First fully automated immunoassay for anti-Müllerian hormone
The increasing importance of anti-Müllerian hormone (AMH) for the assessment of ovarian reserve requires accurate AMH measurements. There have been conflicting results about the reliability of currently existing manual AMH assays. Development of a high sensitive, fast and fully automated AMH assay o...
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| Veröffentlicht in: | Clinical chemistry and laboratory medicine 2014-08, Vol.52 (8), p.1143-1152 |
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| creator | Gassner, Dieter Jung, Rebecca |
| description | The increasing importance of anti-Müllerian hormone (AMH) for the assessment of ovarian reserve requires accurate AMH measurements. There have been conflicting results about the reliability of currently existing manual AMH assays.
Development of a high sensitive, fast and fully automated AMH assay on the Elecsys
electrochemiluminescence immunoassay platform.
Elecsys
AMH is a monoclonal two-site assay used to measure AMH in 50 µL of serum or lithium heparin plasma in about 18 min. Its measuring range is from 0.01 to 23 ng/mL. The assay detects primarily 140 kDa total AMH (proAMH and AMHN,C). Standardization was against the Beckman AMH Gen II. Recovery against the highly cited Immunotech calibration was about 90%. Within-run imprecision coefficient of variation (CV) calculated on 10 serum samples were between 0.5% and 1.8%. Repeatability and intermediate precision calculated on 14 serum samples ranged from 2.6% to 1.7% and 2.9% to 2.1%, respectively. Limit of detection (LoD) [limit of quantitation (LoQ)] was 0.01 ng/mL (0.03 ng/mL). Percent recovery in dilution studies was |
| doi_str_mv | 10.1515/cclm-2014-0022 |
| format | Article |
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Development of a high sensitive, fast and fully automated AMH assay on the Elecsys
electrochemiluminescence immunoassay platform.
Elecsys
AMH is a monoclonal two-site assay used to measure AMH in 50 µL of serum or lithium heparin plasma in about 18 min. Its measuring range is from 0.01 to 23 ng/mL. The assay detects primarily 140 kDa total AMH (proAMH and AMHN,C). Standardization was against the Beckman AMH Gen II. Recovery against the highly cited Immunotech calibration was about 90%. Within-run imprecision coefficient of variation (CV) calculated on 10 serum samples were between 0.5% and 1.8%. Repeatability and intermediate precision calculated on 14 serum samples ranged from 2.6% to 1.7% and 2.9% to 2.1%, respectively. Limit of detection (LoD) [limit of quantitation (LoQ)] was 0.01 ng/mL (0.03 ng/mL). Percent recovery in dilution studies was <10% and after mixing of high and low AMH pools 94% to 103%. Elecsys
AMH, when compared to revised AMH Gen II (or Ansh Labs ultrasensitive AMH ELISA) using 57 female serum samples yielded a correlation coefficient of 0.98 (0.97) and a slope of 0.81 (0.73). There was no evidence for sample instability or variability. Samples stored at 20–25 °C or 2–8 °C up to 7 days showed no significant storage issues. Freeze-thaw cycles or sample storage at −20 °C and −80 °C for up to 9 months was without any effect on measured AMH.
