Abstract：
:Biological variation is inherent in all medical tests and is a major source of error in clinical test interpretation. We use inherent test error due to biological variability as the touchstone by which to validate the clinical acceptability of analytical goals. Analytical goals should consist of sets of complementary limits for total error, bias, and imprecision and a medical usefulness criterion (MUC) to ensure that the total error goal is met with stated certainty. We propose analytical goals that are limits for the total error of a measurement system, the joint capability of the process control procedures and the measurement process. Thus, the goals are the allowable analytical error for proficiency evaluation, internal process control, and the total error budget for design of method performance characteristics. We define MUC as the allowable maximum proportion of test diagnostic efficiency lost due to analytical error near medical decision points. MUCs < 0.03 are not routinely clinically useful; MUCs > 0.08 allow method performance characteristics that are undesirable for general clinical use. Using MUC = 0.05 and recommendations that imprecision not exceed one-half of the biological CV, we propose that fixed bias should not exceed one-fourth to one-third of the intraindividual biological CV of the analyte and that total analytical error should not exceed 1.25 to 1.40 times the biological CV. Modification of these analytical goals may arise for reasons of documented clinical practice or process stability. Our model quantifies in medical utility terms the results of such modifications.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Ross JW,Fraser MDsubject
Has Abstractpub_date
1993-07-01 00:00:00pages
1481-93; discussion 1493-4issue
7eissn
0009-9147issn
1530-8561journal_volume
39pub_type
杂志文章,评审abstract：:In response to the pressures of cost reduction, we established and evaluated a carefully integrated program to deliver clinical laboratory services more promptly and efficiently to the intensive care units (ICUs). The new protocol reduced the steps and turnaround time from ordering tests by physicians to reporting res...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1996-03-01 00:00:00
abstract：BACKGROUND:Lectin-like oxidized LDL receptor 1 (LOX-1) is implicated in atherothrombotic diseases. Activation of LOX-1 in humans can be evaluated by use of the LOX index, obtained by multiplying the circulating concentration of LOX-1 ligands containing apolipoprotein B (LAB) times that of the soluble form of LOX-1 (sLO...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2009.140707
更新日期：2010-04-01 00:00:00
abstract：BACKGROUND:Several plasma proteins have been suggested as markers for a variety of cardiovascular conditions but fail to qualify in independent patient cohorts. This may relate to interference of medication on plasma protein concentrations. We used proteomics to identify plasma proteins that changed in concentration wi...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2017.282665
更新日期：2018-10-01 00:00:00
abstract：:Estrogen receptor (ER) and progestin receptor (PR) concentrations in tumor biopsies are important predictive indicators of a clinical response to endocrine therapy of breast cancer. To assess interference of O.C.T. (optimum cutting temperature) embedding compound in assays of ER and PR by radioligand binding, we deter...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1989-12-01 00:00:00
abstract：:In the present clinical evaluation of Triage immunoassay for detection of drugs of abuse, we examined a possible connection between the laboratory skills of the personnel using it and the quality of analytical results; we also evaluated the degree of concordance between the Triage results and those obtained by an inst...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1996-09-01 00:00:00
abstract：BACKGROUND:Several compounds in the choline oxidation pathway are associated with insulin resistance and prevalent diabetes; however, prospective data are scarce.We explored the relationships between systemic and urinary choline-related metabolites and incident type 2 diabetes in an observational prospective study amon...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2015.250761
更新日期：2016-05-01 00:00:00
abstract：:Autocorrelation of clinical chemistry quality-control (Q/C) measurements causes one of the basic assumptions underlying the use of Levey-Jennings control charts to be violated and performance to be degraded. This is the requirement that the observations be statistically independent. We present a proposal for a new app...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-07-01 00:00:00
