The accuracy of healthcare worker versus self collected (2-in-1) Oropharyngeal and Bilateral Mid-Turbinate (OPMT) swabs and saliva samples for SARS-CoV-2
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Abstract
Self-sampling for SARS-CoV-2 would significantly raise testing capacity and reduce healthcare worker (HCW) exposure to infectious droplets personal, and protective equipment (PPE) use.
Methods
We conducted a diagnostic accuracy study where subjects with a confirmed diagnosis of COVID-19 (n = 401) and healthy volunteers (n = 100) were asked to self-swab from their oropharynx and mid-turbinate (OPMT), and self-collect saliva. The results of these samples were compared to an OPMT performed by a HCW in the same patient at the same session.
Results
In subjects confirmed to have COVID-19, the sensitivities of the HCW-swab, self-swab, saliva, and combined self-swab plus saliva samples were 82.8%, 75.1%, 74.3% and 86.5% respectively. All samples obtained from healthy volunteers were tested negative. Compared to HCW-swab, the sensitivities of a self-swab sample and saliva sample were inferior by 8.7% (95%CI: 2.4% to 15.0%, p = 0.006) and 9.5% (95%CI: 3.1% to 15.8%, p = 0.003) respectively. The combined detection rate of self-swab and saliva had a sensitivity of 2.7% (95%CI: -2.6% to 8.0%, p = 0.321). The sensitivity of both the self-collection methods are higher when the Ct value of the HCW swab is less than 30. The specificity of both the self-swab and saliva testing was 100% (95% CI 96.4% to 100%).
Conclusion
Our study provides evidence that sensitivities of self-collected OPMT swab and saliva samples were inferior to a HCW swab, but they could still be useful testing tools in the appropriate clinical settings.
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SciScore for 10.1101/2020.09.17.20197004: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This study was approved by the SingHealth Centralised Institutional Review Board.
Consent: Written informed consent was obtained from the subjects.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical Analysis: All analyses were performed using SPSS 25.0 with statistical significance set at p < 0.05. SPSSsuggested: (SPSS, RRID:SCR_002865)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 LimitationRecognize…SciScore for 10.1101/2020.09.17.20197004: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: This study was approved by the SingHealth Centralised Institutional Review Board.
Consent: Written informed consent was obtained from the subjects.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical Analysis: All analyses were performed using SPSS 25.0 with statistical significance set at p < 0.05. SPSSsuggested: (SPSS, RRID:SCR_002865)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:A key study limitation however, is that the demographics of the COVID-19-positive population was skewed, consisting solely of male migrant workers, the worst affected group of the pandemic in Singapore, at the time this study was conducted.
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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