Availability of an automated Elecsys
AMH assay offers an attractive alternative to the current manual AMH assays.</description><identifier>ISSN: 1434-6621</identifier><identifier>EISSN: 1437-4331</identifier><identifier>DOI: 10.1515/cclm-2014-0022</identifier><identifier>PMID: 24622790</identifier><language>eng</language><publisher>Germany: De Gruyter</publisher><subject>AMH enzyme-linked immunosorbent assay (ELISA) ; Anti-Mullerian Hormone - metabolism ; anti-Müllerian hormone (AMH) ; automated AMH assay ; Enzyme-Linked Immunosorbent Assay - methods ; Female ; Humans ; Immunoassay - methods ; Immunoassay - standards ; Reproducibility of Results</subject><ispartof>Clinical chemistry and laboratory medicine, 2014-08, Vol.52 (8), p.1143-1152</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-a972b75f58315f75427388dae51cbaab31a3b929d48a5b1a0758e857ca748eea3</citedby><cites>FETCH-LOGICAL-c415t-a972b75f58315f75427388dae51cbaab31a3b929d48a5b1a0758e857ca748eea3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.degruyter.com/document/doi/10.1515/cclm-2014-0022/pdf$$EPDF$$P50$$Gwalterdegruyter$$H</linktopdf><linktohtml>$$Uhttps://www.degruyter.com/document/doi/10.1515/cclm-2014-0022/html$$EHTML$$P50$$Gwalterdegruyter$$H</linktohtml><link.rule.ids>314,777,781,27905,27906,66503,68287</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24622790$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gassner, Dieter</creatorcontrib><creatorcontrib>Jung, Rebecca</creatorcontrib><title>First fully automated immunoassay for anti-Müllerian hormone</title><title>Clinical chemistry and laboratory medicine</title><addtitle>Clin Chem Lab Med</addtitle><description>The increasing importance of anti-Müllerian hormone (AMH) for the assessment of ovarian reserve requires accurate AMH measurements. There have been conflicting results about the reliability of currently existing manual AMH assays.
Development of a high sensitive, fast and fully automated AMH assay on the Elecsys
electrochemiluminescence immunoassay platform.
Elecsys
AMH is a monoclonal two-site assay used to measure AMH in 50 µL of serum or lithium heparin plasma in about 18 min. Its measuring range is from 0.01 to 23 ng/mL. The assay detects primarily 140 kDa total AMH (proAMH and AMHN,C). Standardization was against the Beckman AMH Gen II. Recovery against the highly cited Immunotech calibration was about 90%. Within-run imprecision coefficient of variation (CV) calculated on 10 serum samples were between 0.5% and 1.8%. Repeatability and intermediate precision calculated on 14 serum samples ranged from 2.6% to 1.7% and 2.9% to 2.1%, respectively. Limit of detection (LoD) [limit of quantitation (LoQ)] was 0.01 ng/mL (0.03 ng/mL). Percent recovery in dilution studies was <10% and after mixing of high and low AMH pools 94% to 103%. Elecsys
AMH, when compared to revised AMH Gen II (or Ansh Labs ultrasensitive AMH ELISA) using 57 female serum samples yielded a correlation coefficient of 0.98 (0.97) and a slope of 0.81 (0.73). There was no evidence for sample instability or variability. Samples stored at 20–25 °C or 2–8 °C up to 7 days showed no significant storage issues. Freeze-thaw cycles or sample storage at −20 °C and −80 °C for up to 9 months was without any effect on measured AMH.
Availability of an automated Elecsys
AMH assay offers an attractive alternative to the current manual AMH assays.</description><subject>AMH enzyme-linked immunosorbent assay (ELISA)</subject><subject>Anti-Mullerian Hormone - metabolism</subject><subject>anti-Müllerian hormone (AMH)</subject><subject>automated AMH assay</subject><subject>Enzyme-Linked Immunosorbent Assay - methods</subject><subject>Female</subject><subject>Humans</subject><subject>Immunoassay - methods</subject><subject>Immunoassay - standards</subject><subject>Reproducibility of Results</subject><issn>1434-6621</issn><issn>1437-4331</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kT1PwzAQhi0EoqWwMqKMLCk-f9Tu0AFVFJBALDBbl8SBVE5c7EQo_42NP0ZKCxvTvcNzr3TPEXIOdAoS5FWeuzplFERKKWMHZAyCq1RwDoc_WaSzGYMROYlxTSlIKdQxGTExY0zN6ZgsVlWIbVJ2zvUJdq2vsbVFUtV113iMEfuk9CHBpq3Sx69P52yosEnefKh9Y0_JUYku2rP9nJCX1c3z8i59eLq9X14_pLkA2aY4VyxTspSagyyVFExxrQu0EvIMMeOAPJuzeSE0ygyQKqmtlipHJbS1yCfkcte7Cf69s7E1dRVz6xw21nfRgBTA9XC1GtDpDs2DjzHY0mxCVWPoDVCzVWa2ysxWmdkqGxYu9t1dVtviD_91NACLHfCBrrWhsK-h64dg1r4LzXD2P82SaRg-wL8BaOh75w</recordid><startdate>20140801</startdate><enddate>20140801</enddate><creator>Gassner, Dieter</creator><creator>Jung, Rebecca</creator><general>De