Quality assurance, accreditation, and certification: needs and possibilities.

Abstract:

:Demonstrable quality of laboratory services entails two parts. First, one needs a quality policy statement, identification of user needs, choice of measurement procedures, reference measurement system to provide traceability, control materials, and proficiency testing with materials having reference-measurement-assigned values. Second, it may be useful to obtain recognition of competence in addition to the director's certificate, such as Good Laboratory Practice (when studying toxicity of chemicals), ISO 9000 certification of a self-defined quality system, nongovernmental professional accreditation, or, most demanding, governmental accreditation according to European Standard EN 45,001 with some modifications. These require external quality audit; ISO and EN also require a quality manual, which is valuable documentation in any case.

journal_name

Clin Chem

journal_title

Clinical chemistry

authors

Dybkaer R

subject

Has Abstract

pub_date

1994-07-01 00:00:00

pages

1416-20

issue

7 Pt 2

eissn

0009-9147

issn

1530-8561

journal_volume

40

pub_type

杂志文章,评审
  • Comparison of urinary albumin quantification by immunoturbidimetry, competitive immunoassay, and protein-cleavage liquid chromatography-tandem mass spectrometry.

    abstract:BACKGROUND:Increased urinary albumin excretion is a well-documented diagnostic and prognostic biomarker for renal disease. Urinary albumin is typically measured in clinical settings by immunoassay methods. However, neither a reference method nor a urine albumin calibration reference material is currently available. ME...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2009.129833

    authors: Seegmiller JC,Sviridov D,Larson TS,Borland TM,Hortin GL,Lieske JC

    更新日期:2009-11-01 00:00:00

  • Do enzymatic analyses of serum triglycerides really need blanking for free glycerol?

    abstract::Distributions of concentrations of free glycerol in clinical plasma obtained for triglyceride assay were compiled to determine the frequency with which increased concentrations of free glycerol posed a potential problem for clinical interpretation of triglyceride results. Clinical histories were studied in patients wi...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Jessen RH,Dass CJ,Eckfeldt JH

    更新日期:1990-07-01 00:00:00

  • Enzyme-linked immunosorbent assay for urinary albumin at low concentrations.

    abstract::We describe an enzyme-linked immunosorbent assay (ELISA) for urinary albumin. It requires only commercially available reagents, can detect as little as 16 micrograms of albumin per liter, and analytical recovery ranges from 92 to 116%. The assay is simple, rapid, and inexpensive. Albumin excretion was 6.2 (SD 4.1) mg/...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Krämer BK,Jesse U,Ress KM,Schmülling RM,Risler T

    更新日期:1987-04-01 00:00:00

  • Plasma glucose concentrations of whole blood, as determined with a multilayer-film analytical element.

    abstract::A new type of multilayer film analytical element--consisting of a spreading layer, a blocking layer, an enzymic reagent layer, and a transparent layer--has been developed for blood glucose determination. After a spot of whole blood is dropped on the film, the plasma glucose concentration is determined in 6 min without...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Ohkubo A,Kamei S,Yamanaka M,Arai F,Kitajima M,Kondo A

    更新日期:1981-07-01 00:00:00

  • Capillary electrophoresis for detection of inherited disorders of purine and pyrimidine metabolism.

    abstract:BACKGROUND:Measurement of purine and pyrimidine metabolites presents complex problems for separations currently performed by HPLC and thin-layer chromatography in clinical practice. We developed a novel capillary electrophoresis method for this purpose. METHODS:Separations were performed in 60 mmol/L borate-2-amino-2-...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Adam T,Friedecký D,Fairbanks LD,Sevcík J,Barták P

    更新日期:1999-12-01 00:00:00

  • Human urinary arsenic excretion after one-time ingestion of seaweed, crab, and shrimp.

    abstract::We studied chemical speciation of arsenic compounds in urine samples by using HPLC with inductively coupled plasma mass spectrometry detection. We examined urinary arsenic excretion patterns and the arsenic species excreted from nine human subjects who ingested seaweed products and crab (or shrimp). Fast urinary excre...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Le XC,Cullen WR,Reimer KJ

