Analytical performance of a new two-step ADVIA Centaur® estradiol immunoassay during ovarian stimulation
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Catherine Massart
, Jacqueline Gibassier , Marie-Christine Laurent and Dominique Le Lannou
Abstract
Measurement of estradiol is useful in women undergoing ovarian stimulation for in vitro fertilization and embryo transfer (IVF-ET). The analytical performance of a new two-step estradiol assay (ADVIA Centaur® estradiol-6 III from Bayer Diagnostics) was evaluated in 41 sera from 11 women undergoing ovarian stimulation. The results were compared to those obtained with two radioimmunoassays (RIAs; RIA Estradiol Immunotech IM 1663 from Beckmann Coulter and Coat-A-Count Estradiol from Diagnostic Products Corporation) and with one chemiluminescent immunoassay (CLIA; ADVIA Centaur® estradiol-6). The ADVIA Centaur® estradiol-6 III assay was the most sensitive assay, with a functional sensitivity of 55pmol/L. Within- and between-run coefficients of variation calculated for the new ADVIA Centaur® assay ranged from 3.3% to 9%, which was better than the precision obtained for the other assays. A dilution test showed serum interferences when estradiol was measured in non-diluted samples. No statistical difference was observed between the estradiol results obtained in diluted sera with the new two-step ADVIA Centaur® assay and those measured with the Immunotech RIA and the other CLIA. In conclusion, this new, two-step estradiol assay performed on the ADVIA Centaur® system displays suitable sensitivity, precision and intermethod agreement with the Immunotech RIA for the measurement of serum estradiol concentrations in women undergoing ovarian stimulation and IVF-ET. For correct linearity, estradiol measurement should be performed on diluted samples.
References
1. Vargyas JM, Marrs RP, Kletzky OA, Mishell DR Jr. Correlation of ultrasonic measurement of ovarian follicle size and serum estradiol levels in ovulatory patients following clomifene citrate for in vitro fertilization. Am J Obstet Gynecol 1982; 144:569–73.10.1016/0002-9378(82)90229-0Search in Google Scholar
2. Fossum GT, Vermesh M, Kletzky OA. Biochemical and biophysical indices of follicular development in spontaneous and stimulated ovulatory cycles. Obstet Gynecol 1990; 75:407–11.Search in Google Scholar
3. Sushanek E, Huderer K, Dobec D, Hlavati V, Simunic V, Grizelj V. Number of follicles, oocytes and embryos in human in vitro fertilization is relative to serum estradiol and progesterone patterns during different types of ovarian hyperstimulation. Eur Gynecol Reprod Biol 1994: 56:121–7.10.1016/0028-2243(94)90268-2Search in Google Scholar
4. Hugues EG, Fedorkow DM, Daya S, Sagle MA, Van de Koppel P, Collins JA. The routine use of gonadotropin-releasing hormone agonists prior to in vitro fertilization and gamete intra-Fallopian transfer: a meta-analysis of randomized controlled trials. Fertil Steril 1992; 58:888–96.10.1016/S0015-0282(16)55430-2Search in Google Scholar
5. Schioler V, Thode J. Six direct radioimmunoassay of estradiol evaluated. Clin Chem 1988; 34:949–52.10.1093/clinchem/34.5.949Search in Google Scholar
6. Tummon I, Stemp J, Rose C, Vanderberghe H, Bany B, Tekpetey F, et al. Precision and method bias of two assays for estradiol: consequences for decisions in assisted reproduction. Hum Reprod 1999: 14:1175–7.10.1093/humrep/14.5.1175Search in Google Scholar PubMed
7. Taieb J, Benattar C, Birr AS, Lindenbaum A. Limitations of steroid determination by direct immunoassay. Clin Chem 2002; 48:583–5.10.1093/clinchem/48.3.583Search in Google Scholar
8. Spencer CA, Takeuchi M, Kararosyan M. Current status and performance goals for serum thyrotropin (TSH) assays. Clin Chem 1996; 43:140–5.10.1093/clinchem/42.1.140Search in Google Scholar
9. Yuzpe AA, Nisker JA, Kaplan BR, Tummon IS, Auckland J. Nafarelin acetate for down regulation in in vitro fertilization. J Reprod Med 1995; 40:83–8.Search in Google Scholar
10. Taieb J, Benattar C, Diop R, Birr AS, Lindenbaum A. Use of the Architect-i2000 estradiol immunoassay during in vitro fertilization. Clin Chem 2003; 49:183–6.10.1373/49.1.183Search in Google Scholar PubMed
11. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1:307–10.Search in Google Scholar
12. Mikkelsen AL, Borggaard B, Lebech PE. Results of serial measurement of estradiol in serum with six different methods during ovarian stimulation. Gynecol Obstet Invest 1996; 41:35–40.10.1159/000292032Search in Google Scholar PubMed
13. Lee CS, Smith NM, Kahn SN. Analytical variability and clinical significance of different assays for serum estradiol. J Reprod Med 1991; 36:156–60.Search in Google Scholar
14. Anttila L, Koskinen P, Irjala K, Kaihola HL. Reference intervals for serum sex steroids and gonadotropins in regularly menstruating women. Acta Obstet Gynecol Scand 1991; 70:475–81.10.3109/00016349109007163Search in Google Scholar PubMed
15. Potischman N, Falk RT, Laiming VA, Siiteri PK, Hoover RN. Reproducibility of laboratory assays for steroid hormones and sex hormone-binding globulin. Cancer Res 1994; 54;5363–7.Search in Google Scholar
16. Buttner J. Philosophy of measurement by means of immunoassays. Scand J Clin Lab Invest 1991; 205:11–20.10.3109/00365519109104598Search in Google Scholar PubMed
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