{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T12:25:33Z","timestamp":1791807933265,"version":"4.3.4"},"reference-count":37,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2023,6,14]],"date-time":"2023-06-14T00:00:00Z","timestamp":1686700800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Moderna, Inc.","award":["6U19DD001218"],"award-info":[{"award-number":["6U19DD001218"]}]},{"name":"University of South Carolina\u2019s Disability Research and Dissemination Center (DRDC)","award":["6U19DD001218"],"award-info":[{"award-number":["6U19DD001218"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJNS"],"abstract":"<jats:p>Screening newborns for congenital cytomegalovirus (cCMV) infection is critical for early detection and prompt diagnosis of related long-term consequences of infection, such as sensorineural hearing loss and neurodevelopmental delays. The objective of this study was to describe the validity of different newborn cCMV infection screening approaches and compare the expected number of cCMV cases detected across targeted and universal screening algorithms. The overall sensitivity (OSn) of targeted screening algorithms that required failure of auditory brain stem response and transient evoked otoacoustic emissions (TOAE; two-fail serial testing) or TOAE only (one-fail serial testing) before diagnostic CMV testing using saliva and urine PCR tests was 79% and 88%, respectively. The OSn for two-fail serial testing with diagnostic CMV testing using dried blood spot (DBS) was 75%. In contrast, OSn was 90% for universal screening (saliva and urine PCR tests) and 86% for universal screening with DBS testing alone. Overall, specificities were 100% across all algorithms. Universal screening using DBS testing and universal screening using saliva and urine testing can potentially detect 312 and 373 more cCMV cases per 100,000 live births, respectively, than two-fail serial testing. Overall, implementing universal cCMV newborn screening would improve cCMV detection, ultimately leading to better health outcomes.<\/jats:p>","DOI":"10.3390\/ijns9020033","type":"journal-article","created":{"date-parts":[[2023,6,14]],"date-time":"2023-06-14T02:01:40Z","timestamp":1686708100000},"page":"33","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Comparison of Overall Sensitivity and Specificity across Different Newborn Screening Algorithms for Congenital Cytomegalovirus"],"prefix":"10.3390","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2108-9433","authenticated-orcid":false,"given":"Mark R.","family":"Schleiss","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN 55455, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lori","family":"Panther","sequence":"additional","affiliation":[{"name":"Moderna, Inc., Cambridge, MA 02139, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep","family":"Basnet","sequence":"additional","affiliation":[{"name":"Moderna, Inc., Cambridge, MA 02139, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meklit","family":"Workneh","sequence":"additional","affiliation":[{"name":"Moderna, Inc., Cambridge, MA 02139, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Diaz-Decaro","sequence":"additional","affiliation":[{"name":"Moderna, Inc., Cambridge, MA 02139, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,6,14]]},"reference":[{"key":"ref_1","unstructured":"Gupta, M., and Shorman, M. (2022). StatPearls, StatPearls Publishing."},{"key":"ref_2","unstructured":"Centers for Disease Control and Prevention (2023, February 21). About Cytomegalovirus (CMV), Available online: https:\/\/www.cdc.gov\/cmv\/overview.html."},{"key":"ref_3","unstructured":"Louten, J. (2016). Essential Human Virology, Academic Press."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"S2","DOI":"10.1093\/jpids\/piu069","article-title":"Mother-to-Child Transmission of Cytomegalovirus and Prevention of Congenital Infection","volume":"3","author":"Pass","year":"2014","journal-title":"J. Pediatr. Infect. Dis. Soc."},{"key":"ref_5","unstructured":"Centers for Disease Control and Prevention (2022, August 09). Babies Born with Congenital Cytomegalovirus (CMV), Available online: https:\/\/www.cdc.gov\/cmv\/congenital-infection.html."