Review of actual proficiency-testing performance under CLIA '67 (March 14, 1990) rules: perspective from the first year's data.

Abstract:

:Under the Clinical Laboratory Improvement Act of 1967 the Health Care Financing Administration's proficiency-testing requirement applies to approximately 12,000 hospital, reference, and large-clinic laboratories in the United States. The Wisconsin State Laboratory of Hygiene is approved by the Health Care Financing Administration to provide proficiency testing in all specialties and subspecialties. The focus of the program is to provide highly specialized service and support to a limited number of participants in order to assess intralaboratory performance correctly. We report the findings over the four proficiency-testing events in 1991 for the subspecialty of routine chemistry, which serves approximately 470 participants. Failure rates for individual analytes on single proficiency testing events ranged from 0% to 13%. After four events or one year, if the mandated evaluation criteria and failure rules were strictly applied, as many as 11% of the laboratories could have found themselves involuntarily suspended from offering all routine chemistry testing.

journal_name

Clin Chem

journal_title

Clinical chemistry

authors

Lanphear BJ,Burmeister BJ,Ehrmeyer SS,Laessig RH,Hassemer DJ

subject

Has Abstract

pub_date

1992-07-01 00:00:00

pages

1254-9; discussion 1268-72

issue

7

eissn

0009-9147

issn

1530-8561

journal_volume

38

pub_type

杂志文章
  • Presence of donor-derived DNA and cells in the urine of sex-mismatched hematopoietic stem cell transplant recipients: implication for the transrenal hypothesis.

    abstract:BACKGROUND:The term "transrenal DNA" was coined in 2000 to signify that DNA in urine may come from the passage of plasma DNA through the kidney barrier. Although DNA in the urine has the potential to provide a completely noninvasive source of nucleic acids for molecular diagnosis, its existence remains controversial. ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2008.113530

    authors: Hung EC,Shing TK,Chim SS,Yeung PC,Chan RW,Chik KW,Lee V,Tsui NB,Li CK,Wong CS,Chiu RW,Lo YM

    更新日期:2009-04-01 00:00:00

  • Postanalytical external quality assessment of urine albumin in primary health care: an international survey.

    abstract:BACKGROUND:Microalbuminuria (MA) is recognized as an important risk factor for cardiovascular and renal complications in diabetes. We sought to evaluate how screening for MA is conducted and how urine albumin (UA) results are interpreted in primary care internationally. METHODS:General practitioners (GPs) received a c...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2007.100917

    authors: Aakre KM,Thue G,Subramaniam-Haavik S,Bukve T,Morris H,Müller M,Lovrencic MV,Plum I,Kallion K,Aab A,Kutt M,Gillery P,Schneider N,Horvath AR,Onody R,Oosterhuis W,Ricos C,Perich C,Nordin G,Sandberg S

    更新日期:2008-10-01 00:00:00

  • Deamidation of glutamine by increased plasma gamma-glutamyltransferase is a source of rapid ammonia formation in blood and plasma specimens.

    abstract::Owing to increased enzymatic hydrolysis of glutamine, additional ammonia is formed in blood and plasma specimens with increased gamma-glutamyltransferase activity (gamma-GT, EC 2.3.2.2.). The close correlation between gamma-GT and glutaminase (EC 3.5.1.2) activities (r = 0.97) in plasma, the inhibition with 6-diazo-5-...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: da Fonseca-Wollheim F

    更新日期:1990-08-01 00:00:00

  • Digoxin-like immunoreactive factors induce apoptosis in human acute T-cell lymphoblastic leukemia.

    abstract:BACKGROUND:Plant-derived cardenolides reportedly possess anticancer properties in human leukemic cells via selective induction of apoptosis, cell cycle arrest, and differentiation. Selective induction of apoptosis with mammalian-derived digoxin-like immunoreactive factor (DLIF) could provide new strategies for anticanc...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2006.082081

    authors: Ihenetu K,Qazzaz HM,Crespo F,Fernandez-Botran R,Valdes R Jr

    更新日期:2007-07-01 00:00:00

  • Urinary cannabinoid disposition in occasional and frequent smokers: is THC-glucuronide in sequential urine samples a marker of recent use in frequent smokers?

