The implementation of a system for managing analytical quality in networked laboratories.

Abstract:

BACKGROUND:In a network of laboratories analytical variability between instruments, even of the same type, may exist for reasons beyond the control of laboratory staff. Controlling variability is a prerequisite for the application of shared reference ranges and for ensuring the transferability of patient test results. Controlling variability requires a robust, non-conventional quality system to detect poor performance of analysers that are geographically distant. Essential to this quality system is a set of well-defined quality specifications. METHODS:The approach used in our study started with (1) selection of a model for quality specifications based on biological variation; the 'three-level model' (TLM) was selected on the basis of its flexibility to accommodate various levels of analytical performance; (2) determination of the performance characteristics of the 71 analytes measured in core biochemistry in terms of imprecision and bias; (3) defining quality requirements in the form of imprecision, bias and total error for 71 analytes measured routinely in core biochemistry; and (4) developing software to assist a consistent wide application of the quality specifications and to monitor analytical indices to the common quality specifications. RESULTS:In this paper we describe how we have implemented this model across our network. Forty-six of the 71 analytes in our core laboratory repertoire were allocated to the TLM. We were able to demonstrate equivalence of results on all analysers, for 42 out of 46 analytes allocated to this model. CONCLUSIONS:We propose that other networked laboratories should investigate the suitability of this quality system for use in their network.

journal_name

Ann Clin Biochem

authors

Jassam N,Lindsay C,Harrison K,Thompson D,Bosomworth MP,Barth JH

doi

10.1258/acb.2010.010005

subject

Has Abstract

pub_date

2011-03-01 00:00:00

pages

136-46

issue

Pt 2

eissn

0004-5632

issn

1758-1001

pii

acb.2010.010005

journal_volume

48

pub_type

杂志文章
  • Cerebrospinal fluid biochemistry in the diagnosis of multiple sclerosis.

    abstract::The Poser criteria for diagnosing multiple sclerosis (MS) includes clinical, paraclinical and laboratory information. We studied the influence of cerebrospinal fluid (CSF) biochemistry results on the categorisation of patients with suspected MS. A retrospective study was made of 138 patients who had CSF samples sent o...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456329002700303

    authors: Ratnaike S,Kilpatrick T,Tress B,Davis S,Kilpatrick C,Byron K,Deam D

    更新日期:1990-05-01 00:00:00

  • Severely impaired activity of lipoprotein lipase Arg243His is partially ameliorated by emulsifying phospholipids in in vitro triolein hydrolysis analysis.

    abstract::Background We investigated the in vitro effects of various phospholipids as emulsifiers on the hydrolysing activities of lipoprotein lipase (LPL) Arg243His against triolein as substrate. LPL Arg243His, identified in a patient with hyperchylomicronaemia, displays severely diminished activity for triolein when emulsifie...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/0004563217693258

    authors: Yamaguchi T,Murano T,Tatsuno I,Hiruta N,Suzuki T,Sawada S,Katagiri H,Shirai K,Schneider WJ,Bujo H

    更新日期:2017-11-01 00:00:00

  • Identification of factors limiting the accurate measurement of plasma D-penicillamine in rheumatoid arthritis patients.

    abstract::Free and total reduced concentrations of D-penicillamine have been measured in the plasma of rheumatoid arthritis patients by HPLC and electro-chemical detection. A reverse-phase ion-pair separation in conjunction with a dual porous graphite electrode satisfied the requirements of robustness, sensitivity, selectivity ...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456328802500210

    authors: Webb BA,Richardson SJ,Haslock I

    更新日期:1988-03-01 00:00:00

  • Quality assessment of urinary organic acid analysis.

    abstract::The number of known inherited metabolic disorders resulting in an organic aciduria has increased steadily over the past two decades. Prompt and reliable detection is both clinically and technically demanding but is essential if appropriate treatment is to be undertaken. This is the first study of laboratory performanc...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456329403100203

    authors: Bonham JR,Downing M,Pollitt RJ,Manning NJ,Carpenter KH,Olpin SE,Allen JC,Worthy E

    更新日期:1994-03-01 00:00:00

  • A double heterozygote for familial hypercholesterolaemia and familial defective apolipoprotein B-100.

    abstract::Autosomal dominant hypercholesterolaemia is genetically heterogeneous, but most commonly (approximately 93%) caused by mutations in low-density lipoprotein receptor (LDLR), where the disease is known as familial hypercholesterolaemia (FH), or apolipoprotein B-100 (APOB) (approximately 5.5%), where the disease is known...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/acb.2010.010089

    authors: Taylor A,Bayly G,Patel K,Yarram L,Williams M,Hamilton-Shield J,Humphries SE,Norbury G