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"e20162128","DOI":"10.1542\/peds.2016-2128","article-title":"A Targeted Approach for Congenital Cytomegalovirus Screening within Newborn Hearing Screening","volume":"139","author":"Fowler","year":"2017","journal-title":"Pediatrics"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1002\/rmv.535","article-title":"Review and meta-analysis of the epidemiology of congenital cytomegalovirus (CMV) infection","volume":"17","author":"Kenneson","year":"2007","journal-title":"Rev. Med. Virol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1128\/CMR.00062-12","article-title":"The \u201csilent\u201d global burden of congenital cytomegalovirus","volume":"26","author":"Manicklal","year":"2013","journal-title":"Clin. Microbiol. Rev."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1093\/pch\/pxx002","article-title":"Diagnosis and management of infants with congenital cytomegalovirus infection","volume":"22","author":"Gantt","year":"2017","journal-title":"Paediatr. Child Health"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"e2021055896","DOI":"10.1542\/peds.2021-055896","article-title":"Emerging Concepts in Congenital Cytomegalovirus","volume":"150","author":"Pesch","year":"2022","journal-title":"Pediatrics"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"123","DOI":"10.31486\/toj.18.0095","article-title":"Congenital Cytomegalovirus Infection","volume":"19","author":"Dietrich","year":"2019","journal-title":"Ochsner J."},{"key":"ref_12","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":"ref_13","doi-asserted-by":"crossref","first-page":"S9","DOI":"10.1093\/infdis\/jiz446","article-title":"Congenital cytomegalovirus infection","volume":"221","author":"Kabani","year":"2020","journal-title":"J. Infect. Dis."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"538","DOI":"10.1093\/ije\/dyaa232","article-title":"Early-childhood cytomegalovirus infection and children\u2019s neurocognitive development","volume":"50","author":"Lee","year":"2021","journal-title":"Int. J. Epidemiol."},{"key":"ref_15","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":"ref_16","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1002\/rmv.1790","article-title":"Universal newborn screening for congenital CMV infection: What is the evidence of potential benefit?","volume":"24","author":"Cannon","year":"2014","journal-title":"Rev. Med. Virol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"e205441","DOI":"10.1001\/jamapediatrics.2020.5441","article-title":"Sensitivity of Dried Blood Spot Testing for Detection of Congenital Cytomegalovirus Infection","volume":"175","author":"Dollard","year":"2021","journal-title":"JAMA Pediatr."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1016\/j.jcv.2018.03.006","article-title":"Neonates with congenital Cytomegalovirus and hearing loss identified via the universal newborn hearing screening program","volume":"102","author":"Rawlinson","year":"2018","journal-title":"J. Clin. Virol."},{"key":"ref_19","unstructured":"National Institute on Deafness and Other Communication Disorders (NIDCD) (2022, October 31). Your Baby\u2019s Hearing Screening and Next Steps, Available online: https:\/\/www.nidcd.nih.gov\/health\/your-babys-hearing-screening-and-next-steps."},{"key":"ref_20","unstructured":"Minnesota Department of Health (2022, July 05). Congenital Cytomegalovirus Approved for Addition to Newborn Screening Panel. Available online: https:\/\/www.health.state.mn.us\/index.html."},{"key":"ref_21","unstructured":"Newborn Screening Ontario (2022, June 23). Hearing Loss Risk Factor Screening. Available online: https:\/\/www.newbornscreening.on.ca\/en\/page\/congenital-cytomegalovirus."},{"key":"ref_22","unstructured":"CMV Canada (2022, June 23). Saskatchewan Screens For cCMV!. Available online: https:\/\/cmvcanada.com\/saskatchewan-screens-for-ccmv\/."},{"key":"ref_23","unstructured":"The Office of Governor Ned Lamont (2023, June 13). Governor Lamont Reaches Budget Agreement with Legislative Leaders That Includes the Largest Income Tax Cut in Connecticut History, Available online: https:\/\/portal.ct.gov\/Office-of-the-Governor\/News\/Press-Releases\/2023\/06-2023\/Governor-Lamont-Reaches-Budget-Agreement-With-Legislative-Leaders."