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.