Precision performance at low levels and 99th percentile concentration of the Access AccuTnl assay on two different platforms.

Abstract:

BACKGROUND:Cardiac troponins currently represent the preferred biomarkers for the detection of myocardial necrosis. The objective of the present study was to compare the performance of the Access AccuTnl assay (Beckman Coulter) measured on two different platforms, the UniCel Dxl 800 and the Access 2 (Beckman Coulter). In particular, the serum cardiac troponin I (cTnl) concentration corresponding to 10% coefficient of variation (CV), the cTnl assay minimum detectable concentration (MDC), and the serum cTnl 99th percentile in healthy subjects were calculated. METHODS:The Access AccuTnl is a paramagnetic particle chemiluminescent immunoassay. Imprecision profiles were determined according to the Clinical and Laboratory Standards Institute EP5-A protocol using serum pools. The MDC was calculated as mean +3 SD of 20 determinations of the zero calibrator during one run. The 99th percentile was determined analyzing serum samples from 679 healthy blood donors (523 males, 156 females; 18-71 years old). RESULTS:cTnl concentrations are given in microg/L. 10% CV values (95% confidence interval, CI) were 0.0577 (0.0467-0.0750) (UniCel Dxl 800) and 0.0486 (0.0255-0.0596) (Access 2). MDC values were 0.011 (UniCel Dxl 800) and 0.012 (Access 2). The 99th percentile (95% CI) value was 0.0340 (0.0298-0.0410). CONCLUSIONS:Our data confirm the reliability of the evaluated cTnl assay and demonstrate the comparability of the cTnl values between the platforms studied.

journal_name

Clin Chem Lab Med

authors

Zaninotto M,Mion MM,Novello E,Moretti M,Delprete E,Rocchi MB,Sisti D,Plebani M

doi

10.1515/cclm.2009.080

subject

Has Abstract

pub_date

2009-01-01 00:00:00

pages

367-71

issue

3

eissn

1434-6621

issn

1437-4331

journal_volume

47

pub_type

杂志文章
  • Total iron binding capacity and transferrin concentration in the assessment of iron status.

    abstract::Transferrin concentration and total iron binding capacity (TIBC) are currently used to assess iron status. Although correlation between TIBC and transferrin is generally considered as good, conversion factors between the two analytes found in literature show large differences. Although the price per test is lower for ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2002.176

    authors: Kasvosve I,Delanghe J

    更新日期:2002-10-01 00:00:00

  • Long-distance mountain biking does not disturb the measurement of total, free or complexed prostate-specific antigen in healthy men.

    abstract:PURPOSE:Mechanical manipulation of the prostate is a generally accepted interfering factor for the measurement of prostate-specific antigen (PSA). However, only few studies have focused on common daily mechanical manipulations, such as bicycle riding. Furthermore, physical exercise is also supposed to modulate PSA seru...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2004.061

    authors: Herrmann M,Scharhag J,Sand-Hill M,Kindermann W,Herrmann W

    更新日期:2004-03-01 00:00:00

  • Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods - a prospective multinational trial.

    abstract:BACKGROUND:Procalcitonin (PCT) is increasingly being used for the diagnostic and prognostic work up of patients with suspected infections in the emergency department (ED). Recently, B·R·A·H·M·S PCT direct, the first high sensitive point-of-care test (POCT), has been developed for fast PCT measurement on capillary or ve...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,多中心研究

    doi:10.1515/cclm-2015-0437

    authors: Kutz A,Hausfater P,Oppert M,Alan M,Grolimund E,Gast C,Alonso C,Wissmann C,Kuehn C,Bernard M,Huber A,Mueller B,Schuetz P

    更新日期:2016-04-01 00:00:00

  • Erythrocyte membrane acetylcholinesterase activity in subjects with MTHFR 677C-->T genotype.

    abstract:BACKGROUND:Increased homocysteine (Hcy) blood levels are correlated with vascular and neurological problems. AIM:The aim of the present study was to investigate erythrocyte membrane acetylcholinesterase (AChE) activity in subjects with the MTHFR C677T genotype in relation to Hcy. METHODS:Blood was obtained from 22 in...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2006.005

    authors: Tsakiris S,Schulpis KH,Papaconstantinou ED,Tsakiris T,Tjamouranis I,Giannoulia-Karantana A

    更新日期:2006-01-01 00:00:00

  • Anti DNA antibodies are not restricted to a specific pattern of fluorescence on HEp2 cells.

    abstract:BACKGROUND:Antinuclear autoantibody determination relies on an initial screening step using immunofluorescence on HEp2 cells. This may be followed by anti-deoxyribonucleic acid (DNA) determination, if the fluorescence of nuclei is homogeneous. We assessed the validity of a restricted algorithm and compared this to a mo...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2009.122

    authors: Servais G,Karmali R,Guillaume MP,Badot V,Duchateau J,Corazza F

    更新日期:2009-01-01 00:00:00

  • Faecal haemoglobin concentrations by gender and age: implications for population-based screening for colorectal cancer.