},{"key":"ref_24","unstructured":"National CMV Foundation (2022, July 28). Newborn Screening. Available online: https:\/\/www.nationalcmv.org\/overview\/newborn-screening."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Pellegrinelli, L., Alberti, L., Pariani, E., Barbi, M., and Binda, S. (2020). Diagnosing congenital Cytomegalovirus infection: Don\u2019t get rid of dried blood spots. BMC Infect. Dis., 20.","DOI":"10.1186\/s12879-020-4941-z"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"14","DOI":"10.2214\/ajr.184.1.01840014","article-title":"Clinical Evaluation of Diagnostic Tests","volume":"184","author":"Weinstein","year":"2005","journal-title":"Am. J. Roentgenol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"2151","DOI":"10.1056\/NEJMra050700","article-title":"Newborn hearing screening\u2014A silent revolution","volume":"354","author":"Morton","year":"2006","journal-title":"N. Engl. J. Med."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"461","DOI":"10.1016\/j.otohns.2008.12.022","article-title":"The epidemiology of hearing impairment in the United States: Newborns, children, and adolescents","volume":"140","author":"Mehra","year":"2009","journal-title":"Otolaryngol. Head Neck Surg."},{"key":"ref_29","unstructured":"Centers for Disease Control and Prevention (2022, June 08). Congenital CMV and Hearing Loss, Available online: https:\/\/www.cdc.gov\/cmv\/hearing-loss.html."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"104518","DOI":"10.1016\/j.jcv.2020.104518","article-title":"Maternal type of CMV infection and sequelae in infants with congenital CMV: Systematic review and meta-analysis","volume":"129","author":"Maltezou","year":"2020","journal-title":"J. Clin. Virol."},{"key":"ref_31","first-page":"104","article-title":"Transitory evoked otoacoustic emission (TEOAE) and distortion product otoacoustic emission (DPOAE) outcomes from a three-stage newborn hearing screening protocol","volume":"20","author":"Tzanakakis","year":"2016","journal-title":"Hippokratia"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"244","DOI":"10.1007\/s12070-012-0558-x","article-title":"The role of current audiological tests in the early diagnosis of hearing impairment in infant","volume":"65","author":"Kuki","year":"2013","journal-title":"Indian J. Otolaryngol. Head Neck Surg."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"933","DOI":"10.1056\/NEJMoa1404599","article-title":"Valganciclovir for symptomatic congenital cytomegalovirus disease","volume":"372","author":"Kimberlin","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"ref_34","doi-asserted-by":"crossref","unstructured":"Cannon, M.J., Levis, D.M., McBride, H., Watson, D., Rheaume, C., Hall, M.A.K., Lanzieri, T.M., and Demmler-Harrison, G. (2021). Family Perceptions of Newborn Cytomegalovirus Screening: A Qualitative Study. Int. J. Neonatal Screen., 7.","DOI":"10.3390\/ijns7040080"},{"key":"ref_35","unstructured":"National CMV Foundation (2023, February 21). Advocacy in Action. Available online: https:\/\/www.nationalcmv.org\/about-us\/advocacy."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1016\/j.jiph.2017.09.014","article-title":"Dried blood spots: An evaluation of utility in the field","volume":"11","author":"Su","year":"2018","journal-title":"J. Infect. Public Health"},{"key":"ref_37","unstructured":"Baby\u2019s First Test (2023, February 21). The Recommended Uniform Screening Panel. Available online: https:\/\/www.babysfirsttest.org\/newborn-screening\/the-recommended-uniform-screening-panel."}],"container-title":["International Journal of Neonatal Screening"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2409-515X\/9\/2\/33\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T19:54:27Z","timestamp":1760126067000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2409-515X\/9\/2\/33"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,14]]},"references-count":37,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2023,6]]}},"alternative-id":["ijns9020033"],"URL":"https:\/\/doi.org\/10.3390\/ijns9020033","relation":{},"ISSN":["2409-515X"],"issn-type":[{"value":"2409-515X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,14]]}}}