Diagnostic accuracy of two commercial SARS-CoV-2 antigen-detecting rapid tests at the point of care in community-based testing centers
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Abstract
Determine the diagnostic accuracy of two antigen-detecting rapid diagnostic tests (Ag-RDT) for SARS-CoV-2 at the point of care and define individuals’ characteristics providing best performance.
Methods
We performed a prospective, single-center, point of care validation of two Ag-RDT in comparison to RT-PCR on nasopharyngeal swabs.
Results
Between October 9 th and 23 rd , 2020, 1064 participants were enrolled. The Panbio TM Covid-19 Ag Rapid Test device (Abbott) was validated in 535 participants, with 106 positive Ag-RDT results out of 124 positive RT-PCR individuals, yielding a sensitivity of 85.5% (95% CI: 78.0–91.2). Specificity was 100.0% (95% CI: 99.1–100) in 411 RT-PCR negative individuals. The Standard Q Ag-RDT (SD Biosensor, Roche) was validated in 529 participants, with 170 positive Ag-RDT results out of 191 positive RT-PCR individuals, yielding a sensitivity of 89.0% (95%CI: 83.7–93.1). One false positive result was obtained in 338 RT-PCR negative individuals, yielding a specificity of 99.7% (95%CI: 98.4–100). For individuals presenting with fever 1–5 days post symptom onset, combined Ag-RDT sensitivity was above 95%. Lower sensitivity of 88.2% was seen on the same day of symptom development (day 0).
Conclusions
We provide an independent validation of two widely available commercial Ag-RDTs, both meeting WHO criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, these assays could be beneficial due to their rapid results, ease of use, and independence from existing laboratory structures. Testing criteria focusing on patients with typical symptoms in their early symptomatic period onset could further increase diagnostic value.
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SciScore for 10.1101/2020.11.20.20235341: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics: The study was approved by the Cantonal ethics committee (Nr. 2020-02323).
Consent: All study participants and/or their legal guardians provided written informed consent.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 All analyses were performed using STATA version intercooled 16 STATAsuggested: (Stata, RRID:SCR_012763)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 …SciScore for 10.1101/2020.11.20.20235341: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethics: The study was approved by the Cantonal ethics committee (Nr. 2020-02323).
Consent: All study participants and/or their legal guardians provided written informed consent.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 All analyses were performed using STATA version intercooled 16 STATAsuggested: (Stata, RRID:SCR_012763)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:Re-testing with an Ag-RDT or RT-PCR, in case of persisting symptoms, could overcome this limitation. Furthermore, our validation showed very high SP, with only one false-positive Ag-RDT result in an overall sample of 315 RT-PCR positive patients. Interestingly, the patient with this putative false-positive result returned 3 days later because of persisting respiratory symptoms, and then tested positive for SARS-CoV-2 by RT-PCR. During the time this study was conducted, the Canton of Geneva was experiencing a severe second wave of SARS-CoV-2 infections, with a very high incidence as well as high RT-PCR positivity rates, thus extrapolating the findings of our study to low prevalence settings must be done with caution. Furthermore, our study population consisted mainly of young symptomatic individuals in an outpatient setting, thus diagnostic performance in other groups needs further validation. All diagnostic testing was performed on NPS collected by trained nurses, thus the use of the test with other materials (e.g. anterior nares swabs) or in other settings (e.g. self-testing) needs to be further validated, however a first study on anterior nasal samples showed promising results (30). Due to logistical and ethical reasons, we were not able to perform paired comparisons of both Ag-RDTs at the same time by taking three separate NPS, which would have helped to control for prevalence variation and inter-cohort variability. Nonetheless, we used robust methods to confirm that the S...
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 10.1101/2020.11.20.20235341: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Methods Ethics The study was approved by the Cantonal ethics committee (Nr. 2020-02323). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable The mean age of the study participants was 34.9 years (SD ±10.9) with 53.8% being female. Table 2: Resources
Software and Algorithms Sentences Resources All analyses were performed using STATA version intercooled 16 STATAsuggested: (Stata, RRID:SCR_012763)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are …
SciScore for 10.1101/2020.11.20.20235341: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Methods Ethics The study was approved by the Cantonal ethics committee (Nr. 2020-02323). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable The mean age of the study participants was 34.9 years (SD ±10.9) with 53.8% being female. Table 2: Resources
Software and Algorithms Sentences Resources All analyses were performed using STATA version intercooled 16 STATAsuggested: (Stata, RRID:SCR_012763)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:
Re-testing with an Ag-RDT or RT-PCR, in case of persisting symptoms, could overcome this limitation. Furthermore, our validation showed very high SP, with only one false-positive Ag-RDT result in an overall sample of 315 RT-PCR positive patients. Interestingly, the patient with this putative false-positive result returned 3 days later because of persisting respiratory symptoms, and then tested positive for SARS-CoV-2 by RT-PCR. During the time this study was conducted, the Canton of Geneva was experiencing a severe second wave of SARS-CoV-2 infections, with a very high incidence as well as high RT-PCR positivity rates, thus extrapolating the findings of our study to low prevalence settings must be done with caution. Furthermore, our study population consisted mainly of young symptomatic individuals in an outpatient setting, thus diagnostic performance in other groups needs further validation. All diagnostic testing was performed on NPS collected by trained nurses, thus the use of the test with other materials (e.g. anterior nares swabs) or in other settings (e.g. self-testing) needs to be further validated, however a first study on anterior nasal samples showed promising results (30). Due to logistical and ethical reasons, we were not able to perform paired comparisons of both Ag-RDTs at the same time by taking three separate NPS, which would have helped to control for prevalence variation and inter-cohort variability. Nonetheless, we used robust methods to confirm that the S...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).
Results from JetFighter: We did not find any issues relating to colormaps.
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