    更新日期:2010-09-01 00:00:00

  • A meta-analysis of leptin reference ranges in the healthy paediatric prepubertal population.

    abstract:OBJECTIVE:The initial discovery of leptin (1994) has given rise to a substantial number of published studies. This study aimed at identifying the published data on the reference ranges of total, free and bound leptin concentration in the healthy prepubertal population. METHODS:A search was conducted on original Englis...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章,meta分析

    doi:10.1258/acb.2008.008168

    authors: Venner AA,Doyle-Baker PK,Lyon ME,Fung TS

    更新日期:2009-01-01 00:00:00

  • Measurement of markers of tobacco smoking in patients with coronary heart disease.

    abstract::591 patients with a history of coronary heart disease had one or more biochemical markers of tobacco smoking measured. 26% were self reported smokers and a further 4% were apparent 'smoking deceivers'. The urinary nicotine metabolite concentration is an excellent marker for tobacco smoking; breath CO would be a suitab...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456329503200213

    authors: Archbold GP,Cupples ME,McKnight A,Linton T

    更新日期:1995-03-01 00:00:00

  • Quantitative analysis of elevated serum Golgi protein-73 expression in patients with liver diseases.

    abstract:BACKGROUND:Golgi protein-73 (GP73) is a newly identified candidate serum marker for liver diseases. The utility of this biomarker remains limited, largely due to the lack of quantitative information. The aims of this study were to quantify serum GP73 (sGP73) in healthy individuals and in patients with liver diseases, a...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/acb.2008.008088

    authors: Gu Y,Chen W,Zhao Y,Chen L,Peng T

    更新日期:2009-01-01 00:00:00

  • A new method of measuring the antioxidant activity of polyphenols using cumene hydroperoxide.

    abstract:BACKGROUND:It is well known that polyphenols lower the risk of chronic diseases such as heart disease and cancer. We describe a new method using cumene hydroperoxide (CHP) to determine the antioxidant activity of polyphenols. CHP is considered to be a model reactive lipid peroxidation product. METHODS:The method was b...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/000456304322664744

    authors: Sugita O,Ishizawa N,Matsuto T,Okada M,Kayahara N

    更新日期:2004-01-01 00:00:00

  • Postprandial effect of a high fat meal on plasma lipid, lipoprotein cholesterol and apolipoprotein measurements.

    abstract::We investigated the effect of a fatty meal on plasma concentrations of lipids, apolipoproteins, and the cholesterol component of lipoproteins. Sixteen nonobese, healthy, asymptomatic males, 22-34 years of age, served as subjects for this study. None smoked, consumed more than two alcoholic drinks per day, or took any ...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456329002700512

    authors: Rifai N,Merrill JR,Holly RG

    更新日期:1990-09-01 00:00:00

  • Evaluation of the diagnostic value of serum bile acid in the detection and functional assessment of liver diseases.

    abstract::The diagnostic usefulness of fasting total serum bile acids (SBA/F) in the detection of liver diseases and assessment of different aspects of hepatic function alteration was evaluated in 61 healthy subjects and 186 patients with liver disease. The value of SBA/F was compared with other routine tests. In 49 healthy sub...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456328502200608

    authors: Cravetto C,Molino G,Biondi AM,Cavanna A,Avagnina P,Frediani S

    更新日期:1985-11-01 00:00:00

  • Thyroid guidelines - are thyroid-stimulating hormone assays fit for purpose?

    abstract::Most thyroid-stimulating hormone (TSH) assays now have the sensitivity required by thyroid guidelines and allow the reliable identification of patients with both overt and subclinical hyperthyroidism. Clinical guidelines usually quote decision limits for TSH, but often ignore the issue of whether variability in bias b...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/000456307780480945

    authors: Beckett G,MacKenzie F

    更新日期:2007-05-01 00:00:00

  • Determination of a Beckman Coulter AU turbidometric method-specific caeruloplasmin reference interval.

    abstract:BACKGROUND:Method-dependent variation of caeruloplasmin measurement is significant and necessitates the requirement for assay-specific reference intervals. Local determination becomes necessary in the absence of suitable published or manufacturer-quoted reference intervals. METHODS:Applicability of the Beckman Coulter...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/0004563221989360

    authors: Kaye OE,Cook P

    更新日期:2021-01-27 00:00:00

  • Evaluation of the effect of clinical validation of out of hours critical laboratory results.

