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 Biochemjournal_title
Annals of clinical biochemistryauthors
Jassam N,Lindsay C,Harrison K,Thompson D,Bosomworth MP,Barth JHdoi
10.1258/acb.2010.010005subject
Has Abstractpub_date
2011-03-01 00:00:00pages
136-46issue
Pt 2eissn
0004-5632issn
1758-1001pii
acb.2010.010005journal_volume
48pub_type
杂志文章abstract::It is our aim to summarise and discuss procedures for the evaluation of the concentration of free ionised calcium in serum or plasma. Stress is laid upon the interrelations and relative validity of the most common algebraic expressions to appraise the calcium status. The multitude of formulae proposed in the literatur...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章,评审
doi:10.1177/000456328402100501
更新日期:1984-09-01 00:00:00
abstract:BACKGROUND:Extraction followed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis is the method of choice when it comes to the accurate quantification of 25-OH-vitamin D in blood samples. It is generally assumed that the addition of exogenous internal standard allows for the determination of the endo...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/0004563214533316
更新日期:2015-01-01 00:00:00
abstract::Pancreatic elastase 1 (E1), a digestive protease, is synthesized by the acinar cells of the pancreas. Using an enzyme-linked immunosorbent assay, we evaluated stool E1 levels in the following groups of patients. (a) Specimens submitted for occult blood examination from 20 adults, over 3 consecutive days, to assess the...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456329903600606
更新日期:1999-11-01 00:00:00
abstract::The influence of the glucose concentration in urines being assayed as part of a pancreolauryl test was investigated. Paired patient urines (n = 5) were assayed at 60 degrees and 70 degrees C, before and after spiking to 5% glucose. The influence of assay temperature alone was assessed using glucose-free paired patient...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456329803500212
更新日期:1998-03-01 00:00:00
abstract:BACKGROUND:In humans, leptin circulates in a free form and is also bound to macromolecules. The aim of the present study was to compare a rapid acid-ethanol precipitation (AEP) method of measuring bound leptin with the more laborious gel exclusion chromatography (GEC) reference procedure. Serum samples collected from h...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1258/000456303763046157
更新日期:2003-03-01 00:00:00
abstract::Erythrocyte and fasting plasma magnesium were assayed by a dyebinding colorimetric method using the metallochromic dye, Calmagite, in 51 diabetic Nigerians and 25 controls. Erythrocyte magnesium concentrations were similar in the diabetics and the controls. Fasting plasma magnesium concentrations were significantly lo...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456328902600111
更新日期:1989-01-01 00:00:00
abstract::The purpose of this study was to assess retrospectively the prevalence of severe hyponatraemia in a hospital population and its laboratory investigation, treatment and clinical outcome. Over a 6-month period 47 patients (27 women and 20 men) were found to have a plasma sodium concentration of < or = 120 mmol/L (this n...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456329903600204
更新日期:1999-03-01 00:00:00
abstract::Experience in the use of an in-house urinary free catecholamine assay for the investigation of possible neural crest tumours in a District General Hospital laboratory is described. Elevated excretion of catecholamines and vanillylmandelic acid was found in a number of cases including phaeochromocytoma and neuroblastom...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456328702400512
更新日期:1987-09-01 00:00:00
abstract::The seasonal variation of serum 25-hydroxy vitamin D3 and 1,25-dihydroxy-vitamin D has been investigated. Blood was taken from 27 healthy volunteers, aged 21-44 years old at 3 monthly intervals over a period of 1 year. A scrolling monthly programme with 12 quarterly (3 month) time periods was developed. A summer assoc...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456329403100105
更新日期:1994-01-01 00:00:00
abstract::ISO 22870 standards require protocols for performance of internal quality control for all point-of-care testing devices and training of users in its theory and practice. However, the unique setting of point-of-care testing (i.e. processes conducted by non-scientific users) means that laboratory internal quality contro...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章,评审
doi:10.1177/0004563215615148
更新日期:2016-03-01 00:00:00
abstract::Despite sonographic detection of foetal goitre, uncertainty persists in the initial diagnosis of thyrotoxicosis and hypothyroidism. The aim of this study was to establish foetal and neonatal iodothyronine and thyrotrophin reference values for the ACS-180SE analyser. From 22 to 36 weeks of gestation, median foetal seru...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456320103800509
更新日期:2001-09-01 00:00:00
abstract::We have made an evaluation of glycosylated haemoglobin measurements by affinity chromatography in a paediatric population. Age-related reference values for non-diabetic infants and children are reported. A poor correlation (r = 0.24) was found between glycosylated haemoglobin values in 26 insulin-dependent diabetic ch...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456328602300407
更新日期:1986-07-01 00:00:00
abstract:BACKGROUND:We evaluated the recently released chemiluminescence assay for 25-hydroxy vitamin D (25-OHD) on the Immunodiagnostic Systems iSYS (IDS-iSYS) automated analyser. METHODS:The IDS-iSYS comparison was performed using patient samples previously measured for 25-OHD by a validated liquid chromatography-tandem mass...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1258/acb.2011.011018
