Abstract：
:The topic of quality control often evokes prolific discussion among those whose business is its administration. Reliable methods for identifying mistakes must be developed in both the manufacture and use of test devices. Unit test devices are uncomplicated to run and provide quick results in a world where speed and simplicity are paramount, yet their very nature as individual assay units introduces questions about the relevance of conventional quality control procedures. Hybritech's ICON QSR CKMB assay is a unit test device that requires daily monitoring according to CLIA'88 regulations. The challenge is to ensure that quality-control testing is value-added, assuring clinicians valid patient sample results although controls are run in a separate "assay." We find that conventional quality-control procedures are indeed valid; however, the fundamental difference of unit test devices must be recognized and accounted for by understanding the capability of the assay in each laboratory.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Blase ABsubject
Has Abstractpub_date
1997-05-01 00:00:00pages
897-902issue
5eissn
0009-9147issn
1530-8561journal_volume
43pub_type
杂志文章,评审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：:Haptoglobin is a hemoglobin-binding protein expressed by a genetic polymorphism as three major phenotypes: 1-1, 2-1, and 2-2. Most attention has been paid to determining haptoglobin phenotype as a genetic fingerprint used in forensic medicine. More recently, several functional differences between haptoglobin phenotype...
journal_title：Clinical chemistry
pub_type： 杂志文章,评审
doi：
更新日期：1996-10-01 00:00:00
abstract：BACKGROUND:There is extended urinary excretion of Δ(9)-tetrahydrocannabinol (THC), 11-hydroxy-THC (11-OH-THC), and 11-nor-9-carboxy-THC (THCCOOH) in abstinent frequent cannabis smokers. We characterized THC, 11-OH-THC, THCCOOH, cannabidiol, cannabinol, THC-glucuronide, and THCCOOH-glucuronide disposition in urine of fr...
journal_title：Clinical chemistry
pub_type： 临床试验,杂志文章
doi：10.1373/clinchem.2013.214106
更新日期：2014-02-01 00:00:00
abstract：:We report a method for the extraction of angiotensin peptides from plasma with a mixture of acetone, 1 mol/L HCl, and water (40/1/5 by vol). The method is highly reproducible for the measurement of angiotensin I and angiotensin II in small sample volumes, with analytical recoveries of about 80% for both peptides. We i...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-06-01 00:00:00
abstract：:We tested the diagnostic sensitivity of various urinary analytes for detecting cadmium-induced nephropathy at an early stage. We investigated 73 healthy persons (control group 1) and individuals exposed to cadmium, either environmentally (n = 36, risk group 2) or occupationally (n = 62, exposed group 3). All data were...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1993-05-01 00:00:00
abstract：:Phenobarbital and phenytoin are extracted and concentrated in a single step, without solvent evaporation, followed by on-column methylation and gas-chromatographic quanitation. A similar extraction step for the assay of theophylline by high-pressure liquid chromatography is described. The extraction step can be comple...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1978-09-01 00:00:00
abstract：BACKGROUND:The recent interest of clinical laboratories in developing serum testosterone assays based on isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) stems from the lack of accuracy of direct immunoassays. In this study, we assessed the accuracy and state of standardization (traceabilit...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2008.105841
更新日期：2008-08-01 00:00:00
abstract：:We compared the effects of freezing serum on the determination of high-density lipoprotein (HDL) subfractions by two dual-precipitation methods, heparin and manganese chloride/dextran sulfate (HM/DS) (Gidez et al., J Lipid Res 1982;23:1206-23) and DS/DS (Warnick et al., Clin Chem 1982;28:1574), and by ultracentrifugat...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1994-09-01 00:00:00
abstract：:We evaluated the analytical performance of Trinder's glucose oxidase (EC 1.1.3.4)/peroxidase (EC 1.11.1.7) 4-aminophenazone-phenol method for the quantification of serum glucose as adapted to the Technicon SMAC. Our results correlated well with those by the routine SMAC glucose oxidase/peroxidase 3-methyl-2-benzothiaz...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1979-10-01 00:00:00
abstract：:I determined the in vitro biological half-lives or decay constants for creatine kinase isoenzymes at various temperatures. Values at 37 degrees C are consistent with values reported by others in vivo, which suggests that in vivo irreversible inactivation is primarily thermal. Reversible inactivation appears to be an o...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1977-01-01 00:00:00
abstract：:A patient with the hyperviscosity syndrome exhibited very high concentrations of intermediate to small circulating immune complexes (CIC), involving 40-50% of the IgG present, with IgG rheumatoid factor activity. We demonstrate that precipitation of CIC by polyethylene glycol in the reaction mixture caused interferenc...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1988-04-01 00:00:00
abstract：:The apolipoprotein A-I (apo A-I) radioimmunoassay established in our laboratory involves use of purified apo A-I as the primary standard for quantifying apo A-I in plasma and a pooled plasma (quality-control sample) as a secondary standard to decrease interassay variation. The measured values for apo A-I increased ove...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1986-07-01 00:00:00
abstract：:We find lag phases exceeding 20 min in measuring creatine kinase activity, by using the kinetic creatin phosphate leads to creatine assay, in sera of some patients with carcinoma metastatic to the liver. Such long lag phases are accompanied by a decreased apparent enzyme activity. These problems are eliminated by addi...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1976-11-01 00:00:00
abstract：BACKGROUND:Remnant lipoprotein-cholesterol (RLP-C) concentrations in sera of healthy individuals are very low (0.080-0.437 mmol/L), making conventional cholesterol methods poorly suited to this purpose. We have developed a highly sensitive cholesterol assay (CD method) and applied it to the RLP-C assay. METHODS:The CD...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：2002-05-01 00:00:00
abstract：BACKGROUND:The analysis of bodily fluids using SELDI-TOF MS has been reported to identify signatures of spectral peaks that can be used to differentiate patients with a specific disease from normal or control patients. This report is the 2nd of 2 companion articles describing a validation study of a SELDI-TOF MS approa...
