kwaku Twum, Nichole Korpi-Steiner","doi":"10.1093/jalm/jfaf208","DOIUrl":"10.1093/jalm/jfaf208","url":null,"abstract":"Background: Measurement of serum free light chains (FLC) including kappa FLC, lambda FLC, and calculated kappa to lambda FLC ratio play a vital role in the diagnosis, prognosis, and monitoring of plasma cell disorders. Recent concerns regarding upward drift in The Binding Site's kappa FLC measurements have prompted a reformulation of the kappa FLC calibrator by the manufacturer. This study aims to assess the impact of the reformulated/new kappa FLC calibrator on both the kappa FLC reference interval (RI) and the FLC ratio diagnostic range.Methods: Healthy volunteers (n = 124) from 3 tertiary care medical centers had FLCs measured using both the new and the prior lot of kappa FLC calibrators on an Optilite analyzer (The Binding Site). All samples were screened for monoclonal proteins using capillary electrophoresis. Creatinine was measured to confirm renal function.Results: Comparison of kappa FLC values from the new vs prior calibrator demonstrated minimal differences. Neither calibrator was able to verify manufacturer-suggested RI in our study population. The proportion of samples that had FLC ratios within the manufacturer's claimed diagnostic range was equivalent between calibrators, with roughly 6% to 7% of study participants falling above the diagnostic range of 0.26 to 1.65.Conclusion: The new reformulated kappa FLC calibrator from The Binding Site does not support verification of the manufacturer's claimed kappa FLC RI or improve the number of healthy patients falling within the FLC ratio diagnostic range. Both the kappa FLC RI and diagnostic range for FLC ratio should be reevaluated and updated in consensus guidelines.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"599-605"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145991297","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}

引用次数: 0

Commentary on Investigating Elevated Glutaric Acid in Early Infancy. 婴儿早期戊二酸升高的研究综述。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag028

Olivia D'Annibale

引用次数: 0

Evaluation of Analytical Performance Specifications for Clinical Laboratory Tests Based on Test Misclassification. 基于测试错误分类的临床实验室测试分析性能规范评价

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag030

Qian Sun, Maureen Sampson, Claire Auger, Alan T Remaley, Roa Harb

{"title":"Evaluation of Analytical Performance Specifications for Clinical Laboratory Tests Based on Test Misclassification.","authors":"Qian Sun, Maureen Sampson, Claire Auger, Alan T Remaley, Roa Harb","doi":"10.1093/jalm/jfag030","DOIUrl":"10.1093/jalm/jfag030","url":null,"abstract":"Background: Analytical performance specifications for laboratory tests are essential components of quality assurance for clinical laboratories. A widely adopted performance criterion is total allowable error (TEa), which includes contributions from both bias and imprecision, which may contribute to test inaccuracies. However, the relationship of TEa to test result misclassification, a clinically relevant quality measure, is unclear.Methods: Hypothetical clinical laboratory test results for 4 test models were generated and subjected to proportional bias and imprecision. Test misclassification (TM) as a function of bias and imprecision was determined using pre-defined cutpoint(s). Simulation analyses were then performed on 14 chemistry analytes using 3 data sets from patient results reported at the National Institutes of Health (NIH).Results: We observed a complex and nonlinear relationship between bias and imprecision, and their impact on TM was not additive as may have been expected with TEa. TM scores were influenced by population distribution, the location of cutpoints, and the fraction of abnormal test values at baseline. Stringent TEa requirements did not correspond to low TM scores. On the contrary, TM scores for electrolytes were among the highest. Instead, TM scores closely correlated with the ratio of TEa to the width of the population distribution.Conclusion: TM has the advantage of correctly accounting for the differential effects of bias and imprecision. Compared to TEa, it provides a more accessible metric for evaluating performance and the clinical impact of errors.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"470-482"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147436609","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}

引用次数: 0

Pipetting Performance across Laboratory Personnel: A Comparative Study. 实验室人员移液性能的比较研究。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag006

Ömer Özcan, Patrick J M Grundel, Annemieke C Heijboer, Wendy P J den Elzen

{"title":"Pipetting Performance across Laboratory Personnel: A Comparative Study.","authors":"Ömer Özcan, Patrick J M Grundel, Annemieke C Heijboer, Wendy P J den Elzen","doi":"10.1093/jalm/jfag006","DOIUrl":"10.1093/jalm/jfag006","url":null,"abstract":"Background: Accurate and precise pipetting is critical for reliable laboratory results, especially when handling small volumes or sensitive analytical techniques. Despite the common use of piston-operated pipettes, operator-dependent variability remains a major source of error. This study aimed to evaluate pipetting performance among laboratory personnel with varying levels of experience.Methods: The study included 108 participants: 26 laboratory school students (first to third year), 10 PhD students, 10 clinical chemists, and 62 laboratory technicians. Technicians were stratified into 3 groups based on the extent of sensitive manual pipetting in their work: minimal (Group A), moderate (Group B), and high (Group C). Pipetting performance was evaluated using gravimetric replicates at 10 µL and 100 µL volumes, and a dilution task involving serial dilutions of 1 M copper sulfate. Accuracy and precision metrics were compared across groups.Results: The median coefficient of variation (CV%) was lower for 100 µL replicates (0.3% to 0.8%) than for 10 µL replicates (1.4% to 5.9%). Laboratory students showed the greatest variability and longest task completion times, although performance improved with advancing school year. Ten percent of participants exceeded ISO-defined accuracy limits for 10 µL pipetting, and 22% for 100 µL. Imprecision limits were surpassed by 36% and 20% of participants for 10 µL and 100 µL, respectively. Group C technicians achieved optimal dilution performance (R2 = 1.00), while students showed the highest deviation.Conclusions: Pipetting performance was significantly influenced by experience level and task sensitivity. Even experienced personnel occasionally failed to meet ISO standards, underscoring the need for ongoing training and performance assessment.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"460-469"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146114574","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}