    abstract:AIM:The aim of the study was to review the clinical validation process of out of hours critical biochemistry results by a clinical biochemist and its effect on primary care services. METHODS:A prospective study was conducted of all critical results for primary care patients who were analysed out of hours. The nine-mon...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/0004563215595251

    authors: Chandrajay D,Narayanan D,Barth JH

    更新日期:2016-03-01 00:00:00

  • First trimester maternal serum screening for Down's syndrome: an evaluation of the DPC Immulite 2000 free beta-hCG and pregnancy-associated plasma protein-A assays.

    abstract:BACKGROUND:Recent NICE Guidelines have emphasized the need to have in place by 2007 the capability of offering screening to all women in the first trimester using a combination of maternal age with the ultrasound marker nuchal translucency thickness (NT) and the maternal serum biochemical markers free beta-hCG and preg...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/0004563053026880

    authors: Spencer K

    更新日期:2005-01-01 00:00:00

  • Insulinoma: how reliable is the biochemical evidence?

    abstract:BACKGROUND AND METHODS:We report a case of insulinoma in which the diagnosis was very challenging as some of the biochemical data were consistently equivocal. In order to assess the relative reliability of the analytical tests, retrospective biochemical data on 45 other cases of histologically confirmed insulinoma were...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/000456303770367315

    authors: Chammas NK,Teale JD,Quin JD

    更新日期:2003-11-01 00:00:00

  • An unusual cause of interference in a salicylate assay caused by mitochondrial acetoacetyl-CoA thiolase deficiency.

    abstract::Mitochondrial acetoacetyl-CoA thiolase deficiency (or beta-ketothiolase deficiency) is a rare metabolic disorder characterized by acute episodes of severe acidosis and ketosis. A case is presented of an 18-month-old boy who presented with vomiting and diarrhoea and was found to be markedly acidotic. When the acidosis ...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/acb.2008.007202

    authors: Tilbrook LK,Slater J,Agarwal A,Cyriac J

    更新日期:2008-09-01 00:00:00

  • A comparison of three methods for the estimation of capillary blood glucose in filter paper spots.

    abstract::A comparison has been made between three methods for measuring capillary blood glucose collected on filter paper, including a new method using a Beckman glucose analyser 2. The methods are suitable for use with capillary blood spots collected onto filter paper for monitoring the control of diabetic patients. Their acc...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456328201900105

    authors: Taylor RP,Pennock CA

    更新日期:1982-01-01 00:00:00

  • A simple, rapid and cheap radioimmunoassay for plasma digoxin.

    abstract::A radioimmoassay for digoxin is described which uses commercially available reagents. Two assay procedures are used, one for batch assays, and another, which needs a 5 minute incubation only, for 'stat' assays. The methods are shown to be simple, rapid, precise and inexpensive and the batch procedure compared well wit...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456328502200216

    authors: Moore RA,Turner M,Cousins J,Gales M

    更新日期:1985-03-01 00:00:00

  • Novel mutations in the Dubin-Johnson syndrome gene ABCC2/MRP2 and associated biochemical changes.

    abstract::A patient with sepsis and jaundice was admitted for diagnosis and treatment. Associated biochemical changes included increased C-reactive protein, conjugated bilirubin and gamma-glutamyltransferase, the duration of which was protracted. High urine coproporphyrin isomer-1 and immunostaining of liver tissue suggested Du...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/acb.2012.011279

    authors: Devgun MS,El-Nujumi AM,O'Dowd GJ,Barbu V,Poupon R

    更新日期:2012-11-01 00:00:00

  • Immunoturbidimetric measurement of serum retinol-binding protein in renal and hepatic disease.

    abstract::Serum retinol-binding protein (RBP), with a biological half-life of less than 12 h, is a useful indicator of liver or kidney dysfunction. An automated immunoturbidimetric assay for the measurement of RBP has been developed using the Cobas-BIO centrifugal analyser and commercially available materials. Serum samples wit...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456328802500309

    authors: Bankson DD,Rifai N,Silverman LM

    更新日期:1988-05-01 00:00:00

  • Measurement of copper, zinc and magnesium in serum and urine by DC plasma emission spectrometry.

