Abstract:
BACKGROUND:Serum free light chain (sFLC) measurements are increasingly important in the context of screening for monoclonal gammopathies, prognostic stratification, and monitoring of therapy responses. At the same time, analytical limitations have been reported with the currently available nephelometric and turbidimetric sFLC assays. We have evaluated a new quantitative sFLC ELISA for its suitability in routine clinical use. METHODS:Reference ranges of the Sebia FLC assay were calculated from 208 controls. Assay interference, reproducibility, lot-to-lot variability, and linearity were assessed. Method comparison to the Freelite assay (Binding Site) was conducted by retrospective analysis of 501 patient sera. RESULTS:Reference ranges of the Sebia κ/λFLC-ratio were 0.37-1.44. We observed good sensitivity (1.5 mg/L) and linearity in both polyclonal and monoclonal sFLC samples and never experienced antigen excess. Sebia FLC reproducibility varied between 6.7% and 8.1% with good lot-to-lot consistency. Method comparison with Freelite showed the following correlations: κFLC R=0.94, λFLC R=0.92 and κ/λFLC-ratio R=0.96. The clinical concordance of the κ/λFLC-ratio of both methods was 94%. Significant quantitative differences were observed between both methods, mainly in sera with high FLC concentrations. The Sebia monoclonal FLC concentrations were coherent with those obtained by serum protein electrophoresis (SPE). Freelite monoclonal FLC concentrations were consistently higher, with a mean 12-fold overestimation compared to SPE. CONCLUSIONS:The Sebia FLC assay provides a novel platform for sensitive and accurate sFLC measurements. The Sebia FLC showed good clinical concordance with Freelite. Further studies are warranted to confirm the clinical value of this assay.
journal_name
Clin Chem Lab Medjournal_title
Clinical chemistry and laboratory medicineauthors
Jacobs JFM,de Kat Angelino CM,Brouwers HMLM,Croockewit SA,Joosten I,van der Molen RGdoi
10.1515/cclm-2017-0339subject
Has Abstractpub_date
2018-01-26 00:00:00pages
312-322issue
2eissn
1434-6621issn
1437-4331pii
/j/cclm.ahead-of-print/cclm-2017-0339/cclm-2017-03journal_volume
56pub_type
杂志文章abstract:BACKGROUND:The clinical relevance of chromogranin A (CgA) concentrations depends on the analytical performance of the assay. The goal of the present study was to define the clinical involvements in CgA calibration models by evaluating the confidence intervals (CIs) for values from patients who were undergoing monitorin...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2009.278
更新日期:2009-01-01 00:00:00
abstract::Molecular diagnostics is one of the most rapidly growing areas of laboratory medicine. This rapid growth of clinical molecular tests has outpaced the availability and development of reference methods and reference materials. Such methods and materials are important for the development, validation, and interpretation o...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2010.313
更新日期:2010-11-01 00:00:00
abstract::The erythrocyte sedimentation rate (ESR), now more appropriately referred to as the "length of sedimentation reaction in blood (LSRB)", remains the most widely used laboratory test for monitoring the course of infections, inflammatory diseases and some types of cancer. Thanks to the several recently developed methods ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2002.123
更新日期:2002-07-01 00:00:00
abstract:BACKGROUND:Mutations in BRCA1 and BRCA2 genes are associated with family predisposition to breast and ovarian cancer. Novel screening methods are required for efficient and rapid detection of sequence variants in cancer patients and their family members. METHODS:The screening for variants in the breast and ovarian can...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2008.307
更新日期:2008-01-01 00:00:00
abstract::Primary biliary cholangitis (PBC), also known as primary biliary cirrhosis, is an autoimmune disease of the liver characterized by anti-mitochondrial antibodies (AMA) in 90%-95% of patients. The aim of this study was to evaluate the diagnostic value of several serum biomarkers in patients with PBC but negative for AMA...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2017-0249
更新日期:2017-11-27 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:BACKGROUND:The Schwartz 2009 creatinine-based revised formula is the only pediatric GFR estimating formula, which is compatible with the recent global creatinine standardization. This formula is only applicable if enzymatic creatinine methods are used. We propose an equation, taking into account the relative bias cause...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2012-0033
更新日期:2012-03-09 00:00:00
abstract::The aim of this study was to clarify the effects of anti-dsDNA antibodies on the titer and the nuclear staining pattern(s) in a fluorescent antinuclear antibody (FANA) assay using HEp-2 cells. Anti-dsDNA derived from 14 patients with systemic lupus erythematosus (SLE) was individually affinity-purified. The anti-dsDNA...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2002.009
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND:Gestational age-specific reference values are essential for the accurate interpretation of haemostatic tests during pregnancy. METHODS:Our 1-year prospective study included 40 healthy pregnant women with a median age of 30 (range 22-40) years; the subjects were followed in order to establish the gestational...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2014-1030
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:Serum amino acids, part of a pool of free amino acids, are influenced by metabolism and disease. Few reports exist describing their function and concentrations in serum. Our study aimed to determine age- and gender-related differences in serum amino acid concentrations in healthy Japanese patients, focusing ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2011-0846
更新日期:2012-01-04 00:00:00
abstract:BACKGROUND:Apolipoprotein E (APOE) and choline acetyltransferase (ChAT) have been suggested as candidate genes for determining the risk of late-onset Alzheimer's disease. The aim of this study was to simultaneously detect polymorphisms in codons 112 and 158 of APOE and codon 2 of ChAT by hybridization probe multiplexin...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2007.075
更新日期:2007-01-01 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:BACKGROUND:This paper describes the evolution, structure, operation and some outcomes of the Brazilian Laboratory Indicators Program created by the Brazilian Society of Clinical Pathology/Laboratory Medicine (Sociedade Brasileira de Patologia Clínica/Medicina Laboratorial, or SBPC/ML), in partnership with ControlLab, a...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2012-0357