    abstract:BACKGROUND:Faecal immunochemical tests (FIT) are becoming widely used in colorectal cancer screening. Estimation of faecal haemoglobin concentration in a large group prompted an observational study on gender and age. METHODS:A single estimate of faecal haemoglobin concentration was made using quantitative automated im...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2011.815

    authors: McDonald PJ,Strachan JA,Digby J,Steele RJ,Fraser CG

    更新日期:2011-12-07 00:00:00

  • Regulation of inflammatory responses by activated protein C: the molecular mechanism(s) and therapeutic implications.

    abstract::Activated protein C (APC), a natural anticoagulant, is formed from protein C by the action of the thrombin-thrombomodulin (TM) complex on the endothelial cell surface. Endothelial protein C receptor augments the activation of protein C by the thrombin/TM system. APC inactivates the activated form of coagulation factor...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2004.025

    authors: Okajima K

    更新日期:2004-02-01 00:00:00

  • Haemophilia A: molecular insights.

    abstract::Haemophilia A is the most common inherited bleeding disorder caused by defects in the F8C gene that encodes coagulation factor VIII. This X-linked recessive disorder occurs in approximately 1:5000 males. Haemophilia A is diagnosed based on normal prothrombin time, altered activated partial thromboplastin time and redu...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2007.093

    authors: Castaldo G,D'Argenio V,Nardiello P,Zarrilli F,Sanna V,Rocino A,Coppola A,Di Minno G,Salvatore F

    更新日期:2007-01-01 00:00:00

  • Nucleic acid reference materials (NARMs): definitions and issues.

    abstract::Molecular diagnostics is one of the most rapidly growing areas of laboratory medicine. This rapid growth of clinical molecular tests has outpaced the availability and development of reference methods and reference materials. Such methods and materials are important for the development, validation, and interpretation o...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2010.313

    authors: Payne DA,Mamotte CD,Gancberg D,Pazzagli M,van Schaik RH,Schimmel H,Rousseau F,IFCC Committee for Molecular Diagnostics (C-MD).

    更新日期:2010-11-01 00:00:00

  • Investigation on the ability of first trimester glycodelin and angiopoietin-2 to predict small-for-gestational age pregnancies at delivery.

    abstract:BACKGROUND:The aim was to investigate whether first trimester glycodelin and angiopoietin-2 can predict small-for-gestational age (SGA) at delivery, individually or in combination. METHODS:In this case-control study we measured glycodelin and angiopoietin-2 on serum from 170 singleton pregnant women delivering SGA neo...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2015-0989

    authors: Hansen YB,Myrhøj V,Jørgensen FS,Sørensen S

    更新日期:2016-09-01 00:00:00

  • Long-term biological variability of galectin-3 after heart transplantation.

    abstract:BACKGROUND:Galectin-3 is an emerging biomarker of heart failure and of myocardial fibrosis risk. Monitoring of galectin-3 is essential during treatment with galectin-3 inhibitors. The aim of our study was to assess long-term biological variability in a specific group of unhealthy subjects. METHODS:The biological varia...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 临床试验,杂志文章

    doi:10.1515/cclm-2013-1088

    authors: Franeková J,Kubíček Z,Hošková L,Kotrbatá M,Sečník P,Kautzner J,Jabor A

    更新日期:2015-01-01 00:00:00

  • Lipid peroxidation markers in Crohn's disease: the associations and diagnostic value.

    abstract:BACKGROUND:Crohn's disease (CD) is an incurable and difficult to diagnose condition. While high sensitive C-reactive protein (CRP) remains the best biochemical marker, we evaluated the diagnostic usefulness of lipid peroxidation indices. METHODS:Malondialdehyde/thiobarbituric acid-reactive substances (MDA/TBARS), pero...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2011-0817

    authors: Boehm D,Krzystek-Korpacka M,Neubauer K,Matusiewicz M,Paradowski L,Gamian A

    更新日期:2012-03-03 00:00:00

  • Genetic testing for adult-type hypolactasia in Italian families.

    abstract:BACKGROUND:Adult-type hypolactasia is characterized by the inability to digest lactose during adulthood, due to lactase (LCT) deficiency. It is usually diagnosed by the measurement of breath hydrogen increase after a lactose load (breath hydrogen test, BHT). A substitution of C to T at position -13910 bp upstream the L...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2008.189

    authors: Mottes M,Belpinati F,Milani M,Saccomandi D,Petrelli E,Calacoci M,Chierici R,Pignatti PF,Borgna-Pignatti C