    更新日期:1994-04-01 00:00:00

  • Accuracy and comparability of long-term measurements of cholesterol.

    abstract::Laboratories of the Lipid Research Clinics Program (LRC) maintained the accuracy of their measurements of total cholesterol by using seven pooled serum calibrators supplied by the Centers for Disease Control (CDC). Over the 11-year life of the LRC, each calibrator was prepared in succession and a target value was assi...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Hainline A Jr,Karon JM,Winn CL,Gill JB

    更新日期:1986-04-01 00:00:00

  • Decreased storage stability of creatine kinase in a cardiac reperfusion solution.

    abstract::Creatine kinase (CK; EC 2.7.3.2) has been used as an indicator of myocardial cellular damage. In this study we used a Krebs-Henseleit (KH) solution to reperfuse isolated rat hearts after 24 h of cold preservation and collected the KH reperfusate for assay of CK to assess cellular damage. We wanted to determine the sta...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Dunphy G,Ely D

    更新日期:1990-05-01 00:00:00

  • Interlaboratory/intermethod differences in functional sensitivity of immunometric assays of thyrotropin (TSH) and impact on reliability of measurement of subnormal concentrations of TSH.

    abstract::Clinically relevant interassay precision profiles for thyrotropin (thyroid-stimulating hormone; TSH) were constructed with human serum pools measured over 4-8 weeks by six immunometric assays, in at least two different reagent lots. Functional sensitivities (the concentration at which the interassay CV is < or = 20%) ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Spencer CA,Takeuchi M,Kazarosyan M,MacKenzie F,Beckett GJ,Wilkinson E

    更新日期:1995-03-01 00:00:00

  • Estimating glomerular filtration rate in kidney transplantation: is the new chronic kidney disease epidemiology collaboration equation any better?

    abstract:BACKGROUND:The new Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was developed to address the systematic underestimation of the glomerular filtration rate (GFR) by the Modification of Diet in Renal Disease (MDRD) Study equation in patients with a relatively well-preserved kidney function. The per...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2009.135111

    authors: White CA,Akbari A,Doucette S,Fergusson D,Knoll GA

    更新日期:2010-03-01 00:00:00

  • Multiple drugs of abuse in urine detected with a single reagent and fluorescence polarization.

    abstract::We describe a simple polarization fluoroimmunoassay for the detection of several commonly abused drugs in urine. The single reagent used, prepared by mixing four different antisera and three fluorescein-labeled derivatives, produces a polarization signal that is the average of the individual signals of the derivatives...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Colbert DL,Childerstone M

    更新日期:1987-10-01 00:00:00

  • Fibulin-1 is a marker for arterial extracellular matrix alterations in type 2 diabetes.

    abstract:BACKGROUND:Extracellular matrix alterations are important elements in the arterial changes seen in diabetes, being associated with increased vascular stiffness and the development of cardiovascular diseases. However, no biomarkers for diabetes-related arterial changes have been defined. METHODS:Mammary artery specimen...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2011.162966

    authors: Cangemi C,Skov V,Poulsen MK,Funder J,Twal WO,Gall MA,Hjortdal V,Jespersen ML,Kruse TA,Aagard J,Parving HH,Knudsen S,Høilund-Carlsen PF,Rossing P,Henriksen JE,Argraves WS,Rasmussen LM

    更新日期:2011-11-01 00:00:00

  • Traceability in laboratory medicine.

    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...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:10.1373/clinchem.2008.107052

    authors: Vesper HW,Thienpont LM

    更新日期:2009-06-01 00:00:00

  • Electrophoretic mobility, concentration, and activity of alpha 1-antitrypsin in serum of patients undergoing bone-marrow transplantation.

    abstract::We have observed an electrophoretically abnormal, nonfunctional species of alpha 1-antitrypsin in serum from patients who were receiving bone-marrow transplants for treatment of leukemia or aplastic anemia. Three of four patients in whose serum this protein appeared died soon after; the fourth recovered, and the disap...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Mullins RE,Bennett B,Hunter RL Jr

