Original scientific paper

https://doi.org/10.11613/BM.2020.030701

Analytical bias of automated immunoassays for six serum steroid hormones assessed by LC-MS/MS

Željko Debeljak ; Clinical Institute of Laboratory Diagnostics, Osijek University Hospital, Osijek, Croatia; Faculty of Medicine, JJ Strossmayer University of Osijek, Osijek, Croatia
Ivana Marković ; Clinical Institute of Laboratory Diagnostics, Osijek University Hospital, Osijek, Croatia; Faculty of Medicine, JJ Strossmayer University of Osijek, Osijek, Croatia
Jasna Pavela ; Clinical Institute of Laboratory Diagnostics, Osijek University Hospital, Osijek, Croatia; Faculty of Medicine, JJ Strossmayer University of Osijek, Osijek, Croatia
Iva Lukić ; Clinical Institute of Laboratory Diagnostics, Osijek University Hospital, Osijek, Croatia; Faculty of Medicine, JJ Strossmayer University of Osijek, Osijek, Croatia
Dario Mandić ; Clinical Institute of Laboratory Diagnostics, Osijek University Hospital, Osijek, Croatia; Faculty of Medicine, JJ Strossmayer University of Osijek, Osijek, Croatia
Sanja Mandić ; Clinical Institute of Laboratory Diagnostics, Osijek University Hospital, Osijek, Croatia; Faculty of Medicine, JJ Strossmayer University of Osijek, Osijek, Croatia
Vesna Horvat ; Clinical Institute of Laboratory Diagnostics, Osijek University Hospital, Osijek, Croatia; Faculty of Medicine, JJ Strossmayer University of Osijek, Osijek, Croatia
Vatroslav Šerić ; Clinical Institute of Laboratory Diagnostics, Osijek University Hospital, Osijek, Croatia; Faculty of Medicine, JJ Strossmayer University of Osijek, Osijek, Croatia

Abstract

Introduction: There is a growing amount of evidence showing the significant analytical bias of steroid hormone immunoassays, but large number
of available immunoassays makes conduction of a single comprehensive study of this issue hardly feasible. Aim of this study was to assess
the analytical bias of six heterogeneous immunoassays for serum aldosterone, cortisol, dehydroepiandrosterone sulphate (DHEAS), testosterone,
17-hydroxyprogesterone (OHP) and progesterone using the liquid chromatography coupled to the tandem mass spectrometry (LC-MS/MS).
Materials and methods: This method comparison study included 49 serum samples. Testosterone, DHEAS, progesterone and cortisol immunoassays
were performed on the Abbott Architect i2000SR or Alinity i analysers (Abbott Diagnostics, Chicago, USA). DiaSorin’s Liaison (DiaSorin, Saluggia,
Italy) and DIAsource’s ETI-Max 3000 analysers (DIAsource ImmunoAssays, Louvain-La-Neuve, Belgium) were chosen for aldosterone and OHP
immunoassay testing, respectively. All immunoassays were evaluated against the LC-MS/MS assay relying on the commercial kit (Chromsystems,
Gräfelfing, Germany) and LCMS-8050 analyser (Shimadzu, Kyoto, Japan). Analytical biases were calculated and method comparison was conducted
using weighted Deming regression analysis.
Results: Depending on the analyte and specific immunoassay, mean relative biases ranged from -31 to + 137%. Except for the cortisol, immunoassays
were positively biased. For none of the selected steroids slope and intercept 95% confidence intervals simultaneously contained 0 and 1,
respectively.
Conclusions: Evaluated immunoassays failed to satisfy requirements for methods’ comparability and produced significant analytical biases in respect
to the LC-MS/MS assay, especially at low concentrations.

Keywords

steroid hormone; immunoassay; bias; LC-MS/MS; method comparison

Hrčak ID:

244724

URI

https://hrcak.srce.hr/244724

Publication date:

15.10.2020.

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