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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 , David M. Bunk , Robert H. Christenson , Kenneth D. Cole , Hua-Jun He , Alexei G. Katrukha , Mauro Panteghini , Robert A. Porter , Heinz Schimmel , Jillian R. Tate , Lili Wang and on behalf of the IFCC Working Group on Standardization of Troponin I (WG-TNI)
Published/Copyright: November 1, 2010
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Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 48 Issue 11

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
Corresponding authors: James E. Noble, Analytical Science Group, National Physical Laboratory, Teddington, UK Lili Wang, NIST, 100 Bureau Drive MS 8392, Gaithersburg, MD 20899-8392, USA Fax: +44 301 977-0685,
Published Online: 2010-11-01
Published in Print: 2010-11-01

©2010 by Walter de Gruyter Berlin New York

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  1. Editorial
  2. IFCC Scientific Division
  3. IFCC Documents
  4. Nucleic acid reference materials (NARMs): definitions and issues
  5. An appraisal of statistical procedures used in derivation of reference intervals
  6. An outline for a vocabulary of nominal properties and examinations – basic and general concepts and associated terms
  7. Review
  8. Standardizing plasma protein measurements worldwide: a challenging enterprise
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  10. Standardization activities in the field of thyroid function tests: a status report
  11. 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
  12. Research Articles
  13. Common reference intervals for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT) in serum: results from an IFCC multicenter study
  14. 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
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  28. Letters to the Editor
  29. Thyroid hormones are stable even during prolonged frozen storage
  30. Thyroid hormones after long-term cold storage: stable or unstable, that is the question
  31. Biomarkers for early detection of mesothelioma in asbestos-exposed subjects
  32. Mean platelet volume and platelet distribution width are useful in the differential diagnosis of aplastic anemia and idiopathic thrombocytopenic purpura
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  34. Interferences in red blood cell counting in urinalysis using evacuated tubes
  35. Congress Abstracts
  36. 3rd Annual Congress of the Austrian Society for Laboratory Medicine and Clinical Chemistry Salzburg, Austria, 27-30 October 2010
https://doi.org/10.1515/CCLM.2010.316
Keywords for this article
antibody specificity; antigen-antibody reactions; candidate reference procedure; ELISA; reference standards; troponin I

Articles in the same Issue

  1. Editorial
  2. IFCC Scientific Division
  3. IFCC Documents
  4. Nucleic acid reference materials (NARMs): definitions and issues
  5. An appraisal of statistical procedures used in derivation of reference intervals
  6. An outline for a vocabulary of nominal properties and examinations – basic and general concepts and associated terms
  7. Review
  8. Standardizing plasma protein measurements worldwide: a challenging enterprise
  9. Status Reports
  10. Standardization activities in the field of thyroid function tests: a status report
  11. 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
  12. Research Articles
  13. Common reference intervals for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT) in serum: results from an IFCC multicenter study
  14. 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
  15. Towards the development of a certified reference material for hemoglobin A2
  16. Short Communication
  17. First certified reference material for cystatin C in human serum ERM-DA471/IFCC
  18. General Clinical Chemistry and Laboratory Medicine
  19. Increased γ-glutamyltransferase and decreased total bilirubin are associated with metabolic syndrome in Korean postmenopausal women
  20. Effect of homeostasis model assessment computational method on the definition and associations of insulin resistance
  21. Association between thyroid hormones, lipids and oxidative stress biomarkers in overt hypothyroidism
  22. Biochemical markers of particle induced osteolysis in C57BL/6 mice
  23. An on-line solid phase extraction procedure for the routine quantification of urinary methylmalonic acid by liquid chromatography-tandem mass spectrometry
  24. Cancer Diagnostics
  25. Increased integrity of circulating cell-free DNA in plasma of patients with acute leukemia
  26. The relationship between three heat shock protein 70 gene polymorphisms and susceptibility to lung cancer
  27. Real-time polymerase chain reaction quantification of free DNA in serum of patients with polyps and colorectal cancers
  28. Letters to the Editor
  29. Thyroid hormones are stable even during prolonged frozen storage
  30. Thyroid hormones after long-term cold storage: stable or unstable, that is the question
  31. Biomarkers for early detection of mesothelioma in asbestos-exposed subjects
  32. Mean platelet volume and platelet distribution width are useful in the differential diagnosis of aplastic anemia and idiopathic thrombocytopenic purpura
  33. Kinetics of highly sensitive troponin I and T after eccentric exercise
  34. Interferences in red blood cell counting in urinalysis using evacuated tubes
  35. Congress Abstracts
  36. 3rd Annual Congress of the Austrian Society for Laboratory Medicine and Clinical Chemistry Salzburg, Austria, 27-30 October 2010
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