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Endocrine Abstracts (2016) 41 EP680 | DOI: 10.1530/endoabs.41.EP680

ECE2016 Eposter Presentations Female Reproduction (42 abstracts)

Validation of the Estradiol III assay (Roche) in the ovulatory phase

Anke Laskewitz 1 , Irene Homminga 2 , Lucie Wagenmakers 3 & Anneke Muller Kobold 3


1Laboratory of Clinical chemistry and Hematology, Certe, Leeuwarden, The Netherlands; 2Department of Obstetrics and Gynaecology, Section Reproductive Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; 3Department of Laboratory Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.


Introduction: Estradiol is an important parameter in the evaluation of female fertility. Moreover, the measurement estradiol is essential in determining the right moment for oocyte retrieval in modified natural cycle IVF (MNC-IVF). Estradiol is measured by an immunochemical method and a change between immunoassays usually comes with a change in reference values due to differences in antibodies used and the lack of harmonization. In our hospital we changed in 2014 from the AutoDELFIA assay (AD) (PerkinELmer) to the Roche method because of continuity. Unfortunately, within a year after the introduction of the Estradiol II assay (E2II) (Roche) the manufacturer introduced of the Estradiol III assay (E2III), leading to another change in reference values which is disturbing continuity in patient care.

Methods: Estradiol levels related to follicle size from patients followed in the (MNC-IVF) in 2013 (using AD) were compared with levels from patients from 2015 (using E2II) by status research. E2III was compared to E2II according to the CLSI EP9 and EP5 protocols. Since the given reference levels between the two assays varied more than the two assays differentiated from each other, especially in the ovulatory phase, the E2III assay was evaluated in 23 patients followed in the MNC-IVF.

Results: The E2II assay results in ~25% higher estradiol levels compared to AD assay. At follicle size 18 mm average estradiol levels were 0,87 nmol/l (E2II) vs. 1,06 nmol/l (AD). Passing-Bablok regression from E2II vs. E2III was E2III=0.02+0.93×E2II over the whole range. In the range used in MNC-IVF patients the comparison was E2III=0.02+0.85×E2II.

Conclusion: The E2III resulted in 15% lower values compared to the E2II in patients in MNC-IVF, but are more comparable to the formerly used AD. However, the median reference value for the ovulatory phase set by the manufacturer was 44% lower, therefore, new reference values should be set.

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