Clinical chemistry最新文献

{"title":"Hemoglobin A1c/Glucose Management Indicator Discordance: Our Evolving Understanding.","authors":"Jordan Perlman, Irl B Hirsch","doi":"10.1093/clinchem/hvag109","DOIUrl":"10.1093/clinchem/hvag109","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1011-1013"},"PeriodicalIF":8.3,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148825226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commentary on Diagnostic Challenges in γ-Heavy Chain Disease: A Case of Overestimated IgG Concentration.","authors":"Kade C Flowers","doi":"10.1093/clinchem/hvag103","DOIUrl":"https://doi.org/10.1093/clinchem/hvag103","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"72 10","pages":"1022-1023"},"PeriodicalIF":8.3,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Accuracy-Based Proficiency Testing Surveys for Testosterone Provide Important Information About Measurement Accuracy and Its Impact on Patient Care.","authors":"Joely A Straseski, Hubert W Vesper, Thomas A Long, Gary L Horowitz","doi":"10.1093/clinchem/hvag068","DOIUrl":"10.1093/clinchem/hvag068","url":null,"abstract":"<p><strong>Background: </strong>Many clinical guidelines include laboratory measurements, which require accuracy across laboratories. This study aimed to determine whether testosterone measurements by a small subset of labs using commutable specimens could be used as a surrogate marker of accuracy across widely used testing platforms. It also assessed the frequency of categorization errors that might occur near the male hypogonadal threshold and whether performance on traditional surveys predicted performance using commutable specimens.</p><p><strong>Methods: </strong>Three presumed commutable samples were created using human serum; Sample A was provided in a routine mailing of a traditional (non-commutable) proficiency testing survey (reference value 234 ng/dL, n = 1431 laboratories), Samples B and C were part of a routine mailing of an accuracy-based survey (reference values 277 ng/dL and 196 ng/dL, n = 118 and 138 laboratories).</p><p><strong>Results: </strong>The overall mean bias from the reference method value was less than 2% for all 3 samples, but individual peer (method) group biases ranged -16% to +15%. Five percent of reported values for Sample A were above the hypogonadal threshold (264 ng/dL), falsely indicating \"healthy state\" (peer group miscategorization ranged 29% to 0%). Conversely, 44% of results for Sample B were below the hypogonadal threshold, falsely indicating hypogonadism (peer group miscategorization ranged 100% to 0%). Comparison of results between non-commutable and commutable specimens indicated that bias was different in direction and magnitude for 3 of 6 method groups.</p><p><strong>Conclusions: </strong>Assessing performance using commutable specimens reported by smaller numbers of users may serve as a reasonable approximation for performance of method groups in general.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1046-1055"},"PeriodicalIF":8.3,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148276482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic Value of Cardiac Myosin Binding Protein C in the General Population: The Akershus Cardiac Examination 1950 Study.","authors":"Torbjørn Omland, Michael Paus, Arnljot Tveit, Trygve Berge, Gulser Caliskan, Jon Brynildsen, Kristin M Aakre, Helge Røsjø, Magnus N Lyngbakken","doi":"10.1093/clinchem/hvag082","DOIUrl":"10.1093/clinchem/hvag082","url":null,"abstract":"<p><strong>Background: </strong>Cardiac myosin binding protein C (cMyC) is a cardiac-specific biomarker that is released after acute ischemic myocardial injury. Cardiac troponins are established cardiac biomarkers of myocardial injury and provide prognostic information in patients with cardiovascular disease (CVD) and in healthy persons from the general population. There is limited data documenting the prognostic value of cMyC in a general population setting. Accordingly, we assessed the prognostic value of cMyC for incident major adverse cardiovascular events (MACE) and mortality in a general population cohort and contrasted these associations with those of cardiac troponins.