Analytical performances of the COVISTIX™ and Panbio™ antigen rapid tests for SARS-CoV-2 detection in an unselected population (all commers)
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Abstract
Importance
A steady increase in acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cases worldwide is causing some regions of the world to withstand a third or even fourth wave of contagion. Swift detection of SARS-CoV-2 infection is paramount for the containment of cases, prevention of sustained contagion; and most importantly, for the reduction of mortality.
Objective
To evaluate the performance and validity of the COVISTIX™ rapid antigen test, for the detection of SARS-CoV-2 in an unselected population and compare it to Panbio™ rapid antigen test and RT-PCR.
Design
This is comparative effectiveness study; samples were collected at two point-of-care facilities in Mexico City between May and August 2021.
Participants
Recruited individuals were probable COVID-19 cases, either symptomatic or asymptomatic persons that were at risk of infection due to close contact to SARS-CoV-2 positive cases.
Diagnostic intervention
RT-PCR was used as gold standard for detection of SARS-CoV-2 in nasal and nasopharyngeal swabs, study subjects were tested in parallel either with the COVISTIX™ or with Panbio™ rapid antigen test.
Main outcome
Diagnostic performance of the COVISTIX™ assay is adequate in all commers since its accuracy parameters were not affected in samples collected after 7 days of symptom onset, and it detected almost 65% of samples with a Ct-value between 30 and 34.
Results
For the population tested with COVISTIX™ (n=783), specificity and sensitivity of the was 96.0% (CI95% 94.0-98.0) and 81% (CI95% 76.0-85.0), as for the Panbio™ (n=2202) population, was 99.0% (CI95%: 0.99-1.00) and 62% (CI%: 58.0-64.0%), respectively.
Conclusions and relevance
The COVISTIX™ rapid antigen test shows a high performance in all comers, thus, this test is also adequate for testing patients who have passed the peak of viral shedding or for asymptomatic patients.
Article activity feed
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SciScore for 10.1101/2021.09.10.21263410: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study was approved by the ethics and research committees of Instituto Nacional de Medicina Genómica (CEI/1479/20 and CEI 2020/21). Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources We ran all tests with Thermo Fisher’s ABI QuantStudio 5 or QuantStudio 7 real-time thermal cyclers. Thermo Fisher’ssuggested: 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: An explicit section about the limitations of the techniques …SciScore for 10.1101/2021.09.10.21263410: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study was approved by the ethics and research committees of Instituto Nacional de Medicina Genómica (CEI/1479/20 and CEI 2020/21). Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources We ran all tests with Thermo Fisher’s ABI QuantStudio 5 or QuantStudio 7 real-time thermal cyclers. Thermo Fisher’ssuggested: 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: 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.
Results from scite Reference Check: We found no unreliable references.
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