Clinical and Experimental Reproductive Medicine

The Korean Society for Reproductive Medicine (대한생식의학회)
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Measurement of serum anti-Müllerian hormone by revised Gen II or automated assay: Reproducibility under various blood/serum storage conditions

  • Received : 2022.09.23
  • Accepted : 2023.02.23
  • Published : 2023.06.30
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Abstract

Objective: We investigated the agreement between anti-Müllerian hormone (AMH) levels measured with revised Gen II (rev-Gen II) and automated AMH (Access) assays and evaluated the reproducibility of each method under various blood/serum storage conditions. Methods: AMH levels in blood samples from 74 volunteers were measured by rev-Gen II and Access assays under various conditions: immediate serum separation and AMH measurement (fresh control); serum stored at -20 ℃ and AMH measured after 48 hours, 1 week, and 2 years; serum stored at 0 to 4 ℃ and AMH measured after 48 hours and 1 week; and blood kept at room temperature and delayed serum separation after 48 hours and 1 week, with immediate AMH measurement. Results: In fresh controls, all rev-Gen II-AMH values were higher than comparable Access-AMH values (difference, 8.3% to 19.7%). AMH levels measured with the two methods were strongly correlated for all sample conditions (r=0.977 to 0.995, all p<0.001). For sera stored at -20 ℃ or 0 to 4 ℃ for 48 hours, Access-AMH values were comparable to control measurements, but rev-Gen II-AMH values were significantly lower. AMH levels in sera stored at -20 ℃ or 0 to 4 ℃ for 1 week were significantly lower than in fresh controls, irrespective of method. Across methods, long-term storage at -20 ℃ for 2 years yielded AMH measurements significantly higher than control values. When serum separation was delayed, rev-Gen II-AMH values were significantly lower than control measurements, but Access-AMH values varied. Conclusion: The rev-Gen II and Access-AMH assays showed varying reproducibility across blood/serum storage conditions, but automated Access yielded superior stability to rev-Gen II.

Keywords

Acknowledgement

The authors are very grateful to Doyeong Hwang and Ki Chul Kim for their insightful comments on the article.

