Pub Date : 2024-10-03DOI: 10.1093/clinchem/hvae038
Sean T Campbell
{"title":"Approval of the First CRISPR-Cas9 Gene Editing Therapy for Sickle Cell Disease.","authors":"Sean T Campbell","doi":"10.1093/clinchem/hvae038","DOIUrl":"10.1093/clinchem/hvae038","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"70 10","pages":"1298"},"PeriodicalIF":7.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142368186","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}
Pub Date : 2024-10-03DOI: 10.1093/clinchem/hvae117
Mark A Cervinski
{"title":"Commentary on Negative Sweat Chloride Testing in the Setting of a Positive Newborn Screen and CFTR Compound Heterozygosity.","authors":"Mark A Cervinski","doi":"10.1093/clinchem/hvae117","DOIUrl":"10.1093/clinchem/hvae117","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"70 10","pages":"1205-1206"},"PeriodicalIF":7.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142368187","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}
Pub Date : 2024-10-03DOI: 10.1093/clinchem/hvae102
Lucille De Maria, Marion Marlinge, Melisande Baravalle, Jean-Christophe Dubus, Julien Fromonot
{"title":"Negative Sweat Chloride Testing in the Setting of a Positive Newborn Screen and CFTR Compound Heterozygosity.","authors":"Lucille De Maria, Marion Marlinge, Melisande Baravalle, Jean-Christophe Dubus, Julien Fromonot","doi":"10.1093/clinchem/hvae102","DOIUrl":"10.1093/clinchem/hvae102","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"70 10","pages":"1202-1205"},"PeriodicalIF":7.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364676","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}
Pub Date : 2024-10-03DOI: 10.1093/clinchem/hvae110
Nasir Saeed, Ole-Thomas Steiro, Jørund Langørgen, Hilde L Tjora, Rune O Bjørneklett, Øyvind Skadberg, Vernon V S Bonarjee, Øistein R Mjelva, Tone M Norekvål, Trude Steinsvik, Kjell Vikenes, Torbjørn Omland, Kristin M Aakre
Background: There are limited data regarding the utility of follow-up cardiac troponin (cTn) measurements after admission for acute chest pain and how long-term stability of myocardial injury and prognostic value differ when using cardiac troponin T (cTnT) or I (cTnI).
Methods: We measured high-sensitivity (hs)-cTnT (Roche Diagnostics) and hs-cTnI (Siemens Healthineers) during hospitalization for acute chest pain and after 3 months. Acute myocardial injury was defined as concentrations > sex-specific upper reference limit (URL) during hospitalization and ≤URL at 3-months. Chronic myocardial injury (CMI) was defined as concentrations > URL at both time points. Patients were followed from the 3-month sampling point for a median of 1586 (IQR 1161-1786) days for a primary composite endpoint of all-cause mortality, myocardial infarction (MI), revascularization, and heart failure, and a secondary endpoint of all-cause mortality.
Results: Among 754 patients, 33.8% (hs-cTnT) and 19.2% (hs-cTnI) had myocardial injury during hospitalization. The rate of CMI was 5 times higher by hs-cTnT (20%) assay than hs-cTnI (4%), while acute myocardial injury was equally common; 14% (hs-cTnT) and 15% (hs-cTnI), respectively (6% and 5% when excluding index non-ST-elevation MI (NSTEMI). For hs-cTnT, peak index concentration, 3-month concentration and classification of CMI predicted the primary endpoint; hazard ratios (HRs) 1.38 (95% CI 1.20-1.58), 2.34 (1.70-3.20), and 2.31 (1.30-4.12), respectively. For hs-cTnI, peak index concentration predicted the primary endpoint; HR 1.14 (1.03-1.25). This association was nonsignificant after excluding index NSTEMI.
Conclusions: Acute myocardial injury is equally frequent, whereas CMI is more prevalent using hs-cTnT assay than hs-cTnI. Measuring hs-cTnT 3 months after an acute chest pain episode could assist in further long-term risk assessment. ClinicalTrials.gov Registration Number: NCT02620202.