</p><p><strong>Methods: </strong>We measured cMyC, high-sensitivity cardiac troponin I (hs-cTnI), and high-sensitivity T (hs-cTnT) in serum samples from 3682 community dwellers born in 1950 at the baseline of the Akershus Cardiac Examination 1950 Study obtained from 2012 to 2015. We assessed the associations of all three biomarkers with a composite MACE outcome (nonfatal myocardial infarction, nonfatal ischemic stroke, nonfatal heart failure, myocardial revascularization, or cardiovascular mortality), as well as with all-cause, cardiovascular and non-cardiovascular mortality separately.</p><p><strong>Results: </strong>The median age was 63.9 years and 1885 were male. After a median follow-up of 8.3 years, we recorded 307 composite MACE outcomes and 191 deaths. cMyC was associated with risk of MACE, as was hs-cTnI and hs-cTnT (all P for log-rank test <0.001). cMyC remained independently associated with MACE (hazard ratio per 1 SD in log-transformed biomarker 1.25, 95% CI, 1.14-1.37) and cardiovascular death (hazard ratio 1.41, 95% CI 1.15-1.72) in adjusted analyses and after further adjustment for hs-cTnI or hs-cTnT.</p><p><strong>Conclusions: </strong>cMyC provides strong prognostic information for incident CVD in the general population, independently of that provided by cardiac troponins.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1056-1066"},"PeriodicalIF":8.3,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148469409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic Challenges in γ-Heavy Chain Disease: A Case of Overestimated IgG Concentration.","authors":"Malcolm Tran, Jauntéa Maxey, Dennis L Cooper, Maria A Willrich, Kayode A Balogun","doi":"10.1093/clinchem/hvag087","DOIUrl":"https://doi.org/10.1093/clinchem/hvag087","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"72 10","pages":"1017-1022"},"PeriodicalIF":8.3,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Persistent Atypical Buprenorphine and Naloxone Metabolite Profile in Urine.","authors":"Cheryl L Mathis, Jessica M Boyd","doi":"10.1093/clinchem/hvag091","DOIUrl":"https://doi.org/10.1093/clinchem/hvag091","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"72 10","pages":"1097-1098"},"PeriodicalIF":8.3,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ADLM 2026 Annual Meeting Abstracts: The Meeting of the Minds.","authors":"Jack A Maggiore, Sridevi Devaraj, Amy B Karger","doi":"10.1093/clinchem/hvag117","DOIUrl":"https://doi.org/10.1093/clinchem/hvag117","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"72 10","pages":"1099-1100"},"PeriodicalIF":8.3,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-041 Clinical Performance and Risk Classification Agreement of Point-of-Care i-STAT High-Sensitivity Troponin I Compared with Abbott Alinity hs-cTnI in ED Patients with Suspected Acute Coronary Syndrome","authors":"Merih Tesfazghi, Elif Yucebay, Isabel Espinosa, Mark Pool, Yanina Purim-Shem-Tov","doi":"10.1093/clinchem/hvag086.034","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.034","url":null,"abstract":"Background Point-of-care (POC) high-sensitivity cardiac troponin testing in the emergency department (ED) can streamline triage and reduce length of stay by improving turnaround time and accelerating clinical decision-making, particularly for low-risk patients. However, these efficiency gains must be balanced with diagnostic safety. In this study, we evaluated the clinical performance of the recently FDA-cleared i-STAT high-sensitivity troponin I (hs-cTnI) assay for risk classification of patients presenting to the ED with suspected acute coronary syndrome (ACS), using the accelerated ED hs-cTnI protocol currently implemented at our institution. We hypothesized that the i-STAT hs-cTnI assay would demonstrate high agreement with Abbott Alinity hs-cTnI for ED risk stratification, with acceptable diagnostic safety for identification of low-risk patients. Methods Paired testing was performed on the same lithium heparin specimens (n = 269) obtained from 238 patients, with i-STAT analysis conducted first using whole blood, followed by Abbott Alinity testing on plasma. Demographic and clinical data were retrospectively extracted from electronic medical records. Final diagnosis and clinical risk adjudication were independently