{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T01:39:04Z","timestamp":1792719544202,"version":"4.5.0"},"reference-count":43,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T00:00:00Z","timestamp":1792540800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Clinical Virology"],"published-print":{"date-parts":[[2026,12]]},"DOI":"10.1016\/j.jcv.2026.106022","type":"journal-article","created":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T15:52:52Z","timestamp":1792597972000},"page":"106022","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Clinical performance evaluation of a high-throughput real-time PCR platform for congenital cytomegalovirus screening on saliva swabs with quantitative reporting thresholds"],"prefix":"10.1016","volume":"187","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-2337-7025","authenticated-orcid":false,"given":"Anfal","family":"Marafie","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3416-1139","authenticated-orcid":false,"given":"Aya","family":"Aboulhosn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3630-4175","authenticated-orcid":false,"given":"Sarah","family":"Worley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary Kathryn","family":"Doud","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Tanzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0102-7830","authenticated-orcid":false,"given":"Frank P.","family":"Esper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3712-9188","authenticated-orcid":false,"given":"Hannah","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.jcv.2026.106022_bib1","doi-asserted-by":"crossref","first-page":"1173","DOI":"10.1001\/jamapediatrics.2016.2016","article-title":"Cost-effectiveness of universal and targeted newborn screening for congenital cytomegalovirus infection","volume":"170","author":"Gantt","year":"2016","journal-title":"JAMA Pediatr."},{"key":"10.1016\/j.jcv.2026.106022_bib2","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2021-055896","article-title":"Emerging concepts in congenital cytomegalovirus","volume":"150","author":"Pesch","year":"2022","journal-title":"Pediatrics"},{"issue":"4","key":"10.1016\/j.jcv.2026.106022_bib3","doi-asserted-by":"crossref","first-page":"S178","DOI":"10.1093\/cid\/cit629","article-title":"Congenital cytomegalovirus infection: clinical outcome","volume":"57","author":"Boppana","year":"2013","journal-title":"Clin. Infect. Dis."},{"key":"10.1016\/j.jcv.2026.106022_bib4","first-page":"3","article-title":"Newborn screening for congenital cytomegalovirus (cCMV) infection: universal, targeted, expanded-targeted, or none-of-the-above?","volume":"19","author":"Schleiss","year":"2024","journal-title":"Neonatol. Today"},{"key":"10.1016\/j.jcv.2026.106022_bib5","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1016\/j.clp.2024.10.008","article-title":"Neonatal cytomegalovirus infection","volume":"52","author":"Stark","year":"2025","journal-title":"Advocacy Legis. Chang. Pract. Clin. Perinatol."},{"key":"10.1016\/j.jcv.2026.106022_bib6","doi-asserted-by":"crossref","first-page":"e177","DOI":"10.1016\/S1473-3099(17)30143-3","article-title":"Congenital cytomegalovirus infection in pregnancy and the neonate: consensus recommendations for prevention, diagnosis, and therapy","volume":"17","author":"Rawlinson","year":"2017","journal-title":"Lancet Infect. Dis."},{"key":"10.1016\/j.jcv.2026.106022_bib7","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/S2352-4642(24)00237-2","article-title":"Universal newborn screening for congenital cytomegalovirus infection","volume":"9","author":"Schleiss","year":"2025","journal-title":"Lancet Child. Adolesc. Health"},{"key":"10.1016\/j.jcv.2026.106022_bib8","unstructured":"American Academy of Otolaryngology-Head and Neck Surgery. Universal newborn congenital cytomegalovirus (cCMV) screening. https:\/\/www.entnet.org\/resource\/universal-newborn-congenital-cytomegalovirus-ccmv-screening\/. 2024 (accessed 22 June 2026)."