Diagnostic accuracy and feasibility of patient self-testing with a SARS-CoV-2 antigen-detecting rapid test
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Abstract
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SciScore for 10.1101/2021.01.06.20249009: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Study procedures: After providing written informed consent, the participants received a written and illustrated instruction for self-sampling and self-testing in German or English (Supporting Information S1 and S2), adapted from the manufacturer’s instructions for use.
IRB: All analyses were performed using R version 4.0.3. Ethics: This study was approved by the ethics committee of Charité - Universitätsmedizin (EA1/371/20).Randomization not detected. Blinding All Ag-RDT results were interpreted by two study physicians, each blinded to the result of the other, also in addition to the participant’s interpretation of the self-test. Power Analysis not detected. SciScore for 10.1101/2021.01.06.20249009: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Study procedures: After providing written informed consent, the participants received a written and illustrated instruction for self-sampling and self-testing in German or English (Supporting Information S1 and S2), adapted from the manufacturer’s instructions for use.
IRB: All analyses were performed using R version 4.0.3. Ethics: This study was approved by the ethics committee of Charité - Universitätsmedizin (EA1/371/20).Randomization not detected. Blinding All Ag-RDT results were interpreted by two study physicians, each blinded to the result of the other, also in addition to the participant’s interpretation of the self-test. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data were collected and managed using Research Electronic Data Capture (REDCap) tools [17]. REDCapsuggested: (REDCap, RRID:SCR_003445)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:The recorded sensitivities are also remarkable considering the presumed limitations due to the acute illness and reported nervousness of patients. Furthermore, more than a quarter of the participants had a possible language barrier. This was reflected in the suggestions for improvement from the participants, which include the use of simple and clear language for instructions in additional languages, with more illustrations and a video format. Nevertheless, for most participants (80.9%) the Ag-RDT was rather easy to perform. The strengths of the study are the rigorous methods, including standardized sampling, two independent blinded readers, an additional semi-quantitative assessment of Ag-RDT results, and the observation of procedures without intervention. The study is limited as it was performed in a single centre. Patients were rather young and educated, and almost half had experienced professional sample collection for SARS-CoV-2 in the past. In a sub-analysis, the PPA was similar regardless of whether a patient had previously experienced professional sample collection or not. The generalisability of the findings and applicability to settings with different prevailing patient characteristics needs to be confirmed. Further research should also be directed towards the interest and acceptability of using a self-test in different global regions. The feasibility of self-testing is currently the subject of lively debate [8, 20, 21]. While in the US, the first home self-test was ...
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.
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SciScore for 10.1101/2021.01.06.20249009: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Study procedures After providing written informed consent, the participants received a written and illustrated instruction for self-sampling and self-testing in German or English (Supporting Information S1 and S2), adapted from the manufacturer’s instructions for use. Randomization not detected. Blinding All Ag-RDT results were interpreted by two study physicians, each blinded to the result of the other, also in addition to the participant's interpretation of the self-test. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Experimental Models: Organisms/Strains Sentences Resources Sensitivity 33/40 (82.5%) Sensitivity 34/40 (85.0%) … SciScore for 10.1101/2021.01.06.20249009: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Study procedures After providing written informed consent, the participants received a written and illustrated instruction for self-sampling and self-testing in German or English (Supporting Information S1 and S2), adapted from the manufacturer’s instructions for use. Randomization not detected. Blinding All Ag-RDT results were interpreted by two study physicians, each blinded to the result of the other, also in addition to the participant's interpretation of the self-test. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Experimental Models: Organisms/Strains Sentences Resources Sensitivity 33/40 (82.5%) Sensitivity 34/40 (85.0%) Sensitivity 34/40 (85.0%) No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 1 log 10 RT-PCR (OP/NP) Ct value 14.822 18.293 16.202 16.342 16.892 19.513 17.432 20.303 17.742 20.353 17.942 20.723 18.502 21.343 18.962 19.262 19.292 21.943 19.482 19.492 19.522 19.742 19.952 20.672 23.713 23.993 21.982 24.893 22.672 24.862 25.072 28.583 27.052 29.712 30.032 30.282 35.693 33.292 34.542 34.992 Viral load1 Days of Symptoms Deviations in Ag-RDT self-use 9.57 9.30 9.16 9.12 8.96 8.94 8.80 8.71 8.70 8.69 8.64 8.58 8.48 8.40 8.34 8.25 8.24 8.22 8.19 8.18 8.17 8.11 8.05 7.83 7.70 7.62 7.44 7.35 7.24 6.59 6.52 6.26 5.94 5.15 5.05 4.98 4.15 3.91 3.71 3.41 2 2 2 3 1 2 2 4 3 4 3 1 1 3 7 2 3 1 4 4 4 2 3 3 6 3 7 8 3 7 5 8 1 5 7 7 7 14 8 14 sampling4 extraction5 extraction5 extraction5 sampling4, extraction5 extraction5, volume6 extraction5, volume6 sampling4, extraction5 extraction5, volume6 sampling4, extraction5 extraction5 sampling4 sampling4, extract. sampling4 extraction5 extraction5 extraction5 sampling4, extraction5 extraction5, volume6 extraction5, volume6 sampling4, extraction5 extraction5, volume6 sampling4, extraction5 extraction5 sampling4 sampling4suggested: None5, vol.6 sampling4, extraction5 extraction5 sampling4 extraction5, volume6 sampling4, extraction5 read-out7 sampling4 extraction5, volume6 extraction5 sampling4, extraction5 sampling4, extract. sampling4, extraction5 extraction5 sampling4 extraction5, volume6 sampling4, extraction5 read-out7 sampling4 extraction5, volume6 extraction5 sampling4, extraction5 sampling4suggested: NoneSoftware and Algorithms Sentences Resources Data were collected and managed using Research Electronic Data Capture (REDCap) tools [17]. REDCapsuggested: (REDCap, RRID:SCR_003445)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:
The recorded sensitivities are also remarkable considering the presumed limitations due to the acute illness and reported nervousness of patients. Furthermore, more than a quarter of the participants had a possible language barrier. This was reflected in the suggestions for improvement from the participants, which include the use of simple and clear language for instructions in additional languages, with more illustrations and a video format. Nevertheless, for most participants (80.9%) the Ag-RDT was rather easy to perform. The strengths of the study are the rigorous methods, including standardized sampling, two independent blinded readers, an additional semi-quantitative assessment of Ag-RDT results, and the observation of procedures without intervention. The study is limited as it was performed in a single centre. Patients were rather young and educated, and almost half had experienced professional sample collection for SARS-CoV-2 in the past. In a sub-analysis, the PPA was similar regardless of whether a patient had previously experienced professional sample collection or not. The generalisability of the findings and applicability to settings with different prevailing patient characteristics needs to be confirmed. Further research should also be directed towards the interest and acceptability of using a self-test in different global regions. The feasibility of self-testing is currently the subject of lively debate [8, 20, 21]. While in the US, the first home self-test was ...
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.
About SciScore
SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.
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