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

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http://hdl.handle.net/10138/335774

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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

Title: Clinical validation of automated and rapid mariPOC SARS-CoV-2 antigen test
Author: Koskinen, Juha M.; Antikainen, Petri; Hotakainen, Kristina; Haveri, Anu; Ikonen, Niina; Savolainen-Kopra, Carita; Sundström, Kati; Koskinen, Janne O.
Contributor: University of Helsinki, University of Helsinki
Date: 2021-10-13
Language: eng
Number of pages: 10
Belongs to series: Scientific Reports
ISSN: 2045-2322
URI: http://hdl.handle.net/10138/335774
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.
Subject: 3111 Biomedicine
HUMAN CORONAVIRUS
PCR
VIRUSES
ASSAYS
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