tetano
Editor, Senior Moderator
Sci Rep
. 2021 Oct 13;11(1):20363.
doi: 10.1038/s41598-021-99886-6.
Clinical validation of automated and rapid mariPOC SARS-CoV-2 antigen test
Juha M Koskinen[SUP] #[/SUP][SUP] 1 2 [/SUP], Petri Antikainen[SUP] #[/SUP][SUP] 3 [/SUP], Kristina Hotakainen[SUP] 4 5 [/SUP], Anu Haveri[SUP] 6 [/SUP], Niina Ikonen[SUP] 6 [/SUP], Carita Savolainen-Kopra[SUP] 6 [/SUP], Kati Sundström[SUP] 7 8 [/SUP], Janne O Koskinen[SUP] 3 [/SUP]
Affiliations
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 TCID[SUB]50[/SUB]/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.
. 2021 Oct 13;11(1):20363.
doi: 10.1038/s41598-021-99886-6.
Clinical validation of automated and rapid mariPOC SARS-CoV-2 antigen test
Juha M Koskinen[SUP] #[/SUP][SUP] 1 2 [/SUP], Petri Antikainen[SUP] #[/SUP][SUP] 3 [/SUP], Kristina Hotakainen[SUP] 4 5 [/SUP], Anu Haveri[SUP] 6 [/SUP], Niina Ikonen[SUP] 6 [/SUP], Carita Savolainen-Kopra[SUP] 6 [/SUP], Kati Sundström[SUP] 7 8 [/SUP], Janne O Koskinen[SUP] 3 [/SUP]
Affiliations
- PMID: 34645929
- DOI: 10.1038/s41598-021-99886-6
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 TCID[SUB]50[/SUB]/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.