abstract：:We compared the performance of three methods for quantifying high-density lipoprotein cholesterol (HDL-C) with the Reference Method for HDL-C, using samples with a wide range of triglyceride (TG) concentrations (290-18000 mg/L). All three comparison assays-- utilizing a magnetic dextran sulfate precipitating reagent, ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1996-05-01 00:00:00
abstract：:We divided patients with brain lesions into three groups: (a) patients with primary or metastatic brain cancer, (b) brain infarctions, and (c) brain contusion(s). We analyzed each patient's sera for creatine kinase isoenzyme BB (CK-BB), using a monoclonal antibody kit (Impres-BB; International Immunoassay Laboratories...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1989-04-01 00:00:00
abstract：BACKGROUND:Test repetition could be a readily modifiable component of laboratory utilization. Laboratory test repetition has not been rigorously studied at a population-based level. Our objective was to determine the prevalence of, and charges associated with, repetition of eight common laboratory tests. METHODS:We pe...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2003.021220
更新日期：2003-12-01 00:00:00
abstract：:We describe a simple and convenient method for processing small amounts of tissue samples for trace-metal measurements by atomic absorption spectrometry, by use of a modified Parr microwave digestion bomb. Digestion proceeds rapidly (less than or equal to 90 s) in a sealed Teflon-lined vessel that eliminates contamina...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1989-03-01 00:00:00
abstract：:We describe a time-resolved immunofluorometric assay (IFMA) for corticotropin in unextracted human plasma, based on the use of two monoclonal antibodies: europium-labeled antibody 1A12 and antibody 2A3 coated onto microtiter wells. We compared the results of this assay with those of an immunoradiometric assay (IRMA) p...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1987-10-01 00:00:00
abstract：BACKGROUND:Endothelin-1 (ET-1), a potent vasoconstrictor, is difficult to measure because of its instability and its binding to receptors and plasma proteins. We report a rapid, robust way to indirectly quantify ET-1 release by measuring the C-terminal ET-1 precursor fragment (CT-proET-1) without an extraction step. M...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2005.065581
更新日期：2006-06-01 00:00:00
abstract：:Urinary polyamines were measured by a fluorometric thin-layer chromatographic technique in samples collected daily throughout a single menstrual cycle by each of 13 healthy women. Polyamine excretion fluctuated considerably, but excretion of putrescine, spermidine, and spermine combined was consistently greatest durin...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1978-05-01 00:00:00
abstract：BACKGROUND:To address the continuing need for the standardization of clinical human cardiac troponin I (cTnI) assays, NIST, with the assistance of the AACC/IFCC Cardiac Troponin I Standardization Committee, has developed a new certified reference material, Standard Reference Material (SRM) 2921: Human Cardiac Troponin ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2005.051359
更新日期：2006-02-01 00:00:00
abstract：:Measurement of serum ascorbate may be useful in long-term population studies because of the possible influence of ascorbate on numerous physiological factors. We describe an automated method for determining ascorbate in serum and urine by using the reduction of ferric iron by ascorbate and the formation of a color bet...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1975-09-01 00:00:00
abstract：:We describe a procedure for measuring dialyzable calcium in 60 sera per hour with use of AutoAnalyzer (Technicon) modules. The serum is buffered, then dialyzed in a regular 6-inch (15-cm) dialysis block. A constant proportion of the dialyzable calcium is fluorometrically measured. Analysis of samples containing protei...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1977-07-01 00:00:00
abstract：BACKGROUND:Total prostate-specific antigen (tPSA) is flawed for prostate cancer (PCa) detection. [-2]proprostate-specific antigen (p2PSA), a molecular isoform of free PSA (fPSA), shows higher specificity compared with tPSA or percentage of free PSA (%fPSA). The prostate health index (Phi), a measure based on p2PSA and ...
