Abstract:
:ISO 15189's particular requirements for quality management in medical laboratories provide guidance for (a) relating performance specifications to the intended use of a test or examination procedure, (b) designing internal quality control (IQC) procedures to verify the attainment of the intended quality of test results, as well as (c) determining the uncertainty or results, where relevant and possible. This guidance has particular implications for analytical quality management, specifically for validating method performance relative to quality goals or requirements (intended use), designing statistical quality control procedures on the basis of the quality required for a test and the precision and bias observed for a method, and characterizing the quality achieved in practice by calculating measurement uncertainty. There already exists an error framework that provides practical tools and guidance for managing analytical quality, along with an existing concept of total error that can be used to characterize the quality of laboratory tests, thus there is considerable concern and debate on the merits and usefulness of measurement uncertainty. This paper argues that total error provides a practical top-down estimate of measurement uncertainty in the laboratory, and that the ISO/GUM model should be primarily directed to and applied by manufacturers.
journal_name
Clin Chem Lab Medjournal_title
Clinical chemistry and laboratory medicineauthors
Westgard JOdoi
10.1515/CCLM.2010.024subject
Has Abstractpub_date
2010-01-01 00:00:00pages
31-40issue
1eissn
1434-6621issn
1437-4331journal_volume
48pub_type
杂志文章abstract::Point-of-care testing (POCT) is the fastest growing segment of a US$30 billion worldwide market. "Errors" in the testing process, as well as medical data interpretation and treatment associated with POCT, are recognized as leading to major compromises of patient safety. In today's environment, most testing errors (pre...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2007.164
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Cost-impact models have indicated that in the USA, the use of antibiotic stewardship protocols based on procalcitonin (PCT) levels for patients with suspected acute respiratory tract infection results in cost savings. Our objective was to assess the cost impact of adopting PCT testing among patients with acu...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2016-0349
更新日期:2017-03-01 00:00:00
abstract::There is evidence that angiogenesis plays an important role in the progression of multiple myeloma (MM). Hepatocyte growth factor (HGF) and tumor necrosis factor-alpha (TNF-alpha) are cytokines that potently stimulate angiogenesis. We evaluated the microvascular density (MVD) of bone marrow biopsies (after immunostain...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2004.230
更新日期:2004-01-01 00:00:00
abstract::An increasing incidence of male infertility has been noted over the past few decades. This adds urgency to the need to develop immunohistochemical markers for better evaluation of testicular biopsies. We provide evidence that a histopathological evaluation performed according to morphological criteria and assisted by ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2002.036
更新日期:2002-03-01 00:00:00
abstract::Measurement of total homocysteine (tHcy) in healthy and diseased children has documented the utility of this marker in pediatric research and diagnostics. This article focuses on novel data obtained in infants, children and adolescents, with emphasis on cobalamin status in infants. In children, determinants of plasma ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2003.218
更新日期:2003-11-01 00:00:00
abstract:BACKGROUND:In recent years, fatty acid ethyl esters (FAEEs) and ethyl glucuronide (EtG) in meconium emerged as reliable, direct biological markers for establishing gestational ethanol exposure. We investigated whether EtG in maternal hair measured during the three trimesters of pregnancy correlated with EtG and FAEEs i...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2015-0516
更新日期:2016-03-01 00:00:00
abstract:BACKGROUND:Query fever (Q fever) is a zoonotic infection, caused by the intracellular Gram-negative coccobacillus Coxiella burnetii. From 2007 until 2010, a large Q fever outbreak has occurred in the Netherlands. We studied traditional and less common inflammation markers in seronegative and seropositive patients with ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2011-0810
更新日期:2012-02-04 00:00:00
