Scandinavian journal of clinical and laboratory investigation. Supplementum最新文献_第8页

Biomarkers for rheumatoid arthritis: making it personal. 类风湿关节炎的生物标志物:个人化。

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493406

Tamsin M Lindstrom, William H Robinson

引用次数: 51

Development of novel IVD assays: a manufacturer's perspective. 新型IVD检测方法的发展:制造商的观点。

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493361

Thomas A Metcalfe

引用次数: 9

Cardiac: is this biomarker ready for the prime time? 心脏:这个生物标志物准备好了吗?

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493394

Mauro Panteghini

{"title":"Cardiac: is this biomarker ready for the prime time?","authors":"Mauro Panteghini","doi":"10.3109/00365513.2010.493394","DOIUrl":"https://doi.org/10.3109/00365513.2010.493394","url":null,"abstract":"Today, the increase of the blood concentration of cardiac troponins is designated as surrogate for cardiac necrosis and myocardial infarction, when an appropriate clinical and/or instrumental situation is present. As cardiac troponins reflect myocyte death, biomarkers of reversible myocardial damage in the absence of necrosis are, however, still needed to detect the presence of damage even before the irreversible injury is induced and identify \"vulnerable\" patients before major events occur, permitting adequate treatment. Markers of plaque destabilization and/or markers of myocardial ischemia could be enormously valuable in the emergency department setting if shown to contribute additional independent diagnostic information. However, a new cardiac biomarker is of definitive clinical value only if adequate assays for its measurement are available, its predictive value is defined in the right clinical context, optimal cut-off and release kinetics are known, demonstration of the marker incremental value is clear, there is consistency of marker performance across different settings, and, more importantly, there are data on the effect on patient management and outcome and on cost-effectiveness. Despite the emergence of multiple candidates, sufficient evidence for any of these has yet been demonstrated to recommend their adoption into clinical practice.","PeriodicalId":76518,"journal":{"name":"Scandinavian journal of clinical and laboratory investigation. Supplementum","volume":"242 ","pages":"66-72"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/00365513.2010.493394","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29027511","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: 8

Clinical validity: defining biomarker performance. 临床效度:定义生物标志物的性能。

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493383

Patrick M M Bossuyt

{"title":"Clinical validity: defining biomarker performance.","authors":"Patrick M M Bossuyt","doi":"10.3109/00365513.2010.493383","DOIUrl":"https://doi.org/10.3109/00365513.2010.493383","url":null,"abstract":"A central phase in the evaluation of a biomarker is the assessment of its clinical validity. In most cases, clinical validity will be expressed in terms of the marker's diagnostic accuracy: the degree to which it can be used to identify diseased patients or, more generally, patients with the target condition. Diagnostic accuracy is evaluated in diagnostic accuracy studies, in which the biomarker values are compared to the outcome of the clinical reference standard in the same patients. There are several ways in which the results of diagnostic accuracy studies can be summarized, reported, and interpreted. We present an overview and a critical commentary of the available measures. We classify them as error-based measures, information-based measures, and measures of the strength of the association.The diagnostic accuracy is not a fixed property of a marker. All accuracy measures may vary between studies, not just through chance, but also with changes in the definition of the target condition, the spectrum of disease, the setting, and the amount of prior testing. We discuss the relativity of the claim that likelihood ratios are a superior way of expressing the accuracy of biomarkers, and defend the use of the sometimes downgraded statistics sensitivity and specificity.","PeriodicalId":76518,"journal":{"name":"Scandinavian journal of clinical and laboratory investigation. Supplementum","volume":"242 ","pages":"46-52"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/00365513.2010.493383","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29028127","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: 31

Preanalytical aspects: a neglected issue. 前分析方面:一个被忽视的问题。

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493392

Hartmut Juhl

引用次数: 24

Biomarkers in the era of personalized medicine - a multiplexed SNP assay using capillary electrophoresis for assessing drug metabolism capacity. 个性化医疗时代的生物标志物——毛细管电泳用于评估药物代谢能力的多重SNP测定。

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493355

Alex J Rai, Jessica Yee, Martin Fleisher

{"title":"Biomarkers in the era of personalized medicine - a multiplexed SNP assay using capillary electrophoresis for assessing drug metabolism capacity.","authors":"Alex J Rai, Jessica Yee, Martin Fleisher","doi":"10.3109/00365513.2010.493355","DOIUrl":"https://doi.org/10.3109/00365513.2010.493355","url":null,"abstract":"Abstract Pharmacogenetics is the study of genetic differences in an individual that leads to variability in drug response. Single-nucleotide polymorphisms (SNPs) prove to be important determinants in evaluating and predicting a patient’s response to certain medications and risk of adverse events. The Cytochrome P450 2D6 (CYP2D6) gene is particularly important in the metabolism of many clinically prescribed drugs. In this study, we designed a multiplexed panel to interrogate 8 clinically relevant SNPs of CYP2D6 (*2 at C2856G, *2 at G4181C, *3, *4, *5,*6, *7, and *8). We PCR-amplified a 4.7 kB segment of the CYP2D6 locus containing all the SNPs of interest using genomic DNA extracted from whole blood. Using single base extension and capillary electrophoresis separation, peaks corresponding to the SNPs resolve within a 25–60 bp window. We subsequently analyzed 25 samples using this protocol and compared results to traditional DNA sequencing using an ABI 3730. All samples were 100% concordant between the two methods. This assay can be performed with <24 h turnaround time and minimal hands-on effort. This multiplex SNP panel can be used for interrogation of 8 SNPs within the 2D6 gene, with application to identifying poor metabolizers of 2d6. Patients harbouring SNPs in 2D6 could be triaged to alternative therapies in an effort to maximize therapeutic efficacy and reduce adverse drug reactions.","PeriodicalId":76518,"journal":{"name":"Scandinavian journal of clinical and laboratory investigation. Supplementum","volume":"242 ","pages":"15-8"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/00365513.2010.493355","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29027651","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: 7

