2021
DOI: 10.1093/ajcp/aqab189.017
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Comparison of three serum androstenedione assays: the Siemens Immulite immunoassay, the Roche Elecsys immunoassay, and an LC-MS/MS assay

Abstract: Introduction Serum androstenedione (ASD) is a useful biomarker in the diagnostic workup of hyperandrogenism, congenital adrenal hyperplasia, premature adrenarche, and polycystic ovary syndrome (PCOS). Recently, the Elecsys ASD assay (Roche Diagnostics), a competitive electrochemiluminescence immunoassay, became available in the US. Herein, the analytical and clinical performance of the Elecsys ASD assay was tested and compared with the Immulite assay (our current assay) and an LC-MS/MS assay … Show more

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“…In the light of high accuracy of the LC-MS/MS method in the validation experiments (UK NEQAS proficiency testing), it seems obvious that the found differences are mainly caused by analytical problems of the IA. Several previous studies and data of the UK NEQAS scheme are available for the Siemens assay, which all clearly substantiate our findings for the high inaccuracy in measuring ANDRO [ 56 , 59 , 60 ].…”
Section: Discussionsupporting
confidence: 89%
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“…In the light of high accuracy of the LC-MS/MS method in the validation experiments (UK NEQAS proficiency testing), it seems obvious that the found differences are mainly caused by analytical problems of the IA. Several previous studies and data of the UK NEQAS scheme are available for the Siemens assay, which all clearly substantiate our findings for the high inaccuracy in measuring ANDRO [ 56 , 59 , 60 ].…”
Section: Discussionsupporting
confidence: 89%
“…There are initiatives of IA manufacturers for further enhancements by calibration against reference methods. For example, a new assay for ANDRO was announced by Roche that demonstrated much better agreement with LC-MS/MS than previous IAs [ 59 ].…”
Section: Discussionmentioning
confidence: 99%