Robust Automation and Point of care IDentification of COVID

As a rapid and definitive diagnosis of SARS-CoV-2 is essential, it is also key to consider that a recent data review has shown that 19% of patients with COVID-19 have co-infections and that these show an association with poor outcomes (JS Musuuza et al. 2021). Due to the benefits in the management of treatment and the timely isolation of infected patients with overlapping clinical symptoms, this highlights the need to identify other common viral and bacterial pathogens.
The objective of this study was to evaluate the performance of the Respiratory 1 Panel (RESP003) CE marked kits, developed by GeneFirst (United Kingdom), for multiplex respiratory pathogen testing including 17 common causes of upper-respiratory tract infections and 11 common causes of pneumonia on biobanked clinical samples on the ACSIA - a High Throughput robotic system provided by PrimaDiag (France).
The results from this system were assessed against BioFire® FilmArray®, a comparable testing platform used as the gold standard comparator, to determine the clinical sensitivity and specificity of the tests. Results from conventional microbiology techniques were also considered as necessary or required. APHP established a clinical study protocol and has been granted with the necessary approvals for the study. Samples have been formerly screened with FilmArray® or GeneXpert® in order to include the most adequate number of positives and negative cases.
Overall, the evaluation criteria for the respiratory panels was:
- Clinical sensitivity of the RESP003 test coupled with the ACSIA platform versus the comparator (target: 90%)
- Clinical specificity of the RESP003 test coupled with the ACSIA platform in relation to the comparator (target: 98%)
- Background noise (white limit) will be also evaluated.
The study allowed the constitution of a biobank encompassing all major variants of SARS-CoV-2 samples, along with most of the other respiratory pathogens commonly reported in community acquired respiratory infections. The assay does not yet meet the required sensitivity specification using the automated result call, but the specificity is within range when the automated calling is verified. The reason for the discrepancy between the reference result and the post-biobanking results will be explored to curate and validate the biobank.

鉴于对 SARS-CoV-2 的快速且确切的诊断至关重要，同时，近期数据回顾亦揭示，19% 的 COVID-19 患者存在合并感染，且此类合并感染与不良预后存在关联（JS Musuuza 等人，2021 年）。鉴于治疗管理效益以及及时隔离具有重叠临床症状的感染患者，这突显了识别其他常见病毒和细菌病原体的必要性。本研究旨在评估由英国 GeneFirst 公司开发的 Respiratory 1 Panel（RESP003）CE 标记试剂盒在多联呼吸病原体检测方面的性能，包括 17 种常见的上呼吸道感染原因和 11 种常见的肺炎原因，并在 PrimaDiag（法国）提供的 ACSIA 高通量机器人系统（High Throughput robotic system）上对生物样本库临床样本进行检测。该系统检测结果与作为黄金标准比较者的 BioFire® FilmArray® 相比较，以确定测试的临床灵敏度和特异性。同时，也考虑了传统微生物学技术作为必要或要求的参考。APHP 建立了临床研究方案，并获得了研究所需的批准。样本已通过 FilmArray® 或 GeneXpert® 进行预先筛选，以确保纳入适当数量的阳性和阴性病例。总体而言，呼吸病原体检测的评价标准如下：- RESP003 测试结合 ACSIA 平台的临床灵敏度与比较者（目标值：90%）；- RESP003 测试结合 ACSIA 平台的临床特异性与比较者之间的关系（目标值：98%）；- 亦将评估背景噪声（白限）。研究允许建立包含所有主要 SARS-CoV-2 样本变种的生物样本库，以及大多数在社区获得性呼吸道感染中常见其他呼吸道病原体。该检测在自动结果调用时尚未达到所需灵敏度规格，但自动调用验证后的特异性在合理范围内。将探讨参考结果与生物样本库后结果之间差异的原因，以完善和验证生物样本库。