journal_title：Clinical chemistry
pub_type： 杂志文章,多中心研究
doi：10.1373/clinchem.2007.091496
更新日期：2008-01-01 00:00:00
abstract：:In routine analysis for immunoglobulin light chains in pediatric diagnostics, the age-related reference intervals for serum kappa (kappa) and lambda (lambda) light chains were evaluated in 1543 healthy subjects (newborns to age 16 years, including 168 premature infants). Light-chain analysis was performed by rate neph...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1992-04-01 00:00:00
abstract：BACKGROUND:Identifying novel risk markers in cardiovascular patients remains a research priority. Longer follow-up generally is considered favorable in such studies, but associations of interest may become attenuated with increasing follow-up. This issue has not been adequately addressed in the context of patient cohor...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2016.263202
更新日期：2017-03-01 00:00:00
abstract：:We report results of a quality-control survey of radioimmunoassay (RIA) of eight analytes, participated in by 249 laboratories of various types throughout Japan. For the purpose of the external control survey, lyophilized specimens containing two different concentrations of each analyte were sent to the participating ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1983-08-01 00:00:00
abstract：:Four commercial products for urine glucose determination were evaluated and compared with a quantitative hexokinase procedure. We examined precision, sensitivity, and analytical recovery of glucose from glucose-supplemented urine samples and comparison of methods, using patients' samples. Only "Chemstrip uG" (Bio-Dyna...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1982-10-01 00:00:00
abstract：BACKGROUND:First introduced in 2006, recombinase polymerase amplification (RPA) has stirred great interest, as evidenced by 75 publications as of October 2015, with 56 of them just in the last 2 years. The widespread adoption of this isothermal molecular tool in many diagnostic fields represents an affordable (approxim...
journal_title：Clinical chemistry
pub_type： 杂志文章,评审
doi：10.1373/clinchem.2015.245829
更新日期：2016-07-01 00:00:00
abstract：:Intra-erythrocytic pH, ATP concentrations, and 2,3-diphosphoglycerate relaxation times were studied in living erythrocytes by "high-resolution" 31P NMR spectroscopy to assess homeostasis within the cells. In uremic patients, intra-erythrocytic pH is significantly decreased before hemodialysis, but is corrected equally...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1987-01-01 00:00:00
abstract：:We measured total and dialyzable calcium concentrations in consecutive sera submitted for routine lithium analysis. Of 98 samples from 61 different individuals, six (6.1%) total calcium results and 32 (33%) dialyzable calcium results were above the respective reference intervals. By comparison, when both total and dia...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1979-10-01 00:00:00
abstract：:In this method for separating glycosylated from nonglycosylated hemoglobin in blood by electrophoresis on cellulose acetate membranes, we exploit the affinity of low-molecular-mass dextran sulfate for the nonglycosylated fraction, which increases the mobility of the latter relative to that of glycosylated hemoglobin. ...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1983-02-01 00:00:00
abstract：:The manual Reference Method of the Centers for Disease Control for serum iron (CDC/RM/Fe) and a semiautomated adaptation of it were used to evaluate two working methods: one, a detergent solubilization procedure for the Roche Cobas-Bio analyzer, the other, the Kodak Ektachem 700 procedure, based on dry-film technology...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1990-10-01 00:00:00
abstract：:We report the production and comparative specificities of antisera raised to different immunogens containing codeine, morphine, and oxycodone. Antisera raised to bovine serum albumin (BSA) conjugates of codeine-6-hemisuccinate, ethylmorphine-6-hemisuccinate, or oxycodone-6-carboxymethyloxime had greatest recognition o...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1981-09-01 00:00:00
abstract：BACKGROUND:Understanding the distribution of C-reactive protein (CRP) concentration among adult women in the US helps to establish the magnitude of women at increased risk for cardiovascular disease. METHODS:We examined the distribution and correlates of CRP, using data from 2205 women >or=20 years of age from the Nat...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2003.027359
更新日期：2004-03-01 00:00:00
abstract：:A fluorometric assay for free erythrocyte porphyrins (FEP) is described in detail, the direct test being used for the analysis of blood specimens collected with anticoagulants and the spot test for analysis of blood specimens collected on filter paper. A method for determining the amount of blood absorbed by different...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1977-02-01 00:00:00
abstract：:We have developed a liquid chromatography-isotope dilution mass spectrometry procedure to quantify total cholesterol in serum. A particle-beam interface was used for coupling the liquid chromatograph and the mass spectrometer. After electron impact ionization the ions m/z = 386 and m/z = 389 were used for selective io...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1997-10-01 00:00:00
abstract：BACKGROUND:Direct equilibrium dialysis and direct ultrafiltration free thyroxine (T(4)) assays rely on semipermeable membranes to exclude T(4)-binding serum proteins from dialysates and ultrafiltrates. The presence of these proteins in dialysates or ultrafiltrates will yield spuriously high free T(4) values when free T...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：10.1373/clinchem.2007.085316
更新日期：2007-05-01 00:00:00
abstract：:We studied the specificity of kinetic methods of analysis, with emphasis on creatinine determination. The error contributed by an interferent that reacts with the analytical reagent and absorbs at the wavelength of analysis is shown to be related to the ratio of the equilibrium absorbances of the analyte and interfere...
journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1980-04-01 00:00:00