References

  1. Dewailly D, Andersen CY, Balen A, Broekmans F, Dilaver N, Fanchin R, et al. The physiology and clinical utility of anti-Mullerian hormone in women. Hum Reprod Update 2014;20:370-85. https://doi.org/10.1093/humupd/dmt062
  2. Kumar A, Kalra B, Patel A, McDavid L, Roudebush WE. Development of a second generation anti-Mullerian hormone (AMH) ELISA. J Immunol Methods 2010;362:51-9. https://doi.org/10.1016/j.jim.2010.08.011
  3. Schiffner J, Roos J, Broomhead D, Helden JV, Godehardt E, Fehr D, et al. Relationship between anti-Mullerian hormone and antral follicle count across the menstrual cycle using the Beckman Coulter Access assay in comparison with Gen II manual assay. Clin Chem Lab Med 2017;55:1025-33. https://doi.org/10.1515/cclm-2016-0609
  4. Nelson SM, Pastuszek E, Kloss G, Malinowska I, Liss J, Lukaszuk A, et al. Two new automated, compared with two enzyme-linked immunosorbent, antimullerian hormone assays. Fertil Steril 2015;104:1016-21. https://doi.org/10.1016/j.fertnstert.2015.06.024
  5. Rynning M, Wentzel-Larsen T, Bolann BJ. A model for an uncertainty budget for preanalytical variables in clinical chemistry analyses. Clin Chem 2007;53:1343-8. https://doi.org/10.1373/clinchem.2007.086371
  6. Rustamov O, Smith A, Roberts SA, Yates AP, Fitzgerald C, Krishnan M, et al. The measurement of anti-Mullerian hormone: a critical appraisal. J Clin Endocrinol Metab 2014;99:723-32. https://doi.org/10.1210/jc.2013-3476
  7. Demirdjian G, Bord S, Lejeune C, Masica R, Riviere D, Nicouleau L, et al. Performance characteristics of the Access AMH assay for the quantitative determination of anti-Mullerian hormone (AMH) levels on the Access family of automated immunoassay systems. Clin Biochem 2016;49:1267-73. https://doi.org/10.1016/j.clinbiochem.2016.08.005
  8. Dehghan A, Dupuis J, Barbalic M, Bis JC, Eiriksdottir G, Lu C, et al. Meta-analysis of genome-wide association studies in > 80 000 subjects identifies multiple loci for C-reactive protein levels. Circulation 2011;123:731-8. https://doi.org/10.1161/CIRCULATIONAHA.110.948570
  9. Morse H, Ora I, Turkiewicz A, Andersen CY, Becker C, Isaksson A, et al. Reliability of AMH in serum after long-term storage at -80℃ and an extended thawing episode. Ann Clin Lab Res 2016;4:61.
  10. Fleming R, Fairbairn C, Blaney C, Lucas D, Gaudoin M. Stability of AMH measurement in blood and avoidance of proteolytic changes. Reprod Biomed Online 2013;26:130-2. https://doi.org/10.1016/j.rbmo.2012.11.005
  11. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999;8:135-60. https://doi.org/10.1177/096228029900800204
  12. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Int J Nurs Stud 2010;47:931-6.
  13. van Helden J, Weiskirchen R. Performance of the two new fully automated anti-Mullerian hormone immunoassays compared with the clinical standard assay. Hum Reprod 2015;30:1918-26. https://doi.org/10.1093/humrep/dev127
  14. Pearson K, Long M, Prasad J, Wu YY, Bonifacio M. Assessment of the Access AMH assay as an automated, high-performance replacement for the AMH Generation II manual ELISA. Reprod Biol Endocrinol 2016;14:8.
  15. Dewitte K, Fierens C, Stockl D, Thienpont LM. Application of the Bland-Altman plot for interpretation of method-comparison studies: a critical investigation of its practice. Clin Chem 2002;48:799-801. https://doi.org/10.1093/clinchem/48.5.799
  16. Beckman-Coulter. Access AMH: diagnostic confidence with automated Access AMH testing [Internet]. Beckman-Coulter; 2014 [cited 2023 Mar 6]. Available from: http://www.beckmancoulter.cz/Media/Default/Dx/amh/DS-19401A%20Access%20AMH%20Assay%20Final.pdf
  17. Anckaert E, Oktem M, Thies A, Cohen-Bacrie M, Daan NM, Schiettecatte J, et al. Multicenter analytical performance evaluation of a fully automated anti-Mullerian hormone assay and reference interval determination. Clin Biochem 2016;49:260-7. https://doi.org/10.1016/j.clinbiochem.2015.10.008
  18. Li HW, Wong BP, Ip WK, Yeung WS, Ho PC, Ng EH. Comparative evaluation of three new commercial immunoassays for anti-Mullerian hormone measurement. Hum Reprod 2016;31:2796-802. https://doi.org/10.1093/humrep/dew248
  19. Su HI, Sammel MD, Homer MV, Bui K, Haunschild C, Stanczyk FZ. Comparability of antimullerian hormone levels among commercially available immunoassays. Fertil Steril 2014;101:1766-72. https://doi.org/10.1016/j.fertnstert.2014.02.046
  20. Giavarina D. Understanding Bland Altman analysis. Biochem Med (Zagreb) 2015;25:141-51. https://doi.org/10.11613/BM.2015.015
  21. Zuvela E, Walls M, Matson P. Within-laboratory and between-laboratory variability in the measurement of anti-mullerian hormone determined within an external quality assurance scheme. Reprod Biol 2013;13:255-7. https://doi.org/10.1016/j.repbio.2013.04.005
  22. Clark CA, Laskin CA, Cadesky K. Anti-Mullerian hormone: reality check. Hum Reprod 2014;29:184-5. https://doi.org/10.1093/humrep/det413
  23. Shermock KM, Connor JT, Lavallee DC, Streiff MB. Clinical decision-making as the basis for assessing agreement between measures of the international normalized ratio. J Thromb Haemost 2009;7:87-93. https://doi.org/10.1111/j.1538-7836.2008.03225.x
  24. International Organization for Standardization. ISO 5725-6:1994. Accuracy (trueness and precision) of measurement methods and results. Part 6: Use in practice of accuracy values [Internet]. ISO; 1994 [cited 2023 Mar 6]. Available from: https://www.iso.org/standard/11837.html
  25. Oddoze C, Lombard E, Portugal H. Stability study of 81 analytes in human whole blood, in serum and in plasma. Clin Biochem 2012;45:464-9. https://doi.org/10.1016/j.clinbiochem.2012.01.012
  26. Fraser CG. Test result variation and the quality of evidence-based clinical guidelines. Clin Chim Acta 2004;346:19-24. https://doi.org/10.1016/j.cccn.2003.12.032
  27. Han X, McShane M, Sahertian R, White C, Ledger W. Pre-mixing serum samples with assay buffer is a prerequisite for reproducible anti-Mullerian hormone measurement using the Beckman Coulter Gen II assay. Hum Reprod 2014;29:1042-8. https://doi.org/10.1093/humrep/deu050