{"title":"Diagnosing Myocardial Injury in an Acute Chest Pain Cohort; Long-Term Prognostic Implications of Cardiac Troponin T and I.","authors":"Nasir Saeed, Ole-Thomas Steiro, Jørund Langørgen, Hilde L Tjora, Rune O Bjørneklett, Øyvind Skadberg, Vernon V S Bonarjee, Øistein R Mjelva, Tone M Norekvål, Trude Steinsvik, Kjell Vikenes, Torbjørn Omland, Kristin M Aakre","doi":"10.1093/clinchem/hvae110","DOIUrl":"10.1093/clinchem/hvae110","url":null,"abstract":"<p><strong>Background: </strong>There are limited data regarding the utility of follow-up cardiac troponin (cTn) measurements after admission for acute chest pain and how long-term stability of myocardial injury and prognostic value differ when using cardiac troponin T (cTnT) or I (cTnI).</p><p><strong>Methods: </strong>We measured high-sensitivity (hs)-cTnT (Roche Diagnostics) and hs-cTnI (Siemens Healthineers) during hospitalization for acute chest pain and after 3 months. Acute myocardial injury was defined as concentrations > sex-specific upper reference limit (URL) during hospitalization and ≤URL at 3-months. Chronic myocardial injury (CMI) was defined as concentrations > URL at both time points. Patients were followed from the 3-month sampling point for a median of 1586 (IQR 1161-1786) days for a primary composite endpoint of all-cause mortality, myocardial infarction (MI), revascularization, and heart failure, and a secondary endpoint of all-cause mortality.</p><p><strong>Results: </strong>Among 754 patients, 33.8% (hs-cTnT) and 19.2% (hs-cTnI) had myocardial injury during hospitalization. The rate of CMI was 5 times higher by hs-cTnT (20%) assay than hs-cTnI (4%), while acute myocardial injury was equally common; 14% (hs-cTnT) and 15% (hs-cTnI), respectively (6% and 5% when excluding index non-ST-elevation MI (NSTEMI). For hs-cTnT, peak index concentration, 3-month concentration and classification of CMI predicted the primary endpoint; hazard ratios (HRs) 1.38 (95% CI 1.20-1.58), 2.34 (1.70-3.20), and 2.31 (1.30-4.12), respectively. For hs-cTnI, peak index concentration predicted the primary endpoint; HR 1.14 (1.03-1.25). This association was nonsignificant after excluding index NSTEMI.</p><p><strong>Conclusions: </strong>Acute myocardial injury is equally frequent, whereas CMI is more prevalent using hs-cTnT assay than hs-cTnI. Measuring hs-cTnT 3 months after an acute chest pain episode could assist in further long-term risk assessment. ClinicalTrials.gov Registration Number: NCT02620202.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1241-1255"},"PeriodicalIF":7.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906135","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}
Pub Date : 2024-10-03DOI: 10.1093/clinchem/hvae121
Adrienne Savant
{"title":"Commentary on Negative Sweat Chloride Testing in the Setting of a Positive Newborn Screen and CFTR Compound Heterozygosity.","authors":"Adrienne Savant","doi":"10.1093/clinchem/hvae121","DOIUrl":"10.1093/clinchem/hvae121","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"70 10","pages":"1206-1207"},"PeriodicalIF":7.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142368188","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}
Pub Date : 2024-10-03DOI: 10.1093/clinchem/hvae120
Kobe Truijens, Glynis Frans, Pieter Vermeersch
Background: Timely and accurate notification of critical results is crucial in laboratory medicine and mandated by accreditation standards like ISO15189. Alert lists do, however, vary widely and clinical laboratories typically rely on a combination of in-house agreed and/or literature-based critical values. Communication by phone is still the preferred method of notification, but digital communication could help improve communication of critical results.
Content: We review the available evidence concerning critical result thresholds and critical result notification practices. The evidence is ranked using an adaptation of the Stockholm Hierarchy. In addition, we propose an evidence-based list of critical result thresholds for hospitalized patients that laboratories can use as a starter list and further customize based on the clinical needs of their patient population.
Summary: A clear distinction between critical results and significantly abnormal results is essential for effective and timely healthcare interventions. Implementation of a policy using differentiated thresholds taking into account individual patient characteristics and how fast medical attention is needed, and the use alternative communication methods could enhance communication efficiency and reduce notification fatigue.
{"title":"Critical Results in Laboratory Medicine.","authors":"Kobe Truijens, Glynis Frans, Pieter Vermeersch","doi":"10.1093/clinchem/hvae120","DOIUrl":"10.1093/clinchem/hvae120","url":null,"abstract":"<p><strong>Background: </strong>Timely and accurate notification of critical results is crucial in laboratory medicine and mandated by accreditation standards like ISO15189. Alert lists do, however, vary widely and clinical laboratories typically rely on a combination of in-house agreed and/or literature-based critical values. Communication by phone is still the preferred method of notification, but digital communication could help improve communication of critical results.</p><p><strong>Content: </strong>We review the available evidence concerning critical result thresholds and critical result notification practices. The evidence is ranked using an adaptation of the Stockholm Hierarchy. In addition, we propose an evidence-based list of critical result thresholds for hospitalized patients that laboratories can use as a starter list and further customize based on the clinical needs of their patient population.</p><p><strong>Summary: </strong>A clear distinction between critical results and significantly abnormal results is essential for effective and timely healthcare interventions. Implementation of a policy using differentiated thresholds taking into account individual patient characteristics and how fast medical attention is needed, and the use alternative communication methods could enhance communication efficiency and reduce notification fatigue.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1220-1230"},"PeriodicalIF":7.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153347","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}
Pub Date : 2024-10-03DOI: 10.1093/clinchem/hvae107
Rasmus Bo Hasselbalch, Philip Andreas Schytz, Martin Schultz, Caroline Sindet-Pedersen, Jonas Henrik Kristensen, Nina Strandkjær, Sophie Sander Knudsen, Mia Pries-Heje, Manan Pareek, Kristian H Kragholm, Nicholas Carlson, Morten Schou, Mikkel Porsborg Andersen, Henning Bundgaard, Christian Torp-Pedersen, Kasper Karmark Iversen
Background: The influence of age on cardiac troponin is unclear and may vary between cardiac troponin T (cTnT) and I (cTnI). We aimed to compare the impact of age on the diagnostic and prognostic utility of cTnT and cTnI.
