{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T07:07:46Z","timestamp":1773385666964,"version":"3.50.1"},"reference-count":18,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T00:00:00Z","timestamp":1770681600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T00:00:00Z","timestamp":1770681600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2026,3]]},"abstract":"Abstract<\/jats:title>\n \n Background and Objectives<\/jats:title>\n \n Non\u2010invasive foetal\n RHD<\/jats:italic>\n (\n fRHD<\/jats:italic>\n ) genotyping is widely implemented to prevent unnecessary administration of antenatal anti\u2010D prophylaxis. Reliable assay performance is critical. In line with expert recommendations, we validated and implemented an artificial spike\u2010in extraction control in our previously published assay. In this study, we report on assay verification and its performance in a 2\u2010year cohort.\n <\/jats:p>\n <\/jats:sec>\n \n Study Design and Methods<\/jats:title>\n \n fRHD<\/jats:italic>\n typing was performed with cell\u2010free DNA isolated from maternal plasma from gestational age week 27 or later. A circular plasmid with a fragment of glycoprotein B gene of the Phocid herpes virus type 1 (PhHV1\u2010gB) (spike\u2010in control) was added to the plasma before DNA extraction. Assay accuracy was verified with gestational week\u201027 plasma samples and corresponding cord blood samples from D\u2010negative pregnant women. In addition, assay performance over time was evaluated in a 2\u2010year cohort.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The performance verification of our modified assay showed no false negative and one false positive test result in a small clinical cohort (\n n<\/jats:italic>\n \u2009=\u2009191). In a further 47,391 samples across 1111 runs, we observed eight false negative results due to technical failures that were prevented by the addition of the spike\u2010in control. In this larger series, the spike\u2010in control was the sole detector of a technical problem most likely related to different batches of the DNA extraction kit.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n This study demonstrates the prevention of false negative\n fRHD<\/jats:italic>\n typing results by the addition of an artificial extraction control. This control allows improved monitoring of assay performance, thereby ensuring assay consistency. Findings underscore the importance of thorough quality assurance measures in\n fRHD<\/jats:italic>\n genotyping.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/vox.70188","type":"journal-article","created":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T06:56:51Z","timestamp":1770793011000},"page":"361-369","source":"Crossref","is-referenced-by-count":0,"title":["Routine use of a spike\u2010in\n DNA<\/scp>\n in\u2010process control for foetal\n RHD<\/i>\n genotyping: Testing the real\u2010world effectiveness of this \u2018canary\u2019"],"prefix":"10.1111","volume":"121","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8981-9500","authenticated-orcid":false,"given":"Renske M.","family":"van \u2019t Oever","sequence":"first","affiliation":[{"name":"Department of Obstetrics, Division of Foetal Therapy Leiden University Medical Center Leiden The Netherlands"},{"name":"Department of Immunohematology Diagnostics Sanquin Diagnostic Services Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heleen","family":"Woortmeijer","sequence":"additional","affiliation":[{"name":"Department of Immunohematology Diagnostics Sanquin Diagnostic Services Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahmad","family":"Javadi","sequence":"additional","affiliation":[{"name":"Research, Sanquin, Amsterdam and Landsteiner Laboratory Amsterdam University Medical Center Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aicha Ait","family":"Soussan","sequence":"additional","affiliation":[{"name":"Research, Sanquin, Amsterdam and Landsteiner Laboratory Amsterdam University Medical Center Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbera","family":"Veldhuisen","sequence":"additional","affiliation":[{"name":"Department of Immunohematology Diagnostics Sanquin Diagnostic Services Amsterdam The Netherlands"},{"name":"Research, Sanquin, Amsterdam and Landsteiner Laboratory Amsterdam University Medical Center Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia C.","family":"Folman","sequence":"additional","affiliation":[{"name":"Department of Immunohematology Diagnostics Sanquin Diagnostic Services Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C. Ellen","family":"van der Schoot","sequence":"additional","affiliation":[{"name":"Research, Sanquin, Amsterdam and Landsteiner Laboratory Amsterdam University Medical Center Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3566-7350","authenticated-orcid":false,"given":"Erik H.","family":"van Beers","sequence":"additional","affiliation":[{"name":"Research, Sanquin, Amsterdam and Landsteiner Laboratory Amsterdam University Medical Center Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7044-0525","authenticated-orcid":false,"given":"Masja","family":"de Haas","sequence":"additional","affiliation":[{"name":"Department of Immunohematology Diagnostics Sanquin Diagnostic Services Amsterdam The Netherlands"},{"name":"Medical Affairs, Sanquin Amsterdam The Netherlands"},{"name":"Department of Haematology Leiden University Medical Center Leiden The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,2,10]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12265"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2008.01742.x"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.2478\/immunohematology-2024-004"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0070984"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/tme.12772"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i5789"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/MOH.0b013e32834bab2d"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13172"},{"key":"e_1_2_9_10_1","volume-title":"Prenatale screening Infectieziekten en Erytrocytenimmunisatie (PSIE) Procesmonitor 2022","author":"Ploeg CPBE A","year":"2024"},{"key":"e_1_2_9_11_1","unstructured":"Rijksinstituut voor Volksgezondheid en Milieu.Beleid bij RhD\u2010negatief. Available from:https:\/\/draaiboekpsie.nl\/aandoeningen\/erytrocytenimmunisatie\/beleid-bij-rhd-negatief. Last accessed 21 Dec 2023."},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13777"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13348"},{"key":"e_1_2_9_14_1","first-page":"93","article-title":"Prenatal screening service for fetal RHD genotyping to guide prophylaxis: the two\u2010year experience of the Friuli Venezia Giulia region in Italy","volume":"21","author":"Londero D","year":"2023","journal-title":"Blood Transfus"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-021-06055-1"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1373\/clinchem.2006.074997"},{"key":"e_1_2_9_17_1","first-page":"11","article-title":"Fetal RHD screening in RH1 negative pregnant women: experience in Switzerland","volume":"11","author":"Schimanski B","year":"2023","journal-title":"Biomedicine"},{"key":"e_1_2_9_18_1","first-page":"359","article-title":"Non\u2010invasive foetal RhD genotyping to guide anti\u2010D prophylaxis: an external quality assurance workshop","volume":"16","author":"Clausen FB","year":"2018","journal-title":"Blood Transfus"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-023-39283-3"}],"container-title":["Vox Sanguinis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/vox.70188","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/vox.70188","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/vox.70188","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T02:07:36Z","timestamp":1773367656000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/vox.70188"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,10]]},"references-count":18,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1111\/vox.70188"],"URL":"https:\/\/doi.org\/10.1111\/vox.70188","archive":["Portico"],"relation":{},"ISSN":["0042-9007","1423-0410"],"issn-type":[{"value":"0042-9007","type":"print"},{"value":"1423-0410","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,10]]}}}