Comparison of SARS-COV-2 nasal antigen test to nasopharyngeal RT-PCR in mildly symptomatic patients
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
Abstract
Introduction
COVID 19 has been vastly spreading since December 2019 and the medical teams worldwide are doing their best to limit its spread. In the absence of a vaccine the best way to fight it is by detecting infected cases early and isolate them to prevent its spread. Therefore, a readily available, rapid, and cost-effective test with high specificity and sensitivity for early detection of COVID 19 is required. In this study, we are testing the diagnostic performance of a rapid antigen detection test in mildly symptomatic cases. (RADT).
Methods
The study included 4183 patients who were mildly symptomatic. A nasal sample for the rapid antigen test and a nasopharyngeal sample was taken from each patient. Statistical analysis was conducted to calculate the sensitivity, specificity, positive predictive value, negative predictive value and kappa coefficient of agreement.
Results
The prevalence of COVID 19 in the study population was 17.5% (733/4183). The calculated sensitivity and specificity were 82.1% and 99.1% respectively. Kappa’s coefficient of agreement between the rapid antigen test and RT-PCR was 0.859 (p < 0.001). A stratified analysis was performed and it showed that the sensitivity of the test improved significantly with lowering the cutoff Ct value to 24.
Conclusion
The results of the diagnostic assessment of nasal swabs in the RADT used in our study are promising regarding the potential benefit of using them as a screening tool in mildly symptomatic patients. The diagnostic ability was especially high in cases with high viral load. The rapid antigen test is intended to be used alongside RT-PCR and not replace it. RADT can be of benefit in reducing the use of PCR.
Article activity feed
-
SciScore for 10.1101/2020.11.10.20228973: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: Statistical analysis was performed using STATA (StataCorp. 2017) Ethical considerations: Ethical and research approval was obtained from the National COVID19 research and ethics committee (approval code: CRT-COVID-2020-088).
IRB: All methods and analysis of data was approved by the National COVID-19 Research and Ethics Committee and carried out in accordance with the local guideline and ethical guidelines of the Declaration of Helsinki 1975.
Consent: Written Informed consent was waived by the Research and Ethical Committee for this study due to the absence of any patient identifying information.Randomization not detected. Blinding not detected. Power Analysis n… SciScore for 10.1101/2020.11.10.20228973: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: Statistical analysis was performed using STATA (StataCorp. 2017) Ethical considerations: Ethical and research approval was obtained from the National COVID19 research and ethics committee (approval code: CRT-COVID-2020-088).
IRB: All methods and analysis of data was approved by the National COVID-19 Research and Ethics Committee and carried out in accordance with the local guideline and ethical guidelines of the Declaration of Helsinki 1975.
Consent: Written Informed consent was waived by the Research and Ethical Committee for this study due to the absence of any patient identifying information.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 For rapid antigen test, Abbott panbio COVID 19 antigen rapid test device to detect SARS-CoV-2 nucleocapsid protein was used (Abbott Rapid Diagnostic Jena GmbH, Jena, Germany) 11. Abbottsuggested: (Abbott, RRID:SCR_010477)Data collection was performed through a live google sheet and extracted to Microsoft Excel 2016. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)Statistical analysis was performed using STATA (StataCorp. 2017) Ethical considerations: Ethical and research approval was obtained from the National COVID19 research and ethics committee (approval code: CRT-COVID-2020-088). STATAsuggested: (Stata, RRID:SCR_012763)StataCorpsuggested: (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:Despite the PCR test’s high sensitivity, it has multiple limitations that hold back the efforts in battling this pandemic, especially when reopening had started. Multiple studies showed that RT-PCR was sometimes positive in patients with a corresponding negative culture test for SARS-CoV-2, which indicates that these patients were not infectious 8, 17. This has led to the isolation of people who are noninfectious, and halted reopening measures. Another limitation is that it requires healthcare professionals to collect the swab and to specialized labs and specialists to analyse and interpret the result 5, 6. As the pandemic necessitated mass testing, the turnaround time extended and required on average 2-3 days in many countries 18, 19. This time limitation has kept Bahrain under-armed when fighting the pandemic. One of the main steps forward to fight this pandemic is to have an accurate test that will detect infectious people - who are a public health risk - and return results quickly. The test should also be easily performed by the general population and can be repeated multiple times whenever necessary. This will reduce the workload on healthcare professionals as well as smoothen the reopening process. The use of the nasopharyngeal swab is a limiting factor in the ease and frequency of testing because it is invasive, uncomfortable and aerosolizing 20. For similar reasons, the Centers for Disease Control and Prevention (CDC) permitted self-sampling via nasal swabs to compens...
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.
-