performed by two emergency physicians based on clinical data and Abbott Alinity hs-cTnI results, which served as the institutional reference standard. Risk categorization based strictly on troponin results from both methods (low &amp;lt;5 ng/L; intermediate 5 ng/L to the 99th percentile, sex-specific; high &amp;gt; 99th percentile) was compared with clinician risk classifications. For patients (87%) with only a single specimen available (0 hr.), a high-risk classification based on troponin results was considered consistent with chronic myocardial injury if documented as such by at least one adjudicating clinician, regardless of the assigned risk level. For patients with two specimens available (0 hr. and 2hr.), both cutoffs and deltas were applied according to the ED troponin protocol to determine risk stratification. Results Overall agreement in troponin-based risk classification between i-STAT and Abbott Alinity was 83%. Among discordant cases (17%), the majority (90%) were classified as intermediate risk by i-STAT, while only one case (2%) was classified as low risk. Agreement with clinical adjudication was significantly higher for Abbott Alinity compared with i-STAT (86% vs 71%; p=0.0002). Importantly, all patients ultimately diagnosed with myocardial infarction (n=7) were classified identically by both assays and clinical adjudication, with none misclassified as low risk. Conclusion The i-STAT hs-cTnI assay demonstrated high agreement with the Abbott Alinity platform for troponin-based risk classification and correctly identified all myocardial infarction cases. Although overall agreement with clinical adjudication was lower than that of the Abbott Alinity assay, the very low rate of low-risk misclassification suggests that th","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"91 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-003 Automation for the Isolation of Peripheral Blood Mononuclear cells (PBMCs) with Hamilton Robotics for T-Spot Testing","authors":"Kaelan Duncan, Connie La, Grace Gentile, Ethan Samaniego, Carlos Resureccion, Keene Huynh, Madilynn Vu, Leslie Lim","doi":"10.1093/clinchem/hvag086.338","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.338","url":null,"abstract":"Background Tuberculosis (TB), worldwide, remains to be the second leading infectious killer. Since 2023, the World Health Organization (WHO) reports that the TB response shows a significant recovery from the recent surge of cases with more diagnosis and treatment services provided with development of new methods to detect TB. T-Cell Select is the cell isolation step of the T-Spot test that enriches the desired population of peripheral blood mononuclear cells (PBMC) from whole blood collected using routine phlebotomy. The study uses the T-Cell Select reagent kit that selects targeted immune cells with magnetic bead-based cell separation. With the help of the Hamilton liquid handler to perform the preparation of cells for the T-Spot test, the process is simplified with increased accuracy and performance. Objective The objective of this study is to automate the method separating PBMCs from whole blood samples using magnetic bead reagent with the Hamilton automated liquid handler, in order to process large batch volumes of sample and increase efficiency and accuracy of T-cell spotting for Mycobacterium tuberculosis detection. Methods 1080 µL master mix consisting of DI water, buffer, Antibody 1, Antibody 2, and D-PBS was made and thoroughly mixed with whole blood sample before 64 µL magnetic beads were added. Cell isolation was then conducted using RPMI and the removal of supernatant. The PBMCs were then further isolated using AIM-V, and the WBC count was analyzed using the Sysmex Hematology Analyzer. Mixing and cell isolation was automated using the Hamilton Microlab STAR Liquid Handler. Results The method analysis of the automated bead reagent isolation of PBMCs was done with white blood cell count (WBC-BF). WBC count was determined to be above acceptable concentration value of 2.0 x 10^3 WBC/µl using the Sysmex hemocytometer for all 22 samples that were ran. A level of 2.0 X 103 is necessary for the T-Spot assay. Conclusion The standard method for the isolation of PBMCs for T-Spot