    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

    authors: Desrosiers NA,Lee D,Concheiro-Guisan M,Scheidweiler KB,Gorelick DA,Huestis MA

    更新日期:2014-02-01 00:00:00

  • Multiplex tetra-primer amplification refractory mutation system PCR to detect 6 common germline mutations of the MUTYH gene associated with polyposis and colorectal cancer.

    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

    authors: Piccioli P,Serra M,Gismondi V,Pedemonte S,Loiacono F,Lastraioli S,Bertario L,De Angioletti M,Varesco L,Notaro R

    更新日期:2006-04-01 00:00:00

  • How many mistakes, how to find them.

    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 si...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:

    authors: Blase AB

    更新日期:1997-05-01 00:00:00

  • Analytical problems facing the development of electrochemical transducers for in vivo drug monitoring: an overview.

    abstract::Even though significant progress has been made in the development of electrodes for the in vivo detection of catecholamines, oxygen, and various cations, there has been little research on the feasibility of continuously monitoring drugs in whole blood by electrochemical sensing devices. Electroanalytical problems asso...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Pinkerton TC,Lawson BL

    更新日期:1982-09-01 00:00:00

  • Genetic variants in the fibroblast growth factor pathway as potential markers of ovarian cancer risk, therapeutic response, and clinical outcome.

    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

    authors: Meng QH,Xu E,Hildebrandt MA,Liang D,Lu K,Ye Y,Wagar EA,Wu X

    更新日期:2014-01-01 00:00:00

  • Standardization of C-peptide measurements.

    abstract:BACKGROUND:C-peptide is a marker of insulin secretion in diabetic patients. We assessed within- and between-laboratory imprecision of C-peptide assays and determined whether serum calibrators with values assigned by mass spectrometry could be used to harmonize C-peptide results. METHODS:We sent 40 different serum samp...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,多中心研究

    doi:10.1373/clinchem.2007.101287

    authors: Little RR,Rohlfing CL,Tennill AL,Madsen RW,Polonsky KS,Myers GL,Greenbaum CJ,Palmer JP,Rogatsky E,Stein DT

    更新日期:2008-06-01 00:00:00

  • Copy number and expression alterations of miRNAs in the ovarian cancer cell line OVCAR-3: impact on kallikrein 6 protein expression.

    abstract:BACKGROUND:Kallikrein-related peptidase 6 (KLK6), a member of the serine protease family of kallikrein (KLK) genes, is dysregulated in ovarian carcinomas (OCa) and its overexpression is associated with poor prognosis. Regulation of its expression is poorly understood and is likely to be influenced by multiple mechanism...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2012.193060

    authors: Bayani J,Kuzmanov U,Saraon P,Fung WA,Soosaipillai A,Squire JA,Diamandis EP

    更新日期:2013-01-01 00:00:00

  • Two-dimensional gel electrophoresis of serum specimens from patients with monoclonal gammopathies.

    abstract::We modified the ISO-DALT two-dimensional gel electrophoresis system to allow the routine examination of serum specimens from patients with monoclonal gammopathies. This system, MC-Iso 1, is characterized by a broad pH gradient for resolving the basic immunoglobulin heavy and light chains. The increased resolution of b...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Tracy RP,Currie RM,Kyle RA,Young DS

    更新日期:1982-04-01 00:00:00

  • Determination of some L-3,4-dihydroxyphenylalanine and dopamine metabolites in urine by means of mass fragmentography.

    abstract::We describe a mass-fragmentographic method for determination in urine of the following metabolites of L-3,4-dihydroxyphenylalanine and dopamine: vanillactic acid, 3,4-dihydroxyphenylacetic acid, 3-methoxy-4-hydroxyphenylethanol, and 3,4-dihydroxyphenylethanol. Deuterated analogs were used as internal standards. The me...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Muskiet FA,Fremouw-Ottevangers DC,van der Meulen J,Wolthers BG,de Vries JA

    更新日期:1978-01-01 00:00:00

  • Overview of the complications of diabetes.

    abstract::Currently, we can make the following generalizations about the major long-term complications of diabetes. First, they occur commonly after 10 to 15 years of diabetes. Second, the complications of renal and retinal disease, but not of atherogenic and neurological disease, appear to be related to the severity of hypergl...

    journal_title:Clinical chemistry

    pub_type: 临床试验,杂志文章,评审

    doi:

    authors: Santiago JV

    更新日期:1986-10-01 00:00:00

  • Time series modeling for quality control in clinical chemistry.

