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Can self-testing be enhanced to hasten safe return of healthcare workers in pandemics? Random order, open label trial using two manufacturers’ SARS-CoV-2 lateral flow devices concurrently
Xingna Zhang
Christopher Cheyne
Christopher Jones
Michael Humann
Gary Leeming
Claire Elizabeth Smith
David Hughes
Girvan Burnside
Susanna Dodd
Rebekah Penrice-Randal
Xiaofeng Dong
Malcolm Semple
Timothy Neal
Sarah Tunkel
Tom Fowler
Lance Turtle
Professor Marta García-Fiñana
Iain Buchan
Acceso Abierto
Atribución-NoComercial-SinDerivadas
https://doi.org/10.1101/2024.04.04.24305332
https://www.medrxiv.org/content/10.1101/2024.04.04.24305332v1
Objectives To inform management of competing risks from Covid-19 and key-worker absence, we evaluated whether using two manufacturers’ lateral flow tests (LFTs) concurrently improved SARS-CoV-2 Omicron detection and was acceptable to hospital staff. In a nested study, to understand the risks of return to work after a fixed number of days of isolation or quarantine, we examined virus culture at Days 5-7 after positive test or significant exposure. Methods and Analysis 1419 fully-vaccinated Liverpool (UK) University Hospitals staff participated in a random-order, open-label trial testing whether dual LFTs improved SARS-CoV2 detection, and whether dual swabbing was acceptable to users. Main outcome was self-reported LFT result. Staff enrolled via routine testing sites for symptomatic staff and close contacts. Recruitment took place between 7th February and 8th May 2022. Participants employed nose-throat swab Innova and nose-only swab Orient Gene LFTs for 10 days, with daily LFTs taken in random order. A swab for polymerase chain reaction (PCR) analysis was taken at Day-5 and, if positive, Day-10. A questionnaire on acceptability was administered on exit. Selected participants gave swabs for viral culture on Days 5-7; swabs were delivered and returned by courier. Cultures were considered positive if cytopathic effect was apparent or the SARs-COV2 N gene sub-genomic RNA was detected by sequencing. Results 226 individuals reported 1466 pairs of LFT results. Tests disagreed in 127 cases (8.7%). Orient Gene was more likely (78 cf. 49, P=0.03) to be positive. Orient Gene positive Innova negative result-pairs became more frequent over time (P<0.001). If Innova was swabbed second, it was less likely to agree with a positive Orient Gene result (P=0.005); swabbing first with Innova made no significant difference (P=0.85). Of 311 individuals completing the exit questionnaire, 90.7% reported dual swabbing was easy, 57.1% said it was no barrier to their daily routine and 65.6% preferred dual testing. Respondents had more confidence in dual c.f. single test results (median 9 cf. 8 on 10-point scale, P<0.001). Viral cultures from swabs taken at Days 5-7 were positive for 6/31 (19.4%, 7.5%-37.5%) and indeterminate for 11/31 (35.5%, 19.2%-54.6%) LFT-positive participants, indicating they were likely still infectious. Conclusions Dual brand testing increased LFT detection of SARS-CoV-2 antigen by a small but meaningful margin and was acceptable to hospital workers. Viral
cultures demonstrated that policies recommending safe return to work ∼5 days after Omicron infection/exposure were flawed. Key-workers should be prepared for dynamic self-testing protocols in future pandemics.
bioRxiv
05-04-2024
Preimpreso
Inglés
Público en general
VIRUS RESPIRATORIOS
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