    更新日期:1987-01-01 00:00:00

  • Affinity binding assay of glycohemoglobin by two-dimensional centrifugation referenced to hemoglobin A1c.

    abstract::We describe an automated assay of glycohemoglobin performed with the Abbott Vision analyzer. The assay is based on batch affinity-extraction with 3-aminophenylboronic acid-derivatized agarose beads. Reagents are packaged in a disposable test pack. Whole-blood specimens are hemolyzed with saponin within a glass capilla...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Fiechtner M,Ramp J,England B,Knudson MA,Little RR,England JD,Goldstein DE,Wynn A

    更新日期:1992-12-01 00:00:00

  • Newborn screening for cystic fibrosis by use of a multiplex immunoassay.

    abstract:BACKGROUND:Since its beginnings, newborn screening for cystic fibrosis (CF) using an assay for immunoreactive trypsinogen (IRT) has been plagued by a high rate of false-positive results (screen positive, diagnosis negative), despite attempts to reduce this rate by use of altered cutoffs and second-tier DNA testing. IRT...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2009.132480

    authors: Lindau-Shepard BA,Pass KA

    更新日期:2010-03-01 00:00:00

  • A double-monoclonal immunoenzymometric assay for alpha 1-fetoprotein modified for increased analytical precision.

    abstract::We modified a one-step, two-site, double monoclonal immunoenzymometric assay (Abbott Laboratories) for serum alpha1-fetoprotein (AFP) to increase its sensitivity and improve test precision at the low end. We increased sample size, incubation interval, and reaction time and temperature, and decreased the final reaction...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Shahangian S,Fritsche HA Jr,Hughes JI

    更新日期:1987-04-01 00:00:00

  • Immobilization of antibodies on ultraflat polystyrene surfaces.

    abstract:BACKGROUND:Functional antibody surfaces were prepared on ultraflat polystyrene surfaces by physical adsorption, and the uniform distribution of monoclonal antibodies against hepatitis B surface antigen (anti-HBs) on such surfaces and the presence of dense hepatitis B surface antigen (HBsAg) particles captured by immobi...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Qian W,Yao D,Yu F,Xu B,Zhou R,Bao X,Lu Z

    更新日期:2000-09-01 00:00:00

  • Rapid automated enzyme immunoassay of serum amyloid A.

    abstract::Serum amyloid A (SAA), a sensitive acute-phase protein, is the precursor of AA fibrils in reactive amyloidosis. However, SAA is poorly immunogenic, and development and standardization of immunoassays of this protein have been difficult. We established an automated polyclonal/monoclonal microparticle capture enzyme imm...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Wilkins J,Gallimore JR,Tennent GA,Hawkins PN,Limburg PC,van Rijswijk MH,Moore EG,Pepys MB

    更新日期:1994-07-01 00:00:00

  • C-reactive protein and coronary heart disease: predictive test or therapeutic target?

    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

    authors: Hingorani AD,Shah T,Casas JP,Humphries SE,Talmud PJ

    更新日期:2009-02-01 00:00:00

  • Mass concentration and activity concentration of creatine kinase isoenzyme MB compared in serum after acute myocardial infarction.

    abstract::We compared three current methods (immunoinhibition, "Isomune-CK" immunoprecipitation, and the Tandem-E CKMB II immunoenzymometric assay) for determination of creatine kinase (CK; EC 2.7.3.2) isoenzyme MB in serum. Although results inter-correlated well, the immunoinhibition assay gave higher activity values. Atypical...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Delanghe JR,De Mol AM,De Buyzere ML,De Scheerder IK,Wieme RJ

    更新日期:1990-01-01 00:00:00

  • Centrifugal ion-selective electrode system for potassium in whole blood.

    abstract::We describe a novel ion-selective electrode (ISE) system that can be used in the Abbott Vision analyzer. A reusable sensor pack and a disposable test pack have been miniaturized to approximately the size and weight of a conventional Vision test pack, thus eliminating the need for a separate ISE module. The sensor pack...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Brackett J,Durley B,Janczak R,Kazlauskas V,Kmiec J,Norlie J,Rosencranz R,Schultz S,Spring T,Theusch W

