Russell Sophie, Munro Katie, Foulkes Sarah, Broad Jonathan, Sparkes Dominic, Atti Ana, Islam Jasmin, Hopkins Susan, Hall Victoria
SIREN study team, AMR & HCAI Division, United Kingdom Health Security Agency (UKHSA), London, United Kingdom.
PLoS One. 2025 Jun 23;20(6):e0310758. doi: 10.1371/journal.pone.0310758. eCollection 2025.
In winter 2022, SIREN, a prospective healthcare worker cohort study monitoring SARS-CoV-2, ran a pilot sub-study introducing multiplex PCR testing for SARS-CoV-2, influenza, and RSV to investigate winter pressures. Three pathways were trialled: (A) on-site (at hospital) swabbing for PCR testing, using the local laboratory for testing, (B) on-site swabbing using a UKHSA-commissioned laboratory for testing, and (C) postal swabbing using a UKHSA-commissioned laboratory for testing. Here, we compare pathways in relation to recruitment, testing coverage, participant acceptability, and UKHSA SIREN research team feedback.
A mixed methods evaluation using metrics of quality assurance and study fidelity (participant recruitment and retention; multiplex PCR testing timing and coverage), an adapted NIHR 'participant in research' feedback questionnaire, and thematic analysis of a UKHSA SIREN research team workshop.
With 7,774 participants recruited, target recruitment (N = 7,500) was achieved. Thirty-nine sites took part in the sub-study (4,289 participants). Thirty-three used pathway A (3,713 participants), and six used pathway B (576 participants). 3,485 participants were enrolled into pathway C (27.8% of invitees). The median number of tests per participant was similar across pathways (6; 4; 5). However, sites using local laboratories showed a wide variation in the date they switched to multiplex testing (28th November 2022-16th March 2023). Consequently, influenza and RSV testing coverage was higher for pathways using UKHSA-commissioned laboratories (100.0% vs 45.6% at local laboratories). 1,204/7,774 (15.5%) participants completed the feedback survey. All pathways were acceptable to participants; 98.9% of postal and 97.5% of site-based participants 'would consider taking part again'.
Transitioning SARS-CoV-2 PCR testing to include influenza and RSV was challenging to achieve rapidly across multiple sites. The postal testing pathway proved more agile, and UKHSA-commissioned laboratory testing provided more comprehensive data collection than local laboratory testing. This sub-study indicates that postal protocols are effective, adaptable at pace, and acceptable to participants.
2022年冬季,SIREN这一监测SARS-CoV-2的前瞻性医护人员队列研究开展了一项试点子研究,引入针对SARS-CoV-2、流感和呼吸道合胞病毒(RSV)的多重PCR检测,以调查冬季面临的压力。试验了三种途径:(A)现场(在医院)拭子采样用于PCR检测,使用当地实验室进行检测;(B)现场拭子采样,使用英国卫生安全局(UKHSA)委托的实验室进行检测;(C)邮寄拭子采样,使用UKHSA委托的实验室进行检测。在此,我们比较这几种途径在招募、检测覆盖范围、参与者可接受性以及UKHSA SIREN研究团队反馈方面的情况。
采用混合方法进行评估,使用质量保证和研究保真度指标(参与者招募和留存;多重PCR检测时间和覆盖范围)、一份改编自英国国家卫生研究院(NIHR)的“研究参与者”反馈问卷,以及对UKHSA SIREN研究团队研讨会进行主题分析。
共招募了7774名参与者,实现了目标招募人数(N = 7500)。39个地点参与了子研究(4289名参与者)。33个地点采用途径A(3713名参与者),6个地点采用途径B(576名参与者)。3485名参与者被纳入途径C(占受邀者的27.8%)。各途径中每位参与者的检测中位数相似(分别为6次、4次、5次)。然而,使用当地实验室的地点在转换为多重检测的日期上差异很大(2022年11月28日至2023年3月16日)。因此,使用UKHSA委托实验室的途径在流感和RSV检测覆盖范围方面更高(当地实验室为45.6%,UKHSA委托实验室为100.0%)。1204/7774(15.5%)名参与者完成了反馈调查。所有途径对参与者来说都是可以接受的;98.9%的邮寄参与者和97.5%的现场参与者“会考虑再次参与”。
将SARS-CoV-2 PCR检测扩展到包括流感和RSV,要在多个地点迅速实现具有挑战性。邮寄检测途径被证明更灵活,并且与当地实验室检测相比,UKHSA委托实验室检测能提供更全面的数据收集。这项子研究表明,邮寄方案是有效的,能快速适应变化,并且为参与者所接受。