    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:

    authors: Alwan LC,Bissell MG

    更新日期:1988-07-01 00:00:00

  • Personalized medicine in diabetes.

    abstract:BACKGROUND:Multiple genes that are associated with the risk of developing diabetes or the risk of diabetes complications have been identified by candidate gene analysis and genomewide scanning. These molecular markers, together with clinical data and findings from proteomics, metabolomics, pharmacogenetics, and other m...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:10.1373/clinchem.2010.156901

    authors: Malandrino N,Smith RJ

    更新日期:2011-02-01 00:00:00

  • Assay of delta-aminolaevulinate dehydratase in 10 microL of blood.

    abstract::A method is presented for the assay of delta-aminolaevulinate dehydratase (EC 4.2.1.24) to be performed on 10 microL of whole blood. Results compare favorably with those obtained with an accepted method (J. Clin. Chem. Clin. Bio-chem. 12: 389-390, 1974) that involves use of 200 microL of blood. ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Wigfield DC,Farant JP

    更新日期:1981-01-01 00:00:00

  • Analysis for diazepam and nordiazepam by electron-capture gas chromatography and by liquid chromatography.

    abstract::We describe the use of electron-capture gas chromatography or reversed-phase "high-performance" liquid chromatography for concurrent analysis for diazepam and nordiazepam in serum. In the gas-chromatographic analysis our use of a new chemically deactivated stationary liquid phase, SP 2250-DB (Supelco, Inc.), resulted ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Wallace JE,Schwertner HA,Shimek EL Jr

    更新日期:1979-07-01 00:00:00

  • Assessment of urea and other uremic markers for quantification of dialysis efficacy.

    abstract::To validate azotemic markers as an index for intradialytic changes in solute concentration, we compared eight solutes (pseudouridine, xanthine, hypoxanthine, peak 4, peak 5, p-hydroxyhippuric acid, indoxyl sulfate, and hippuric acid) with five classical azotemic markers (urea, creatinine, uric acid, phosphate, and pot...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Vanholder RC,De Smet RV,Ringoir SM

    更新日期:1992-08-01 00:00:00

  • Competitive solid-phase enzyme immunoassay for measuring digoxin in serum.

    abstract::In this clinically useful enzyme immunoassay of digoxin in serum, we mix sample, beta-galactosidase-labeled digoxin, and anti-digoxin Fab fragments for 30 min at room temperature, then use Sepharose-bound second antibody for phase separation, and measure the unbound enzyme activity directly in the supernate of the equ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Hinds JA,Pincombe CF,Morris H,Duffy P

    更新日期:1986-01-01 00:00:00

  • Adaptation of a T3-uptake test and of radioimmunoassays for serum digoxin, thyroxine, and triiodothyronine to an automated radioimmunoassay system--"Centria".

    abstract::We report the adaptation of four radioassays to the prototype of an automated radioimmunoassay system ("Centria," Union Carbide). The system consists of three integrated modules: (a) an automated pipettor, which dispenses samples and reagents; (b) the key module, an incubator/separator, in which centrifugal force is u...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Ertingshausen G,Shapiro SI,Green G,Zborowski G

    更新日期:1975-08-01 00:00:00

  • Improved column method for separating lactate dehydrogenase isoenzymes 1 and 2.

    abstract::Lactate dehydrogenase (LD) isoenzymes 1 and 2 in human serum were separated on a column of diethylaminoethyl-Sephadex. Samples layered on mini-columns were eluted with buffered sodium chloride (100, 150, and 200 mmol/liter). Lactate dehydrogenase activity in column effluents was measured by the Wacker method, and thei...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Mercer DW

    更新日期:1978-03-01 00:00:00

  • Clinical evaluation of the Triage analytic device for drugs-of-abuse testing.

