The evaluation of a newly developed antigen test (QuickNavi™-COVID19 Ag) for SARS-CoV-2: A prospective observational study in Japan
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SciScore for 10.1101/2020.12.27.20248876: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: During the study period, additional samples for antigen test were collected from patients who have been referred from a local public health center and 89 primary care facilities (Supplementary Table 1) and healthcare workers of TMCH, and their clinical information was obtained after receiving the subjects’ informed consent.
IRB: The ethics committee of TMCH approved the present study (approval number: 2020-033).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
Experimental Models: Cell Lines Sentences Resources Limit of detection of … SciScore for 10.1101/2020.12.27.20248876: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: During the study period, additional samples for antigen test were collected from patients who have been referred from a local public health center and 89 primary care facilities (Supplementary Table 1) and healthcare workers of TMCH, and their clinical information was obtained after receiving the subjects’ informed consent.
IRB: The ethics committee of TMCH approved the present study (approval number: 2020-033).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
Experimental Models: Cell Lines Sentences Resources Limit of detection of QuickNavi™-COVID19 Ag: The limit of detection of QuickNavi™-COVID19 Ag was investigated as follows: the 2019-nCoV/JPN/TY/WK-521 strain (4.2×105 TCID50/mL) cultured in VeroE6/TMPRSS2 cells were diluted two-fold stepwise with QuickNavi™ specimen buffer and used as samples. VeroE6/TMPRSS2suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)Software and Algorithms Sentences Resources Limit of detection of QuickNavi™-COVID19 Ag: The limit of detection of QuickNavi™-COVID19 Ag was investigated as follows: the 2019-nCoV/JPN/TY/WK-521 strain (4.2×105 TCID50/mL) cultured in VeroE6/TMPRSS2 cells were diluted two-fold stepwise with QuickNavi™ specimen buffer and used as samples. QuickNavi™suggested: 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:Several limitations associated with the present study warrant mention. First, reference real-time RT-PCR examinations employed frozen samples. Despite all samples being frozen at -80 °C, their viral load may have been reduced through the storage process. Second, although we investigated whether or not the intervals between the symptom onset and examination timing influenced the performance of the antigen test, the sample size was not sufficient to draw a definitive conclusion (Supplementary Figure 2). Third, using anterior nasal samples was beyond the scope of this study. Sample collection from the anterior nasal cavity is less invasive than that from the nasopharynx and is now approved for QuickNavi™-COVID19 Ag [21]. The clinical performance of the test with these samples has not yet been evaluated, and further research is necessary. In conclusion, the QuickNavi™-COVID19 Ag showed very high specificity and sufficient sensitivity for the detection of SARS-CoV-2. Given the simple procedures and shorter turnaround time involved with this test, it is a promising option as an alternative diagnostic modality especially in symptomatic patients.
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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