Evaluation of real-life use of Point-Of-Care Rapid Antigen TEsting for SARS-CoV-2 in schools (EPOCRATES)
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Abstract
Background
We evaluated the use of rapid antigen detection tests (RADT) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in school settings to determine RADT’s performance compared to PCR.
Methods
In this real-world, prospective observational cohort study, high-school students and staff were recruited from two high-schools in Montreal (Canada) and followed from January 25 th to June 10 th , 2021. Twenty-five percent of asymptomatic participants were tested weekly by RADT (nasal) and PCR (gargle). Class contacts of cases were tested. Symptomatic participants were tested by RADT (nasal) and PCR (nasal and gargle). The number of cases and outbreaks were compared to other high schools in the same area.
Results
Overall, 2,099 students and 286 school staff members consented to participate. The overall RADT’s specificity varied from 99.8 to 100%, with a lower sensitivity, varying from 28.6% in asymptomatic to 83.3% in symptomatic participants. Secondary cases were identified in 10 of 35 classes. Returning students to school after a 7-day quarantine, with a negative PCR on D6-7 after exposure, did not lead to subsequent outbreaks. Of cases for whom the source was known, 37 of 57 (72.5%) were secondary to household transmission, 13 (25%) to intra-school transmission and one to community contacts between students in the same school.
Conclusion
RADT did not perform well as a screening tool in asymptomatic individuals. Reinforcing policies for symptom screening when entering schools and testing symptomatic individuals with RADT on the spot may avoid subsequent significant exposures in class.
Table of Contents Summary
Rapid antigen tests were compared to standard PCR to diagnose SARS-CoV-2 infections in high-school students. They performed better in symptomatic individuals.
What’s Known on This Subject
Rapid antigen detection tests (RADT) are often used to diagnose respiratory pathogens at the point-of-care. Their performance characteristics vary, but they usually have high specificity and moderate sensitivity compared with PCR.
What This Study Adds
RADT sensitivity ranged from 28.6% in asymptomatic individuals to 83.3% in symptomatic individuals. Return to school after 7 days of quarantine was safe in exposed students. Secondary cases were identified in 28% of classes with an index case.
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SciScore for 10.1101/2021.10.13.21264960: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical considerations: This project was approved by the CHU Ste-Justine Research Ethics Board (#MP-21-2021-3271).
Consent: Online informed parental consent, as well as assent, was required for all students.Sex as a biological variable not detected. Randomization Outcomes: The primary outcome was to assess the performance characteristics of RADT in: a) asymptomatic participants randomly screened (compared to gargle PCR); b) asymptomatic close contacts of a confirmed positive case (compared to PCR on nasal swab and gargle); c) symptomatic participants (compared to PCR on nasal swab and gargle). Blinding not detected. Power Analysis not detected. Table 2: Resources
… SciScore for 10.1101/2021.10.13.21264960: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical considerations: This project was approved by the CHU Ste-Justine Research Ethics Board (#MP-21-2021-3271).
Consent: Online informed parental consent, as well as assent, was required for all students.Sex as a biological variable not detected. Randomization Outcomes: The primary outcome was to assess the performance characteristics of RADT in: a) asymptomatic participants randomly screened (compared to gargle PCR); b) asymptomatic close contacts of a confirmed positive case (compared to PCR on nasal swab and gargle); c) symptomatic participants (compared to PCR on nasal swab and gargle). Blinding not detected. Power Analysis not detected. Table 2: Resources
Experimental Models: Organisms/Strains Sentences Resources Decisions about management of cases and contacts were taken by two members of the research team (AB, CQ), in collaboration with local public health (CT, OS), based on RADT and PCR results and history of contacts. ABsuggested: RRID:BDSC_203)Software and Algorithms Sentences Resources The RADT used in this study was a lateral flow immunoassay [PanBio™ COVID-19 Ag test (Abbott Laboratories, Illinois, USA)], authorised by Health Canada22. Abbott Laboratoriessuggested: 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: We detected the following sentences addressing limitations in the study:This study had several limitations. First, we did not collect socio-demographic and behavioral data, including risk perception, adherence to public health measures, nor did we systematically document individual contacts with positive cases occurring outside of school. However, for the most part, we were able to identify when significant household transmission occurred and relied on both the transparency of participants as well as local public health, with whom we communicated daily. We cannot infer whether PCR positive individuals were contagious. The study was performed before the advent of the delta variant in our region. Because RADT detects the N protein, we expect that its sensitivity and specificity would not be affected negatively, as viral loads of delta variant infections are reported to be higher35. Finally, the sensitivity of RADT in symptomatic individuals was based on a relatively small number (12 students and 2 staff members) of people with PCR-confirmed SARS-CoV-2 infections. This is the largest study to date assessing the use of RADT in school settings. The strengths of this study included its prospective data collection, as well as the real-world use of RADT in direct comparison to PCR. We also assigned participants to earlier versus standard return to school with serial RADT testing, showing that there were no adverse outcomes or secondary outbreaks when allowing students to return to school after a shorter quarantine. Although the current study was not powe...
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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