},{"key":"10.1016\/j.jcv.2026.106022_bib9","doi-asserted-by":"crossref","first-page":"728","DOI":"10.1002\/ohn.1079","article-title":"American cochlear implant alliance position statement on newborn congenital cytomegalovirus screening","volume":"172","author":"Pesch","year":"2025","journal-title":"Otolaryngol. Head. Neck Surg."},{"key":"10.1016\/j.jcv.2026.106022_bib10","doi-asserted-by":"crossref","first-page":"1575","DOI":"10.1007\/s10995-025-04175-7","article-title":"Variations in screening practices for congenital cytomegalovirus infections among birthing hospitals in the United States","volume":"29","author":"Khaki","year":"2025","journal-title":"Matern. Child. Health J."},{"key":"10.1016\/j.jcv.2026.106022_bib11","doi-asserted-by":"crossref","DOI":"10.3390\/ijns9030037","article-title":"A qualitative assessment of clinical practice guidelines and patterns for congenital cytomegalovirus in the United States","volume":"9","author":"Kalb","year":"2023","journal-title":"Int. J. Neonatal Screen."},{"key":"10.1016\/j.jcv.2026.106022_bib12","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2021-055368","article-title":"An ethical analysis of newborn congenital cytomegalovirus screening","volume":"149","author":"Pesch","year":"2022","journal-title":"Pediatrics"},{"key":"10.1016\/j.jcv.2026.106022_bib13","doi-asserted-by":"crossref","first-page":"226","DOI":"10.1016\/j.jcv.2005.09.016","article-title":"Congenital cytomegalovirus (CMV) infection and hearing deficit","volume":"35","author":"Fowler","year":"2006","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.jcv.2026.106022_bib14","doi-asserted-by":"crossref","first-page":"568","DOI":"10.1093\/infdis\/132.5.568","article-title":"Comparative serial virologic and serologic studies of symptomatic and subclinical congenitally and natally acquired cytomegalovirus infections","volume":"132","author":"Stagno","year":"1975","journal-title":"J. Infect. Dis."},{"key":"10.1016\/j.jcv.2026.106022_bib15","doi-asserted-by":"crossref","first-page":"2111","DOI":"10.1056\/NEJMoa1006561","article-title":"Saliva polymerase-chain-reaction assay for cytomegalovirus screening in newborns","volume":"364","author":"Boppana","year":"2011","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.jcv.2026.106022_bib16","doi-asserted-by":"crossref","first-page":"1415","DOI":"10.1093\/infdis\/jiu263","article-title":"Detection of congenital cytomegalovirus infection by real-time polymerase chain reaction analysis of saliva or urine specimens","volume":"210","author":"Ross","year":"2014","journal-title":"J. Infect. Dis."},{"key":"10.1016\/j.jcv.2026.106022_bib17","series-title":"Red Book Atlas of Pediatric Infectious Diseases","author":"Tan","year":"2022"},{"key":"10.1016\/j.jcv.2026.106022_bib18","doi-asserted-by":"crossref","DOI":"10.3389\/fped.2022.909646","article-title":"Universal newborn screening for congenital cytomegalovirus infection - from infant to maternal infection: a prospective multicenter study","volume":"10","author":"Chiereghin","year":"2022","journal-title":"Front. Pediatr."},{"key":"10.1016\/j.jcv.2026.106022_bib19","doi-asserted-by":"crossref","DOI":"10.3390\/ijns9030046","article-title":"The use of saliva samples to test for congenital cytomegalovirus infection in newborns: examination of false-positive samples associated with donor milk use","volume":"9","author":"Wunderlich","year":"2023","journal-title":"Int. J. Neonatal Screen."},{"key":"10.1016\/j.jcv.2026.106022_bib20","doi-asserted-by":"crossref","first-page":"e487","DOI":"10.1542\/hpeds.2025-008434","article-title":"Implementing a hearing-targeted congenital CMV screening program in a low-prevalence region","volume":"15","author":"Wang","year":"2025","journal-title":"Hosp. Pediatr."