Modification of the Beckman-Coulter second-generation enzyme-linked immunosorbent assay protocol improves the reliability of serum antimüllerian hormone measurement

Craciunas, Laurentiu; Roberts, Stephen A; Yates, Allen P.; Smith, Alwyn; Fitzgerald, Cheryl; Pemberton, Philip W.

doi:10.1016/j.fertnstert.2014.10.052

Cited by 36 publications

(23 citation statements)

References 20 publications

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“…Here, the median magnitude shift was 68.0 % (range 3.4 to 283.3 %), although if interference from complement is to blame, this shift may not be as large for nonpregnant samples as complement levels are higher during pregnancy [18]. Our study is supported by a recent publication by Craciunas et al [19], who compared 156 samples from women undergoing subfertility investigation and found that samples with the revised protocol read on average 51.4 % higher than the original protocol. In contrast, Welsh et al [20] found insubstantial differences for 37 non-pregnant serum samples measured with the original and revised Gen II protocol.…”

Section: Discussionsupporting

confidence: 85%

“…It should also be noted that additional confusion is likely to arise from which protocol version a laboratory has used given that the manufacturer has not clearly labelled the protocol change, either by updating the kit name or protocol version. Consequently, Craciunas et al [19] have suggested distinguishing protocol versions by naming the revised Gen II protocol as Gen IIm (for Gen II modified).…”

Section: Discussionmentioning

confidence: 99%

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The original Beckman Coulter Generation II assay significantly underestimates AMH levels compared with the revised protocol

Bonifacio¹,

Bradley²,

Karia³

et al. 2015

J Assist Reprod Genet

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Purpose Anti-Müllerian hormone (AMH) is used as a marker for ovarian reserve. Since 2011, the standard test for AMH has been the Beckman Coulter Generation (Gen) II assay. However, in July 2013, the protocol was revised due to falsely low readings. The aim of this study was to compare AMH levels measured with the original and revised Gen II assay and to establish a fertile female reference range for the revised protocol. Methods Serum AMH levels were measured for 492 natural conception first trimester pregnant women using the original and revised Gen II assay. Results The original protocol significantly underestimated AMH levels compared with the revised protocol (p<0.001), the median being 8.4 and 14.2 pmol/L, respectively. In all samples with detectable AMH levels, the revised protocol yielded a higher concentration compared with the original protocol, the magnitude shift ranging from 3.4 to 283.3 % (median 68.0 %). AMH levels measured with the revised protocol were collated to generate an age-specific reference range, with median levels peaking at 27 years then declining with advancing age. The median AMH concentration for ages 20-24 was 17.3 pmol/L, ages 25-29 was 20.5 pmol/L, ages 30-34 was 17.8 pmol/L, ages 35-39 was 10.8 pmol/L, and ages 40-44 was 6.1 pmol/L. Conclusions Our study demonstrated that the original Gen II assay significantly underestimated AMH levels, suggesting caution is required when interpreting literature and testing results achieved with this assay. We also established the revised Gen II assay reference range for AMH in women with unassisted proven fertility.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

The original Beckman Coulter Generation II assay significantly underestimates AMH levels compared with the revised protocol

Bonifacio¹,

Bradley²,

Karia³

et al. 2015

J Assist Reprod Genet

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“…In 2013, the modified protocol for second-generation assay for AMH was released (Gen IIm). It included a predilution step of the specimen in assay buffer before addition to the ELISA plate, which gave more reliable AMH results [55]. Currently, fully automatic measurements of serum AMH concentrations are also available (Elecsys, AMH, Roche and Access, AMH, Beckman Coulter) [56].…”

Section: Amh In Pcos Diagnosismentioning

confidence: 99%

“…Następnie, te metody zostały zastąpione metodą ELISA II generacji przygotowaną przez laboratorium Beckman Coulter [54]. W 2013 roku wprowadzono modyfikację do oznaczeń II generacji, która polegała na dodatkowym rozcieńczeniu próbki, co dawało bardziej wiarygodne oznaczenia stężenia AMH w badanym materiale [55]. Obecnie, dostępne są w pełni zautomatyzowane metody do oznaczenia stężeń AMH w materiale biologicznym (Elecsys AMH, Roche oraz Acess, AMH, Beckam Coulter) [56].…”

Section: Amh W Diagnostyce Pcosunclassified

Hormon anty-müllerowski i zespół policystycznych jajników

Łebkowska

Kowalska

2015

Endokrynologia Polska

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Anti-Müllerian hormone (AMH) is a glycoprotein, a member of the transforming growth factor β family, reflecting the number of ovarian antral follicles. Polycystic ovary syndrome (PCOS) is a common endocrinopathy predisposing to infertility, and metabolic and cardiovascular complications. In our review, we discuss the role of AMH in PCOS pathophysiology and its clinical applications according to the published studies. Improvement of AMH assay validity will allow the clinical utility of this valuable biomarker to be widened.

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“…In contrast documentation from Beckman Coulter suggests equivalent values of the Access AMH assay to those reported by the AMH Gen II ELISA. To date we are unaware of any external validation of the performance of these two new automated AMH assays (Beckman Coulter Access AMH assay and the Roche Diagnostics Elecsys AMH assay) relative each other and to the two current clinical standard assays (Beckman Coulter Generation II ELISA and the Ansh Labs ultrasensitive AMH/MIS ELISA).The importance of such post-marketing external validation has previously been highlighted by the release of field safety notices by Beckman Coulter, when laboratories observed discordance between anticipated and actual results (8,14,15). To address this urgent need for external validation we have used a pragmatic design and compared the performance of all four AMH assays utilizing patients referred for assisted conception.…”

Section: Introductionmentioning

confidence: 99%

Two new automated, compared with two enzyme-linked immunosorbent, antimüllerian hormone assays

Nelson

Pastuszek

Kloss³

et al. 2015

Fertility and Sterility

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3 Capsule:The new automated AMH assays provide values that are substantially lower than existing AMH ELISAs. Assay specific interpretation is necessary with international standardization urgently required. Conclusions:The novel automated assays exhibit strong concordance in calibration but derived values are substantially lower than obtained from preexisting assays with assay specific interpretation required for routine clinical use. These results highlight the need for an international AMH standard.5

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Modification of the Beckman-Coulter second-generation enzyme-linked immunosorbent assay protocol improves the reliability of serum antimüllerian hormone measurement

Cited by 36 publications

References 20 publications

The original Beckman Coulter Generation II assay significantly underestimates AMH levels compared with the revised protocol

The original Beckman Coulter Generation II assay significantly underestimates AMH levels compared with the revised protocol

Hormon anty-müllerowski i zespół policystycznych jajników

Two new automated, compared with two enzyme-linked immunosorbent, antimüllerian hormone assays

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