    abstract::The application of a DC plasma emission spectrometer to the measurement of copper, zinc and magnesium in serum and urine is reported. Each assay requires only a simple dilution in 1% nitric acid. Comparisons with standard atomic absorption techniques showed good analytical agreement, especially for copper and magnesiu...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456328502200512

    authors: Roberts NB,Fairclough D,McLoughlin S,Taylor WH

    更新日期:1985-09-01 00:00:00

  • Salivary theophylline concentrations in neonates.

    abstract::Salivary theophylline concentrations in neonates were measured by a homogeneous enzyme immunoassay and compared with serum concentrations. Free serum theophylline concentrations were also compared with salivary concentrations and the values obtained were almost identical. Results using the immunoassay agreed well with...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456329403100311

    authors: Thompson SJ

    更新日期:1994-05-01 00:00:00

  • Comparison of sample types for N-terminal pro-B-type natriuretic peptide measured on the Siemens Immulite 2500 and Dimension Vista LOCI methods.

    abstract:BACKGROUND:Measurement of serum natriuretic peptides is recommended in patients with suspected heart failure. Assays for N-terminal pro-B-type natriuretic peptide (NT-proBNP) are available on several platforms and can be measured in serum or heparinized plasma. Siemens Healthcare Diagnostics do not recommend the use of...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/acb.2012.012053

    authors: Peake RW,Turner HE,Leaper W,Deans KA,Hannah A,Croal BL

    更新日期:2012-09-01 00:00:00

  • A systematic evaluation of immunoassay point-of-care testing to define impact on patients' outcomes.

    abstract::Background Point-of-care testing has been developed to provide rapid test results. Most published studies focus on analytical performance, neglecting its impact on patient outcomes. Objective To review the analytical performance and accuracy of point-of-care testing specifically planned for immunoassay and to evaluate...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/0004563217694377

    authors: Pecoraro V,Banfi G,Germagnoli L,Trenti T

    更新日期:2017-07-01 00:00:00

  • The evaluation of a novel conductometric device for the diagnosis of cystic fibrosis.

    abstract:BACKGROUND:We evaluated the diagnostic discrimination of a new micro-flow cell device (Nanoduct) which measures sweat conductivity in situ at a regional referral centre for cystic fibrosis (CF). METHODS:The device was evaluated in comparison to the measurement of sweat chloride with the established quantitative piloca...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/000456306778520025

    authors: Losty HC,Wheatley H,Doull I

    更新日期:2006-09-01 00:00:00

  • Development of a rapid assay for the analysis of serum cortisol and its implementation into a routine service laboratory.

    abstract:BACKGROUND:LC-MS/MS is rapidly becoming the technology of choice for measuring steroid hormones. We have developed a rapid LC-MS/MS assay for the routine analysis of serum cortisol. We have used this assay to investigate the effects of gender and exogenous steroid interference on the immunoassay measurement of serum co...

    journal_title:Annals of clinical biochemistry

    pub_type: 临床试验,杂志文章

    doi:10.1177/0004563212473448

    authors: Owen LJ,Adaway JE,Davies S,Neale S,El-Farhan N,Ducroq D,Evans C,Rees DA,MacKenzie F,Keevil BG

    更新日期:2013-07-01 00:00:00

  • Effect of heat inactivation of HIV on specific serum proteins and tumour markers.

    abstract::The effect on the concentrations of specific serum proteins and tumour markers, of heat-treating samples at 56 degrees C for 30 min to inactivate HIV, was investigated. Statistically significant decreases, that may affect clinical decisions, were observed for alpha-1-antitrypsin, beta-2-microglobulin, IgE, fibrinogen,...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1177/000456329002700611

    authors: Gleeson M,Herd L,Burns C

    更新日期:1990-11-01 00:00:00

  • The case of stainless statins.

    abstract::Two cases of hypercholesterolaemic patients are presented in whom raised plasma creatine kinase was noted during treatment with statins. The plasma creatine kinase failed to fall following cessation of therapy. Further investigation revealed the aetiology of the raised plasma creatine kinase to be due to previously un...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/000456303322326542

    authors: Barth JH,Brownjohn AM,Jamieson DR

    更新日期:2003-09-01 00:00:00

  • Are biochemistry interpretative comments helpful? Results of a general practitioner and nurse practitioner survey.

    abstract:BACKGROUND:Adding or incorporating clinical interpretative comments on biochemistry results is widespread in UK laboratories; although this consumes considerable human resource, there is still little evidence to suggest that it is either effective or appreciated by our clinical colleagues. I therefore decided to survey...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章

    doi:10.1258/acb.2007.007134

    authors: Barlow IM

    更新日期:2008-01-01 00:00:00