Characterization of a universal screening approach for congenital CMV infection based on a highly-sensitive, quantitative, multiplex real-time PCR assay

dc.contributor.authorNagel, Angela
dc.contributor.authorDimitrakopoulou, Emmanouela
dc.contributor.authorTeig, Norbert
dc.contributor.authorKern, Peter
dc.contributor.authorLücke, Thomas
dc.contributor.authorMichna, Dariusz
dc.contributor.authorKorn, Klaus
dc.contributor.authorSteininger, Philipp
dc.contributor.authorShahada, Khalid
dc.contributor.authorNeumann, Katrin
dc.contributor.authorÜberla, Klaus
dc.date.accessioned2020-08-06
dc.date.available2020-08-01
dc.date.created2020
dc.date.issued2020-08-06
dc.description.abstractThe majority of congenital cytomegalovirus (cCMV) infections are asymptomatic at birth and therefore not diagnosed. Approximately 10–15% of these infants develop late-onset hearing loss and other developmental disorders. Implementation of a universal screening approach at birth may allow early initiation of symptomatic interventions due to a closer follow-up of infants at risk and offers the opportunity to consider treatment of late-onset disease. Real-time PCR assays for the detection of CMV DNA in buccal swab samples demonstrated feasibility and good clinical sensitivity in comparison to a rapid culture screening assay. Because most cCMV infections remain asymptomatic, a universal screening assay that stratifies CMV infected infants according to low and high risk of late-onset cCMV disease could limit the parental anxiety and reduce follow-up costs. We therefore developed and characterized a screening algorithm based on a highly-sensitive quantitative real-time PCR assay that is compatible with centralized testing of samples from universal screening and allows to determine CMV DNA load of saliva samples either as International Units (IU)/ml saliva or IU/105 cell equivalents. 18 of 34 saliva samples of newborns that tested positively by the screening algorithm were confirmed by detection of CMV DNA in blood and/or urine samples obtained during the first weeks of life. All screening samples that could not be confirmed had viral loads of <2.3x105 IU/ml saliva (median: 6.8x103) or 1.3x105 IU/105 cell equivalents (median: 4.0x102). The viral load of screening samples with confirmed cCMV infection ranged from 7.5x102 to 8.2x109 IU/ml saliva (median: 9.3x107) or 1.5x102 to 5.6x1010 IU/105 cell equivalents (median: 3.5x106). Clinical follow-up of these newborns with confirmed cCMV infection should reveal whether the risk of late-onset cCMV disease correlates with CMV DNA load in early life saliva samples and whether a cut-off can be defined identifying cCMV infected infants with or without risk for late-onset cCMV disease.en
dc.identifier.citationPLoS ONE 15.1 (2020). <https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0227143>
dc.identifier.doihttps://doi.org/10.1371/journal.pone.0227143
dc.identifier.opus-id14274
dc.identifier.urihttps://open.fau.de/handle/openfau/14274
dc.identifier.urnurn:nbn:de:bvb:29-opus4-142748
dc.language.isoen
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/deed.de
dc.subjectSaliva
dc.subjectPolymerase chain reaction
dc.subjectUrine
dc.subjectViral load
dc.subjectAlbumins
dc.subjectDNA extraction
dc.subjectBlood
dc.subjectNeonates
dc.subject.ddcDDC Classification::6 Technik, Medizin, angewandte Wissenschaften :: 61 Medizin und Gesundheit :: 610 Medizin und Gesundheit
dc.titleCharacterization of a universal screening approach for congenital CMV infection based on a highly-sensitive, quantitative, multiplex real-time PCR assayen
dc.typearticle
dcterms.publisherFriedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
local.journal.issue1
local.journal.titlePLoS ONE
local.journal.volume15
local.sendToDnbfree*
local.subject.fakultaetMedizinische Fakultät
local.subject.sammlungUniversität Erlangen-Nürnberg / Open Access Artikel ohne Förderung / Open Access Artikel ohne Förderung 2020
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