    更新日期:1990-12-01 00:00:00

  • Serum thyrotropin as measured with a one-step monoclonal-antibody radioimmunometric assay compared with two commercial radioimmunoassay kits.

    abstract::We compared results obtained with a commercial immunoradiometric assay kit for human thyrotropin in which monoclonal antibodies are used (Tandem -R TSH (ONE STEP) ImmunoRadioMetricAssay; Hybritech Inc.) with those obtained with two commercial radioimmunoassay methods: GAMMA-DAB [125I]HS-hTSH RIA (Clinical Assays) and ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Pekary AE,Hershman JM

    更新日期:1986-06-01 00:00:00

  • Determination of sodium and potassium with ion-selective electrodes.

    abstract::We compared different sample-handling techniques for measurement of Na+ and K+ with ion-selective electrodes (ISE). Imprecision was less for venous blood (with a minimum of heparin) than for plasma, serum, or capillary blood. The results for K+ were higher for serum than for whole blood, and higher for whole blood tha...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Fogh-Andersen N,Wimberley PD,Thode J,Siggaard-Andersen O

    更新日期:1984-03-01 00:00:00

  • Rapid capillary zone electrophoresis in isoelectric histidine buffer: high resolution of the poly-T tract allelic variants in intron 8 of the CFTR gene.

    abstract::The poly-T tract in intron 8 of the cystic fibrosis conductance transmembrane regulator (CFTR) gene exists in three variants, 5T, 7T, and 9T. The 7T and 9T variants generate a predominantly normal transcript, whereas the 5T variant engenders an anomalous product. The analysis of the poly-T tract is assuming increasing...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Gelfi C,Perego M,Righetti PG,Cainarca S,Firpo S,Ferrari M,Cremonesi L

    更新日期:1998-05-01 00:00:00

  • Measurement of different forms of tissue plasminogen activator in plasma.

    abstract:BACKGROUND:We evaluated assays to measure both total tissue plasminogen activator (tPA) and the three principle forms of tPA in plasma: active tPA, tPA complexed with plasminogen activator inhibitor type 1 (PAI-1), and tPA complexed with C1-inhibitor. METHODS:Active tPA was measured by use of an indirect amidolytic as...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Chandler WL,Jascur ML,Henderson PJ

    更新日期:2000-01-01 00:00:00

  • Glycated proteins in serum: effect of their relative proportions on their alkaline reducing activity in the fructosamine test.

    abstract::The fructosamine test is considered clinically useful for assessing short-term integrated control of blood glucose, but there are few published data to support this hypothesis. We fractionated glycated and nonglycated proteins by affinity chromatography on phenylboronate columns and, with specific immunochemical metho...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Zoppi F,Mosca A,Granata S,Montalbetti N

    更新日期:1987-10-01 00:00:00

  • Measurement and characterization of angiotensin peptides in plasma.

    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:

    authors: Hermann K,Ganten D,Unger T,Bayer C,Lang RE

    更新日期:1988-06-01 00:00:00

  • Lipoprotein lipids in women with androgen excess: independent associations with increased insulin and androgen.

    abstract::Concentrations of triglycerides are increased and concentrations of high-density lipoprotein (HDL) cholesterol are low in women with hyperandrogenism. These alterations could be related to excessive androgen or estrogen, to hyperinsulinism, or to a combination of these abnormalities. We examined their independent infl...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Wild RA,Applebaum-Bowden D,Demers LM,Bartholomew M,Landis JR,Hazzard WR,Santen RJ

    更新日期:1990-02-01 00:00:00

  • A case of sulfhemoglobinemia and emergency measurement of sulfhemoglobin with an OSM3 CO-oximeter.

    abstract::We describe a case of sulfhemoglobinemia associated with toxic paint ingestion. Blood gases, oxygen content, and fractional hemoglobin derivatives were assayed with Radiometer 520 and OSM3 instruments. Although the CO-oximeters indicated the presence of sulfhemoglobin (SulfHb), the results were not quantitative. An OS...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Wu C,Kenny MA

    更新日期:1997-01-01 00:00:00