更新日期:2012-03-01 00:00:00
abstract::Fasting glycosylated haemoglobin was analysed in 535 consecutive patients having an oral 75 g glucose tolerance test for diagnostic purposes. A reference range for fasting glycosylated haemoglobin was established from patients with a non-diabetic glucose tolerance test as defined by the World Health Organisation Exper...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456328502200106
更新日期:1985-01-01 00:00:00
abstract::Tiaprofenic acid is a non-steroidal anti-inflammatory drug which also has hypouriceamic effect. Studies involving 10 healthy volunteers were designed to investigate the mode of this effect. We postulate that the site of action of tiaprofenic acid is at the cell membrane, the mechanism being an interference with the tr...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456328802500601
更新日期:1988-11-01 00:00:00
abstract::Background After adrenalectomy, urinary fractionated metanephrine concentrations are expected to be reduced. However, there are few studies suggesting cut-offs for adrenalectomy patients. Methods Urinary metanephrine and normetanephrine concentrations in adrenalectomy patients and two controls were compared and hormon...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/0004563215620822
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:It has been suggested that for the accurate measurement of calcium in urine, samples must be collected into bottles containing acid. Acidification poses risks to both patients and laboratory staff. Here we reappraise whether acidification is a preanalytical necessity. METHODS:Twenty-four-hour urine samples ...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1258/acb.2009.009027
更新日期:2009-11-01 00:00:00
abstract:BACKGROUND:To investigate the reasons why general practitioners (GPs) request rheumatoid factor (RF) assays, we studied 200 consecutive requests for RF from general practice in 1995. METHOD:By means of an audit questionnaire, we studied 100 negative, 50 positive and 50 borderline RF results and compared these with the...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1258/000456303763046049
更新日期:2003-03-01 00:00:00
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
更新日期:1985-11-01 00:00:00
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
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:The reporting interval is the incremental value chosen in reporting analyte concentration. Reporting intervals for different analytes are often inappropriately narrow, when analytical imprecision and biological variability are considered. METHODS:We have used statistical techniques to determine intervals fo...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1258/0004563041731583
更新日期:2004-09-01 00:00:00
abstract:BACKGROUND:About 10 years ago, a survey showed significant deficiencies in the quality of gastrointestinal investigations performed by UK laboratories. Subsequently, several clinical guidelines have been developed and external quality assessment schemes introduced. This survey was performed to assess whether earlier de...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1258/000456307780117911
更新日期:2007-03-01 00:00:00
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
更新日期:1982-01-01 00:00:00
abstract:BACKGROUND:Circulating levels of bioavailable oestradiol and testosterone are often desirable for clinical practice or investigational studies of children. However, assays to measure circulating hormone levels might not always be accessible. We sought to validate the empirical calculation of circulating bioavailable te...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章,随机对照试验
doi:10.1258/acb.2010.009112
更新日期:2010-05-01 00:00:00
abstract:BACKGROUND:For nearly 20 years, we and others have used a three-parameter power function as a direct estimation error model for immunoassays. The main application is imprecision profile plots (after translating from variance to coefficient of variation) but other uses include weighting functions for regression analysis...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1258/acb.2008.007230
更新日期:2008-09-01 00:00:00
abstract::Simultaneous localisation of the isoenzymes of alkaline phosphatase and gamma-glutamyl transferase was carried out on 173 serum samples from patients with hepatobiliary and bone disease to determine (i) if a better discrimination of the underlying pathology could be obtained by such an approach, and (ii) if the pathol...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456328001700104
更新日期:1980-01-01 00:00:00
abstract::Erythrocuprein (superoxide dismutase) has recently been shown to have an enzymic function towards superoxide anions. The discovery of superoxide dismutase, its mode of action, and estimation are reviewed along with a brief introduction to oxygen activation and free-radical chemistry. The formation, activity, and destr...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456327601300125
更新日期:1976-05-01 00:00:00
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
更新日期:1988-03-01 00:00:00
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
更新日期:1990-09-01 00:00:00
abstract::Three sensitive assays (Behring, Organon and LKB-Pharmacia) for measurement of serum thyrotropin (TSH) were evaluated. All three assays showed good precision, sensitivity, linearity and for practical purposes negligible high dose hook effects. The correlations between the assays were excellent, but due to standardisat...
journal_title:Annals of clinical biochemistry
pub_type: 杂志文章
doi:10.1177/000456328902600609
更新日期:1989-11-01 00:00:00