journal_title：Clinical chemistry
pub_type： 杂志文章,多中心研究
doi：10.1373/clinchem.2012.195784
更新日期：2013-01-01 00:00:00
abstract：:Creatine kinase (CK) isoenzymes MM, MB, and BB are located primarily in the cell cytosol, and increased CKMB in plasma is the hallmark of myocardial infarction. However, whether CK is released with reversible ischemic injury remains controversial. Here, we assessed plasma CK activity--cytosolic and mitochondrial CK--i...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1997-03-01 00:00:00
abstract：BACKGROUND:At concentrations <500 microg/L, serum alpha-fetoprotein (AFP) has low specificity in the diagnosis of hepatocellular carcinoma (HCC), but monosialylated AFP (msAFP) is more specific for HCC. We describe two strategies for quantitative analysis of msAFP and explore their diagnostic accuracy in cases of HCC w...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：2002-07-01 00:00:00
abstract：:In this study we determined the prevalence of autoantibodies against casein kinase II (CKII) in patients positive for anti-70K marker antibodies, which is indicative of mixed connective tissue disease. An anti-CKII ELISA was established with the use of bacterially expressed recombinant CKII proteins. Eight out of 52 a...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1993-12-01 00:00:00
abstract：BACKGROUND:High-sensitivity C-reactive protein (hsCRP) testing is relatively inexpensive and has been shown to predict the risk of cardiovascular disease (CVD) and diabetes in multiple patient groups, including those treated with statin therapy. JUPITER (Justification for the Use of Statins in Primary Prevention: An In...
journal_title：Clinical chemistry
pub_type： 杂志文章,评审
doi：10.1373/clinchem.2008.109728
更新日期：2009-02-01 00:00:00
abstract：:The human ras gene plays a fundamental role in the transduction of extracellular signals to the nucleus, thereby regulating cell growth and differentiation. Point mutations in the ras gene convert it into a transforming oncogene that has been found in many solid and hematologic malignancies. We describe a rapid and se...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1994-05-01 00:00:00
abstract：BACKGROUND:Prediction of cyclosporine (CSA) efficacy and toxicity in individual patients is difficult. There is no practical, biologically relevant, pharmacodynamic measure of CSA effect. A major effect of CSA is to decrease interleukin-2 (IL-2) production; however, measurement of this effect in isolated lymphocytes as...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1999-09-01 00:00:00
abstract：:We describe the measurement of human immunoglobulins IgG, IgA, and IgM in diluted sera, with diluted commercial monospecific antisera, with use of a 36-place centrifugal analyzer (RotoChem IIa; American Instrument Co., Silver Spring, MD 20920). The assay involves a two-point kinetic turbidimetric technique. The change...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1979-04-01 00:00:00
abstract：BACKGROUND:The fibroblast growth factor (FGF) and FGF receptor (FGFR) axis plays a critical role in tumorigenesis, but little is known of its influence in ovarian cancer. We sought to determine the association of genetic variants in the FGF pathway with risk, therapeutic response, and survival of patients with ovarian ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2013.211490
更新日期：2014-01-01 00:00:00
abstract：BACKGROUND:There are 45 known genetic diseases that impair the lysosomal degradation of macromolecules. The loss of a single lysosomal hydrolase leads to the accumulation of its undegraded substrates in tissues and increases of related glycoconjugates in urine, some of which can be detected by screening of free oligosa...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2012.201053
更新日期：2013-09-01 00:00:00
abstract：:Optimal reaction conditions for assaying human lactate dehydrogenase pyruvate-to-lactate were determined for isoenzymes 1 and 5 at 25, 30, and 37 degrees C. Three of the nine different buffers examined--imidazole, triethanolamine, and N-tris(hydroxymethyl)-methyl-2-aminoethane sulfonic acid--are satisfactory. Beta-NAD...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1978-02-01 00:00:00
abstract：:A sensitive method, inductively coupled plasma atomic emission spectroscopy, is used to measure desferrioxamine in blood plasma. The desferrioxamine is transformed into its iron chelate, ferrioxamine, which is extracted into benzyl alcohol, then re-extracted into HCl (0.5 mol/L), which is used as the sample for the sp...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1987-01-01 00:00:00
abstract：:We compared three radioligands for use in a cytoplasmic estrogen-receptor assay, using pooled cytosol from human breast adenocarcinomas. The estrogen receptor content was determined in vitro by a dextran-coated charcoal method involving a 4-h incubation with and without diethylstilbestrol. Tritiated moxestrol failed t...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1982-03-01 00:00:00
