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. 2022 May 10:31:e00279.
doi: 10.1016/j.plabm.2022.e00279. eCollection 2022 Aug.

The Androstenedione Roche Elecsys immunoassay has superior comparability to the LC-MS/MS assay than the Siemens Immulite immunoassay

Ruhan Wei  1 , Kathleen Bowers  1 , Grace M Kroner  1 , Drew Payto  1 , Jessica M Colón-Franco  1
Affiliations

The Androstenedione Roche Elecsys immunoassay has superior comparability to the LC-MS/MS assay than the Siemens Immulite immunoassay

Ruhan Wei et al. Pract Lab Med. .

Abstract

Androstenedione (ASD) is a biomarker used in the diagnostic workup of hyperandrogenism, congenital adrenal hyperplasia, premature adrenarche, and polycystic ovary syndrome (PCOS). The Elecsys ASD competitive electrochemiluminescence immunoassay (Roche Diagnostics, Indianapolis, IN) is a new assay recently available in the US.

Objective: This study evaluated the analytical and clinical performance of the Elecsys ASD assay.

Design & methods: We evaluated the linearity/analytical measuring range (AMR), precision, and accuracy of the Elecsys ASD assay on the cobas e601 analyzer. ASD was measured in serum/plasma in the Elecsys ASD, Immulite (Siemens Medical Solutions USA, Inc. Malvern, PA), and LC-MS/MS assays. Reference intervals (RI) were evaluated across genders, menopausal status, and in children. Statistical analysis was performed using EP evaluator and R program.

Results: The Elecsys ASD assay had a linear response across the AMR. The intra- and inter-assay coefficients of variation at various concentrations were ≤4.5%. The Elecsys ASD assay had a mean difference of -0.04 ng/mL (-1.7%) with the LC-MS/MS assay, whereas the Immulite assay had a mean difference of 1.17 ng/mL (66%) and -1.22 ng/mL (-38%) compared to the LC-MS/MS and Elecsys ASD assays, respectively. The Roche recommended RIs for healthy men (0.280-1.52 ng/mL) and postmenopausal women (0.187-1.07 ng/mL) were successfully verified. The RIs for children were adopted from published data. For pre-menopausal women, a RI of <1.60 ng/mL was established. The ASD concentrations in women with and without PCOS overlapped.

Conclusions: The Elecsys ASD assay has superior comparability to the LC-MS/MS assay than the Immulite assay.

Keywords: Androstenedione; Immunoassay; LC-MS/MS; Polycystic ovary syndrome; Reference interval.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Deming regression, Bland-Altman difference and percent difference plots of three androstenedione assays. Roche Elecsys ASD vs. LC-MS/MS Deming regression (A), Bland-Altman difference and percent difference plots (B–C); Roche Elecsys ASD vs. Siemens Immulite ASD Deming regression (D), Bland-Altman difference and percent difference plots (E–F); Siemens Immulite ASD vs. LC-MS/MS Deming regression (G), Bland-Altman difference and percent difference plots (H–I). In the Bland-Altman plots, the solid thin lines represent the mean, the dotted lines represent 2 SD of the mean, the horizontal histograms show the distribution of the average ASD concentrations, and the vertical histograms show the distribution of the ASD difference and percent difference by the two assays.
Fig. 2
Fig. 2
Androstenedione concentration in the specimens from the healthy women and the PCOS groups.
See this image and copyright information in PMC

References

    1. Jeelani R., Bluth M. In: Williams Textbook of Endocrinology. fourteenth ed. Melmed S., Koenig R., Rosen C., Auchus R., Goldfine A., editors. Elsevier; 2019. Reproductive function and pregnancy.
    1. Ballerini M.G., Gaido V., Rodríguez M.E., Chiesa A., Ropelato M.G. Prospective and descriptive study on serum androstenedione concentration in healthy children from birth until 18 Years of age and its associated factors. Dis. Markers. 2017 doi: 10.1155/2017/9238304. - DOI - PMC - PubMed
    1. Nerenz R., Jungheim E., Gronowski A. In: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. sixth ed. Rifai N., editor. Elsevier; 2018. Reproductive endocrinology and related disorders.
    1. Ceolotto G., Antonelli G., Maiolino G., et al. Androstenedione and 17-α-Hydroxyprogesterone are better indicators of adrenal vein sampling selectivity than cortisol. Hypertension. 2017;70(2):342–346. doi: 10.1161/HYPERTENSIONAHA.117.09415. - DOI - PubMed
    1. Diagnostics S.H. 2018. Siemens Immulite 2000 Androstenedione.

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