| Examination of the pregnancy-associated plasma protein-A assay on the Beckman Coulter Access(®) platform: suitability for use in first trimester Down's syndrome screening. | |
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MedLine Citation:
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PMID: 20956719 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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OBJECTIVE: To explore the clinical validity of the new Access(®) pregnancy-associated plasma protein-A (PAPP-A) assay for Down's syndrome screening. SETTING: Academic hospital. METHOD: Residual serum samples (n = 416) received for routine first trimester Down's syndrome screening (10-13 weeks) were retrieved from freezer storage and tested using two PAPP-A immunoassay methods. The new Access(®) assay was specifically compared, on a subset of these samples (n = 194), with an assay proven to give acceptable Down's syndrome screening performance, the PerkinElmer (PE) AutoDELFIA method. Access(®) PAPP-A levels were examined in relation to gestational age and maternal weight, and were compared with the PE method by regression and Bland-Altman analyses. RESULTS: Access(®) PAPP-A assay results were highly correlated with the PE AutoDELFIA method (r = 0.97). PAPP-A levels obtained using the Access(®) assay increased with advancing gestational age and were inversely related to maternal weight, as expected. The distribution of multiples of the median (MoM) values fit a log Gaussian distribution and the standard deviation of the log MoM (0.2331) matched published estimates. PAPP-A MoM levels in Down's syndrome pregnancies (n = 6, median 0.30) showed the expected reduction. CONCLUSION: Using an appropriate gestational age-specific median equation, the Access(®) PAPP-A assay is expected to perform acceptably in first trimester Down's syndrome screening. |
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Authors:
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Geralyn Lambert-Messerlian; Glenn E Palomaki; Jacob A Canick |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of medical screening Volume: 17 ISSN: 1475-5793 ISO Abbreviation: J Med Screen Publication Date: 2010 |
Date Detail:
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Created Date: 2010-10-19 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9433359 Medline TA: J Med Screen Country: England |
Other Details:
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Languages: eng Pagination: 109-13 Citation Subset: IM |
Affiliation:
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Department of Pathology and Laboratory Medicine, Division of Medical Screening and Special Testing, Women and Infants Hospital, 70 Elm St, Suite 2, Providence, RI 02903, USA. Gmesserlian@wihri.org |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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