Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18

We sought to evaluate performance of a noninvasive prenatal test for fetal trisomy 21 (T21) and trisomy 18 (T18). A multicenter cohort study was performed whereby cell-free DNA from maternal plasma was analyzed. Chromosome-selective sequencing on chromosomes 21 and 18 was performed with reporting of...

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Veröffentlicht in:	American journal of obstetrics and gynecology Jg. 207; H. 2; S. 137.e1 - 137.e8
Hauptverfasser:	Norton, Mary E., Brar, Herb, Weiss, Jonathan, Karimi, Ardeshir, Laurent, Louise C., Caughey, Aaron B., Rodriguez, M. Hellen, Williams, John, Mitchell, Michael E., Adair, Charles D., Lee, Hanmin, Jacobsson, Bo, Tomlinson, Mark W., Oepkes, Dick, Hollemon, Desiree, Sparks, Andrew B., Oliphant, Arnold, Song, Ken
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	New York, NY Mosby, Inc 01.08.2012 Elsevier
Schlagworte:	Adolescent Adult Algorithms aneuploidy detection Biological and medical sciences cell-free fetal DNA Chromosome aberrations Chromosomes, Human, Pair 18 - genetics Chromosomes, Human, Pair 21 - genetics DNA - blood Down syndrome Down Syndrome - diagnosis Female Gynecology. Andrology. Obstetrics Humans Medical genetics Medical sciences Middle Aged noninvasive prenatal diagnosis Obstetrics and Gynecology Predictive Value of Tests Pregnancy Prenatal Diagnosis - methods Prospective Studies Risk Assessment Sensitivity and Specificity trisomy Trisomy - diagnosis Trisomy - genetics Young Adult aneuploidy detection noninvasive prenatal diagnosis Down syndrome trisomy cell-free fetal DNA Chromosomal aberration Trisomy Multicenter study Gynecology Aneuploidy Obstetrics Pregnancy Chromosome E18 Cohort study Non invasive method Fetus Detection Edwards syndrome
ISSN:	0002-9378, 1097-6868, 1097-6868
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Abstract	We sought to evaluate performance of a noninvasive prenatal test for fetal trisomy 21 (T21) and trisomy 18 (T18). A multicenter cohort study was performed whereby cell-free DNA from maternal plasma was analyzed. Chromosome-selective sequencing on chromosomes 21 and 18 was performed with reporting of an aneuploidy risk (High Risk or Low Risk) for each subject. Of the 81 T21 cases, all were classified as High Risk for T21 and there was 1 false-positive result among the 2888 normal cases, for a sensitivity of 100% (95% confidence interval [CI], 95.5–100%) and a false-positive rate of 0.03% (95% CI, 0.002–0.20%). Of the 38 T18 cases, 37 were classified as High Risk and there were 2 false-positive results among the 2888 normal cases, for a sensitivity of 97.4% (95% CI, 86.5–99.9%) and a false-positive rate of 0.07% (95% CI, 0.02–0.25%). Chromosome-selective sequencing of cell-free DNA and application of an individualized risk algorithm is effective in the detection of fetal T21 and T18.
AbstractList	We sought to evaluate performance of a noninvasive prenatal test for fetal trisomy 21 (T21) and trisomy 18 (T18). A multicenter cohort study was performed whereby cell-free DNA from maternal plasma was analyzed. Chromosome-selective sequencing on chromosomes 21 and 18 was performed with reporting of an aneuploidy risk (High Risk or Low Risk) for each subject. Of the 81 T21 cases, all were classified as High Risk for T21 and there was 1 false-positive result among the 2888 normal cases, for a sensitivity of 100% (95% confidence interval [CI], 95.5-100%) and a false-positive rate of 0.03% (95% CI, 0.002-0.20%). Of the 38 T18 cases, 37 were classified as High Risk and there were 2 false-positive results among the 2888 normal cases, for a sensitivity of 97.4% (95% CI, 86.5-99.9%) and a false-positive rate of 0.07% (95% CI, 0.02-0.25%). Chromosome-selective sequencing of cell-free DNA and application of an individualized risk algorithm is effective in the detection of fetal T21 and T18. We sought to evaluate performance of a noninvasive prenatal test for fetal trisomy 21 (T21) and trisomy 18 (T18).OBJECTIVEWe sought to evaluate performance of a noninvasive prenatal test for fetal trisomy 21 (T21) and trisomy 18 (T18).A multicenter cohort study was performed whereby cell-free DNA from maternal plasma was analyzed. Chromosome-selective sequencing on chromosomes 21 and 18 was performed with reporting of an aneuploidy risk (High Risk or Low Risk) for each subject.STUDY DESIGNA multicenter cohort study was performed whereby cell-free DNA from maternal plasma was analyzed. Chromosome-selective sequencing on chromosomes 21 and 18 was performed with reporting of an aneuploidy risk (High Risk or Low Risk) for each subject.Of the 81 T21 cases, all were classified as High Risk for T21 and there was 1 false-positive result among the 2888 normal cases, for a sensitivity of 100% (95% confidence