引用次数: 0

Assessment of Instrument-Specific Variation between Measured and Calculated Bicarbonate. 测量和计算的碳酸氢盐之间仪器特异性差异的评估。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfaf201

Nga Yeung Tang, Carmen Gherasim, Lee Schroeder, Hsuan-Chieh Liao, Qian Sun

{"title":"Assessment of Instrument-Specific Variation between Measured and Calculated Bicarbonate.","authors":"Nga Yeung Tang, Carmen Gherasim, Lee Schroeder, Hsuan-Chieh Liao, Qian Sun","doi":"10.1093/jalm/jfaf201","DOIUrl":"10.1093/jalm/jfaf201","url":null,"abstract":"Background: Bicarbonate concentration is widely used to assess acid-base disorders in patients, and the concentration can be directly measured or calculated. When discrepant results between measured bicarbonate (mHCO3-) and calculated bicarbonate (cHCO3-) are observed, it can lead to confusion among clinicians and potential for misdiagnosis. Here we assessed the agreement between cHCO3- from the Radiometer blood gas analyzer and mHCO3- from 3 different chemistry instruments.Methods: Three institutions that measure bicarbonate using chemistry analyzers from 3 different manufacturers and derive bicarbonate on Radiometer blood gas analyzers participated in this study. De-identified patient data include plasma mHCO3- and blood gas cHCO3- results (arterial and venous) collected within +/- 20 min. Correlations and biases were determined.Results: Deming regression analysis showed good correlations between cHCO3- and mHCO3-. Bland-Altman analysis revealed the greatest bias between Radiometer and Abbott Architect (-2.63 mmol/L), followed by Siemens Advia (0.49 mmol/L) and Beckman AU680 (-0.45 mmol/L).Conclusions: This is the first study to compare cHCO3- from the Radiometer blood gas analyzer against mHCO3- results from multiple chemistry analyzers. Our results suggest that the Radiometer blood gas analyzer, Siemens Advia, and Beckman AU680 agree well with each other. However, bicarbonate results may be negatively biased when measured on the Abbott Architect compared with the other methods.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"483-492"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918912","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}

引用次数: 0

Correction to: Analytical Characterization and Validation of a Novel Automated Amino-Terminal proB-Type Natriuretic Peptide Assay. 修正：一种新型自动氨基末端prob型利钠肽测定的分析表征和验证。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag003

引用次数: 0

Extracellular Vesicles for Acute Care Testing: A Review of Potential Laboratory Applications. 细胞外囊泡急性护理测试：潜在的实验室应用综述。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfaf200

Nikita Mohapatra, Randy P Carney, Aijun Wang, Kristin N Grimsrud, Nam K Tran

{"title":"Extracellular Vesicles for Acute Care Testing: A Review of Potential Laboratory Applications.","authors":"Nikita Mohapatra, Randy P Carney, Aijun Wang, Kristin N Grimsrud, Nam K Tran","doi":"10.1093/jalm/jfaf200","DOIUrl":"10.1093/jalm/jfaf200","url":null,"abstract":"Background: Rapid, accurate diagnosis in acute and emergent care remains a major challenge, with delays directly impacting patient outcomes. Extracellular vesicles (EVs), nanoscale membranous particles secreted by all cell types and found in virtually all biological fluids, have the potential to transform acute diagnostics as minimally invasive biomarkers. As key intercellular messengers and carriers of biological cargo, EVs reflect the physiological and pathological states of their parent cells. While EV research has largely focused on chronic diseases such as cancer and neurodegeneration, their role in acute pathologies remains under-investigated.Content: This review describes the current landscape of EVs in laboratory medicine, with a focus on their potential for acute and emergent conditions, including sepsis, stroke, traumatic brain injury, and myocardial infarction. We examine advances in EV isolation and characterization techniques and discuss the unique challenges of implementing these approaches in a clinical setting. In particular, we highlight emerging technologies that aim to address existing barriers, including lack of standardization, long processing times, and limited clinical scalability.Summary: By summarizing existing knowledge and identifying critical research gaps, this review intends to refocus attention toward EV applications for acute care. As EV-based diagnostics continue to advance, their successful integration into clinical work flows has the potential to significantly transform healthcare delivery, enabling real-time, personalized diagnostics and improving health outcomes across a wide range of settings.","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"606-619"},"PeriodicalIF":1.9,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918870","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}

引用次数: 0

Acute Kidney Injury Alert! KDIGO vs AACC-AKI Criteria. 急性肾损伤警报！KDIGO与AACC-AKI标准。

IF 1.9

Journal of Applied Laboratory Medicine Pub Date : 2026-05-05 DOI: 10.1093/jalm/jfag012

Joe M El-Khoury

引用次数: 0