Journal of Applied Laboratory Medicine最新文献

{"title":"Holotranscobalamin vs Total Vitamin B12: Current Evidence and Laboratory Challenges.","authors":"Martina Marandola, Giulia Napoli, Simone Leggeri, Carla Lombardi, Andrea Urbani, Silvia Baroni","doi":"10.1093/jalm/jfag131","DOIUrl":"https://doi.org/10.1093/jalm/jfag131","url":null,"abstract":"<p><strong>Background: </strong>Vitamin B12 is an essential water-soluble vitamin required for critical biological processes such as DNA synthesis, erythrocyte maturation, and maintenance of nervous system integrity. Deficiency of vitamin B12 can lead to serious clinical outcomes, including megaloblastic anemia and potentially irreversible neurological damage. Conversely, hypercobalaminemia may be associated with severe disorders, including solid neoplasms and hematological malignancies, or may result from inappropriate supplementation or immunoglobulin-B12 macrocomplexes. Current guidelines recommend total serum vitamin B12 and holotranscobalamin (holoTC) as first-line biomarkers for assessing cobalamin status.</p><p><strong>Content: </strong>Despite guideline recommendations, total serum vitamin B12 remains the most widely used test in routine clinical practice. However, holoTC represents the biologically active fraction of vitamin B12 available for receptor-mediated cellular uptake and may therefore provide a more reliable assessment of cobalamin status, particularly in specific clinical settings. Compared with total vitamin B12 measurement, holoTC is evaluated using a more limited number of analytical methods, and most commercially available assays are traceable to the WHO reference standard, improving interassay harmonization. This review examines the role of vitamin B12 and holoTC, focusing on analytical challenges and clinical interpretation.</p><p><strong>Summary: </strong>The available evidence suggests that holoTC may offer important advantages over total serum vitamin B12 in the evaluation of B12 status. Its biological relevance and improved analytical harmonization support its potential utility as a more reliable biomarker in selected clinical contexts.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148991928","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":"Redesigning Microbiology Order Architecture to Improve Laboratory Efficiency.","authors":"Justin McCallum, Lance Harlan, Beverley Orr, Karen Krajewski, Eliezer Nussbaum, Sankha Basu, Zoe Freeman Weiss","doi":"10.1093/jalm/jfag140","DOIUrl":"https://doi.org/10.1093/jalm/jfag140","url":null,"abstract":"<p><strong>Background: </strong>Clinical microbiology culture interpretation depends on accurate specimen context, including specimen type, anatomic source, and collection method. However, electronic ordering systems often permit nonspecific culture orders that do not capture the information needed for appropriate processing, reporting, and result interpretation.</p><p><strong>Methods: </strong>We performed a quality improvement intervention at an academic tertiary care center to replace a generic \"aerobic culture\" order with specimen-specific wound, sterile body fluid, and tissue/biopsy culture orders linked to required specimen type and anatomic source fields. Ordering pathways were harmonized across procedural and nonprocedural work flows, and available tests were constrained based on the selected specimen type and source.</p><p><strong>Results: </strong>Before intervention, 1115 of 2528 eligible culture orders required laboratory cancellation and reordering, compared with 78 of 508 eligible orders after implementation, 44.1% vs 15.4%, risk ratio 0.35, 95% CI 0.28-0.43, P < 0.001. Generic aerobic culture ordering declined to zero 5 months after residual ordering pathways were identified and corrected. Remaining errors were largely attributable to retained preference-list orders, previously placed future or standing orders, and gaps in clinician education.</p><p><strong>Conclusions: </strong>Specimen-specific microbiology order design reduced preanalytical ordering error and laboratory rework. These findings support microbiology order architecture as a practical diagnostic stewardship strategy that can improve specimen-context capture, reduce downstream laboratory correction, and better align culture ordering with laboratory processing requirements.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148977933","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":"Supporting Correct Use of Reference Intervals-An Ongoing Saga.","authors":"Graham R D Jones","doi":"10.1093/jalm/jfag146","DOIUrl":"https://doi.org/10.1093/jalm/jfag146","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148977987","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":"Comparability of GFAP and UCH-L1 Measurements Using Handheld and Core Laboratory TBI Plasma Tests and Their Diagnostic Performance for Traumatic Intracranial Lesions.","authors":"Nathan B Roberts, Carmen Gherasim, Kexin Li, Tian Xie, Hayley Falk, Jayapalli Bapuraj, Debra Demski, Christopher M Fung, Nathan L Haas, Keith E Kocher, Katharine S Seagly, Richard P Medlin, Jacob Joseph, Matthew J Schipper, Raj Chandran, Jaime A Marino, Beth McQuiston, Swati Pradhan-Bhatt, Frederick K Korley","doi":"10.1093/jalm/jfag093","DOIUrl":"https://doi.org/10.1093/jalm/jfag093","url":null,"abstract":"<p><strong>Background: </strong>Glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) are cleared by the U.S. Food and Drug Administration (FDA) to aid computed tomography (CT) decision-making in patients with traumatic brain injury (TBI). Two commercial assays, i-STAT TBI Plasma test and Alinity i TBI test, quantify these biomarkers using distinct detection technologies. Limited comparative data exist, creating uncertainty about cross-platform agreement and interchangeability of results in clinical and research applications.