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2022-04-16Zeitschriftenartikel
Multicentric Evaluation of SeeGene Allplex Real-Time PCR Assays Targeting 28 Bacterial, Microsporidal and Parasitic Nucleic Acid Sequences in Human Stool Samples
dc.contributor.authorWeinreich, Felix
dc.contributor.authorHahn, Andreas
dc.contributor.authorEberhardt, Kirsten Alexandra
dc.contributor.authorKann, Simone
dc.contributor.authorKöller, Thomas
dc.contributor.authorWarnke, Philipp
dc.contributor.authorDupke, Susann
dc.contributor.authorDekker, Denise
dc.contributor.authorMay, Jürgen
dc.contributor.authorFrickmann, Hagen
dc.contributor.authorLoderstädt, Ulrike
dc.date.accessioned2022-06-20T13:14:44Z
dc.date.available2022-06-20T13:14:44Z
dc.date.issued2022-04-16none
dc.identifier.other10.3390/diagnostics12041007
dc.identifier.urihttp://edoc.rki.de/176904/9837
dc.description.abstractPrior to the implementation of new diagnostic techniques, a thorough evaluation is mandatory in order to ensure diagnostic reliability. If positive samples are scarcely available, however, such evaluations can be difficult to perform. Here, we evaluated four SeeGene Allplex real-time PCR assays amplifying a total of 28 bacteria, microsporidal and parasitic nucleic acid sequence targets in human stool samples in a multicentric approach. In the assessments with strongly positive samples, sensitivity values ranging between 13% and 100% were recorded for bacteria, between 0% and 100% for protozoa and between 7% and 100% for helminths and microsporidia; for the weakly positive samples, the recorded sensitivity values for bacteria ranged from 0% to 100%; for protozoa, from 0% to 40%; and for helminths and microsporidia, from 0% to 53%. For bacteria, the recorded specificity was in the range between 87% and 100%, while a specificity of 100% was recorded for all assessed PCRs targeting parasites and microsporidia. The intra- and inter-assay variations were generally low. Specifically for some helminth species, the sensitivity could be drastically increased by applying manual nucleic acid extraction instead of the manufacturer-recommended automatic procedure, while such effects were less obvious for the bacteria and protozoa. In summary, the testing with the chosen positive control samples showed varying degrees of discordance between the evaluated Allplex assays and the applied in-house reference assays associated with higher cycle threshold values in the Allplex assays, suggesting that samples with very low pathogen densities might be missed. As the targeted species can occur as harmless colonizers in the gut of individuals in high-endemicity settings as well, future studies should aim at assessing the clinical relevance of the latter hint.eng
dc.language.isoengnone
dc.publisherRobert Koch-Institut
dc.rights(CC BY 3.0 DE) Namensnennung 3.0 Deutschlandger
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/de/
dc.subjecttest evaluationeng
dc.subjectreal-time PCReng
dc.subjectparasiteeng
dc.subjectbacteriaeng
dc.subjectenteric pathogeneng
dc.subjectgastrointestinal infectioneng
dc.subjectdiagnosiseng
dc.subjecttest comparisoneng
dc.subjectSeeGeneeng
dc.subjectAllplexeng
dc.subject.ddc610 Medizin und Gesundheitnone
dc.titleMulticentric Evaluation of SeeGene Allplex Real-Time PCR Assays Targeting 28 Bacterial, Microsporidal and Parasitic Nucleic Acid Sequences in Human Stool Samplesnone
dc.typearticle
dc.identifier.urnurn:nbn:de:0257-176904/9837-6
dc.type.versionpublishedVersionnone
local.edoc.container-titleDiagnosticsnone
local.edoc.container-issn2075-4418none
local.edoc.type-nameZeitschriftenartikel
local.edoc.container-typeperiodical
local.edoc.container-type-nameZeitschrift
local.edoc.container-urlhttps://www.mdpi.com/2075-4418/12/4/1007/htmnone
local.edoc.container-publisher-nameMDPInone
local.edoc.container-volume12none
local.edoc.container-issue4none
local.edoc.container-year2022none
dc.description.versionPeer Reviewednone

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