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Enzyme-linked immunoassay for plasma-free metanephrines in the biochemical diagnosis of phaeochromocytoma in adults is not ideal

  • Fiona Mullins EMAIL logo , Paula O’Shea , Roland FitzGerald and William Tormey
Published/Copyright: October 8, 2011
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Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 50 Issue 1

Abstract

Background: The aim of the study was to define the analytical and diagnostic performance of the Labor Diagnostica Nord (LDN) 2-Met plasma ELISA assay for fractionated plasma metanephrines in the biochemical diagnosis of phaeochromocytoma.

Methods: The stated manufacturer’s performance characteristics were assessed. Clinical utility was evaluated against liquid chromatography tandem mass spectrometry (LC-MS/MS) using bias, sensitivity and specificity outcomes. Samples (n=73) were collected from patients in whom phaeochromocytoma had been excluded (n=60) based on low probability of disease, repeat negative testing for urinary fractionated catecholamines and metanephrines, lack of radiological and histological evidence of a tumour and from a group (n=13) in whom the tumour had been histologically confirmed. Blood collected into k2EDTA tubes was processed within 30 min. Separated plasma was aliquoted (×2) and frozen at –40°C prior to analyses. One aliquot was analysed for plasma metanephrines using the LDN 2-Met ELISA and the other by LC-MS/MS.

Results: The mean bias of –32% for normetanephrine (ELISA) when compared to the reference method (LC-MS/MS) makes under-diagnosis of phaeochromocytoma likely. The sensitivity of the assay (100%) was equal to the reference method, but specificity (88.3%) lower than the reference method (95%), making it less than optimum for the biochemical diagnosis of phaeochromocytoma.

Conclusions: Plasma-free metanephrines as measured by Labor Diagnostica Nord (LDN) 2-Met ELISA do not display test characteristics that would support their introduction or continuation as part of a screening protocol for the biochemical detection of phaeochromocytoma unless the calibration problem identified is corrected and other more accurate and analytically specific methods remain unavailable.

Keywords: bias; fractionated plasma metanephrines; immunoassay; mass spectrometry; phaeo­chromocytoma; sensitivity; specificity
Corresponding author: Fiona Mullins, Department of Chemical Pathology, Beaumont Hospital, Beaumont Road, Dublin 9, Ireland Phone: +353 1 8092668, Fax: +353 1 8092435
Received: 2011-7-7
Accepted: 2011-9-20
Published Online: 2011-10-08
Published in Print: 2012-01-01

©2011 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/cclm.2011.742
Keywords for this article
bias; fractionated plasma metanephrines; immunoassay; mass spectrometry; phaeo­chromocytoma; sensitivity; specificity

Articles in the same Issue

  1. Editorial
  2. Targeted therapy for HER-2: personalized medicine for her, too
  3. Review
  4. Circulating levels of HER-2/neu oncoprotein in breast cancer
  5. Mini Review
  6. The human epidermal growth factor receptor 2 (HER2)
  7. Opinion Paper
  8. Proposed criteria for sorting examined properties in clinical laboratory reports
  9. Guidelines and Recommendations
  10. Properties and units in the clinical laboratory sciences, Part XXIII. The NPU terminology, principles and implementation –a user’s guide (Technical Report 2011) (IFCC–IUPAC)
  11. Genetics and Molecular Diagnostics
  12. Establishing high resolution melting analysis: method validation and evaluation for c-RET proto-oncogene mutation screening
  13. Decreased mRNA expression of CCL5 [RANTES] in Alzheimer's disease blood samples
  14. General Clinical Chemistry and Laboratory Medicine
  15. A risk-analysis approach to the evaluation of analytical quality
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  18. External quality assessment of point-of-care International Normalized Ratio (INR) testing in Europe
  19. Comparison of two point-of-care testing (POCT) devices for fetal lactate during labor
  20. Simultaneous quantification of 19 drugs/metabolites in urine important for pain management by liquid chromatography-tandem mass spectrometry
  21. Enzyme-linked immunoassay for plasma-free metanephrines in the biochemical diagnosis of phaeochromocytoma in adults is not ideal
  22. The old and new tests for celiac disease: which is the best test combination to diagnose celiac disease in pediatric patients?
  23. Improving diagnosis of adult-type hypolactasia in patients with abdominal complaints
  24. Synovial and serum levels of uncarboxylated matrix Gla-protein (ucMGP) in patients with arthritis
  25. The diagnostic performance of allergen-molecules in comparison to allergen-extracts
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  29. Diurnal variability of total calcium during normal sleep and after an acute shift of sleep
  30. Infections Diseases
  31. Comparison of two immunoassays for determining hepatitis B virus serum markers
  32. Cardiovascular Diseases
  33. Ultra-sensitive troponin I levels to exclude acute myocardial infarction from myocardial injury
  34. Diabetes
  35. Extracellular matrix-associated (GAGs, CTGF), angiogenic (VEGF) and inflammatory factors (MCP-1, CD40, IFN-γ) in type 1 diabetes mellitus nephropathy
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