</p><p><strong>Methods: </strong>GFAP and UCH-L1 concentrations were measured twice from 829 adults who underwent brain CT within 24 h of blunt trauma, first using the Abbott i-STAT TBI Plasma test and second using the Alinity i TBI test. Agreement was assessed using percent agreement (binary outcomes), Bland-Altman plots, Passing-Bablok regression, and Pearson correlation, with and without imputed values for out-of-range results. Diagnostic accuracy for traumatic intracranial lesions (tICLs) was calculated at assay-specific cutoffs.</p><p><strong>Results: </strong>For GFAP + UCH-L1 in combination, the overall cross-platform agreement was 92.28%. GFAP and UCH-L1 showed strong cross-platform correlations with imputed (r = 0.916 and 0.916, respectively) and non-imputed data (r = 0.942 and 0.909, respectively). Both tests detected all clinically significant tICLs, with sensitivities of 100% (95% CI, 89%-100%) and negative predictive value (NPV) of 100% (95% CI, 98%-100%). Specificities were 29% (95% CI, 26%-32%) for i-STAT and 25% (95% CI, 22%-28%) for Alinity i.</p><p><strong>Conclusions: </strong>GFAP and UCH-L1 showed strong cross-platform agreement, individually and in combination, with equivalent sensitivity for tICL, supporting clinical interchangeability of the binary positive/negative test results.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148921235","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: Hepcidin Isoforms in Chronic Obstructive Pulmonary Disease Compared with the General Population.","authors":"","doi":"10.1093/jalm/jfag123","DOIUrl":"https://doi.org/10.1093/jalm/jfag123","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148931507","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":"Single-Sample Rule-Out Pathway for Acute Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay.","authors":"Ziwen Li, Takeshi Fujisawa, Øyvind Skadberg, Alexander J F Thurston, Yong Yong Tew, Kristin M Aakre, Nicholas L Mills, Ryan Wereski","doi":"10.1093/jalm/jfag107","DOIUrl":"https://doi.org/10.1093/jalm/jfag107","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":"11 5","pages":"1285-1289"},"PeriodicalIF":2.3,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148889114","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 Diagnostic Pivot Triggered by a Cerebrospinal Fluid Critical Value.","authors":"Huini Zheng, Li Zou, Junge Zhang","doi":"10.1093/jalm/jfag040","DOIUrl":"10.1093/jalm/jfag040","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1271-1275"},"PeriodicalIF":2.3,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147989442","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":"Reference Material Choice Affects LC-MS/MS Infliximab Quantitation.","authors":"Paula M Ladwig, Bo Zhong, Preejith P Vachali, Maria Alice V Willrich, Adam J McShane","doi":"10.1093/jalm/jfag064","DOIUrl":"10.1093/jalm/jfag064","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1278-1281"},"PeriodicalIF":2.3,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148044120","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":"Unmasking Hidden Monoclonal Proteins: Leveraging the Lipemia Index.","authors":"Victoria Higgins, Mikayla Steinbach, Fahed Elian, Ola Z Ismail, Albert K Y Tsui, Miranda Brun, Mathew P Estey, Ashley Newbigging, Michelle L Parker, Dustin Proctor, Natalia Volodko, Lily Olayinka","doi":"10.1093/jalm/jfag066","DOIUrl":"10.1093/jalm/jfag066","url":null,"abstract":"<p><strong>Background: </strong>Early detection of monoclonal gammopathies is challenging, as they often remain undiagnosed until morbidity develops. Monoclonal proteins (M-proteins), particularly IgM, can interfere with the lipemia index (L-index) on chemistry analyzers, producing elevations in visually clear samples. The L-index may allow incidental detection of M-proteins, but its clinical value is uncertain.</p><p><strong>Methods: </strong>A retrospective chart review was conducted on 78 patients with visually clear serum samples with Siemens Atellica CH930 L-index ≥2 to assess diagnoses and follow-up of previously known and newly identified M-proteins. L-index was measured on Atellica, Roche cobas Pro c503, and Ortho VITROS XT3400 in 40 additional samples from patients with an IgM M-protein to assess L-index sensitivity for M-proteins. A survey of laboratories examined current practices for managing such samples.</p><p><strong>Results: </strong>Sixty-three of 78 patients with visually clear serum samples with a reproducible Atellica L-index ≥2 had an M-protein(s) (34 previously known; 29 newly identified). Among these, IgM kappa predominated (47/63; 66%), and 5/29 newly identified cases were diagnosed with Waldenström macroglobulinemia. In 40 additional samples with known IgM M-proteins, only one had an elevated Atellica L-index, and none were elevated on cobas or Vitros. Survey results showed wide variation in managing these samples.</p><p><strong>Conclusions: </strong>An elevated L-index on the Atellica in visually clear serum samples, though insensitive, is predictive of the presence of an M-protein. These findings were inconsistent across platforms, highlighting the lack of L-index standardization. Protocol development of an elevated L-index in clear samples will help recognize and manage incidental M-proteins.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1148-1160"},"PeriodicalIF":2.3,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148007029","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":"Isoform-Specific TRIOBP Truncating Variants in Deafness, Autosomal Recessive 28: A Case Study of Postlingual Moderate Sensorineural Hearing Loss.","authors":"Dario Degiorgio, Eliana Greco, Marianna Beggio, Edoardo Peroni, Giulia Favretto, Erennio Natale, Cristina Gondiu, Elona Cama, Pietro Scimemi, Rosamaria Santarelli, Mosè Favarato","doi":"10.1093/jalm/jfag060","DOIUrl":"10.1093/jalm/jfag060","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"1255-1261"},"PeriodicalIF":2.3,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148158660","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}