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

Juha M. Koskinen, Petri Antikainen, Kristina Hotakainen, Anu Haveri, Niina Ikonen, Carita Savolainen-Kopra, Kati Sundström, Janne O. Koskinen

    Research output: Contribution to journalArticleScientificpeer-review

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    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.

    Original languageEnglish
    Article number20363
    JournalScientific Reports
    Volume11
    Issue number1
    DOIs
    Publication statusPublished - Oct 2021
    Publication typeA1 Journal article-refereed

    Publication forum classification

    • Publication forum level 1

    ASJC Scopus subject areas

    • General

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