abstract::The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) formed a Task Force on the Application of Cardiac Bio-markers (TF-CB) in 2008, re-designated in 2018 as a committee (C-CB), to produce educational materials on cardiac biomarkers. Established in June 2017, definitive tables covering the ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2018-1211
更新日期:2019-04-24 00:00:00
abstract:BACKGROUND:Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT) measurements are important for the assessment of liver damage. The aim of this study was to define the reference intervals (RIs) for these enzymes in adults, paying attention to standardization of the methods us...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,多中心研究
doi:10.1515/CCLM.2010.315
更新日期:2010-11-01 00:00:00
abstract:BACKGROUND:Cardiac troponin T (cTnT) has been reported to be a predictor of stroke outcome. We hypothesized that the high-sensitivity cTnT (hs-cTnT) assay is superior to its previous assay generation for stroke outcome prediction. METHODS:cTnT was measured on emergency department admission in 60 consecutive patients (...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2012-0176
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND:Improving quality and patient safety in the medical biochemistry laboratory accredited according to the International Standard Organization (ISO 15189:2012) requires the patient-centered evaluation of errors based on the implementation of quality indicators (QIs) across the total testing process. Our main go...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2016-0235
更新日期:2017-03-01 00:00:00
abstract:BACKGROUND:Crimean-Congo hemorrhagic fever (CCHF) is a public health problem in many countries. Chitotriosidase (ChT) is an enzyme secreted by activated macrophages that catalyzes the hydrolysis of chitin and chitin-like substrates. The goal of this study was to assess the relationship between serum ChT activity and mo...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2009.347
更新日期:2009-01-01 00:00:00
abstract::Background Direct oral anticoagulants (DOACs) may cause false results of activated protein C resistance (APC-R) ratio. DOAC-Remove, a new reagent based on activated carbon, has been designed to eliminate the interference of DOACs on coagulation assays. The aim of the study was to investigate whether the use of DOAC-Re...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2019-0650
更新日期:2020-02-25 00:00:00
abstract:BACKGROUND:Pleomorphic adenoma (PA) is a benign tumour of the salivary gland with a tendency to malignancy which creates many diagnostic problems. N-acetyl-beta-hexosaminidase (HEX) is a lysosomal exoglycosidase involved in degradation of oligosaccharide chains of glycoproteins, glycolipids and glycosaminoglycans, know...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2008.018
更新日期:2008-01-01 00:00:00
abstract::In the relatively short time frame since the introduction of next generation sequencing, it has become a method of choice for complex genomic research studies. As a paradigm shifting technology, we are now witnessing its translation into clinical diagnostic laboratories for patient care. Multi-gene panels for a variet...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2011-0841
更新日期:2011-12-23 00:00:00
abstract:BACKGROUND:Lysosphingolipids (LysoSLs) are derivatives of sphingolipids which have lost the amide-linked acyl chain. More recently, LysoSLs have been identified as storage compounds in several sphingolipidoses, including Gaucher, Fabry and Niemann-Pick diseases. To date, different methods have been developed to measure...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2016-0340
更新日期:2017-03-01 00:00:00
abstract::Drug-induced cardiotoxicity is a major clinical problem; cardiotoxic drugs may induce both cardiac dysfunction and myocardial injury. Several recent studies reported that cardiac troponins measured with high-sensitivity methods (hs-cTn) can enable the early detection of myocardial injury related to chemotherapy or abu...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2020-0566
更新日期:2020-08-26 00:00:00
abstract:BACKGROUND:Gilbert's syndrome is a common metabolic dysfunction characterized by elevated levels of unconjugated bilirubin in the bloodstream. This condition is usually caused by additional (TA) insertions in a promoter region of the uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) gene, which instead of the se...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2012-0656
更新日期:2013-06-01 00:00:00
abstract::Elevated plasma levels of angiotensin converting enzyme (ACE) are associated with granulomatous diseases. However, several families of autosomal dominant hyper-ACE-emia without disease association have already been reported. Recently, the ACE mutation c.3705C>T (Pro1199Leu) was identified as the genetic correlate in E...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2006.200
