Abstract:
BACKGROUND:External quality assessment/proficiency test (EQA/PT) organizers play an important role in monitoring the performance of HbA1c measurements. With increasing quality of the assays, HbA1c is increasingly used for diagnosis of diabetes and the demands on EQA/PT organizers themselves are rising constantly. EQA organizers in Germany (INSTAND), Belgium (WIV/IPV), and the Netherlands (SKML) organized a program with commutable samples and target values assigned with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference system. The aim of this project was to confirm the logistic feasibility of organizing synchronically in the three countries, an accuracy-based EQA program with fresh whole blood, to investigate the performance of HbA1c assays within and across countries and manufacturers, and to review the EQA acceptance limits. METHODS:Throughout 2015, ten fresh whole blood samples were supplied to the participants. Aggregated results were evaluated according to the IFCC model for quality targets at four levels: overall, per country, per manufacturer, and per country per manufacturer. RESULTS:Robust results in summer and winter demonstrated the feasibility of organizing an EQA with fresh whole blood samples in three countries. The overall performances, as well as the performance for each country were very similar: results fell within the IFCC criteria. Although substantial differences between results from different manufacturers were present, the performances of laboratories using tests of the same manufacturer were strikingly similar in the three countries, suggesting that the quality of HbA1c assays is for the most part manufacturer- related. The improved design of the EQA program also suggested that acceptance limits for performance can be reduced to approximately 8%.
journal_name
Clin Chem Lab Medjournal_title
Clinical chemistry and laboratory medicineauthors
Kaiser P,Spannagl M,van Campenhout C,Lenga Y,Siebelder C,Weykamp Cdoi
10.1515/cclm-2016-0123subject
Has Abstractpub_date
2016-11-01 00:00:00pages
1769-1775issue
11eissn
1434-6621issn
1437-4331pii
/j/cclm.ahead-of-print/cclm-2016-0123/cclm-2016-01journal_volume
54pub_type
杂志文章abstract::Translational research and translational medicine (referred to hereafter as translational research) are interchangeable terms that underline the pressing need to translate into practical benefits for those affected by disease the extensive investments divested by the private and public sectors in biomedical research. ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2006.238
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:Placental protein-13 (PP13) is involved in placental invasion and has been suggested as a maternal serum marker of preeclampsia (PE) development. However, the discriminatory ability of PP13 in first trimester has not been completely clarified. METHODS:PP13 was measured in first trimester (week 10+3-13+6) ma...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2017-0356
更新日期:2017-11-27 00:00:00
abstract::Both technological advances and economic drivers have led to major changes in clinical laboratories across the world, with vastly improved testing productivity. However, the production process capability advances have far outpaced the clinical pathologists' success in assuring optimal test utilization and interpretati...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2010.194
更新日期:2010-07-01 00:00:00
abstract:BACKGROUND:Whereas N-terminal pro-brain natriuretic peptide (NT-proBNP) is approved for risk stratification of patients with acute coronary syndromes (ACS), short-term temporal changes in NT-proBNP concentrations and the optimal time points for sampling are not clear. The purpose of this study was to better define the ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2010.164
更新日期:2010-06-01 00:00:00
abstract::It has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%-68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recom...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,实务指引
doi:10.1515/cclm-2016-0426
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:Chronic atrophic gastritis (CAG) is a precursor of the intestinal type of gastric cancer, the second leading cause of cancer-related death worldwide. GastroPanel is a recently marketed serological kit for the non-invasive diagnosis of CAG, defined by some authors "even more reliable than biopsy histology". T...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2010.256
更新日期:2010-09-01 00:00:00
abstract::The variability of the tumor markers cancer antigen (CA) 15.3, carcinoembryonic antigen (CEA) and tissue polypeptide antigen (TPA) during steady state concentrations and the rate of increase during progression is described. One hundred and ninety-two patients were monitored during first-line chemotherapy for metastati...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2000.066
更新日期:2000-05-01 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::The recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,实务指引
doi:10.1515/cclm-2015-0257
更新日期:2015-07-01 00:00:00
abstract:BACKGROUND:Increased homocysteine (Hcy) blood levels are correlated with vascular and neurological problems. AIM:The aim of the present study was to investigate erythrocyte membrane acetylcholinesterase (AChE) activity in subjects with the MTHFR C677T genotype in relation to Hcy. METHODS:Blood was obtained from 22 in...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2006.005
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:The usefulness of serum antibodies to common food antigens (immunoglobulin G4; IgG4) assay in management of patients suffering from food intolerance was assessed. METHODS:A total of 22 asymptomatic healthy subjects and 68 patients with symptoms referred for suspected food intolerance were studied. Serum IgG...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm.2008.131
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:The differential diagnosis between bacterial and viral meningitis is not easy in some cases. Cerebrospinal fluid (CSF) analysis is essential for establishing this diagnosis. The objectives were to quantitate lactic acid (LA) concentrations in bacterial and viral meningitis, and other central nervous system (...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2009.160
更新日期:2009-01-01 00:00:00
