Pathology
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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. ⋯ 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.
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Reliable reporting of laboratory results is an important component in the diagnosis and management of infectious diseases. We investigated the frequency of pre- and post-analytical errors by participants in the Royal College of Pathologists of Australasia (RCPA) Microbiology Quality Assurance Program (MQAP). ⋯ Pre- and post-analytical errors are not rare amongst participants in the RCPA MQAP. These non-analytical components of the testing pathway require improvement because of their potential to adversely affect patient care.