    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:

    authors: de la Torre R,Domingo-Salvany A,Badia R,Gonzàlez G,McFarlane D,San L,Torrens M

    更新日期:1996-09-01 00:00:00

  • Detecting benzodiazepines: immunoassays compared with negative chemical ionization gas chromatography/mass spectrometry.

    abstract::We tested 231 urine samples by six immunoassay methods--EMIT d.a.u., EMIT II, Roche Abuscreen Online, Abbott TDx, Diagnostic Products Corp. (DPC) double-antibody radioimmunoassay (RIA), and Biosite Triage--and by negative chemical ionization gas chromatography/mass spectrometry to determine how the immunoassays perfor...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Fitzgerald RL,Rexin DA,Herold DA

    更新日期:1994-03-01 00:00:00

  • Two-site immunoenzymometric assay for thyrotropin in dried blood samples on filter paper.

    abstract::We describe a sensitive, simple, and rapid two-site immunoenzymometric assay for thyrotropin in dried blood samples on filter paper, for use in screening for neonatal primary hypothyroidism. In this method, two dried-blood spots of 3 mm diameter (equivalent to about 5.4 microliter of blood) are incubated overnight wit...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Miyai K,Ishibashi K,Kawashima M

    更新日期:1981-08-01 00:00:00

  • A multiplex assay for detecting genetic variations in CYP2C9, VKORC1, and GGCX involved in warfarin metabolism.

    abstract:BACKGROUND:Patients differ in responses to warfarin, which is commonly prescribed to treat thromboembolic events. Genetic variations in the cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), vitamin K epoxide reductase complex, subunit 1 (VKORC1), and gamma-glutamyl carboxylase (GGCX) genes have been shown...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2008.118497

    authors: Rai AJ,Udar N,Saad R,Fleisher M

    更新日期:2009-04-01 00:00:00

  • Evaluation of pteroylglutamic acid and n-5-methyltetrahydrofolic acid reference standards in a new "No-Boil" radioassay for serum folate.

    abstract::Serum folate, pteroylglutamic acid standards, and N-5-methyltetrahydrofolate standards extract differently during sample preparation for radiometric assay. B/B0 values for each material were determined before and after an alkaline extraction procedure. Serum folate most closely resembled N-5-methyltetrahydrofolate sta...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Theobald RA,Batchelder M,Sturgeon MF

    更新日期:1981-04-01 00:00:00

  • Two-dimensional electrophoretic patterns of proteins of normal mucosa, polyps, and carcinomas of the large intestine.

    abstract::Two-dimensional protein maps of biopsies from normal mucosa, tubular adenomas (polyps), and colonic carcinomas in humans have been studied in order to obtain information on the possible precancerous role of intestinal polyps. The maps are complex and several hundred protein spots are seen after staining with Coomassie...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Thorsrud AK,Vatn MH,Jellum E

    更新日期:1982-04-01 00:00:00

  • Quantifying Atherogenic Lipoproteins: Current and Future Challenges in the Era of Personalized Medicine and Very Low Concentrations of LDL Cholesterol. A Consensus Statement from EAS and EFLM.

    abstract:BACKGROUND:The European Atherosclerosis Society-European Federation of Clinical Chemistry and Laboratory Medicine Consensus Panel aims to provide recommendations to optimize atherogenic lipoprotein quantification for cardiovascular risk management. CONTENT:We critically examined LDL cholesterol, non-HDL cholesterol, a...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2018.287037

    authors: Langlois MR,Chapman MJ,Cobbaert C,Mora S,Remaley AT,Ros E,Watts GF,Borén J,Baum H,Bruckert E,Catapano A,Descamps OS,von Eckardstein A,Kamstrup PR,Kolovou G,Kronenberg F,Langsted A,Pulkki K,Rifai N,Sypniewska G,Wik

    更新日期:2018-07-01 00:00:00

  • Evaluation of Ciba Corning ACS:180 automated immunoassay system.

    abstract::We evaluated the technical performance of the Ciba Corning ACS:180 automated immunoassay system for the following analytes: thyroid-stimulating hormone, free thyroxine, luteinizing hormone, follicle-stimulating hormone, prolactin, human chorionic gonadotropin, carcino-embryonic antigen, and prostate-specific antigen. ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Mora-Brugués J,Gascón-Roche N,Rodríguez-Espinosa J,Cortés-Rius M,González-Sastre F

    更新日期:1994-03-01 00:00:00