Abstract

Introduction

Nucleic acid amplification tests (NAAT) are considered the gold standard for coronavirus disease 2019 (COVID-19) diagnosis. These tests require professional manpower and equipment, long processing and are very unpleasant to the patients. Diagnostic breath tests are available for several diseases. Several volatile organic compounds (VOCs) have been identified in the breath of COVID-19 patients. Detection of these VOCs using a breath test could help rapidly identify COVID-19 patients.

Aim

Assess the accuracy of 'Breath of health' (BOH) COVID-19 Fourier-transform infrared (FTIR) Spectroscopy-based breath test

Methods

Breath samples were collected from patients with or without symptoms suggestive for COVID-19 who had positive or negative NAAT results. Samples were collected using Tedlar bags and blindly analyzed using BOH FTIR spectroscopy in a central laboratory. BOH Measures several VOCs simultaneously and calculates a composite score differentiating positive and negative results. BOH results were compered to NAAT results.

Results

Breath samples from 531 patients were analyzed using the BOH methodology and compared to NAAT results as gold standard. The sensitivity of BOH breath test was found to be 79.5% (95% confidence interval [CI] 72.7-85.3%) while specificity is 87.2% (95% CI 85.3-90.5%). Positive predictive value is 74.7% (95% CI 69.1-79.7%) and the negative predictive value is 90% (95% CI 86.9-92.4%). Accuracy rate is 84.8% (95% CI 81.4-87.7%) and area under the curve is 0.834 (P<0.001).

Conclusion

BOH COVID-19 breath test is a patient friendly, rapid, noninvasive diagnostic test with good accuracy rate that can lead the way for additional breath tests for respiratory diseases.