Abstract：
BACKGROUND:In patient and population samples, generation of analytical results that are comparable and independent of the measurement system, time, and location is essential for the utility of laboratory information supplied in healthcare. Obtaining analytical measurement results with such characteristics is the aim of traceability in laboratory medicine. As awareness of the benefits of having traceable measurement results has increased, associated efforts have been directed toward making traceability a regulatory requirement and developing approaches to enable and facilitate the implementation of traceability. Although traceability has been a main focus of many laboratory standardization activities in the past, discussions are still ongoing with regard to traceability and its implementation. CONTENT:This review provides information about the traceability concept and what needs can be fulfilled and benefits achieved by the availability of traceable measurement results. Special emphasis is given to the new metrological terminology introduced with this concept. The review addresses and describes approaches for technical implementation of traceable methods as well as the associated challenges. Traceability is also discussed in the context of other activities to improve the overall measurement process. SUMMARY:Establishing metrological traceability of measurement results satisfies basic clinical and public health needs, thus improving patient care and disease control and prevention. Large advances have been made to facilitate the implementation of traceability. However, details in the implementation process, such as lack of available commutable reference materials and insufficient resources to develop new reference measurement systems continue to challenge the laboratory medicine community.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Vesper HW,Thienpont LMdoi
10.1373/clinchem.2008.107052subject
Has Abstractpub_date
2009-06-01 00:00:00pages
1067-75issue
6eissn
0009-9147issn
1530-8561pii
clinchem.2008.107052journal_volume
55pub_type
杂志文章,评审abstract：:We evaluated "borderline" increases in overnight albumin excretion rates (AERs)----i.e., those between the upper 95th percentile of normal (7.6 micrograms/min) and the lowest value currently considered predictive of nephropathy (30 micrograms/min)----to determine their importance and to see whether glucose control inf...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1991-12-01 00:00:00
abstract：:We have compared the operational, medical, and fiscal consequences of performing urgent glucose testing at the bedside vs in the central laboratory. The turnaround time (TAT) with bedside testing was only 1-2 min shorter than that from the central laboratory, to which specimens are sent by pneumatic tube and from whic...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1994-08-01 00:00:00
abstract：BACKGROUND:Few data compare cardiac troponin T (cTnT) and cardiac troponin I (cTnI) in a general population. We sought to evaluate the distribution and association between cTnT, cTnI, and cardiovascular risk factors in a large general population cohort. METHODS:High-sensitivity cTnT and cTnI were measured in serum fro...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2018.292086
更新日期：2018-11-01 00:00:00
abstract：:To study the effect of fatty acid chain saturation on the fluorescence polarization assay as a measure of fetal lung maturity, we used purified phospholipids isolated from human amniotic fluid and various commercial phospholipids. We found that the fluorescence polarization value decreased as the concentration of unsa...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1986-03-01 00:00:00
abstract：:Methods are described for detection of lactate dehydrogenase (LDH) inhibitors in preparations of reduced nicotinamide adenine dinucleotide. They are (a) comparison of values by kinetic methods with those measured for highly purified NADH and (b) examination of Lineweaver-Burk plots. Chromatographic inhomogeneities are...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1976-10-01 00:00:00
abstract：BACKGROUND:Quantitative, miniaturized nucleic acid assays and immunoassays can be developed with single microparticles, microfluorometric detection, and intrinsically fluorescent lanthanide chelates in a multiple assay format to decrease reagent consumption, cost, and assay time. We used recombinant Fab fragments to ca...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：2000-11-01 00:00:00
abstract：:We describe a sensitive and precise gas-chromatographic method, in which cytosine is used as the internal standard, for determination of an antifungal agent, 5-fluorocytosine, in serum. The trimethylsilyl derivative of this drug is well separated from the internal standard and from normal serum constituents. Amphoteri...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1976-06-01 00:00:00
abstract：:Using a solid-phase monoclonal antibody enzyme immuno-assay, we evaluated in a multicenter study (18 laboratories) the utility of evaluating catalytic activity of human placental alkaline phosphatase (hPLAP, EC 3.1.3.1) in serum as a potential tumor marker. We determined hPLAP in serum samples from 130 patients with o...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-10-01 00:00:00
abstract：BACKGROUND:Our previously developed assay for detection of the factor V Leiden mutation (G1691A) based on a nucleic acid photo-cross-linking technology used two allele-specific capture probes and six fluorescein-modified signal-generating reporter probes. We wished to improve the sensitivity and performance of the meth...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2003.023556
更新日期：2004-02-01 00:00:00
abstract：:In this report on trace-element concentrations (As, Ca, Cd, Cl, Co, Cr, Cu, Fe, Hg, K, Mg, Mn, Mo, Na, Ni, Pb, Rb, Sb, Se, Zn) in human heart, liver, kidney, aorta, and rib obtained from 200 autopsied patients, we give special attention to sampling procedure, analysis technique, and various sources of error (autolysis...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1987-11-01 00:00:00
abstract：:We analyzed pancreatic enzyme data from 508 patients with suspected pancreatitis by neural network analysis, by an Expert multirule generation protocol, and by receiver-operator characteristic (ROC) curve analysis of a single test result. Neural network analysis showed that use of lipase provided the best means for di...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1993-09-01 00:00:00
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journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2005.061838
