Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands
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SciScore for 10.1101/2020.11.18.20234104: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: At the entrance of the testing site all people over 18 years of age were approached for inclusion and following informed consent people were enrolled and directed to one of the dedicated testing stations for the Ag RDT.
IRB: Ethical clearance: The medical research ethics committee (MREC) of Utrecht decided the study was not subject to the Medical Research Involving Human Subjects Act (WMO) and did not require full review by an accredited MREC (protocol number 20-606/C).Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentenc… SciScore for 10.1101/2020.11.18.20234104: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: At the entrance of the testing site all people over 18 years of age were approached for inclusion and following informed consent people were enrolled and directed to one of the dedicated testing stations for the Ag RDT.
IRB: Ethical clearance: The medical research ethics committee (MREC) of Utrecht decided the study was not subject to the Medical Research Involving Human Subjects Act (WMO) and did not require full review by an accredited MREC (protocol number 20-606/C).Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Samples were cultured for seven days, and, once cytopathic effect (CPE) was visible, the presence of SARS-CoV-2 was confirmed with immunofluorescent detection of SARS CoV-2 nucleocapsid protein (Rabbit polyclonal antibody Sino Biological inc.). CoV-2 nucleocapsid proteinsuggested: NoneExperimental Models: Cell Lines Sentences Resources The virus transport medium from the same oro- and nasopharyngeal swabs were also directly inoculated onto Vero cells clone 118, without prior freezing [10]. Verosuggested: NoneResults 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:Our study has some limitations. In our setting results of RT-PCR and Ag RDT are compared but in contrast to the instructions for the Ag RDT, two swabs were taken for RT-PCR and virus culture which probably results in a higher amount of viral material collected. This might explain some of the discrepancies between Ag RDT and PCR/culture. Furthermore, the same nostril was used to take the second swab for the Ag RDT which meant to grant comparability between the two tests but might have resulted in lower viral load in the second sample. We used culture as a correlate of infectivity which has certain limitations but it is still the best available technique to measure infectivity. When filling out the questionnaires recall bias by the enrolled people could have affected the data provided. Furthermore, testing is free of charge only for people either with relevant symptoms and/or notified contact with an infected person, therefore some people might have provided symptoms falsely in order to be tested for other reasons. Despite these possible drawbacks, we conclude that the use of Ag RDT in our drive through test stations would provide a good method to identify the majority of infectious people. For further roll-out, logistics of implementation are important, including a safe working environment for personnel performing the assays if implemented on site, and a system that allows follow-up testing by PCR for risk groups. The national outbreak management team of The Netherlands recomm...
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 10.1101/2020.11.18.20234104: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement At the entrance of the testing site all people over 18 years of age were approached for inclusion and following informed consent people were enrolled and directed to one of the dedicated testing stations for the Ag RDT. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable Of the included people the average age was 42 years (range 18-86 years), the majority was female (n=525, 54.7%) and had symptom onset ≤7 days (n=650, 89.7%). Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Samples were cultured for seven days, and, once cytopathic effect (CPE) was visible, the presence of … SciScore for 10.1101/2020.11.18.20234104: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement At the entrance of the testing site all people over 18 years of age were approached for inclusion and following informed consent people were enrolled and directed to one of the dedicated testing stations for the Ag RDT. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable Of the included people the average age was 42 years (range 18-86 years), the majority was female (n=525, 54.7%) and had symptom onset ≤7 days (n=650, 89.7%). Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Samples were cultured for seven days, and, once cytopathic effect (CPE) was visible, the presence of SARS-CoV-2 was confirmed with immunofluorescent detection of SARS CoV-2 nucleocapsid protein (Rabbit polyclonal antibody Sino Biological inc.) . CoV-2 nucleocapsid proteinsuggested: NoneExperimental Models: Cell Lines Sentences Resources The virus transport medium from the same oro- and nasopharyngeal swabs were also directly inoculated onto Vero cells clone 118, without prior freezing [10]. Verosuggested: NoneResults 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:
Our study has some limitations. In our setting results of RT-PCR and Ag RDT are compared but in contrast to the instructions for the Ag RDT, two swabs were taken for RT-PCR and virus culture which probably results in a higher amount of viral material collected. This might explain some of the discrepancies between Ag RDT and PCR/culture. Furthermore, the same nostril was used to take the second swab for the Ag RDT which meant to grant comparability between the two tests but might have resulted in lower viral load in the second sample. We used culture as a correlate of infectivity which has certain limitations but it is still the best available technique to measure infectivity. When filling out the questionnaires recall bias by the enrolled people could have affected the data provided. Furthermore, testing is free of charge only for people either with relevant symptoms and/or notified contact with an infected person, therefore some people might have provided symptoms falsely in order to be tested for other reasons. Despite these possible drawbacks, we conclude that the use of Ag RDT in our drive through test stations would provide a good method to identify the majority of infectious people. For further roll-out, logistics of implementation are important, including a safe working environment for personnel performing the assays if implemented on site, and a system that allows follow-up testing by PCR for risk groups. The national outbreak management team of The Netherlands recomm...
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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