    更新日期:2008-01-01 00:00:00

  • Elevated group II phospholipase A2 mass concentration in serum and colonic mucosa in Crohn's disease.

    abstract::Group II phospholipase A2 has been proposed to play an important role in the pathophysiology of inflammatory bowel diseases. This enzyme has also been linked to host defence mechanisms against bacteria. The current study aimed at measuring the mass concentrations of group II phospholipase A2 in serum and colonic mucos...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.1998.133

    authors: Haapamäki MM,Grönroos JM,Nurmi H,Söderlund K,Peuravuori H,Alanen K,Nevalainen TJ

    更新日期:1998-10-01 00:00:00

  • Short-term variability in the concentration of serum interleukin-6 and its soluble receptor in subjectively healthy persons.

    abstract::The effects of the time of the day and breakfast on the outcome of interleukin-6 and its soluble receptor in serum were studied on 22 subjectively health volunteers. We collected blood specimens at 8.00 a.m. after an overnight fast, at 9.30 a.m. after usual breakfast, and at 11.30 a.m. A second group of volunteers (n ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.1998.054

    authors: Dugué B,Leppänen E

    更新日期:1998-05-01 00:00:00

  • Development of a pregnancy-specific reference material for thyroid biomarkers, vitamin D, and nutritional trace elements in serum.

    abstract:Objectives:Matrix differences among serum samples from non-pregnant and pregnant patients could bias measurements. Standard Reference Material 1949, Frozen Human Prenatal Serum, was developed to provide a quality assurance material for the measurement of hormones and nutritional elements throughout pregnancy. Methods:...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2020-0977

    authors: Boggs ASP,Kilpatrick LE,Burdette CQ,Tevis DS,Fultz ZA,Nelson MA,Jarrett JM,Kemp JV,Singh RJ,Grebe SKG,Wise SA,Kassim BL,Long SE

    更新日期:2020-10-26 00:00:00

  • Polymorphisms of coagulation factor genes--a review.

    abstract::Common genetic variants of coagulation factor genes associated with differences in concentration and/or function of coagulation factors have been studied in search of variability that could explain the individual susceptibility to thrombosis and atherothrombotic diseases. The more outstanding polymorphisms in genes of...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.1998.156

    authors: Ferrer-Antunes C

    更新日期:1998-12-01 00:00:00

  • A candidate reference method for serum potassium measurement by inductively coupled plasma mass spectrometry.

    abstract:BACKGROUND:Potassium is an important serum ion that is frequently assayed in clinical laboratories. Quality assurance requires reference methods; thus, the establishment of a candidate reference method for serum potassium measurements is important. METHODS:An inductively coupled plasma mass spectrometry (ICP-MS) metho...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2016-0803

    authors: Yan Y,Han B,Zeng J,Zhou W,Zhang T,Zhang J,Chen W,Zhang C

    更新日期:2017-08-28 00:00:00

  • Clinical relevance of circulating midkine in ulcerative colitis.

    abstract:BACKGROUND:Non-invasive biochemical markers are needed to support the diagnosis of ulcerative colitis (UC), an incurable disease of unknown pathology. Midkine is an angiogenic cytokine, chemotactic towards neutrophils and macrophages, and a T-regulatory cell suppressor. METHODS:Serum midkine was measured immunoenzymat...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2009.248

    authors: Krzystek-Korpacka M,Neubauer K,Matusiewicz M

    更新日期:2009-01-01 00:00:00

  • Multicenter evaluation of the analytical and clinical performance of the Elecsys S100 immunoassay in patients with malignant melanoma.

    abstract::The aim of this multicenter study was to evaluate the technical and clinical performance of the Elecsys S100 electrochemiluminescence immunoassay and to assess its utility as a tumor marker in patients with malignant melanoma. Imprecision studies yielded within-run coefficients of variation (CVs) of 0.7-2.0% and betwe...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,多中心研究

    doi:10.1515/CCLM.2005.097

    authors: Alber B,Hein R,Garbe C,Caroli U,Luppa PB

    更新日期:2005-01-01 00:00:00

  • Cigarette smoking and hypertension influence nitric oxide release and plasma levels of adhesion molecules.

    abstract::Progression of atherosclerosis is currently believed to involve interactions between leukocytes and vascular endothelium. Epidemiological risk factors for atherosclerosis such as hypertension and smoking are known to cause endothelial dysfunction, which is an early event in the atherosclerotic process; they also may b...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2001.136

    authors: Mazzone A,Cusa C,Mazzucchelli I,Vezzoli M,Ottini E,Ghio S,Tossini G,Pacifici R,Zuccaro P

    更新日期:2001-09-01 00:00:00

  • New sequence variants in BRCA1 and BRCA2 genes detected by high-resolution melting analysis in an elderly healthy female population in Croatia.