更新日期：2006-04-01 00:00:00
abstract：:A gas-chromatographic method for urinary organic acid analysis is described, designed to be used routinely for the diagnosis of organic aciduria. It involves extraction of urine with ethyl acetate, dehydration of extract residues, and trimethylsilylation. Organic acids are identified by using an extensive list of rete...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1980-12-01 00:00:00
abstract：:Light that penetrates scattering media shows nonlinearities that mask the broad and shallow perturbations made by trace analytes on the background illuminant spectrum. Narrow-band spectroscopic decomposition and deconvolution of such weak bands is a formidable analytical task that pushes the fundamentally linear spect...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1994-09-01 00:00:00
abstract：BACKGROUND:Noninvasive prenatal diagnosis of monogenic disorders using maternal plasma and targeted massively parallel sequencing is being investigated actively. We previously demonstrated that comprehensive genetic diagnosis of a Duchenne muscular dystrophy (DMD) patient is feasible using a single targeted sequencing ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2014.236380
更新日期：2015-06-01 00:00:00
abstract：:The diagnosis of thyroid disease now often can be achieved reliably by measuring thyrotropin (TSH) alone. Thyroxine (T4), triiodothyronine, and other analytes are only needed if TSH and the accompanying clinical condition are discordant. We describe here work that confirms the age independence of TSH in both inpatient...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1997-11-01 00:00:00
abstract：BACKGROUND:Insulin, growth hormone (GH), and growth factors (insulin-like growth factors [IGFs] and their binding proteins [IGFBPs]) are known to influence fetal growth and also the synthesis/secretion of the recently discovered hormones leptin and ghrelin. METHODS:In 153 delivering mothers and their offspring at birt...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2007.095299
更新日期：2008-03-01 00:00:00
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journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2003.023853
更新日期：2004-02-01 00:00:00
abstract：:Immunoradiometric analysis has made it possible to measure ferritin reliably in serum. The determination is a sensitive means of assessing body iron because concentrations of ferritin closely parallel the body's reticuloendothelial iron stores. The information provided is similar to that obtained from bone-marrow aspi...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1980-01-01 00:00:00
abstract：BACKGROUND:We describe a simple tetra-primer amplification refractory mutation system PCR (T-ARMS-PCR) for detecting MUTYH mutations, which are associated with colorectal adenomas and colorectal cancer. METHODS:We designed specific T-ARMS-PCR assays for 6 mutations (Y165C, G382D, 1395_7delGGA, Y90X, 1103delC, and R231...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2005.060137
更新日期：2006-04-01 00:00:00
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journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1977-12-01 00:00:00
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journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1980-06-01 00:00:00
abstract：:Erythrocyte protoporphyrin content is increased in several human and veterinary disorders in which heme synthesis is disrupted. The nature of the defect determines whether zinc protoporphyrin, unchelated (free) protoporphyrin, or both are present in the erythrocytes. Extraction of the protoporphyrin into acetone/water...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1981-02-01 00:00:00
abstract：:Diabetic patients in poor glycemic control show increased glycation of total plasma proteins, but little is yet known about the relative extents to which the various individual proteins are glycated. Thus, we studied the non-enzymic glycation of several major plasma proteins and plasma protein fractions in normal and ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1987-12-01 00:00:00
abstract：BACKGROUND:The hepatocyte-derived acute-phase reactant C-reactive protein (CRP) has been the subject of intense research over the last 2 decades for its possible role in the pathogenesis of cardiovascular diseases. This research has spawned interest in the use of the blood concentration of CRP for predicting a first co...
journal_title：Clinical chemistry
pub_type： 杂志文章,评审
doi：10.1373/clinchem.2008.115923
更新日期：2009-02-01 00:00:00
abstract：:I present the general pattern relationship between (a) plasma fibrinogen and cholinesterase activity and (b) plasma fibrinogen and hemoglobin, in 250 and 310 hospitalized adults, respectively. Although responses of cholinesterase were often unrelated to fibrinogen, when its activity in plasma was depressed, above-norm...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1977-01-01 00:00:00
abstract：BACKGROUND:Quantitative PCR of viral nucleic acids can be useful clinically in diagnosis, risk assessment, and monitoring of antiviral therapy. We wished to develop a chemiluminescence competitive PCR (cPCR) for parvovirus B19. METHODS:Parvovirus DNA target sequences and competitor sequences were coamplified and direc...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1999-09-01 00:00:00
abstract：:Use of immunoassays that do not detect endogenous digoxin-like immunoreactive factors (DLIF) in serum significantly improves the between-assay correlation of digoxin results for patients. We investigated five different immunoassay methods (Abbott, Clinical Assays, Corning, Du Pont, and Syva), measuring digoxin by all ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1987-06-01 00:00:00
abstract：:Creatinine and specific gravity (relative density) measurements both allow differences in urine concentration to be taken into account in determining urine cotinine concentrations. In this study we demonstrate that the variance of urine cotinine measurements is reduced comparably when either creatinine or specific gra...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1994-04-01 00:00:00
abstract：BACKGROUND:Plasma concentrations of small dense (sd)-LDL are associated with the prevalence of cardiovascular events. However, the special equipment and long assay times required for sd-LDL measurement have hindered its clinical application. Herein, we report development of a simple homogeneous assay for sd-LDL-cholest...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2010.149559
更新日期：2011-01-01 00:00:00