TB testing utilizes centrifugation to create a density gradient. By automating this test using Hamilton Robotics, samples can be run in larger quantities in a shorter time and yield more accurate results due to purer extraction product. The Hamilton Robotics method isolates the WBCs using magnetic beads that bind to the antibodies, isolating WBCs without any other unwanted blood components. The study yielded a WBC-BF above the accepted value of 2.0 x 10^3 WBC/µl in blood. An increase in whole blood or binding beads used for testing could produce more favorable results. Next steps would be to run the whole automated method and compare against the centrifugation method.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"66 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-287 Discordant Estimates, Divergent Risk: Reclassification of Kidney Function in High-Risk Ghanaian Adults","authors":"Mildred Martey, Edwin Sam, Richeal Owusu, Cate Omosule","doi":"10.1093/clinchem/hvag086.571","DOIUrl":"https://doi.org/10.1093/clinchem/hvag086.571","url":null,"abstract":"Background Estimated glomerular filtration rate (eGFR) is central to the diagnosis and management of CKD. Emerging evidence shows that discordance between creatinine and cystatin C–based eGFR is independently associated with increased risks of mortality, cardiovascular events, and kidney failure. However, the extent of such discordance among Africans with hypertension and diabetes, the two leading risk factors for CKD, remains largely unexplored. Also, although validation data for the 2021 CKD-EPI and EKFC equations in Ghana and much of sub-Saharan Africa are limited, emerging studies suggest the EKFC equation may demonstrate improved accuracy in African populations. This study compared creatinine- and cystatin C–based equations among hypertensive and diabetic adults in Ghana who had normal baseline creatinine-based eGFR (CKD-EPI), and quantified CKD reclassification and discordance. Methods Participants were adults with hypertension and/or diabetes enrolled in a longitudinal kidney biomarker study at the University of Ghana Medical Centre, Accra. Serum creatinine was measured using an IDMS-traceable sarcosine oxidase assay (Beckman Coulter), and cystatin C was measured using an immunoturbidimetric assay (Beckman Coulter). Only non-pregnant participants without known kidney disease and with normal baseline creatinine-based eGFR (2021 CKD-EPI =90 mL/min/1.73 m², or =60 mL/min/1.73 m² if aged =60 years) were included. Absolute eGFR values and CKD stage classifications derived from the CKD-EPI equations (2021 creatinine, 2012 cystatin C, combined creatinine–cystatin C), and EKFC (creatinine, cystatin C, and averages) were compared per KDIGO thresholds. Results The cohort included 115 participants with hypertension, 35 with diabetes, and 54 with both conditions (mean age 56 years; 53% male). By CKD-EPI-creatinine, 71% were classified as G1 and 28% as G2. CKD-EPI cystatin C reclassified participants to 34% G1, 54% G2, 11% G3a, and 1% G3b, while the combined equation yielded 55% G1, 41% G2, and 4% G3a. Among those classified as G3 by CKD-EPI cystatin C (n=25), 22% had both diabetes and hypertension, compared with 10% with hypertension alone and 5.7% with diabetes alone. Mean absolute discordance between creatinine- and cystatin C–based CKD-EPI equations was 11 mL/min/1.73 m², with 32% exceeding 15 mL/min/1.73 m². Using EKFC, creatinine classified 44% as G1, 41% as G2, 13% as G3a, and 2% as G3b, whereas cystatin C classified 27% as G1, 62% as G2, 9.4% as G3a, and 1% as G3b. The combined EKFC equation yielded 33% G1, 60% G2, and 6.9% G3a. Similarly, 22% of individuals with both diabetes and hypertension were classified as G3 by EKFC cystatin C. Mean absolute discordance between EKFC creatinine and cystatin C equations was 15 mL/min/1.73 m², with 9 individuals exceeding 20 mL/min/1.73 m². Conclusion Substantial eGFR discordance was observed despite normal baseline creatinine eGFR. Cystatin C–based equations consistently identified a higher burden of stage","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"8 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149086421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}