Diagnostic accuracy of noninvasive polymerase chain reaction testing for the determination of fetal rhesus C, c and E status in early pregnancy
Please cite this paper as: Gutensohn K, Müller S, Thomann K, Stein W, Suren A, Körtge‐Jung S, Schlüter G, Legler T. Diagnostic accuracy of noninvasive polymerase chain reaction testing for the determination of fetal rhesus C, c and E status in early pregnancy. BJOG 2010; DOI: 10.1111/j.1471‐0528.201...
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description | Please cite this paper as: Gutensohn K, Müller S, Thomann K, Stein W, Suren A, Körtge‐Jung S, Schlüter G, Legler T. Diagnostic accuracy of noninvasive polymerase chain reaction testing for the determination of fetal rhesus C, c and E status in early pregnancy. BJOG 2010; DOI: 10.1111/j.1471‐0528.2010.02518.x.
Objective The aim of the study was to determine the sensitivity, specificity and accuracy of noninvasive tests for the fetal rhesus CcEc (RHCE) alleles C, c and E in early pregnancy.
Design A prospective clinical trial was carried out to evaluate diagnostic accuracy.
Setting Women were recruited at four centres specialising in prenatal diagnosis. Peripheral blood and amniotic fluid samples were obtained and sent to a single laboratory for analysis.
Sample A total of 233 tests (46 for C, 87 for c and 100 for E) were performed on 181 specimens obtained from pregnant women at weeks 12 to 28 (median week 16) of gestation.
Methods Following automated extraction of fetal DNA from maternal plasma, two different real‐time polymerase chain reaction (PCR) protocols were used for the detection of the C, c and E alleles of RHCE. The results of the PCR were compared with genotyping results for the amniotic fluid.
Main outcome measures Failure rate, sensitivity, specificity and accuracy were the main outcome measures.
Results Unequivocal results were obtained for all specimens. With the first PCR protocol, the sensitivity was 100% for C, 38% for c and 59% for E. In contrast, with the second protocol, the sensitivity for C, c and E was 100%. The specificity for all assays was found to be between 99% and 100%.
Conclusions A highly accurate protocol has been identified for the detection of fetal RHCE alleles in maternal plasma in early pregnancy. This noninvasive approach can be considered as a useful test in the management of pregnancies with anti‐c, anti‐E or anti‐C alloimmunisation. |
doi_str_mv | 10.1111/j.1471-0528.2010.02518.x |
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Objective The aim of the study was to determine the sensitivity, specificity and accuracy of noninvasive tests for the fetal rhesus CcEc (RHCE) alleles C, c and E in early pregnancy.
Design A prospective clinical trial was carried out to evaluate diagnostic accuracy.
Setting Women were recruited at four centres specialising in prenatal diagnosis. Peripheral blood and amniotic fluid samples were obtained and sent to a single laboratory for analysis.
Sample A total of 233 tests (46 for C, 87 for c and 100 for E) were performed on 181 specimens obtained from pregnant women at weeks 12 to 28 (median week 16) of gestation.
Methods Following automated extraction of fetal DNA from maternal plasma, two different real‐time polymerase chain reaction (PCR) protocols were used for the detection of the C, c and E alleles of RHCE. The results of the PCR were compared with genotyping results for the amniotic fluid.
Main outcome measures Failure rate, sensitivity, specificity and accuracy were the main outcome measures.
Results Unequivocal results were obtained for all specimens. With the first PCR protocol, the sensitivity was 100% for C, 38% for c and 59% for E. In contrast, with the second protocol, the sensitivity for C, c and E was 100%. The specificity for all assays was found to be between 99% and 100%.