Gruyter</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20140801</creationdate><title>First fully automated immunoassay for anti-Müllerian hormone</title><author>Gassner, Dieter ; Jung, Rebecca</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-a972b75f58315f75427388dae51cbaab31a3b929d48a5b1a0758e857ca748eea3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>AMH enzyme-linked immunosorbent assay (ELISA)</topic><topic>Anti-Mullerian Hormone - metabolism</topic><topic>anti-Müllerian hormone (AMH)</topic><topic>automated AMH assay</topic><topic>Enzyme-Linked Immunosorbent Assay - methods</topic><topic>Female</topic><topic>Humans</topic><topic>Immunoassay - methods</topic><topic>Immunoassay - standards</topic><topic>Reproducibility of Results</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gassner, Dieter</creatorcontrib><creatorcontrib>Jung, Rebecca</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical chemistry and laboratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gassner, Dieter</au><au>Jung, Rebecca</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>First fully automated immunoassay for anti-Müllerian hormone</atitle><jtitle>Clinical chemistry and laboratory medicine</jtitle><addtitle>Clin Chem Lab Med</addtitle><date>2014-08-01</date><risdate>2014</risdate><volume>52</volume><issue>8</issue><spage>1143</spage><epage>1152</epage><pages>1143-1152</pages><issn>1434-6621</issn><eissn>1437-4331</eissn><abstract>The increasing importance of anti-Müllerian hormone (AMH) for the assessment of ovarian reserve requires accurate AMH measurements. There have been conflicting results about the reliability of currently existing manual AMH assays.
Development of a high sensitive, fast and fully automated AMH assay on the Elecsys
electrochemiluminescence immunoassay platform.
Elecsys
AMH is a monoclonal two-site assay used to measure AMH in 50 µL of serum or lithium heparin plasma in about 18 min. Its measuring range is from 0.01 to 23 ng/mL. The assay detects primarily 140 kDa total AMH (proAMH and AMHN,C). Standardization was against the Beckman AMH Gen II. Recovery against the highly cited Immunotech calibration was about 90%. Within-run imprecision coefficient of variation (CV) calculated on 10 serum samples were between 0.5% and 1.8%. Repeatability and intermediate precision calculated on 14 serum samples ranged from 2.6% to 1.7% and 2.9% to 2.1%, respectively. Limit of detection (LoD) [limit of quantitation (LoQ)] was 0.01 ng/mL (0.03 ng/mL). Percent recovery in dilution studies was <10% and after mixing of high and low AMH pools 94% to 103%. Elecsys
AMH, when compared to revised AMH Gen II (or Ansh Labs ultrasensitive AMH ELISA) using 57 female serum samples yielded a correlation coefficient of 0.98 (0.97) and a slope of 0.81 (0.73). There was no evidence for sample instability or variability. Samples stored at 20–25 °C or 2–8 °C up to 7 days showed no significant storage issues. Freeze-thaw cycles or sample storage at −20 °C and −80 °C for up to 9 months was without any effect on measured AMH.
Availability of an automated Elecsys
AMH assay offers an attractive alternative to the current manual AMH assays.</abstract><cop>Germany</cop><pub>De Gruyter</pub><pmid>24622790</pmid><doi>10.1515/cclm-2014-0022</doi><tpages>10</tpages></addata></record> |
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| ispartof | Clinical chemistry and laboratory medicine, 2014-08, Vol.52 (8), p.1143-1152 |
| issn | 1434-6621 1437-4331 |
| language | eng |
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| source | MEDLINE; De Gruyter journals |
| subjects | AMH enzyme-linked immunosorbent assay (ELISA) Anti-Mullerian Hormone - metabolism anti-Müllerian hormone (AMH) automated AMH assay Enzyme-Linked Immunosorbent Assay - methods Female Humans Immunoassay - methods Immunoassay - standards Reproducibility of Results |
| title | First fully automated immunoassay for anti-Müllerian hormone |
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