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Comparison of two different methods for measuring anti-mullerian hormone in a clinical series.

Hyldgaard J, Bor P, Ingerslev HJ, Tørring N - Reprod. Biol. Endocrinol. (2015)

Bottom Line: We found a good correlation between the two methods; there was a bias of approximately 32 %.Applying the goals for optimal assay performance, the Elecsys Cobas method achieved optimal performance throughout the measuring range, whereas the AMH Gen II only achieved optimal performance in the high end of the measuring range.In the clinical setting, the Elecsys Cobas AMH assay performs well according to the optimal standard for biochemical assays.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Regional Hospital of Randers, Randers, Denmark.

ABSTRACT

Background: Anti Mullerian hormone (AMH) has previously been measured using a manual method, but a fully automated assay from Roche Diagnostics was recently introduced. The aim of this study was to compare the results from the AMH gen II ELISA and Elecsys Cobas AMH methods in a clinical setting to evaluate whether the assays achieve the goals of analytical performance. A prospective observational study with 23 women seeking laparoscopic sterilization was conducted. Blood samples were collected preoperatively as well as 1 week and 1, 3 and 6 months postoperatively; they were evaluated with the AMH gen II ELISA and Elecsys Cobas AMH methods. The assays were validated according to the optimal performance of biochemical assays: CV Analytical < 0.25* CV Within Biological Variation.

Findings: We found a good correlation between the two methods; there was a bias of approximately 32 %. The total within-person biological variability ranged from approximately 21 to 32 %. The analytical variability of the AMH gen II ELISA and Elecsys Cobas methods ranged from 5.5 to 10.3 % and 2.8 to 3.3 %, respectively. Applying the goals for optimal assay performance, the Elecsys Cobas method achieved optimal performance throughout the measuring range, whereas the AMH Gen II only achieved optimal performance in the high end of the measuring range. Furthermore, the Elecsys Cobas assay had a low limit of quantitation of 0.5 pmol/l compared to 3.0 pmol/l for the AMH gen II ELISA.

Conclusions: In the clinical setting, the Elecsys Cobas AMH assay performs well according to the optimal standard for biochemical assays.

No MeSH data available.


Related in: MedlinePlus

Comparison between the Beckmann Coulter AMH Gen II ELISA and Elecsys Roche AMH (Anti Müllerian Hormone) assays. a: Passing-Bablok plot displaying the regression (solid line) and 95 % confidence interval (dotted lines) and b: Bias plot displaying the difference between methods (as a percentage). Results are given in pmol/l
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Fig1: Comparison between the Beckmann Coulter AMH Gen II ELISA and Elecsys Roche AMH (Anti Müllerian Hormone) assays. a: Passing-Bablok plot displaying the regression (solid line) and 95 % confidence interval (dotted lines) and b: Bias plot displaying the difference between methods (as a percentage). Results are given in pmol/l

Mentions: As depicted in Fig. 1, the concentrations of AMH measured by the Elecsys Cobas assay were, on average, 32 % lower than the concentrations measured by ELISA (Fig. 1a), and there was a tendency of increased bias between the two assays in the high concentration range (Fig. 1b).Fig. 1


Comparison of two different methods for measuring anti-mullerian hormone in a clinical series.

Hyldgaard J, Bor P, Ingerslev HJ, Tørring N - Reprod. Biol. Endocrinol. (2015)

Comparison between the Beckmann Coulter AMH Gen II ELISA and Elecsys Roche AMH (Anti Müllerian Hormone) assays. a: Passing-Bablok plot displaying the regression (solid line) and 95 % confidence interval (dotted lines) and b: Bias plot displaying the difference between methods (as a percentage). Results are given in pmol/l
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4580367&req=5

Fig1: Comparison between the Beckmann Coulter AMH Gen II ELISA and Elecsys Roche AMH (Anti Müllerian Hormone) assays. a: Passing-Bablok plot displaying the regression (solid line) and 95 % confidence interval (dotted lines) and b: Bias plot displaying the difference between methods (as a percentage). Results are given in pmol/l
Mentions: As depicted in Fig. 1, the concentrations of AMH measured by the Elecsys Cobas assay were, on average, 32 % lower than the concentrations measured by ELISA (Fig. 1a), and there was a tendency of increased bias between the two assays in the high concentration range (Fig. 1b).Fig. 1

Bottom Line: We found a good correlation between the two methods; there was a bias of approximately 32 %.Applying the goals for optimal assay performance, the Elecsys Cobas method achieved optimal performance throughout the measuring range, whereas the AMH Gen II only achieved optimal performance in the high end of the measuring range.In the clinical setting, the Elecsys Cobas AMH assay performs well according to the optimal standard for biochemical assays.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Regional Hospital of Randers, Randers, Denmark.

ABSTRACT

Background: Anti Mullerian hormone (AMH) has previously been measured using a manual method, but a fully automated assay from Roche Diagnostics was recently introduced. The aim of this study was to compare the results from the AMH gen II ELISA and Elecsys Cobas AMH methods in a clinical setting to evaluate whether the assays achieve the goals of analytical performance. A prospective observational study with 23 women seeking laparoscopic sterilization was conducted. Blood samples were collected preoperatively as well as 1 week and 1, 3 and 6 months postoperatively; they were evaluated with the AMH gen II ELISA and Elecsys Cobas AMH methods. The assays were validated according to the optimal performance of biochemical assays: CV Analytical < 0.25* CV Within Biological Variation.

Findings: We found a good correlation between the two methods; there was a bias of approximately 32 %. The total within-person biological variability ranged from approximately 21 to 32 %. The analytical variability of the AMH gen II ELISA and Elecsys Cobas methods ranged from 5.5 to 10.3 % and 2.8 to 3.3 %, respectively. Applying the goals for optimal assay performance, the Elecsys Cobas method achieved optimal performance throughout the measuring range, whereas the AMH Gen II only achieved optimal performance in the high end of the measuring range. Furthermore, the Elecsys Cobas assay had a low limit of quantitation of 0.5 pmol/l compared to 3.0 pmol/l for the AMH gen II ELISA.

Conclusions: In the clinical setting, the Elecsys Cobas AMH assay performs well according to the optimal standard for biochemical assays.

No MeSH data available.


Related in: MedlinePlus