{"title":"抗苗勒管激素的测定:基于abei的全自动免疫分析法的初步评价。","authors":"Damien Gruson, Akdim Siham, Catherine Fillée","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The added value of Anti-Müllerian hormone (AMH) measurement is recognized for several clinical applications such as assessment of the ovarian reserve, monitoring of <i>in vitro</i> fertilization protocol or in the field of oncofertility. Our study objective was to determine the performances of a novel fully automated chemiluminescent assay for AMH testing.</p><p><strong>Methods: </strong>We evaluated the performances of the Maglumi<sup>®</sup> 800 AMH chemiluminescent immunoassay that applies N-(4-Aminobutyl)-N-ethylisoluminol (ABEI) labels. Assay imprecision was assessed with two levels of control materials. Method comparison was performed with an ultrasensitive AMH ELISA assay (Ansh Laboratories, Inc, Webster, TX, USA) with 88 patients' samples.</p><p><strong>Results: </strong>The within-run and between-run coefficients of variation (CVs) were below <i>3%</i> for both low and high internal quality controls. The automated and ELISA methods were significantly correlated. Bland-Altman plot evidenced a bias between the methods with a mean bias of 0.6 ng/mL.</p><p><strong>Conclusions: </strong>Our preliminary evaluation showed overall good analytical performances for the Maglumi<sup>®</sup> AMH fully automated immunoassay and good concordance with a routinely used assay.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 1","pages":"4-9"},"PeriodicalIF":0.0000,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/74/a1/ejifcc-34-004.PMC10131241.pdf","citationCount":"0","resultStr":"{\"title\":\"Measurement of Anti-Mullerian Hormone: Preliminary Evaluation of an ABEI-Based Fully Automated Immunoassay.\",\"authors\":\"Damien Gruson, Akdim Siham, Catherine Fillée\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The added value of Anti-Müllerian hormone (AMH) measurement is recognized for several clinical applications such as assessment of the ovarian reserve, monitoring of <i>in vitro</i> fertilization protocol or in the field of oncofertility. Our study objective was to determine the performances of a novel fully automated chemiluminescent assay for AMH testing.</p><p><strong>Methods: </strong>We evaluated the performances of the Maglumi<sup>®</sup> 800 AMH chemiluminescent immunoassay that applies N-(4-Aminobutyl)-N-ethylisoluminol (ABEI) labels. Assay imprecision was assessed with two levels of control materials. Method comparison was performed with an ultrasensitive AMH ELISA assay (Ansh Laboratories, Inc, Webster, TX, USA) with 88 patients' samples.</p><p><strong>Results: </strong>The within-run and between-run coefficients of variation (CVs) were below <i>3%</i> for both low and high internal quality controls. The automated and ELISA methods were significantly correlated. Bland-Altman plot evidenced a bias between the methods with a mean bias of 0.6 ng/mL.</p><p><strong>Conclusions: </strong>Our preliminary evaluation showed overall good analytical performances for the Maglumi<sup>®</sup> AMH fully automated immunoassay and good concordance with a routinely used assay.</p>\",\"PeriodicalId\":37192,\"journal\":{\"name\":\"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine\",\"volume\":\"34 1\",\"pages\":\"4-9\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/74/a1/ejifcc-34-004.PMC10131241.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Measurement of Anti-Mullerian Hormone: Preliminary Evaluation of an ABEI-Based Fully Automated Immunoassay.
Background: The added value of Anti-Müllerian hormone (AMH) measurement is recognized for several clinical applications such as assessment of the ovarian reserve, monitoring of in vitro fertilization protocol or in the field of oncofertility. Our study objective was to determine the performances of a novel fully automated chemiluminescent assay for AMH testing.
Methods: We evaluated the performances of the Maglumi® 800 AMH chemiluminescent immunoassay that applies N-(4-Aminobutyl)-N-ethylisoluminol (ABEI) labels. Assay imprecision was assessed with two levels of control materials. Method comparison was performed with an ultrasensitive AMH ELISA assay (Ansh Laboratories, Inc, Webster, TX, USA) with 88 patients' samples.
Results: The within-run and between-run coefficients of variation (CVs) were below 3% for both low and high internal quality controls. The automated and ELISA methods were significantly correlated. Bland-Altman plot evidenced a bias between the methods with a mean bias of 0.6 ng/mL.
Conclusions: Our preliminary evaluation showed overall good analytical performances for the Maglumi® AMH fully automated immunoassay and good concordance with a routinely used assay.
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