Conclusions A highly accurate protocol has been identified for the detection of fetal RHCE alleles in maternal plasma in early pregnancy. This noninvasive approach can be considered as a useful test in the management of pregnancies with anti‐c, anti‐E or anti‐C alloimmunisation.</description><identifier>ISSN: 1470-0328</identifier><identifier>EISSN: 1471-0528</identifier><identifier>DOI: 10.1111/j.1471-0528.2010.02518.x</identifier><identifier>PMID: 20175873</identifier><identifier>CODEN: BIOGFQ</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Accuracy ; Adolescent ; Adult ; Biological and medical sciences ; Diagnostic tests ; Female ; Genes ; Genetic Markers - genetics ; Genotype ; Genotype & phenotype ; Genotyping ; Gynecology. Andrology. Obstetrics ; Humans ; maternal ; Medical sciences ; Middle Aged ; Phenotype ; Polymerase chain reaction ; Polymerase Chain Reaction - methods ; Polymerase Chain Reaction - standards ; Pregnancy ; Pregnancy Trimester, First ; Pregnancy Trimester, Second ; Prenatal Diagnosis - methods ; Prenatal Diagnosis - standards ; Rh Isoimmunization - diagnosis ; Rh Isoimmunization - embryology ; Rh-Hr Blood-Group System - genetics ; RHCE gene ; sensitivity ; Sensitivity and Specificity ; specificity ; Young Adult</subject><ispartof>BJOG : an international journal of obstetrics and gynaecology, 2010-05, Vol.117 (6), p.722-729</ispartof><rights>2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology</rights><rights>2015 INIST-CNRS</rights><rights>Journal compilation © 2010 RCOG</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4258-2347b49bd893dcdbe3f72bc104abb9827a954c1852580453279193d321015f113</citedby><cites>FETCH-LOGICAL-c4258-2347b49bd893dcdbe3f72bc104abb9827a954c1852580453279193d321015f113</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1471-0528.2010.02518.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1471-0528.2010.02518.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27923,27924,45573,45574</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22770000$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20175873$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gutensohn, K</creatorcontrib><creatorcontrib>Müller, SP</creatorcontrib><creatorcontrib>Thomann, K</creatorcontrib><creatorcontrib>Stein, W</creatorcontrib><creatorcontrib>Suren, A</creatorcontrib><creatorcontrib>Körtge‐Jung, S</creatorcontrib><creatorcontrib>Schlüter, G</creatorcontrib><creatorcontrib>Legler, TJ</creatorcontrib><title>Diagnostic accuracy of noninvasive polymerase chain reaction testing for the determination of fetal rhesus C, c and E status in early pregnancy</title><title>BJOG : an international journal of obstetrics and gynaecology</title><addtitle>BJOG</addtitle><description>Please cite this paper as: Gutensohn K, Müller S, Thomann K, Stein W, Suren A, Körtge‐Jung S, Schlüter G, Legler T. Diagnostic accuracy of noninvasive polymerase chain reaction testing for the determination of fetal rhesus C, c and E status in early pregnancy. BJOG 2010; DOI: 10.1111/j.1471‐0528.2010.02518.x.
Objective The aim of the study was to determine the sensitivity, specificity and accuracy of noninvasive tests for the fetal rhesus CcEc (RHCE) alleles C, c and E in early pregnancy.
Design A prospective clinical trial was carried out to evaluate diagnostic accuracy.
Setting Women were recruited at four centres specialising in prenatal diagnosis. Peripheral blood and amniotic fluid samples were obtained and sent to a single laboratory for analysis.
Sample A total of 233 tests (46 for C, 87 for c and 100 for E) were performed on 181 specimens obtained from pregnant women at weeks 12 to 28 (median week 16) of gestation.
Methods Following automated extraction of fetal DNA from maternal plasma, two different real‐time polymerase chain reaction (PCR) protocols were used for the detection of the C, c and E alleles of RHCE. The results of the PCR were compared with genotyping results for the amniotic fluid.
Main outcome measures Failure rate, sensitivity, specificity and accuracy were the main outcome measures.
Results Unequivocal results were obtained for all specimens. With the first PCR protocol, the sensitivity was 100% for C, 38% for c and 59% for E. In contrast, with the second protocol, the sensitivity for C, c and E was 100%. The specificity for all assays was found to be between 99% and 100%.
