Self-Testing of 5 Respiratory Viruses in Adult VACCELERATE Volunteers in Germany Allowing Large-Scale Epidemiological Studies in Real-Time

Abstract

Objectives: Acute respiratory infections (ARI) are the most common human infections. Respiratory pathogen testing is restricted to medical institutions. Self-testing may capture pathogen epidemiology in real-time and in those not seeking medical attention.

Methods: Adults from the VACCELERATE Volunteer Registry were provided the multiple respiratory antigen test-kit (MAK5, BioTeke, Wuxi, China), a laminar flow device (LFD) detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza viruses A and B, respiratory syncytial virus (RSV) and adenovirus (ADV) from a single nasal swab. Participants self-tested upon ARI symptoms for ≥24 hours, sent a photo of the LFD, reported symptoms, vaccination history, and underlying diseases. Participants remaining asymptomatic self-tested on June 1, 2023.

Results: Between December 7 2022, and June 2 2023, results from 1,408 participants were processed. Of these 1,098 (77.9%) individuals developed ARI symptoms and self-tested until May 31 2023. Cumulative incidence regarding a first symptomatic ARI during the longitudinal assessment period was 12.6% for SARS-CoV-2, 7.9% for RSV, 5.3% for influenza A virus, 0.8% for ADV and 0.4% for influenza B virus. Temporal variability in terms of peaks were observed especially for influenza A and SARS-CoV-2 during winter (Figure 1). Participants with influenza A detection presented significantly more often cough (90%), fever (57%), and myalgia (43%) compared to RSV or SARS-CoV-2, while 310 (22%) remained asymptomatic. In June 2023, RSV point prevalence was 7.1% among 310 (22.1%) participants, regardless of symptoms.

Conclusions: This study allowed real-time reporting of five endemic ARI pathogens in a citizen science project. Symptom burden was highest in influenza A. Seasonal and off-seasonal RSV detection hint towards its presence in the adult population all year, which may contribute to ARI activity in Germany.

Funding: The VACCELERATE volunteer registry receives funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement 101037867. Test kits were donated by the manufacturer. Both had no influence on study design or interpretation of results.

Declaration of Interest: JSG has received speaker honoraria from Gilead and Pfizer. SM has received grants by DZIF, DMyKG and the University Hospital Cologne. She has received speaker honoraria from Pfizer. SM has been a consultant to Octapharma. HJS has received consultancy or speaker honoraria from Pfizer. OAC reports grants or contracts from Cidara, F2G, Gilead, MedPace, MSD, Mundipharma, Octapharma, Pfizer, Scynexis; Consulting fees from Abbvie, AiCuris, Biocon, Cidara, Gilead, IQVIA, Janssen, Matinas, MedPace, Menarini, Moderna, Molecular Partners, MSG-ERC, Noxxon, Octapharma, Pfizer, PSI, Scynexis, Seres; Honoraria for lectures from Abbott, Abbvie, Al-Jazeera Pharmaceuticals/Hikma, Gilead, Grupo Biotoscana/United Medical/Knight, MedScape, MedUpdate, Merck/MSD, Noscendo, Pfizer, Shionogi, streamedup!; Payment for expert testimony from Cidara; Participation on a Data Safety Monitoring Board or Advisory Board from Boston Strategic Partners, Cidara, IQVIA, Janssen, MedPace, PSI, Pulmocide, Shionogi, The Prime Meridian Group; A patent at the German Patent and Trade Mark Office (DE 10 2021 113 007.7); Stocks from CoRe Consulting, EasyRadiology. JS has received research grants by the Ministry of Education and Research (BMBF) and Basilea Pharmaceuticals Inc.; has received speaker honoraria by Pfizer Inc., Gilead, Hikma and AbbVie; has been a consultant to Gilead, Produkt&Markt GmbH, Alvea Vax. and Micron Research. All remaining authors declare no conflict of interest.

Ethical Approval: For this prospective nation-wide citizen science study, the web based VACCELERATE Volunteer Registry was used, which was approved by the Ethics Committee of the Medical Faculty of the University of Cologne, Germany (identifier 20–1536).

Keywords: Rapid antigen test, multiplex, MAK5, acute respiratory infection, incidence, point prevalence, surveillance, viral, COVID-19, lateral flow, outbreaks, endemic viruses, burden of disease