},{"key":"10.1016\/j.jcv.2026.106022_bib21","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcv.2023.105527","article-title":"False positive congenital cytomegalovirus saliva screening results with an FDA-approved assay at two institutions","volume":"166","author":"Atwood","year":"2023","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.jcv.2026.106022_bib22","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcv.2025.105800","article-title":"Universal screening for congenital Cytomegalovirus infection using saliva from the neonate","volume":"178","author":"Halwachs-Baumann","year":"2025","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.jcv.2026.106022_bib23","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0227143","article-title":"Characterization of a universal screening approach for congenital CMV infection based on a highly-sensitive, quantitative, multiplex real-time PCR assay","volume":"15","author":"Nagel","year":"2020","journal-title":"PLoS. One"},{"key":"10.1016\/j.jcv.2026.106022_bib24","doi-asserted-by":"crossref","first-page":"398","DOI":"10.1093\/cid\/cix337","article-title":"Risk factors for congenital cytomegalovirus infection following primary and nonprimary maternal infection: a prospective neonatal screening study using polymerase chain reaction in saliva","volume":"65","author":"Leruez-Ville","year":"2017","journal-title":"Clin. Infect. Dis."},{"key":"10.1016\/j.jcv.2026.106022_bib25","doi-asserted-by":"crossref","first-page":"1205","DOI":"10.1097\/INF.0000000000001763","article-title":"Congenital cytomegalovirus: a European expert consensus statement on diagnosis and management","volume":"36","author":"Luck","year":"2017","journal-title":"Pediatr. Infect. Dis. J."},{"key":"10.1016\/j.jcv.2026.106022_bib26","doi-asserted-by":"crossref","DOI":"10.1128\/jcm.00283-23","article-title":"Multicenter evaluation of the DiaSorin molecular simplexa congenital CMV direct PCR test on neonatal saliva and urine specimens","volume":"61","author":"Dunn","year":"2023","journal-title":"J. Clin. Microbiol."},{"key":"10.1016\/j.jcv.2026.106022_bib27","doi-asserted-by":"crossref","DOI":"10.1128\/JCM.01951-19","article-title":"Performance of the alethia CMV assay for detection of cytomegalovirus by use of neonatal saliva swabs","volume":"58","author":"Gantt","year":"2020","journal-title":"J. Clin. Microbiol."},{"key":"10.1016\/j.jcv.2026.106022_bib28","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2026-076776","article-title":"Implementing congenital CMV screening in a large hospital system","volume":"158","author":"Tanzo","year":"2026","journal-title":"Pediatrics"},{"key":"10.1016\/j.jcv.2026.106022_bib29","doi-asserted-by":"crossref","DOI":"10.1002\/jmv.29223","article-title":"Performance evaluation of fully automated cobas(R) 6800 CMV PCR for the detection and quantification of cytomegalovirus DNA in neonatal urine and saliva, and adult urine, saliva, and vaginal secretion","volume":"95","author":"Tan","year":"2023","journal-title":"J. Med. Virol."},{"key":"10.1016\/j.jcv.2026.106022_bib30","unstructured":"Roche Diagnostics. cobas CMV: Quantitative nucleic acid test for use on the cobas 6800\/8800 Systems (PMA P160041). https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf16\/P160041C.pdf.: U.S. Food and Drug Administration; 2017 (accessed 23 June 2026)."},{"key":"10.1016\/j.jcv.2026.106022_bib31","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2026-078595","article-title":"Care of the infant with congenital cytomegalovirus infection: clinical report","volume":"158","author":"Tesini","year":"2026","journal-title":"Pediatrics"},{"key":"10.1016\/j.jcv.2026.106022_bib32","doi-asserted-by":"crossref","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support","volume":"42","author":"Harris","year":"2009","journal-title":"J. Biomed. Inform."},{"key":"10.1016\/j.jcv.2026.106022_bib33","doi-asserted-by":"crossref","first-page":"102","DOI":"10.1136\/bmj.309.6947.102","article-title":"Diagnostic tests 2: predictive values","volume":"309","author":"Altman","year":"1994","journal-title":"BMJ"},{"key":"10.1016\/j.jcv.2026.106022_bib34","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/j.jcv.2007.09.004","article-title":"Congenital cytomegalovirus (CMV) infection as a cause of permanent bilateral hearing loss: a quantitative assessment","volume":"41","author":"Grosse","year":"2008","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.jcv.2026.106022_bib35","doi-asserted-by":"crossref","first-page":"1261","DOI":"10.1111\/dmcn.13556","article-title":"Long-term impairment attributable to congenital cytomegalovirus infection: a retrospective cohort study","volume":"59","author":"Korndewal","year":"2017","journal-title":"Dev. Med. Child. Neurol."