Conclusions A highly accurate protocol has been identified for the detection of fetal RHCE alleles in maternal plasma in early pregnancy. This noninvasive approach can be considered as a useful test in the management of pregnancies with anti‐c, anti‐E or anti‐C alloimmunisation.</description><subject>Accuracy</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Diagnostic tests</subject><subject>Female</subject><subject>Genes</subject><subject>Genetic Markers - genetics</subject><subject>Genotype</subject><subject>Genotype & phenotype</subject><subject>Genotyping</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>maternal</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Phenotype</subject><subject>Polymerase chain reaction</subject><subject>Polymerase Chain Reaction - methods</subject><subject>Polymerase Chain Reaction - standards</subject><subject>Pregnancy</subject><subject>Pregnancy Trimester, First</subject><subject>Pregnancy Trimester, Second</subject><subject>Prenatal Diagnosis - methods</subject><subject>Prenatal Diagnosis - standards</subject><subject>Rh Isoimmunization - diagnosis</subject><subject>Rh Isoimmunization - embryology</subject><subject>Rh-Hr Blood-Group System - genetics</subject><subject>RHCE gene</subject><subject>sensitivity</subject><subject>Sensitivity and Specificity</subject><subject>specificity</subject><subject>Young Adult</subject><issn>1470-0328</issn><issn>1471-0528</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU1v1DAQhiMEoqXwF5CFhLiQxR9x7Rw4wFK-VKkXOFuOM9n1KrEXOynNr-AvM9ldisSJuXg088zrsd-iIIyuGMab3YpVipVUcr3iFKuUS6ZXdw-K8_vGw0NOSyq4Piue5LyjlF1yKh4XZzijpFbivPj1wdtNiHn0jljnpmTdTGJHQgw-3Nrsb4HsYz8PkGwG4rbWB5LAutHHQEbAwbAhXUxk3AJpYYQ0-GAPXZTpYLQ9SVvIUybr1wQvCS25Inm0I1ZQC2zqZ7JPsAk2uPlp8aizfYZnp_Oi-P7x6tv6c3l98-nL-t116SoudclFpZqqblpdi9a1DYhO8cYxWtmmqTVXtpaVY1oiTCspuKoZkoIzymTHmLgoXh119yn-mPAZZvDZQd_bAHHKRgkhKsGURvLFP-QuTingcoZzeUklyiOkj5BLMecEndknP9g0G0bNYpnZmcUZszhjFsvMwTJzh6PPT_pTM0B7P_jHIwRengCbne27hP_k81-OK0UxkHt75H76Hub_XsC8_3qzZOI3YXixoA</recordid><startdate>201005</startdate><enddate>201005</enddate><creator>Gutensohn, K</creator><creator>Müller, SP</creator><creator>Thomann, K</creator><creator>Stein, W</creator><creator>Suren, A</creator><creator>Körtge‐Jung, S</creator><creator>Schlüter, G</creator><creator>Legler, TJ</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><general>Wiley Subscription Services, Inc</general><scope>IQODW</scope><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>7QP</scope><scope>ASE</scope><scope>FPQ</scope><scope>K6X</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201005</creationdate><title>Diagnostic accuracy of noninvasive polymerase chain reaction testing for the determination of fetal rhesus C, c and E status in early pregnancy</title><author>Gutensohn, K ; Müller, SP ; Thomann, K ; Stein, W ; Suren, A ; Körtge‐Jung, S ; Schlüter, G ; Legler, TJ</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4258-2347b49bd893dcdbe3f72bc104abb9827a954c1852580453279193d321015f113</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Accuracy</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Diagnostic tests</topic><topic>Female</topic><topic>Genes</topic><topic>Genetic Markers - genetics</topic><topic>Genotype</topic><topic>Genotype & phenotype</topic><topic>Genotyping</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>maternal</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Phenotype</topic><topic>Polymerase chain reaction</topic><topic>Polymerase Chain Reaction - methods</topic><topic>Polymerase Chain Reaction - standards</topic><topic>Pregnancy</topic><topic>Pregnancy Trimester, First</topic><topic>Pregnancy Trimester, Second</topic><topic>Prenatal Diagnosis - methods</topic><topic>Prenatal Diagnosis - standards</topic><topic>Rh Isoimmunization - diagnosis</topic><topic>Rh Isoimmunization - embryology</topic><topic>Rh-Hr Blood-Group System - genetics</topic><topic>RHCE gene</topic><topic>sensitivity</topic><topic>Sensitivity and