interval [CI], 95.5-100%) and a false-positive rate of 0.03% (95% CI, 0.002-0.20%). Of the 38 T18 cases, 37 were classified as High Risk and there were 2 false-positive results among the 2888 normal cases, for a sensitivity of 97.4% (95% CI, 86.5-99.9%) and a false-positive rate of 0.07% (95% CI, 0.02-0.25%).RESULTSOf the 81 T21 cases, all were classified as High Risk for T21 and there was 1 false-positive result among the 2888 normal cases, for a sensitivity of 100% (95% confidence interval [CI], 95.5-100%) and a false-positive rate of 0.03% (95% CI, 0.002-0.20%). Of the 38 T18 cases, 37 were classified as High Risk and there were 2 false-positive results among the 2888 normal cases, for a sensitivity of 97.4% (95% CI, 86.5-99.9%) and a false-positive rate of 0.07% (95% CI, 0.02-0.25%).Chromosome-selective sequencing of cell-free DNA and application of an individualized risk algorithm is effective in the detection of fetal T21 and T18.CONCLUSIONChromosome-selective sequencing of cell-free DNA and application of an individualized risk algorithm is effective in the detection of fetal T21 and T18. Objective We sought to evaluate performance of a noninvasive prenatal test for fetal trisomy 21 (T21) and trisomy 18 (T18). Study Design A multicenter cohort study was performed whereby cell-free DNA from maternal plasma was analyzed. Chromosome-selective sequencing on chromosomes 21 and 18 was performed with reporting of an aneuploidy risk (High Risk or Low Risk) for each subject. Results Of the 81 T21 cases, all were classified as High Risk for T21 and there was 1 false-positive result among the 2888 normal cases, for a sensitivity of 100% (95% confidence interval [CI], 95.5–100%) and a false-positive rate of 0.03% (95% CI, 0.002–0.20%). Of the 38 T18 cases, 37 were classified as High Risk and there were 2 false-positive results among the 2888 normal cases, for a sensitivity of 97.4% (95% CI, 86.5–99.9%) and a false-positive rate of 0.07% (95% CI, 0.02–0.25%). Conclusion Chromosome-selective sequencing of cell-free DNA and application of an individualized risk algorithm is effective in the detection of fetal T21 and T18.
Author	Tomlinson, Mark W. Sparks, Andrew B. Oliphant, Arnold Laurent, Louise C. Oepkes, Dick Rodriguez, M. Hellen Mitchell, Michael E. Caughey, Aaron B. Williams, John Jacobsson, Bo Song, Ken Karimi, Ardeshir Norton, Mary E. Brar, Herb Weiss, Jonathan Lee, Hanmin Adair, Charles D. Hollemon, Desiree
Author_xml	– sequence: 1 givenname: Mary E. surname: Norton fullname: Norton, Mary E. email: menorton@stanford.edu organization: Department of Obstetrics and Gynecology, Stanford University/Lucile Packard Children's Hospital, Stanford, CA – sequence: 2 givenname: Herb surname: Brar fullname: Brar, Herb organization: Riverside Perinatal Diagnostic Center, Riverside, CA – sequence: 3 givenname: Jonathan surname: Weiss fullname: Weiss, Jonathan organization: East Bay Perinatal Medical Associates, Oakland, CA – sequence: 4 givenname: Ardeshir surname: Karimi fullname: Karimi, Ardeshir organization: Institute of Prenatal Diagnosis and Reproductive Genetics, San Gabriel, CA – sequence: 5 givenname: Louise C. surname: Laurent fullname: Laurent, Louise C. organization: Department of Obstetrics and Gynecology, University of California, San Diego, San Diego, CA – sequence: 6 givenname: Aaron B. surname: Caughey fullname: Caughey, Aaron B. organization: Department of Obstetrics and Gynecology, Oregon Health Sciences University, Portland, OR – sequence: 7 givenname: M. Hellen surname: Rodriguez fullname: Rodriguez, M. Hellen organization: San Gabriel Valley Perinatal Medical Group, West Covina, CA – sequence: 8 givenname: John surname: Williams fullname: Williams, John organization: Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, CA – sequence: 9 givenname: Michael E. surname: Mitchell fullname: Mitchell, Michael E. organization: Department of Surgery, Medical College of Wisconsin, Milwaukee, WI – sequence: 10 givenname: Charles D. surname: Adair fullname: Adair, Charles D. organization: Department of Obstetrics and Gynecology, College of Medicine, University of Tennessee Health Science Center, Chattanooga, TN – sequence: 11 givenname: Hanmin surname: Lee fullname: Lee, Hanmin organization: Department of Surgery, University of California, San Francisco, San Francisco, CA – sequence: 12 givenname: Bo surname: Jacobsson fullname: Jacobsson, Bo organization: Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden – sequence: 13 givenname: Mark W. surname: Tomlinson fullname: Tomlinson, Mark W. organization: Northwest Perinatal Center, Portland, OR – sequence: 14 givenname: Dick surname: Oepkes fullname: Oepkes, Dick organization: Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands – sequence: 15 givenname: Desiree surname: Hollemon fullname: Hollemon, Desiree organization: Ariosa Diagnostics, San Jose, CA – sequence: 16 givenname: Andrew B. surname: Sparks fullname: Sparks, Andrew B. organization: Ariosa Diagnostics, San Jose, CA – sequence: 17 givenname: Arnold surname: Oliphant fullname: Oliphant, Arnold organization: Ariosa Diagnostics, San Jose, CA – sequence: 18 givenname: Ken surname: Song fullname: Song, Ken organization: Ariosa Diagnostics, San Jose, CA
