Serological Tests for SARS-CoV-2 Coronavirus by Commercially Available Point-of-Care and Laboratory Diagnostics in Pre-COVID-19 Samples in Japan
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Abstract
The number of COVID-19 patients in Japan is considered low, compared with U.S. and European countries. However, recent serological survey reported that several percent of population showed IgG positive to SARS-CoV-2. Specificity in the assays might influence the estimate, and possibility of overdiagnosis should be investigated. Serological tests for SARS-CoV-2 coronavirus were performed in pre-COVID-19 sera in Japan (400 healthy subjects in 2012–2015). Lateral flow assay (LFA) and enzyme-linked immunosorbent assay (ELISA) showed 1.5% (6/400) and 1.75% (7/400) IgG positives, respectively. Among those false positive samples, only one sample was positive in both LFA and ELISA (0.25%; 95% CI: 0.006–1.39%). Possible bias from pooling method was examined by Monte Carlo method and the possibility was unlikely at low false positive rate. Previous surveys might overestimate COVID-19 seroprevalence in several populations of Japan. These false positives could be excluded by combination of different diagnostics. Nonetheless, the result of seroprevalence should be carefully interpreted in less prevalent areas.
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SciScore for 10.1101/2020.07.10.20150904: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. 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: 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 …
SciScore for 10.1101/2020.07.10.20150904: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. 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: 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.
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