Comparison of Four Active SARS-CoV-2 Surveillance Strategies in Representative Population Sample Points: Two-Factor Factorial Randomized Controlled Trial (Preprint)

• DOI: 10.2196/preprints.44204
• Publication Date: 2023-08-17T14:01:00Z
• Authors: Andreas Deckert; Simon Anders; Ivonne Morales; Manuela De Allegri; Hoa Thi Nguyen; Aurélia Souares; Shannon McMahon; Matthias Meurer; Robin Burk; Dan Lou; Lucia Brugnara; Matthias Sand; Lisa Koeppel; Lena Maier-Hein; Tobias Ross; Tim J Adler; Stephan Brenner; Christopher Dyer; Konrad Herbst; Svetlana Ovchinni...; Michael Marx; Paul Schnitzler; Michael Knop; Till Bärnighausen; Claudia M Denkinger
• Keywords: Pandemic

<sec> <title>BACKGROUND</title> The COVID-19 pandemic is characterized by rapid increases in infection burden owing to the emergence of new variants with higher transmissibility and immune escape. To date, monitoring has mainly relied on passive surveillance, yielding biased epidemiological measures disproportionate number undetected asymptomatic cases. Active surveillance could provide accurate estimates true prevalence forecast evolution pandemic, enabling evidence-based decision-making. </sec> <title>OBJECTIVE</title> This study compared 4 different approaches active SARS-CoV-2 focusing feasibility outcomes. <title>METHODS</title> A 2-factor factorial randomized controlled trial was conducted 2020 a German district 700,000 inhabitants. outcome comprised its precision. arms combined 2 factors: individuals versus households direct testing conditioned symptom prescreening. Individuals aged ≥7 years were eligible. Altogether, 27,908 addresses from 51 municipalities randomly allocated 15 consecutive recruitment weekdays. Data collection logistics highly digitized, website 5 languages enabled low-barrier registration tracking results. Gargle sample kits sent post. Participants collected gargle at home mailed it laboratory. Samples analyzed reverse transcription loop-mediated isothermal amplification (RT-LAMP); positive weak results confirmed real-time transcription–polymerase chain reaction (RT-PCR). <title>RESULTS</title> Recruitment between November 18 December 11, 2020. response rates varied 34.31% (2340/6821) 41.17% (2043/4962). prescreening classified 16.61% (1207/7266) patients as symptomatic. 4232 persons without 7623 participating provided 5351 samples, which 5319 (99.4%) be analyzed. yielded 17 infections 0.36% (95% CI 0.14%-0.59%) 0.05% 0.00%-0.108%) (initial contacts only). Specifically, we found 0.31% 0.06%-0.58%) for 0.35% 0.09%-0.61%) households, lower (0.07%, 95% 0.0%-0.15% 0.02%, 0.0%-0.06% households). Asymptomatic occurred 27% (3/11) cases data. performed best regarding effectiveness accuracy. <title>CONCLUSIONS</title> showed that postal mailing returning home-based self-collected liquid samples followed high-sensitivity RT-LAMP analysis feasible way conduct population burdening routine diagnostic testing. Efforts improve participation integration into public health system may increase potential monitor course pandemic. <title>CLINICALTRIAL</title> Deutsches Register Klinischer Studien (DRKS) DRKS00023271; https://tinyurl.com/3xenz68a <title>INTERNATIONAL REGISTERED REPORT</title> RR2-10.1186/s13063-021-05619-5