Methods: This Danish nationwide, register-based cohort study included patients with at least one cardiac troponin (cTn) measurement from 2009 through June 2022, stratified into decades of age. We used peak cTn concentration during admission, dichotomized as positive/negative and normalized to the 99th percentile. Receiver operating characteristics for myocardial infarction (MI) and logistic regression were used to estimate the odds ratio (OR) for mortality at 1 year.
Results: We included 541 817 patients; median age 66 years (interquartile range [IQR] 51-77) and 256 545 (47%) female. A total of 40 359 (7.4%) had an MI, and 59 800 (14.1%) patients died within 1 year of admission. The predictive ability of both cTns for MI were highest for patients 30 to 50 years. This was most pronounced for cTnT, the specificity of which fell from 83% among patients 40 to 49 years to 4% for patients ≥90 years. The prognostic ability of both cTns for 1-year mortality declined with age. cTnT had stronger prognostic ability for all age-groups; OR for a positive cTnT 28.4 (95% CI, 20.1-41.0) compared with 9.4 (95% CI, 5.0-16.7) for cTnI among patients <30 years.
Conclusions: The predictive and prognostic ability of cTnT and cTnI declined with age. cTnT had a low specificity for MI in elderly patients. However, cTnT was the strongest prognostic marker among all age groups.
{"title":"Implications of Age for the Diagnostic and Prognostic Value of Cardiac Troponin T and I.","authors":"Rasmus Bo Hasselbalch, Philip Andreas Schytz, Martin Schultz, Caroline Sindet-Pedersen, Jonas Henrik Kristensen, Nina Strandkjær, Sophie Sander Knudsen, Mia Pries-Heje, Manan Pareek, Kristian H Kragholm, Nicholas Carlson, Morten Schou, Mikkel Porsborg Andersen, Henning Bundgaard, Christian Torp-Pedersen, Kasper Karmark Iversen","doi":"10.1093/clinchem/hvae107","DOIUrl":"10.1093/clinchem/hvae107","url":null,"abstract":"<p><strong>Background: </strong>The influence of age on cardiac troponin is unclear and may vary between cardiac troponin T (cTnT) and I (cTnI). We aimed to compare the impact of age on the diagnostic and prognostic utility of cTnT and cTnI.</p><p><strong>Methods: </strong>This Danish nationwide, register-based cohort study included patients with at least one cardiac troponin (cTn) measurement from 2009 through June 2022, stratified into decades of age. We used peak cTn concentration during admission, dichotomized as positive/negative and normalized to the 99th percentile. Receiver operating characteristics for myocardial infarction (MI) and logistic regression were used to estimate the odds ratio (OR) for mortality at 1 year.</p><p><strong>Results: </strong>We included 541 817 patients; median age 66 years (interquartile range [IQR] 51-77) and 256 545 (47%) female. A total of 40 359 (7.4%) had an MI, and 59 800 (14.1%) patients died within 1 year of admission. The predictive ability of both cTns for MI were highest for patients 30 to 50 years. This was most pronounced for cTnT, the specificity of which fell from 83% among patients 40 to 49 years to 4% for patients ≥90 years. The prognostic ability of both cTns for 1-year mortality declined with age. cTnT had stronger prognostic ability for all age-groups; OR for a positive cTnT 28.4 (95% CI, 20.1-41.0) compared with 9.4 (95% CI, 5.0-16.7) for cTnI among patients <30 years.</p><p><strong>Conclusions: </strong>The predictive and prognostic ability of cTnT and cTnI declined with age. cTnT had a low specificity for MI in elderly patients. However, cTnT was the strongest prognostic marker among all age groups.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1231-1240"},"PeriodicalIF":7.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906136","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}
Pub Date : 2024-10-03DOI: 10.1093/clinchem/hvae123
Ziwen Li, Jasper Boeddinghaus, Nicholas L Mills
{"title":"Cardiac Troponin I or T for the Diagnosis of Myocardial Infarction and Prediction of Outcomes-Does It Matter?","authors":"Ziwen Li, Jasper Boeddinghaus, Nicholas L Mills","doi":"10.1093/clinchem/hvae123","DOIUrl":"10.1093/clinchem/hvae123","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1197-1199"},"PeriodicalIF":7.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055139","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}
Pub Date : 2024-10-03DOI: 10.1093/clinchem/hvae116
Louis Nevejan, Mark Perkins, Martine Vercammen, Thibault Vanhove, Michel Delforge, Xavier Bossuyt
{"title":"Failure of Serum Immunofixation Electrophoresis to Detect Intact Monoclonal IgD Lambda Unraveled by Mass Spectrometry.","authors":"Louis Nevejan, Mark Perkins, Martine Vercammen, Thibault Vanhove, Michel Delforge, Xavier Bossuyt","doi":"10.1093/clinchem/hvae116","DOIUrl":"10.1093/clinchem/hvae116","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"1291-1293"},"PeriodicalIF":7.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003797","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}