Specificity</topic><topic>specificity</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gutensohn, K</creatorcontrib><creatorcontrib>Müller, SP</creatorcontrib><creatorcontrib>Thomann, K</creatorcontrib><creatorcontrib>Stein, W</creatorcontrib><creatorcontrib>Suren, A</creatorcontrib><creatorcontrib>Körtge‐Jung, S</creatorcontrib><creatorcontrib>Schlüter, G</creatorcontrib><creatorcontrib>Legler, TJ</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>British Nursing Index</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>BJOG : an international journal of obstetrics and gynaecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gutensohn, K</au><au>Müller, SP</au><au>Thomann, K</au><au>Stein, W</au><au>Suren, A</au><au>Körtge‐Jung, S</au><au>Schlüter, G</au><au>Legler, TJ</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Diagnostic accuracy of noninvasive polymerase chain reaction testing for the determination of fetal rhesus C, c and E status in early pregnancy</atitle><jtitle>BJOG : an international journal of obstetrics and gynaecology</jtitle><addtitle>BJOG</addtitle><date>2010-05</date><risdate>2010</risdate><volume>117</volume><issue>6</issue><spage>722</spage><epage>729</epage><pages>722-729</pages><issn>1470-0328</issn><eissn>1471-0528</eissn><coden>BIOGFQ</coden><abstract>Please cite this paper as: Gutensohn K, Müller S, Thomann K, Stein W, Suren A, Körtge‐Jung S, Schlüter G, Legler T. Diagnostic accuracy of noninvasive polymerase chain reaction testing for the determination of fetal rhesus C, c and E status in early pregnancy. BJOG 2010; DOI: 10.1111/j.1471‐0528.2010.02518.x.
Objective The aim of the study was to determine the sensitivity, specificity and accuracy of noninvasive tests for the fetal rhesus CcEc (RHCE) alleles C, c and E in early pregnancy.
Design A prospective clinical trial was carried out to evaluate diagnostic accuracy.
Setting Women were recruited at four centres specialising in prenatal diagnosis. Peripheral blood and amniotic fluid samples were obtained and sent to a single laboratory for analysis.
Sample A total of 233 tests (46 for C, 87 for c and 100 for E) were performed on 181 specimens obtained from pregnant women at weeks 12 to 28 (median week 16) of gestation.
Methods Following automated extraction of fetal DNA from maternal plasma, two different real‐time polymerase chain reaction (PCR) protocols were used for the detection of the C, c and E alleles of RHCE. The results of the PCR were compared with genotyping results for the amniotic fluid.
Main outcome measures Failure rate, sensitivity, specificity and accuracy were the main outcome measures.
Results Unequivocal results were obtained for all specimens. With the first PCR protocol, the sensitivity was 100% for C, 38% for c and 59% for E. In contrast, with the second protocol, the sensitivity for C, c and E was 100%. The specificity for all assays was found to be between 99% and 100%.
Conclusions A highly accurate protocol has been identified for the detection of fetal RHCE alleles in maternal plasma in early pregnancy. This noninvasive approach can be considered as a useful test in the management of pregnancies with anti‐c, anti‐E or anti‐C alloimmunisation.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>20175873</pmid><doi>10.1111/j.1471-0528.2010.02518.x</doi><tpages>8</tpages></addata></record> |
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subjects | Accuracy Adolescent Adult Biological and medical sciences Diagnostic tests Female Genes Genetic Markers - genetics Genotype Genotype & phenotype Genotyping Gynecology. Andrology. Obstetrics Humans maternal Medical sciences Middle Aged Phenotype Polymerase chain reaction Polymerase Chain Reaction - methods Polymerase Chain Reaction - standards Pregnancy Pregnancy Trimester, First Pregnancy Trimester, Second Prenatal Diagnosis - methods Prenatal Diagnosis - standards Rh Isoimmunization - diagnosis Rh Isoimmunization - embryology Rh-Hr Blood-Group System - genetics RHCE gene sensitivity Sensitivity and Specificity specificity Young Adult |
title | Diagnostic accuracy of noninvasive polymerase chain reaction testing for the determination of fetal rhesus C, c and E status in early pregnancy |
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