Overreporting of vitamin D deficiency by the Roche Elecsys vitamin D3 (25-OH) method

Connell, A. B., Jenkins, N., Black, M., Pasco, J. A., Kotowicz, M. A. and Schneider, H. G. 2011, Overreporting of vitamin D deficiency by the Roche Elecsys vitamin D3 (25-OH) method, Pathology, vol. 43, no. 4, pp. 368-371, doi: 10.1097/PAT.0b013e328346431c.

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Title Overreporting of vitamin D deficiency by the Roche Elecsys vitamin D3 (25-OH) method
Author(s) Connell, A. B.
Jenkins, N.
Black, M.
Pasco, J. A.ORCID iD for Pasco, J. A. orcid.org/0000-0002-8968-4714
Kotowicz, M. A.ORCID iD for Kotowicz, M. A. orcid.org/0000-0002-8094-1411
Schneider, H. G.
Journal name Pathology
Volume number 43
Issue number 4
Start page 368
End page 371
Total pages 4
Publisher Lippincott Williams & Wilkins
Place of publication London, U. K.
Publication date 2011-06
ISSN 0031-3025
Keyword(s) cholecalciferol
vitamin D
vitamin D deficiency
Summary Background: Vitamin D deficiency is common. Recently Roche Diagnostics removed their Elecsys Vitamin D3 (25OH) electrochemiluminescence immunoassay (ECLIA) from use, citing deteriorating traceability to the reference method (liquid chromatography tandem mass spectrometry; LCMSMS). We investigated the performance of the Roche assay (2 assay formulations) against an LCMSMS method and the widely used DiaSorin radioimmunoassay (RIA) method.

Methods: Two sets of samples from separate populations were assayed for vitamin D. The first set was assayed using three different methods: RIA (DiaSorin) in 2004, polyclonal ECLIA (Roche) in early 2009 and LCMSMS in early 2010. The second set was assayed using polyclonal and monoclonal ECLIA (Roche) and LCMSMS in mid-2010.

Results: The correlation of the polyclonal ECLIA with the RIA was poor (ECLIA = 0.45 x RIA + 19, r2 = 0.59, n = 773). LCMSMS results correlated with RIA (RIA = 0.86 x LCMSMS + 4, r2 = 0.69, n = 49) better than with polyclonal ECLIA (polyclonal ECLIA = 0.55 x LCMSMS + 6, r2 = 0.62, n = 55) despite a storage interval of 6 years.

In recently collected samples monoclonal and polyclonal immunoassays gave similar results (monoclonal ECLIA = 0.93 polyclonal ECLIA -3, r2 = 0.60, n = 153). The correlation between monoclonal Roche ECLIA and LCMSMS in these samples was very poor (monoclonal ECLIA = 0.31 x LCMSMS + 23, r2 = 0.27).

Conclusions: At the time of its removal from the market, the Roche Elecsys Vitamin D3 (25OH) assay showed unacceptable performance, underestimating vitamin D levels. It seems that this bias preceded the introduction of the monoclonal assay. The worldwide distribution of the assay and the duration of this bias likely led to a significant number of patients starting supplementation unnecessarily.
Language eng
DOI 10.1097/PAT.0b013e328346431c
Field of Research 110399 Clinical Sciences not elsewhere classified
Socio Economic Objective 920199 Clinical Health (Organs, Diseases and Abnormal Conditions) not elsewhere classified
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2011, Royal College of Pathologists of Australasia
Persistent URL http://hdl.handle.net/10536/DRO/DU:30042769

Document type: Journal Article
Collection: School of Medicine
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