Approval of novel biomarkers: FDA's perspective and major requests. 新型生物标志物的批准:FDA的观点和主要要求。

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493415

Uwe Scherf, Robert Becker, Maria Chan, Sally Hojvat

{"title":"Approval of novel biomarkers: FDA's perspective and major requests.","authors":"Uwe Scherf, Robert Becker, Maria Chan, Sally Hojvat","doi":"10.3109/00365513.2010.493415","DOIUrl":"https://doi.org/10.3109/00365513.2010.493415","url":null,"abstract":"FDA has been regulating diagnostic tests (including biomarkers) since passage of the Medical Device Amendments of 1976. Although always of interest as diagnostic tools, biomarkers (particularly genetic/genomic) have become of increased interest because of their potential impact on the development and personalized use of drugs. Unfortunately, there seem to be uncertainties among translational researchers as to the specific analytical and clinical measurement criteria needed for the approval of these novel biomarkers. This meeting presentation describes the current FDA perspective and major requirements and data for the validation/approval of an in vitro diagnostic device (IVD) based on a biomarker. The approval process for an IVD based on a biomarker used in the identification of a disease or condition (diagnosing, screening, monitoring) is well established, and is essentially identical to the process to generate sufficient analytical and clinical data for the approval of regular diagnostic devices. On the contrary, approvals for IVDs based on biomarker which may be designed to evaluate the efficacy or answer safety questions for new drug entities are less streamlined. The clinical studies are more complex, resulting in higher ethical standards, increased costs and requiring complex statistical evaluation. There is a small but growing literature on new models for co-development of drugs and diagnostics which will be discussed. Regulators like the FDA develop and bring a flexible regulatory toolbox to the table and are committed to assuring that scientific and regulatory thresholds are tempered to assure rapid access to new technologies while protecting public health.","PeriodicalId":76518,"journal":{"name":"Scandinavian journal of clinical and laboratory investigation. Supplementum","volume":"242 ","pages":"96-102"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/00365513.2010.493415","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29027516","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: 17

Hans Ulrich Bergmeyer (1920-1999). 汉斯·乌尔里希·伯格迈耶（1920-1999）。

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493437

Walter G Guder

引用次数: 1

Qualification versus validation of biomarkers. 生物标志物的鉴定与验证。

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493380

Jenny Doust

引用次数: 8

Integrating biomarkers: the new frontier? 整合生物标记物:新前沿?

Scandinavian journal of clinical and laboratory investigation. Supplementum Pub Date : 2010-01-01 DOI: 10.3109/00365513.2010.493427

Wolfgang Koenig

{"title":"Integrating biomarkers: the new frontier?","authors":"Wolfgang Koenig","doi":"10.3109/00365513.2010.493427","DOIUrl":"https://doi.org/10.3109/00365513.2010.493427","url":null,"abstract":"Risk stratification for cardiovascular diseases (CVD) remains suboptimal even after the introduction of global risk assessment by various scores. This has prompted the search for additional biomarkers which might help to improve risk stratification. Basically, there are blood biomarkers representing various pathophysiological pathways of atherosclerosis, markers of subclinical disease, and potentially genetic markers. Since inflammatory processes accompany all stages of atherosclerosis, measurement of plasma/serum concentrations of circulating inflammatory biomarkers has received great attention. Such biomarkers can be measured systemically by sensitive assays and elevated concentrations in the circulation have been shown to be associated with future CVD events. Thus, they might add to the predictive value of the atherogenic lipoprotein phenotype to further improve CVD risk assessment. In addition, several non-invasive imaging techniques are available for which also a predictive value for CVD could be established, in particular measurement of the intima-media thickness of the carotid artery using high resolution ultrasound and measurements of coronary calcium by coronary computed tomography. However, for most of these biomarkers the clinical utility has not yet been firmly established. This applies even more to an integrated approach combining blood biomarkers and markers of subclinical disease. Thus, more data, preferably from serial measurements in large populations taking also into account new candidates from \"omics\" technology are needed to gain further insight in the potential clinical usefulness of an integrated approach.","PeriodicalId":76518,"journal":{"name":"Scandinavian journal of clinical and laboratory investigation. Supplementum","volume":"242 ","pages":"117-23"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3109/00365513.2010.493427","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29029719","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: 8