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Keywords	aneuploidy detection noninvasive prenatal diagnosis Down syndrome trisomy cell-free fetal DNA Chromosomal aberration Trisomy Multicenter study Gynecology Aneuploidy Obstetrics Pregnancy Chromosome E18 Cohort study Non invasive method Fetus Detection Edwards syndrome
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article-title: Fetal fraction in maternal plasma cell-free DNA at 11-13 weeks' gestation: effect of maternal and fetal factors publication-title: Fetal Diagn Ther doi: 10.1159/000337373 – volume: 14 start-page: 296 year: 2012 ident: 10.1016/j.ajog.2012.05.021_bib13 article-title: DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13 as well as Down syndrome: an international collaborative study publication-title: Genet Med doi: 10.1038/gim.2011.73 – volume: 3 year: 2003 ident: 10.1016/j.ajog.2012.05.021_bib6 article-title: Amniocentesis and chorionic villus sampling for prenatal diagnosis publication-title: Cochrane Database Syst Rev – volume: 204 start-page: 183 year: 2011 ident: 10.1016/j.ajog.2012.05.021_bib7 article-title: One small step and one giant leap for non-invasive prenatal screening: an editorial publication-title: Am J Obstet Gynecol doi: 10.1016/j.ajog.2011.01.042 – volume: 30 start-page: 418 year: 2010 ident: 10.1016/j.ajog.2012.05.021_bib19 article-title: A new methodology to preserve the original proportion and integrity of cell-free fetal DNA in maternal plasma during sample processing and storage publication-title: Prenat Diagn doi: 10.1002/pd.2484 – volume: 109 start-page: 217 year: 2007 ident: 10.1016/j.ajog.2012.05.021_bib1 article-title: ACOG practice bulletin no. 77: screening for fetal chromosomal abnormalities publication-title: Obstet Gynecol doi: 10.1097/00006250-200701000-00054 – volume: 32 start-page: 1 year: 2012 ident: 10.1016/j.ajog.2012.05.021_bib15 article-title: Selective analysis of cell-free DNA in maternal blood for evaluation of fetal trisomy publication-title: Prenat Diagn doi: 10.1002/pd.2922 – volume: 353 start-page: 2001 year: 2005 ident: 10.1016/j.ajog.2012.05.021_bib2 article-title: First-trimester or second-trimester screening, or both, for Down's syndrome publication-title: N Engl J Med doi: 10.1056/NEJMoa043693 – volume: 110 start-page: 1459 year: 2007 ident: 10.1016/j.ajog.2012.05.021_bib5 article-title: ACOG practice bulletin No. 88, December 2007: invasive prenatal testing for aneuploidy publication-title: Obstet Gynecol doi: 10.1097/01.AOG.0000291570.63450.44 – volume: 201 start-page: 97.e1 year: 2009 ident: 10.1016/j.ajog.2012.05.021_bib22 article-title: Down syndrome screening in the United States in 2001 and 2007: a survey of maternal-fetal medicine specialists publication-title: Am J Obstet Gynecol doi: 10.1016/j.ajog.2009.02.029
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Snippet	We sought to evaluate performance of a noninvasive prenatal test for fetal trisomy 21 (T21) and trisomy 18 (T18). A multicenter cohort study was performed... Objective We sought to evaluate performance of a noninvasive prenatal test for fetal trisomy 21 (T21) and trisomy 18 (T18). Study Design A multicenter cohort... We sought to evaluate performance of a noninvasive prenatal test for fetal trisomy 21 (T21) and trisomy 18 (T18).OBJECTIVEWe sought to evaluate performance of...
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SubjectTerms	Adolescent Adult Algorithms aneuploidy detection Biological and medical sciences cell-free fetal DNA Chromosome aberrations Chromosomes, Human, Pair 18 - genetics Chromosomes, Human, Pair 21 - genetics DNA - blood Down syndrome Down Syndrome - diagnosis Female Gynecology. Andrology. Obstetrics Humans Medical genetics Medical sciences Middle Aged noninvasive prenatal diagnosis Obstetrics and Gynecology Predictive Value of Tests Pregnancy Prenatal Diagnosis - methods Prospective Studies Risk Assessment Sensitivity and Specificity trisomy Trisomy - diagnosis Trisomy - genetics Young Adult
Title	Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18
URI	https://www.clinicalkey.com/#!/content/1-s2.0-S0002937812005844 https://www.clinicalkey.es/playcontent/1-s2.0-S0002937812005844 https://dx.doi.org/10.1016/j.ajog.2012.05.021 https://www.ncbi.nlm.nih.gov/pubmed/22742782 https://www.proquest.com/docview/1030348567
Volume	207
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