A Feasibility study using the ETL CoronaCheck® device to Identify iNciDent cases of SARS-CoV-2: FIND SARS-CoV-2

BACKGROUND: The feasibility of using a novel, non-invasive breath-based diagnostic test for detecting SARS-CoV-2 was evaluated in a real-world clinical setting. The study aimed to assess the device's performance, usability and integration into routine point-of-care pathways, while also obtaining preliminary diagnostic accuracy metrics to inform future validation studies.

METHODS: This was a cross-sectional study performed in a single NHS hospital. Participants in cohort A were recruited with prior knowledge of their PCR swab results. Cohort B were sequential participants in a prospective "real-world" evaluation.

RESULTS: 385 participants were recruited, with 214 participants achieving a suitable sample for analysis. Of 179 participants in cohort A, 60 (33.5%) had clinically suspected SARS-CoV-2 confirmed with a positive PCR swab, 31 (17.3%) had clinically suspected SARS-CoV-2, but a negative PCR swab, 22 (12.3%) were asymptomatic but with a positive PCR swab and 66 (36.9%) had a low clinical suspicion of SARS-CoV-2 and negative PCR swab. Across all participants with a suitable sample for analysis, the ETL CoronaCheck® had a sensitivity of 99% and specificity of 96%. Cohen's K score confirmed an excellent agreement between a positive vs negative CoronaCheck outcome against a positive vs negative PCR result (k=0.990, 99%, SE:0.10). The CoronaCheck demonstrated an excellent predictive value for a positive PCR result, with low variability (both cohorts: ROC=0.98 (CI:94-100%)). Most participants (88%) reported the CoronaCheck was easy to use, highlighting its potential utility in clinical practice.

CONCLUSION: This study demonstrates it is feasible to use exhaled breath condensate and the ETL CoronaCheck® device to detect SARS-CoV-2 in a rapid point-of-care test. This trial is registered at Clinicaltrials.gov, registration number NCT04742712.