Objective: To compare the results of two automated analysers by measuring reproductive hormones using the same quality control.
Methods: Results obtained by the Roche Cobas e411 automated analyser in a specialised fertility clinic were compared to the Siemens Centaur CP for the reproductive hormones oestradiol, progesterone, LH, FSH and hCG.
Results: Commercially-available quality control (QC) samples showed significant differences between the two assays for all five hormones at one or more levels. In clinical samples, the range of concentrations encountered was similar to the QC samples for LH and FSH but much higher for oestradiol, progesterone, and hCG showing the limitations of such QC samples in a specialised fertility setting when they are intended for general pathology use. There was a high degree of correlation for all hormones (all r>0.985) and a gradient close to 1 for all, except for hCG when the Siemens analyser read ≥1 000 IU/L (r=1.209) and this is reflected in a large mean bias (-2 647.9 IU/L) and coefficient of repeatability (11 690.0 IU/L) when using a Bland-Altman plot.
Conclusions: Despite an overall agreement between the two assay platforms for progesterone, LH and FSH, small differences between the two analysers in the concentrations of oestradiol and hCG as encountered in natural ovarian cycles or at the time of pregnancy testing may require a redefinition of clinical cut-offs.
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