},{"key":"10.1016\/j.jcv.2026.106022_bib36","doi-asserted-by":"crossref","first-page":"875","DOI":"10.1038\/jp.2017.41","article-title":"Long-term outcomes of children with symptomatic congenital cytomegalovirus disease","volume":"37","author":"Lanzieri","year":"2017","journal-title":"J. Perinatol."},{"key":"10.1016\/j.jcv.2026.106022_bib37","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2019-3945","article-title":"Vestibular, gaze, and balance disorders in asymptomatic congenital cytomegalovirus infection","volume":"147","author":"Pinninti","year":"2021","journal-title":"Pediatrics"},{"key":"10.1016\/j.jcv.2026.106022_bib38","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2025.54486","article-title":"Universal screening for congenital cytomegalovirus infection","volume":"9","author":"Sanchez","year":"2026","journal-title":"JAMA Netw. Open."},{"key":"10.1016\/j.jcv.2026.106022_bib39","doi-asserted-by":"crossref","first-page":"523","DOI":"10.1016\/j.clp.2025.06.003","article-title":"The case for universal newborn congenital cytomegalovirus screening","volume":"52","author":"Sanchez","year":"2025","journal-title":"Clin. Perinatol."},{"key":"10.1016\/j.jcv.2026.106022_bib40","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1055\/s-0043-1768036","article-title":"American Academy of Audiology position statement on early identification of cytomegalovirus in newborns","volume":"34","author":"Kettler","year":"2023","journal-title":"J. Am. Acad. Audiol."},{"key":"10.1016\/j.jcv.2026.106022_bib41","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2021.20736","article-title":"Congenital cytomegalovirus infection burden and epidemiologic risk factors in countries with universal screening: a systematic review and meta-analysis","volume":"4","author":"Ssentongo","year":"2021","journal-title":"JAMA Netw. Open."},{"key":"10.1016\/j.jcv.2026.106022_bib42","doi-asserted-by":"crossref","first-page":"5131","DOI":"10.1007\/s00431-023-05183-x","article-title":"Optimizing congenital cytomegalovirus detection by pool testing in saliva by a rapid molecular test","volume":"182","author":"Izquierdo","year":"2023","journal-title":"Eur. J. Pediatr."},{"key":"10.1016\/j.jcv.2026.106022_bib43","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1093\/jpids\/piad013","article-title":"Urine and saliva viral load in children with congenital cytomegalovirus infection","volume":"12","author":"Kabani","year":"2023","journal-title":"J. Pediatr. Infect. Dis. Soc."}],"container-title":["Journal of Clinical Virology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1386653226001149?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1386653226001149?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T01:21:08Z","timestamp":1792718468000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1386653226001149"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,12]]},"references-count":43,"alternative-id":["S1386653226001149"],"URL":"https:\/\/doi.org\/10.1016\/j.jcv.2026.106022","relation":{},"ISSN":["1386-6532"],"issn-type":[{"value":"1386-6532","type":"print"}],"subject":[],"published":{"date-parts":[[2026,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Clinical performance evaluation of a high-throughput real-time PCR platform for congenital cytomegalovirus screening on saliva swabs with quantitative reporting thresholds","name":"articletitle","label":"Article Title"},{"value":"Journal of Clinical Virology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jcv.2026.106022","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"106022"}}