Bean extract-based gargle for efficient diagnosing COVID-19 at early-stage using rapid antigen tests : a clinical, prospective, diagnostic study
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Abstract
Importance
The antigen-based rapid diagnostic test (Ag-RDT), using saliva specimens, is fast, non-invasive and suitable for SARS-CoV-2 self-testing, unlike nasopharyngeal swab (NPS) testing.
Objective
To assess the diagnostic sensitivity of a novel Beanguard gargle™ (BG)-based virus detection method for early diagnosis of COVID-19.
Design
This clinical trial was conducted at Gunsan Medical Center, Namwon Medical Center, and Jeonbuk National University Hospital, between May 7 and July 7, 2021.
Setting
Paired NPS and BG-based saliva specimens collected from COVID-19 patients and healthy individuals were analyzed using NPS-RT-PCR, BG-RT-PCR, and BG-Ag-RDTs.
Participants
The study comprised 102 COVID-19-positive patients hospitalized after governmental screening process and 100 healthy individuals. Forty-five COVID-19 patients were sampled within 6 days of illness and 57 within 7–15 days; 27 were categorized as asymptomatic and 75, as symptomatic. Eight and 2 patients carried the SARS-CoV-2 Alpha and Delta variants, respectively.
Intervention
The diagnostic performances of BG-Ag-RDT, BG-RT-PCR, and NPS-RT-PCR for detecting SARS-CoV-2 were compared.
Main outcomes
The sensitivities of BG-Ag-RDT and BG-RT-PCR towards salivary viral detection were highly concordant, with no discrimination between symptomatic, asymptomatic, or SARS-CoV-2 variant cases.
Results
Among total participants (mean age, 43.7 years), 51% were women. BG-Ag-RDTs showed high sensitivity (97.8%, [95% CI, 88.4% to 99.6%]) and specificity (100%, [95% CI, 96.3% to 100%) in 45 patients within 6 days of illness and could detect all cases of SARS-CoV-2 Alpha and Delta variants. In 11 asymptomatic early-stage cases, both BG-Ag-RDTs and BG-RT-PCR showed excellent sensitivity and specificity of 100% (95% CI, 74.1% to 100% and 95% CI, 20.7% to 100%, respectively). The interaction between SARS-CoV-2 spike proteins and truncated canavalin, an active ingredient from bean extract (BE) and the ultrastructural features of SARS-CoV-2 particles coated with BE were observed. The detachment of the SARS-CoV-2 receptor-binding domain from hACE2 increased as the BE concentration increased, allowing the release of the virus from hACE2 for early diagnosis.
Conclusions and Relevance
Using BG-based saliva remarkably enhances the Ag-RDT diagnostic performance as an alternative to NPS and enables rapid and accurate COVID-19 self-testing and mass screening, supporting efficient COVID-19 management.
Trial Registration
KCT0006438
Key Points
Question
How can we collect SARS-CoV-2 from oral cavity to improve the sensitivity of antigen-based rapid diagnostic test (Ag-RDT)?
Findings
In this clinical study involving 102 hospitalized COVID-19 patients, the Ag-RDT test using Beanguard gargle™-based saliva specimens showed significantly enhanced sensitivity and specificity towards detection of SARS-CoV-2 along with Alpha and Delta variants in all patients tested within 6 days of illness.
Meaning
Our self-testing method represents an attractive alternative to nasopharyngeal swab RT-PCR for the early diagnosis of symptomatic and asymptomatic COVID-19 cases.
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SciScore for 10.1101/2021.08.13.21261463: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical approval for the study was granted by the Institutional Review Board of Jeonbuk National University
Consent: Hospital (CUH 2021-04-036-002) and written informed consent statements were obtained from all participants.Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis Minimal sample size was calculated with 90 percent power at a significance level of 0.05 for the estimated sensitivity and specificity, according to the equation:Where, Z(1-α)/2 and Z1-β are Z-values for the corresponding level of confidence and the desired power, respectively. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analysis: All … SciScore for 10.1101/2021.08.13.21261463: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical approval for the study was granted by the Institutional Review Board of Jeonbuk National University
Consent: Hospital (CUH 2021-04-036-002) and written informed consent statements were obtained from all participants.Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis Minimal sample size was calculated with 90 percent power at a significance level of 0.05 for the estimated sensitivity and specificity, according to the equation:Where, Z(1-α)/2 and Z1-β are Z-values for the corresponding level of confidence and the desired power, respectively. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analysis: All statistical analyses were performed using GraphPad Prism v.7, and statistical multiple comparisons were performed using one-way ANOVA followed by post hoc Dunnett’s test. GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.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 rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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