Clinical validation of automated and rapid mariPOC SARS-CoV-2 antigen test

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dc.contributor.author Koskinen, Juha M.
dc.contributor.author Antikainen, Petri
dc.contributor.author Hotakainen, Kristina
dc.contributor.author Haveri, Anu
dc.contributor.author Ikonen, Niina
dc.contributor.author Savolainen-Kopra, Carita
dc.contributor.author Sundström, Kati
dc.contributor.author Koskinen, Janne O.
dc.date.accessioned 2021-10-28T07:33:01Z
dc.date.available 2021-10-28T07:33:01Z
dc.date.issued 2021-10-13
dc.identifier.citation Koskinen , J M , Antikainen , P , Hotakainen , K , Haveri , A , Ikonen , N , Savolainen-Kopra , C , Sundström , K & Koskinen , J O 2021 , ' Clinical validation of automated and rapid mariPOC SARS-CoV-2 antigen test ' , Scientific Reports , vol. 11 , no. 1 , 20363 . https://doi.org/10.1038/s41598-021-99886-6
dc.identifier.other PURE: 169850130
dc.identifier.other PURE UUID: ebb2f54a-48c8-4272-b1c9-de3f73c68249
dc.identifier.other Scopus: 85117384155
dc.identifier.other WOS: 000707032500004
dc.identifier.uri http://hdl.handle.net/10138/335774
dc.description Publisher Copyright: © 2021, The Author(s).
dc.description.abstract COVID-19 diagnostics was quickly ramped up worldwide early 2020 based on the detection of viral RNA. However, based on the scientific knowledge for pre-existing coronaviruses, it was expected that the SARS-CoV-2 RNA will be detected from symptomatic and at significant rates also from asymptomatic individuals due to persistence of non-infectious RNA. To increase the efficacy of diagnostics, surveillance, screening and pandemic control, rapid methods, such as antigen tests, are needed for decentralized testing and to assess infectiousness. A novel automated mariPOC SARS-CoV-2 test was developed for the detection of conserved structural viral nucleocapsid proteins. The test utilizes sophisticated optical laser technology for two-photon excitation and individual detection of immunoassay solid-phase particles. We validated the new method against qRT-PCR. Sensitivity of the test was 100.0% (13/13) directly from nasopharyngeal swab specimens and 84.4% (38/45) from swab specimens in undefined transport mediums. Specificity of the test was 100.0% (201/201). The test's limit of detection was 2.7 TCID50/test. It showed no cross-reactions. Our study shows that the new test can detect infectious individuals already in 20 min with clinical sensitivity close to qRT-PCR. The mariPOC is a versatile platform for syndromic testing and for high capacity infection control screening of infectious individuals. en
dc.format.extent 10
dc.language.iso eng
dc.relation.ispartof Scientific Reports
dc.rights cc_by
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject 3111 Biomedicine
dc.subject HUMAN CORONAVIRUS
dc.subject PCR
dc.subject VIRUSES
dc.subject ASSAYS
dc.title Clinical validation of automated and rapid mariPOC SARS-CoV-2 antigen test en
dc.type Article
dc.contributor.organization University of Helsinki
dc.contributor.organization Department of Clinical Chemistry and Hematology
dc.contributor.organization Medicum
dc.description.reviewstatus Peer reviewed
dc.relation.doi https://doi.org/10.1038/s41598-021-99886-6
dc.relation.issn 2045-2322
dc.rights.accesslevel openAccess
dc.type.version publishedVersion
dc.identifier.url http://www.scopus.com/inward/record.url?scp=85117384155&partnerID=8YFLogxK

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