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

Hdl Handle:
http://hdl.handle.net/10147/207321
Title:
Enzyme-linked immunoassay for plasma-free metanephrines in the biochemical diagnosis of phaeochromocytoma in adults is not ideal.
Affiliation:
Department of Chemical Pathology, Beaumont Hospital, Dublin, Ireland.
Citation:
Clin Chem Lab Med. 2011 Oct 8.
Journal:
Clinical chemistry and laboratory medicine : CCLM / FESCC
Issue Date:
1-Feb-2012
URI:
http://hdl.handle.net/10147/207321
DOI:
10.1515/CCLM.2011.742
PubMed ID:
21981378
Abstract:
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 k(2)EDTA tubes was processed within 30 min. Separated plasma was aliquoted (x2) and frozen at -40 degrees 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.
Language:
ENG
ISSN:
1434-6621 (Electronic); 1434-6621 (Linking)

Full metadata record

DC FieldValue Language
dc.date.accessioned2012-02-01T10:04:48Z-
dc.date.available2012-02-01T10:04:48Z-
dc.date.issued2012-02-01T10:04:48Z-
dc.identifier.citationClin Chem Lab Med. 2011 Oct 8.en_GB
dc.identifier.issn1434-6621 (Electronic)en_GB
dc.identifier.issn1434-6621 (Linking)en_GB
dc.identifier.pmid21981378en_GB
dc.identifier.doi10.1515/CCLM.2011.742en_GB
dc.identifier.urihttp://hdl.handle.net/10147/207321-
dc.description.abstractAbstract 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 k(2)EDTA tubes was processed within 30 min. Separated plasma was aliquoted (x2) and frozen at -40 degrees 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.en_GB
dc.language.isoENGen_GB
dc.titleEnzyme-linked immunoassay for plasma-free metanephrines in the biochemical diagnosis of phaeochromocytoma in adults is not ideal.en_GB
dc.contributor.departmentDepartment of Chemical Pathology, Beaumont Hospital, Dublin, Ireland.en_GB
dc.identifier.journalClinical chemistry and laboratory medicine : CCLM / FESCCen_GB
dc.description.provinceLeinster-
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