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND:The Intermountain Mortality Risk Score (IMRS), a sex-specific mortality-prediction metric, has proven to be effective in various populations. IMRS is comprised of the complete blood count (CBC), basic metabolic panel (BMP), and age. Whether the addition of factors from the comprehensive metabolic panel (CMP)...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2015-1258
更新日期:2016-10-01 00:00:00
abstract::There is some evidence from recent observational studies that hyperhomocysteinemia is a risk factor for cognitive dysfunction, including Alzheimer's disease and vascular dementia. There are only a few intervention studies, and the results are disappointing for such a frequent disease. Prospective double-blind and plac...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2001.119
更新日期:2001-08-01 00:00:00
abstract::The importance of nutrition factors such as calcium, vitamin D and vitamin K for the integrity of the skeleton is well known. Moreover, bone health is positively influenced by certain elements (e.g., zinc, copper, fluorine, manganese, magnesium, iron and boron). Deficiency of these elements slows down the increase of ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2012-0868
更新日期:2013-08-01 00:00:00
abstract::Severe thermal injury causes an immune dysfunction which includes a decrease of monocyte human leukocyte antigen DR (HLA-DR) expression. Interleukin-10 exerts a negative influence on this parameter in vitro. In this study we determined the prognostic value of reduced monocyte HLA-DR expression with regard to infectiou...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1999.036
更新日期:1999-03-01 00:00:00
abstract::Cardiovascular risk is associated with high lipoprotein(a) (Lp(a)) concentrations and low molecular weight apolipoprotein(a) (apo(a)) isoforms. We studied the relationship between these two biological parameters, particularly in subjects expressing two apo(a) isoforms. Plasma Lp(a) was measured by immunonephelometry i...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2003.096
更新日期:2003-05-01 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::Transferrin concentration and total iron binding capacity (TIBC) are currently used to assess iron status. Although correlation between TIBC and transferrin is generally considered as good, conversion factors between the two analytes found in literature show large differences. Although the price per test is lower for ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2002.176
更新日期:2002-10-01 00:00:00
abstract:BACKGROUND:The compatibility of immunoassay tests in different sample matrices is extremely important during the assay validation process. In this study, we investigated the interchangeability of some Access (and therefore all the UniCel Family platforms) assays between serum and plasma. METHODS:We tested approximatel...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2008.032
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Procalcitonin (PCT) is increasingly being used for the diagnostic and prognostic work up of patients with suspected infections in the emergency department (ED). Recently, B·R·A·H·M·S PCT direct, the first high sensitive point-of-care test (POCT), has been developed for fast PCT measurement on capillary or ve...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,多中心研究
doi:10.1515/cclm-2015-0437
更新日期:2016-04-01 00:00:00
abstract::Total prostate-specific antigen (PSA) and complexed PSA were determined in venous blood from 12 patients with prostate cancer before and after radical prostatectomy by using Immuno 1 PSA assays. The elimination kinetics of complexed PSA were compared with that of total PSA. Nearly constant concentrations of complexed ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2000.044
更新日期:2000-04-01 00:00:00
abstract:BACKGROUND:The goal of this study was to detect modification in the expression of plasma proteins and/or post-translational modifications of their structure in patients with end stage renal disease. METHODS:Serum samples from 19 adult patients treated by maintenance hemodialysis (MHD) were analyzed in comparison to se...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2009.303
更新日期:2009-01-01 00:00:00
abstract::The term "clinical proteomics" refers to the application of available proteomics technologies to current areas of clinical investigation. The ability to simultaneously and comprehensively examine changes in large numbers of proteins in the context of disease or other changes in physiological conditions holds great pro...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2003.239
更新日期:2003-12-01 00:00:00
abstract:BACKGROUND:An effective quality control (QC) program requires the establishment of control limits within which the results of the QC sample is expected to fall. Traditionally, the mean plus/minus two standard deviations calculated for a set of QC sample results is used to establish control limits. Allowable total error...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2014-0546
更新日期:2015-02-01 00:00:00
abstract::Portable meters for blood glucose concentrations are used at the patients bedside, as well as by patients for self-monitoring of blood glucose. Even though most devices have important technological advances that decrease operator error, the analytical goals proposed for the performance of glucose meters have been rece...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2005.147
更新日期:2005-01-01 00:00:00
abstract::Neopterin is elevated in infections, autoimmune diseases and post-transplant. Recently neopterin elevation was linked to stress response and malignancy. To determine early changes of serum neopterin caused by surgical stress and to investigate their association with other inflammatory markers and with malignancy, we m...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2002.113
更新日期:2002-07-01 00:00:00
abstract:BACKGROUND:Aging is the result of several mechanisms which operate simultaneously. Among them, glycation is of particular interest because it is a reaction which affects slowly renewing tissues and macromolecules with elevated half-life, like the dermis, a skin compartment highly affected by aging. Glycation produces c...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2013-0091
更新日期:2014-01-01 00:00:00
abstract:BACKGROUND:Despite remarkable advances in technology and laboratory automation, results of laboratory testing still suffer from a high degree of preanalytical variability. Although there is no definitive evidence, the use of small-gauge needles for venipuncture is usually discouraged to reduce the chance of producing u...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2006.172
更新日期:2006-01-01 00:00:00