Abstract:
:Evidence of the acute lack of interchangeable laboratory results and consensus in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus is mainly on the standardization of measurement procedures, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference intervals and decision limits, as well as test profiles and criteria for the interpretation of results. This review provides further insight on the issue of harmonization in laboratory medicine in view of the urgent need for a complete picture now that old and new drivers are calling for more effective efforts in this field. The main drivers for standardization and harmonization projects are first and foremost patient safety, but also the increasing trends towards consolidation and networking of clinical laboratories, accreditation programs, clinical governance, and advances in Information Technology (IT), including the electronic patient record. The harmonization process, which should be considered a three-tier approach involving local, national and international fronts, must go beyond the harmonization of methods and analytical results to include all other aspects of laboratory testing. A pertinent example of the importance of a complete picture in harmonization programs is given by the National Bone Health Alliance working in the field of bone turnover markers in cooperation with scientific societies including the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).
journal_name
Clin Chem Lab Medjournal_title
Clinical chemistry and laboratory medicineauthors
Plebani Mdoi
10.1515/cclm-2013-0075subject
Has Abstractpub_date
2013-04-01 00:00:00pages
741-51issue
4eissn
1434-6621issn
1437-4331pii
/j/cclm.ahead-of-print/cclm-2013-0075/cclm-2013-00journal_volume
51pub_type
杂志文章,评审abstract:BACKGROUND:To date, no practical tools are available to obtain optimal settings for moving average (MA) as a continuous analytical quality control instrument. Also, there is no knowledge of the true bias detection properties of applied MA. We describe the use of bias detection curves for MA optimization and MA validati...
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更新日期:2017-02-01 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
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journal_title:Clinical chemistry and laboratory medicine
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更新日期:2001-08-01 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
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journal_title:Clinical chemistry and laboratory medicine
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doi:10.1515/cclm-2015-0603
更新日期:2016-04-01 00:00:00
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doi:10.1515/CCLM.2005.121
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2008.040
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:The plasma total and low-density lipoprotein-cholesterol (LDL-C) levels that are used as diagnostic criteria for familial hypercholesterolaemia (FH) probands in the general population are too stringent for use in relatives, given the higher prior probability of a first-degree relative being FH (50% vs. 1/500...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2008.135
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Measurement of late-night salivary cortisol concentrations is increasingly used as a screening test in suspected Cushing's syndrome. Cortisol concentrations are typically extremely low in late-night samples and discordant assay-specific reference ranges have been reported. Therefore, the aim of our study was...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2006.244
更新日期:2006-01-01 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2005.197
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND:Exosomes are cytoplasm containing vesicles released by many cells that can be found in several biological fluids including urine. Urinary exosomes are released from every segment of the nephron, are detectable in urine, constitutively contain RNA (small RNAs and mRNAs) and harbor unique subset of proteins, r...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2013-0562
更新日期:2014-03-01 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1999.098
更新日期:1999-06-01 00:00:00
abstract:BACKGROUND:Neutrophil gelatinase-associated lipocalin (NGAL) has been suggested as the most promising biomarker of acute kidney injury. However, there are no reliable data on analytical sensitivity and reference limits of urinary NGAL (uNGAL) assay in pediatric age. The aim of the present study is to evaluate the analy...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2012-0540
更新日期:2013-05-01 00:00:00
abstract::Quality in diagnostic testing represents a key target of laboratory medicine, for which an assurance around the quality of testing is expected from all involved in the process. Laboratories attempt to assure the quality of their testing by various processes, but especially by performance of internal quality control an...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2018-0077
更新日期:2018-12-19 00:00:00
abstract:BACKGROUND:Accurate outcome prediction in gastroesophageal malignancies is challenging. Acute-phase response proteins (APRPs) have been claimed to be independent prognosticators, although the basis for their association with prognosis remains unexplained. We hypothesized that, similarly to pancreatic and lung cancers, ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2008.089
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:The Sysmex DI-60 system (DI-60, Sysmex, Kobe, Japan) is a new automated digital cell imaging analyzer. We explored the performance of DI-60 in comparison with Sysmex XN analyzer (XN, Sysmex) and manual count. METHODS:In a total of 276 samples (176 abnormal and 100 normal samples), white blood cell (WBC) dif...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2017-0132
更新日期:2017-11-27 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2011.779
更新日期:2011-11-10 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2000.188
更新日期:2000-11-01 00:00:00
abstract::Objectives Cerebrospinal fluid (CSF) is a clear, colorless body fluid filling the central nervous system. The determination of the CSF total protein (TP) content represents an important screening test of various pathologies. We aimed to address the effect of sex and age on CSF-TP content and the use of the current upp...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
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更新日期:2020-10-25 00:00:00
abstract:BACKGROUND:The VU University Medical Center (VUmc) was the first hospital in the Netherlands to introduce the Delfia Xpress for the analysis of free beta-human chorionic gonadotrophin (beta-hCG) and pregnancy associated plasma protein-A (PAPP-A) in the first trimester screening program for Down syndrome. Since then, ot...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2009.042
更新日期:2009-01-01 00:00:00
abstract::Background The present study was undertaken to evaluate the clinical impact of a thyroglobulin (Tg) minirecovery test (Tg-mRec) in a large series of differentiated thyroid carcinoma (DTC) patients treated and monitored homogeneously in a tertiary referral center. Methods Included were 1120 serum samples from 798 DTC p...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2018-1390
更新日期:2019-07-26 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2003.106
更新日期:2003-05-01 00:00:00
abstract:BACKGROUND:It has been proposed that only anti-thyroid-peroxidase (TPOAb) and not anti-thyroglobulin (TgAb) antibodies should be assayed in the diagnosis of autoimmune thyroid disease (AITD). METHODS:We analyzed the thyroid autoantibody profile with a multiplex bead array system, which allows simultaneous measurement ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2006.137
更新日期:2006-01-01 00:00:00
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pub_type: 杂志文章
doi:10.1515/CCLM.2010.255
更新日期:2010-09-01 00:00:00
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journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2000.198
更新日期:2000-12-01 00:00:00
abstract::Early diagnosis of cobalamin deficiency is crucial, owing to the latent nature of this disorder and the resulting possible irreversible neurological damage. A normal serum cobalamin concentration does not reliably rule out a functional cobalamin deficiency and there does not at present seem to be any single diagnostic...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 临床试验,杂志文章
doi:10.1515/CCLM.2004.109
更新日期:2004-01-01 00:00:00