更新日期:2006-01-01 00:00:00
abstract::Despite substantial evidence indicating the association of hyperhomocysteinemia (hHcys) and end-stage renal disease (ESRD), the pathogenic role of increased plasma homocysteine (Hcys) levels in the progression of ESRD remains unclear. This review will briefly summarize recent findings regarding the role of hHcys in th...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2007.344
更新日期:2007-01-01 00:00:00
abstract::Primary hypertension is a very common disorder particularly in the aging population but hypertensive disorders can appear earlier in life, especially when obesity and unhealthy lifestyle are present. Also pregnant women can be at risk of developing gestational hypertension and/or pre-eclampsia, which causes complicati...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2013-0405
更新日期:2013-12-01 00:00:00
abstract::We have previously reported two novel mutations in the 5'-untranslated region (UTR) of the gene for folate receptor-alpha (FOLR1). In our search for additional mutations, 92 patient samples with elevated levels of homocysteine were screened by single-strand conformation polymorphism (SSCP) between nt -425 and -782, an...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2006.029
更新日期:2006-01-01 00:00:00
abstract::Two reverse transcription-polymerase chain reaction methods to detect the AML1/ETO rearrangement in the M2 subtype of acute myeloid leukaemia those of Downing et al. (Blood 1993; 81: 2860-5) and Satake et al. (Br J Haematol 1995; 91: 892-8) were evaluated. Bone marrow samples, one at diagnosis and two in complete remi...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1998.026
更新日期:1998-03-01 00:00:00
abstract:BACKGROUND:Recent studies have suggested that omentin-1 plays a critical role in the development of cardiovascular disease. However, reported findings are inconsistent, and no study has evaluated the association between omentin-1 levels and a poor functional outcome after ischemic stroke onset. METHODS:A total of 266 ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2017-0282
更新日期:2018-01-26 00:00:00
abstract::This article provides an overview of the role of metabolite toxicity, low-grade inflammation and disturbed cellular signaling in obesity, glucose intolerance and diabetes. It also highlights links between this continuum of deteriorating glucose tolerance and atherosclerosis. Obesity, diabetes mellitus, and cardiovascu...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2003.194
更新日期:2003-09-01 00:00:00
abstract::Venous blood sampling (phlebotomy) is the most common invasive procedure performed in patient care. Guidelines on the correct practice of phlebotomy are available, including the H3-A6 guideline issued by the Clinical Laboratory Standards Institute (CLSI). As the quality of practices and procedures related to venous bl...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2015-1089
更新日期:2016-07-01 00:00:00
abstract::Group II phospholipase A2 has been proposed to play an important role in the pathophysiology of inflammatory bowel diseases. This enzyme has also been linked to host defence mechanisms against bacteria. The current study aimed at measuring the mass concentrations of group II phospholipase A2 in serum and colonic mucos...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1998.133
更新日期:1998-10-01 00:00:00
abstract::Cryoglobulins are proteins that precipitate at temperatures below 37 degrees C. Cold-induced precipitation of proteins may occur in vivo secondary to several important diseases, and lead to pathological manifestations involving different organs. Cryoprecipitation may be observed in vitro by exposing serum samples, sup...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2003.025
更新日期:2003-02-01 00:00:00
abstract::The drug-metabolizing cytochrome P450 (CYP) enzyme CYP2D6 is involved in the metabolism of several clinically important drugs. So far more than 50 different CYP2D6 allelic variants have been described, and thus there is an increased need for routine high-performance liquid chromatography (HPLC) methods for the evaluat...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2005.046
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND:Highly-sensitive cardiac troponin (cTn) assays are being introduced into the market. In this study we argue that the classification of cTn assays into sensitive and highly-sensitive is flawed and recommend a more appropriate way to characterize analytical sensitivity of cTn assays. STUDY:The raw data of 225...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2013-0679
更新日期:2014-04-01 00:00:00