abstract::Choroid plexus has the highest concentration of transthyretin (TTR) mRNA in the body, 4.4 microg TTR mRNA/g wet weight tissue, compared with 0.39 microg in the liver. The proportion of TTR to total protein synthesis in choroid plexus is 12%. All newly synthesized TTR is secreted towards the ventricles. Net transfer of...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2002.210
更新日期:2002-12-01 00:00:00
abstract::Gastric juice is known to have phospholipase A2 catalytic activity. Helicobacter pylori (H. pylori) has been reported to produce phospholipase A2, which is believed to hydrolyse the protective layer of gastric mucosal phospholipids and to promote mucosal damage. The current study aimed at identifying secretory phospho...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 临床试验,杂志文章
doi:10.1515/CCLM.1999.009
更新日期:1999-01-01 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::We estimated the frequencies of phenotype (isoelectric focusing; IEF) vs. genotype (PCR/Hhal) discordance in a sample of an aged population (> 65 years). Both phenotype and genotype techniques have been used in the study of apolipoprotein E (apoE) polymorphism in 125 elderly subjects. The discordance between phenotype...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2001.065
更新日期:2001-05-01 00:00:00
abstract::Although affinity and kinetic measurements on their own provide useful information regarding the suitability of antibodies for various immunoassays, a thermodynamic analysis provices additional information that throws light on the molecular forces at work in the antigen-antibody interaction. It may then be possible to...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1998.059
更新日期:1998-06-01 00:00:00
abstract:BACKGROUND:The circulating levels of plasminogen activator inhibitor type 1 (PAI-1) are increased in individuals carrying the 4G allele at position -675 of the PAI-1 gene. In turn, overexpression of PAI-1 has been found to affect both atheroma and thrombosis. However, the association between PAI-1 levels and the incide...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,meta分析
doi:10.1515/cclm-2013-1124
更新日期:2014-07-01 00:00:00
abstract:BACKGROUND:Electrospray ionization mass spectrometry (ESI-MS) can be used for the measurement of glycated adult hemoglobin. Here, we describe the evaluation of ESI-MS for measurement of glycated (GHbF) and acetylated (AcHbF) fetal hemoglobin and the identification by mass of different chains of fetal hemoglobin. METHO...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2008.257
更新日期:2008-01-01 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:BACKGROUND:Surface-enhanced laser desorption and ionization time-of-flight mass spectrometry (SELDI-TOF/MS), a laboratory-friendly technique, is used to identify biomarkers for cancer. The aim of the present study was to explore the application of SELDI proteomic patterns in serum for distinguishing between cases of pa...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2009.158
更新日期:2009-01-01 00:00:00
abstract::The availability of so-called high-sensitivity troponin assays (hsTn) has scored a compelling goal for laboratory medicine, allowing the safe clinical application of international recommendations for the definition of acute myocardial infarction (AMI). However, the introduction of hsTn has not been welcomed by clinici...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2014-0812
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND:Prostate-specific antigen (PSA) is used as an outcome measure for relapsed disease in prostate cancer. Nonetheless, there are considerable concerns about its indiscriminate use as a surrogate endpoint for cell growth or survival. We hypothesized that treatment with a luteinizing hormone releasing hormone (LH...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2013-0535
更新日期:2014-03-01 00:00:00
abstract:BACKGROUND:The presence of fibronectin fragments has been observed in some inflammatory diseases and is believed to reflect tissue breakdown. In this study, possible fibronectin fragmentation and alterations in its domain and sialyl and fucosyl glycotope expressions were analyzed in amniotic fluids in relation to intra...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2007.041
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Cystatin C (CST3), a strong inhibitor of cysteine proteinases, is freely filtered by the kidney glomerulus and is reabsorbed by the tubules, where it is almost totally catabolized, with the remainder then eliminated in urine. In tubular diseases, it seems sensible to postulate that CST3 degradation would be ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2006.050
更新日期:2006-01-01 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
doi:10.1515/cclm-2020-0419
更新日期:2020-10-25 00:00:00
abstract:BACKGROUND:International recommendations highlight the superior value of cardiac troponins (cTns) for early diagnosis of myocardial infarction along with analytical requirements of improved precision and detectability. In this multicenter study, we investigated the analytical performance of a new high sensitive cardiac...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,多中心研究
doi:10.1515/cclm-2014-0107
更新日期:2014-11-01 00:00:00
abstract:BACKGROUND:The timely detection of severe inflammatory conditions is of great importance for early therapy initiation and the patient's prognosis. The complex humoral and cellular processes involved in inflammation offer many opportunities for diagnostic testing, which are still unused in clinical practice. We investig...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2014-0482
更新日期:2015-03-01 00:00:00
abstract::The concentration of leukocyte elastase/alpha1-proteinase inhibitor complexes in plasma and polymorphonuclear neutrophil extracts, and plasma trypsin inhibitory capacity were determined in 88 patients with type 2 diabetes and 47 control subjects. Higher values of these variables were found in patients as compared to c...
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:BACKGROUND:The pathogenesis of pre-eclampsia (PE) is incompletely understood. The placenta is considered to play a key role in this disease. Recent research showed that many microRNAs (miRNAs) are expressed in human placenta. Our aim in this study was to determine differential expression of miRNAs in placenta with seve...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2009.228
更新日期:2009-01-01 00:00:00