{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T13:03:00Z","timestamp":1792587780831,"version":"4.5.0"},"reference-count":41,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,3,27]],"date-time":"2023-03-27T00:00:00Z","timestamp":1679875200000},"content-version":"vor","delay-in-days":26,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Non\u2010invasive prenatal testing (NIPT) using cell\u2010free DNA (cfDNA) circulating in maternal blood provides a sensitive and specific screening technique for common fetal aneuploidies, but the high cost and workflow complexity of conventional methodologies limit its widespread implementation. A unique rolling circle amplification methodology reduces cost and complexity, providing a promising alternative for increased global accessibility as a first\u2010tier test.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this clinical study, 8160 pregnant women were screened on the Vanadis system for trisomies 13, 18, and 21, and positive results were compared to clinical outcomes where available.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The Vanadis system yielded a 0.07% no\u2010call rate, a 98% overall sensitivity, and a specificity of over 99% based on available outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The Vanadis system provided a sensitive, specific, and cost\u2010effective cfDNA assay for trisomies 13, 18, and 21, with good performance characteristics and low no\u2010call rate, and it eliminated the need for either next\u2010generation sequencing or polymerase chain reaction amplification.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24870","type":"journal-article","created":{"date-parts":[[2023,3,27]],"date-time":"2023-03-27T19:44:07Z","timestamp":1679946247000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Non\u2010Invasive prenatal testing with rolling circle amplification: Real\u2010world clinical experience in a non\u2010molecular laboratory"],"prefix":"10.1002","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0543-7976","authenticated-orcid":false,"given":"Matthew L.","family":"Saidel","sequence":"first","affiliation":[{"name":"Women's Health USA and Medical Director, Women's Health Connecticut  Rocky Hill Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uma","family":"Ananth","sequence":"additional","affiliation":[{"name":"Umagen LLC  Shrewsbury Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna","family":"Rose","sequence":"additional","affiliation":[{"name":"Women's Health Connecticut Laboratory  Rocky Hill Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cara","family":"Farrell","sequence":"additional","affiliation":[{"name":"Ancillary Growth Women's Health Connecticut  Rocky Hill Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,3,27]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3399\/bjgp17X691625"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2021.01.008"},{"issue":"4","key":"e_1_2_10_4_1","first-page":"1","article-title":"Noninvasive prenatal testing for Trisomies 21, 18, and 13, sex chromosome aneuploidies, and microdeletions: a Health technology assessment","volume":"19","author":"Health Quality Ontario","year":"2019","journal-title":"Ont Health Technol Assess Ser"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/gim.2011.73"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e31824fb482"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0109173"},{"issue":"26","key":"e_1_2_10_8_1","first-page":"2582","article-title":"Cell\u2010free DNA analysis for noninvasive examination of trisomy","volume":"373","author":"Norton ME","year":"2015","journal-title":"N Engl J Med"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.12504"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2014.08.006"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-018-22606-0"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.5528"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.3390\/cimb43020068"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics11101837"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41431-018-0188-1"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm3030809"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.5620"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2022.05.024"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/hvac131"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/aogs.14125"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.6050"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000004084"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.14792"},{"key":"e_1_2_10_24_1","article-title":"Genomics\u2010based non\u2010invasive prenatal testing for detection of fetal chromosomal aneuploidy in pregnant women","volume":"11","author":"Badeau M","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.3390\/genes12040478"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41431-019-0443-0"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2015-010002"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.21904"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.14664"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1097\/GIM.0b013e3182368a0e"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000000363"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1159\/000357198"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.4804"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/hvab014"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000000452"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.1038\/gim.2018.22"},{"key":"e_1_2_10_37_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-020-03394-w"},{"key":"e_1_2_10_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejmg.2020.104001"},{"key":"e_1_2_10_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.5036"},{"key":"e_1_2_10_40_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.4125"},{"key":"e_1_2_10_41_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa043693"},{"key":"e_1_2_10_42_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa025273"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24870","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T23:21:39Z","timestamp":1692573699000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.24870"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3]]},"references-count":41,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2023,3]]}},"alternative-id":["10.1002\/jcla.24870"],"URL":"https:\/\/doi.org\/10.1002\/jcla.24870","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3]]},"assertion":[{"value":"2022-10-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-03-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-03-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e24870"}}