Artikel
Lizenziert
Nicht lizenziert
Erfordert eine Authentifizierung
Development of a candidate secondary reference procedure (immunoassay based measurement procedure of higher metrological order) for cardiac troponin I: I. Antibody characterization and preliminary validation
-
James E. Noble
Veröffentlicht/Copyright:
1. November 2010
Abstract
In this study, the first steps in the development of a secondary reference measurement procedure (RMP) ‘higher metrological order measurement procedure’ to support the cardiac troponin I (cTnI) standardization initiative is described. The RMP should be used to assign values to serum-based secondary reference materials (RMs) without analytical artifacts causing bias. A multiplexed bead-based assay and sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) were used to identify the optimum monoclonal antibody pair (clones 560 and 19C7) for the RMP. Using these antibodies, an ELISA-based procedure was developed to accurately measure the main cTnI forms present in blood. The proposed RMP appears to show no bias when tested on samples containing various troponin complexes, phosphorylated and dephosphorylated forms, and heparin. The candidate assay displayed suitable linearity and sensitivity (limit of detection, 0.052 μg/L) for the measurement of the proposed cTnI secondary RMs. Preliminary comparison data on patient samples with a commercial cTnI assay are also provided to support the suitability of RMP for value assignment to RMs. Full validation and final assessment of the RMP will be performed through transferability and inter-comparison studies.
Clin Chem Lab Med 2010;48:1603–10.
Keywords: antibody specificity; antigen-antibody reactions; candidate reference procedure; ELISA; reference standards; troponin I
Published Online: 2010-11-01
Published in Print: 2010-11-01
©2010 by Walter de Gruyter Berlin New York
Sie haben derzeit keinen Zugang zu diesem Inhalt.
Sie haben derzeit keinen Zugang zu diesem Inhalt.
Artikel in diesem Heft
- Editorial
- IFCC Scientific Division
- IFCC Documents
- Nucleic acid reference materials (NARMs): definitions and issues
- An appraisal of statistical procedures used in derivation of reference intervals
- An outline for a vocabulary of nominal properties and examinations – basic and general concepts and associated terms
- Review
- Standardizing plasma protein measurements worldwide: a challenging enterprise
- Status Reports
- Standardization activities in the field of thyroid function tests: a status report
- Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: II. Performance of a laboratory network running the HPLC candidate reference measurement procedure and evaluation of a candidate reference material
- Research Articles
- Common reference intervals for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT) in serum: results from an IFCC multicenter study
- Development of a candidate secondary reference procedure (immunoassay based measurement procedure of higher metrological order) for cardiac troponin I: I. Antibody characterization and preliminary validation
- Towards the development of a certified reference material for hemoglobin A2
- Short Communication
- First certified reference material for cystatin C in human serum ERM-DA471/IFCC
- General Clinical Chemistry and Laboratory Medicine
- Increased γ-glutamyltransferase and decreased total bilirubin are associated with metabolic syndrome in Korean postmenopausal women
- Effect of homeostasis model assessment computational method on the definition and associations of insulin resistance
- Association between thyroid hormones, lipids and oxidative stress biomarkers in overt hypothyroidism
- Biochemical markers of particle induced osteolysis in C57BL/6 mice
- An on-line solid phase extraction procedure for the routine quantification of urinary methylmalonic acid by liquid chromatography-tandem mass spectrometry
- Cancer Diagnostics
- Increased integrity of circulating cell-free DNA in plasma of patients with acute leukemia
- The relationship between three heat shock protein 70 gene polymorphisms and susceptibility to lung cancer
- Real-time polymerase chain reaction quantification of free DNA in serum of patients with polyps and colorectal cancers
- Letters to the Editor
- Thyroid hormones are stable even during prolonged frozen storage
- Thyroid hormones after long-term cold storage: stable or unstable, that is the question
- Biomarkers for early detection of mesothelioma in asbestos-exposed subjects
- Mean platelet volume and platelet distribution width are useful in the differential diagnosis of aplastic anemia and idiopathic thrombocytopenic purpura
- Kinetics of highly sensitive troponin I and T after eccentric exercise
- Interferences in red blood cell counting in urinalysis using evacuated tubes
- Congress Abstracts
- 3rd Annual Congress of the Austrian Society for Laboratory Medicine and Clinical Chemistry Salzburg, Austria, 27-30 October 2010
Schlagwörter für diesen Artikel
antibody specificity;
antigen-antibody reactions;
candidate reference procedure;
ELISA;
reference standards;
troponin I
Artikel in diesem Heft
- Editorial
- IFCC Scientific Division
- IFCC Documents
- Nucleic acid reference materials (NARMs): definitions and issues
- An appraisal of statistical procedures used in derivation of reference intervals
- An outline for a vocabulary of nominal properties and examinations – basic and general concepts and associated terms
- Review
- Standardizing plasma protein measurements worldwide: a challenging enterprise
- Status Reports
- Standardization activities in the field of thyroid function tests: a status report
- Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: II. Performance of a laboratory network running the HPLC candidate reference measurement procedure and evaluation of a candidate reference material
- Research Articles
- Common reference intervals for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT) in serum: results from an IFCC multicenter study
- Development of a candidate secondary reference procedure (immunoassay based measurement procedure of higher metrological order) for cardiac troponin I: I. Antibody characterization and preliminary validation
- Towards the development of a certified reference material for hemoglobin A2
- Short Communication
- First certified reference material for cystatin C in human serum ERM-DA471/IFCC
- General Clinical Chemistry and Laboratory Medicine
- Increased γ-glutamyltransferase and decreased total bilirubin are associated with metabolic syndrome in Korean postmenopausal women
- Effect of homeostasis model assessment computational method on the definition and associations of insulin resistance
- Association between thyroid hormones, lipids and oxidative stress biomarkers in overt hypothyroidism
- Biochemical markers of particle induced osteolysis in C57BL/6 mice
- An on-line solid phase extraction procedure for the routine quantification of urinary methylmalonic acid by liquid chromatography-tandem mass spectrometry
- Cancer Diagnostics
- Increased integrity of circulating cell-free DNA in plasma of patients with acute leukemia
- The relationship between three heat shock protein 70 gene polymorphisms and susceptibility to lung cancer
- Real-time polymerase chain reaction quantification of free DNA in serum of patients with polyps and colorectal cancers
- Letters to the Editor
- Thyroid hormones are stable even during prolonged frozen storage
- Thyroid hormones after long-term cold storage: stable or unstable, that is the question
- Biomarkers for early detection of mesothelioma in asbestos-exposed subjects
- Mean platelet volume and platelet distribution width are useful in the differential diagnosis of aplastic anemia and idiopathic thrombocytopenic purpura
- Kinetics of highly sensitive troponin I and T after eccentric exercise
- Interferences in red blood cell counting in urinalysis using evacuated tubes
- Congress Abstracts
- 3rd Annual Congress of the Austrian Society for Laboratory Medicine and Clinical Chemistry Salzburg, Austria, 27-30 October 2010
