Clinical validation of automated and rapid mariPOC SARS-CoV-2 antigen test
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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 TCID 50 /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.
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SciScore for 10.1101/2021.02.08.21250086: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Two consecutive specimens were collected from 127 patients giving an oral consent to participate in the study.
IRB: The specimens were collected during an internal laboratory method validation study, which does not require external ethical review board permission and was not linked with recruitment or treatment of patients (36).Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results …SciScore for 10.1101/2021.02.08.21250086: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Two consecutive specimens were collected from 127 patients giving an oral consent to participate in the study.
IRB: The specimens were collected during an internal laboratory method validation study, which does not require external ethical review board permission and was not linked with recruitment or treatment of patients (36).Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:A minor limitation of the study is that cross-reactivity for MERS coronavirus and coronavirus HKU1 were assessed using purified protein and sequence analysis (supplemental material) and not with clinical samples or cultured virus. Our verification cohort showed 90% positivity rate for the mariPOC below qRT-PCR Ct 25 (Table 1 and Figure 2). This was an excellent result taking into account that the samples were unfavorable for the fluorescent mariPOC platform. Colorful transport media are not recommended for mariPOC testing since they elevate fluorescent signal levels (44) and unnecessarily dilute the samples, which reduces sensitivity. The obtained results were, nevertheless, similar compared to what has been reported in the literature for the correlation between SARS-CoV-2 viral culture and qRT-PCR results, as summarized in Table 1. In addition, our results are in line with at least two other N-protein detecting tests that were evaluated against RT-PCR and culture (35, 45). Several studies have shown that infectivity of SARS-CoV-2 declines rapidly in samples showing qRT-PCR Ct above 25, and viable virus is rarely isolated after 8 days from onset of the symptoms. The detection of sole viral RNA, especially at low levels without the detectable level of viral N-protein or culture positivity, is a questionable marker of acute infection and infectiousness (10-14, 16, 46-48). In the clinical validation study, the specificity of the mariPOC SARS-CoV-2 test was high (100.0%), with hi...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from scite Reference Check: We found one citation with an erratum. We recommend checking the erratum to confirm that it does not impact the accuracy of your citation.
DOI Status Title 10.1038/s41586-020-2404-8 Has correction The effect of large-scale anti-contagion policies on the COV… -