Journal of Applied Laboratory Medicine最新文献

{"title":"Commentary on An Unexpected Cause of Rhabdomyolysis.","authors":"Jessica M Colón-Franco","doi":"10.1093/jalm/jfaf019","DOIUrl":"10.1093/jalm/jfaf019","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"754-755"},"PeriodicalIF":1.8,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143665029","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":"Analytical Validation and Performance of a Blood-Based P-tau217 Diagnostic Test for Alzheimer Disease.","authors":"Adam Abel, Antonio Chambers, Jeff Fill, Heinz Reiske, Ming Lu, Amanda Morris, Paul Faya, Rose C Beck, Michael J Pontecorvo, Emily C Collins, Andrew E Schade, Mark A Mintun, Michael E Hodsdon","doi":"10.1093/jalm/jfae155","DOIUrl":"10.1093/jalm/jfae155","url":null,"abstract":"<p><strong>Background: </strong>Blood-based biomarkers, especially P-tau217, have been gaining interest as diagnostic tools to measure Alzheimer disease (AD) pathology.</p><p><strong>Methods: </strong>We developed a plasma P-tau217 chemiluminescent immunoassay using 4G10E2 and IBA493 as antibodies, a synthetic tau peptide as calibrator, and the Quanterix SP-X imager. Analytical validation performed in a College of American Pathologists-accredited CLIA laboratory involved multiple kit lots, operators, timepoints, and imagers. Florbetapir positron emission tomography was used to quantify amyloid for clinical validation.</p><p><strong>Results: </strong>Precision across 80 runs was ≤20% CV using 23 patient-derived samples ranging from 0.09 U/mL to 3.35 U/mL. No significant lot-to-lot differences were observed. There was no interference from purified tau (2N4R) or lipemia, but hemolysis greater than 2 + was not acceptable. Functional analytical sensitivity (lower limit of quantitation) was 0.08 U/mL. Linearity studies support the use of a standard 1:2 plasma dilution. Samples demonstrated stability at 7 freeze/thaw cycles, with room temperature and refrigerated stability established for up to 72 hours. The final analytical measurement range was 0.08 to 2.81 U/mL. The calibration curve maintained ≤20% CV for raw signal intensity and 80% to 120% relative error for back-fitted concentration using a log-log power regression. Initial clinical assessment using plasma samples from 1091 individuals screened in TRAILBLAZER-ALZ 2 demonstrated an area under the curve of 91.6% (95% CI 0.90-0.94) with brain amyloid as the comparator. Positive and negative predictive value was >90% and >85%, respectively.</p><p><strong>Conclusions: </strong>Through analytical validation, this assay demonstrated robust performance across multiple lots, operators, and instruments and could be used as a tool for diagnosing AD.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"533-545"},"PeriodicalIF":1.8,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143013726","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 Acute Sodium Fluctuation in Altered Consciousness: A Puzzle or a Key to Diagnosis?","authors":"Sharon M Geaghan","doi":"10.1093/jalm/jfaf016","DOIUrl":"10.1093/jalm/jfaf016","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"762-763"},"PeriodicalIF":1.8,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143674742","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 Therapeutic Monoclonal Antibody Pemivibart Causes Persistent Interference in Immunofixation Electrophoresis.","authors":"Susan L Fink, Rebecca S Treger","doi":"10.1093/jalm/jfaf002","DOIUrl":"10.1093/jalm/jfaf002","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"771-774"},"PeriodicalIF":1.8,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190567","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":"Persistently Suppressed TSH without Overt Symptoms.","authors":"William Butler, Rebecca G Ramesh, Benjamin Cooperberg, Daniel S Herman","doi":"10.1093/jalm/jfae160","DOIUrl":"10.1093/jalm/jfae160","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":"743-747"},"PeriodicalIF":1.8,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143651358","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":"Impact of the Choosing Wisely Campaign on Folate Test Utilization: An Observational Study in a National Reference Laboratory.","authors":"Ato Aikins, Sanjai Nagendra, Zahra Shajani-Yi, David Alfego, Pratistha Ranjitkar","doi":"10.1093/jalm/jfaf058","DOIUrl":"https://doi.org/10.1093/jalm/jfaf058","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144051789","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":"Persistent Microcytosis in a Young Woman with Bone Pain.","authors":"Seema Khattri Bhandari, Shu-Ling Fan","doi":"10.1093/jalm/jfaf007","DOIUrl":"https://doi.org/10.1093/jalm/jfaf007","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144052877","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 Persistent Microcytosis in a Young Woman with Bone Pain.","authors":"Brian D Adkins, Hung S Luu","doi":"10.1093/jalm/jfaf060","DOIUrl":"https://doi.org/10.1093/jalm/jfaf060","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990905","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 a Reusable, Thermally Protective Specimen Shipper for Decentralized Sample Collections.","authors":"Ulrich Y Schaff, Bradley B Collier, Gabriella Iacovetti, Mitchell Peevler, Nicolas Tokunaga, Jason Ragar, Whitney C Brandon, Matthew R Chappell, Russell P Grant, Greg J Sommer","doi":"10.1093/jalm/jfaf052","DOIUrl":"https://doi.org/10.1093/jalm/jfaf052","url":null,"abstract":"<p><strong>Background: </strong>The proliferation of decentralized sample collection models improves patient access and experience with laboratory medicine. However, many analytes have limited stability in liquid whole blood, serum, or plasma such that prompt transport under controlled temperature protection is crucial to analytical accuracy. Here we validate the Labcorp TrueTherm™ reusable shipper intended to thermally protect small volume specimens.</p><p><strong>Methods: </strong>Various TrueTherm shipper models were configured using stainless steel vacuum bottles, rigid phase change material (PCM) packs, and foam stoppers. A series of bench and real-world trans-US shipping studies were performed to evaluate thermal endurance against frozen, refrigerated, room temperature, and incubated temperature allowance criteria under summer and winter exposure conditions. Analytical utility was assessed by measuring 25 serum-based clinical chemistry markers using Roche cobas® 8000 analyzers following shipment in microvolume containers centrifuged or uncentrifuged and using various shipping methods. Additional studies evaluated the effect of centrifugation and thermal exposures on specimens exposed to ISTA-7D summer and winter shipping profiles.</p><p><strong>Results: </strong>The TrueTherm shipper exceeded 72-hour thermal endurance for most targeted applications when subjected to standard shipping validation thermal profiles. In real-world shipping studies, TrueTherm shippers paired with sample centrifugation prior to transport enabled most chemistry analytes to be measured with pair-wise comparisons within 2024 CLIA acceptance limits. Microsample hemolysis measurements showed that without centrifugation and thermal protection, average hemolysis levels fell well above maximum-allowable thresholds for laboratory analyzers.</p><p><strong>Conclusion: </strong>The TrueTherm shipper provides a simple, effective, and reusable method for ensuring thermally protected shipment of small volume samples into centralized laboratories.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144015044","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":"In Reply to The Environmental Impact of Inappropriate Clinical Laboratory Testing: What's New?","authors":"Emilie Catry, Giuseppe Lippi, Pauline Modrie, Solemne Durand, Luigi Devis, Jonathan Degosserie, François Mullier, Mélanie Closset","doi":"10.1093/jalm/jfaf051","DOIUrl":"https://doi.org/10.1093/jalm/jfaf051","url":null,"abstract":"","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033874","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}