    abstract:BACKGROUND:Mutations in BRCA1 and BRCA2 genes are associated with family predisposition to breast and ovarian cancer. Novel screening methods are required for efficient and rapid detection of sequence variants in cancer patients and their family members. METHODS:The screening for variants in the breast and ovarian can...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2008.307

    authors: Cvok ML,Cretnik M,Musani V,Ozretic P,Levanat S

    更新日期:2008-01-01 00:00:00

  • Comparison of two reverse transcription-polymerase chain reaction methods for detection of AML1/ETO rearrangement in the M2 subtype of acute myeloid leukaemia.

    abstract::Two reverse transcription-polymerase chain reaction methods to detect the AML1/ETO rearrangement in the M2 subtype of acute myeloid leukaemia those of Downing et al. (Blood 1993; 81: 2860-5) and Satake et al. (Br J Haematol 1995; 91: 892-8) were evaluated. Bone marrow samples, one at diagnosis and two in complete remi...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.1998.026

    authors: Barragán E,Bonanad S,López JA,Bolufer P,Sanz MA

    更新日期:1998-03-01 00:00:00

  • Compensating for the influence of total serum protein in the Schwartz formula.

    abstract:BACKGROUND:The Schwartz 2009 creatinine-based revised formula is the only pediatric GFR estimating formula, which is compatible with the recent global creatinine standardization. This formula is only applicable if enzymatic creatinine methods are used. We propose an equation, taking into account the relative bias cause...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2012-0033

    authors: Speeckaert MM,Wuyts B,Stove V,Walle JV,Delanghe JR

    更新日期:2012-03-09 00:00:00

  • Biovariability of plasma adiponectin.

    abstract:BACKGROUND:Adiponectin is a cytokine produced by adipose tissue with insulin sensitising and anti-atherosclerotic effects. Low plasma adiponectin levels are used as a marker of the metabolic syndrome and incipient type 2 diabetes. METHODS:We carried out a series of studies to determine the short- and long-term variabi...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2006.227

    authors: Shand B,Elder P,Scott R,Frampton C,Willis J

    更新日期:2006-01-01 00:00:00

  • Rule-out of non-ST elevation myocardial infarction by five point of care cardiac troponin assays according to the 0 h/3 h algorithm of the European Society of Cardiology.

    abstract:BACKGROUND:Point of care (POC) assays for cardiac troponins I or T (cTnI or cTnT) may accelerate the diagnosis of patients with suspected acute coronary syndrome (ACS). However, their clinical utility according to the 0 h/3 h algorithm recommended by the European Society of Cardiology (ESC) for non-ST elevation myocard...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2017-0486

    authors: Suh D,Keller DI,Hof D,von Eckardstein A,Gawinecka J

    更新日期:2018-03-28 00:00:00

  • Molecular diagnostics for cardiovascular disease.

    abstract::The etiology of cardiovascular diseases is known to be multi-factorial. Some forms of cardiovascular disease are influenced by unclear genetic factors but are predominantly affected by factors such as diet, obesity, cigarette smoking, diabetes mellitus and dyslipidaemia. Some are caused by specific gene defects, with ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.1998.106

    authors: Pang CP

    更新日期:1998-08-01 00:00:00

  • Validation of a reverse-hybridization StripAssay for the simultaneous analysis of common alpha-thalassemia point mutations and deletions.

    abstract:BACKGROUND:alpha-Thalassemia is a worldwide disease and considered to be a major public health problem in countries within the so-called thalassemia belt. The complex genetics of alpha-thalassemias requires diagnostic methods with the capacity to screen rapidly and accurately for common causative mutations. METHODS:We...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,多中心研究

    doi:10.1515/CCLM.2007.125

    authors: Puehringer H,Najmabadi H,Law HY,Krugluger W,Viprakasit V,Pissard S,Baysal E,Taher A,Farra C,Al-Ali A,Al-Ateeq S,Oberkanins C

    更新日期:2007-01-01 00:00:00

  • Research translation: a new frontier for clinical laboratories.

    abstract::Translational research and translational medicine (referred to hereafter as translational research) are interchangeable terms that underline the pressing need to translate into practical benefits for those affected by disease the extensive investments divested by the private and public sectors in biomedical research. ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/CCLM.2006.238

    authors: Plebani M,Marincola FM

    更新日期:2006-01-01 00:00:00

  • Evaluation of serum levels of p53 in hepatocellular carcinoma in Egypt.

    abstract::Hepatocellular carcinoma (HCC) is one of the most common causes of cancer-induced death. Somatic mutation of the p53 gene is the most common genetic abnormality so far described in human cancer and there is evidence that supports a high level of p53 alterations in HCC. The aim of this study was to investigate serum le...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2006.091

    authors: El Far MA,Atwa MA,Yahya RS,El Basuni MA

    更新日期:2006-01-01 00:00:00