On the initiative of Leiden University Medical Centre (LUMC) and Breathomix, and with the support of CZ and VWS, Star-shl and Franciscus Gasthuis & Vlietland conducted a study on breath analysis of patients suspected of having COVID-19.
The aim was to determine the diagnostic value of the SpiroNose. This ‘electronic nose’ measures the composition of volatile organic compounds (VOC) in the exhaled breath of patients. The self-learning diagnostic method, based on artificial intelligence, has been considered promising for many years for various diseases, but never before has it received as much attention and recognition as during the current COVID-19 pandemic.
Between April and June, Star-shl as a participating study centre did a great deal of work in the preparation for this study.
Mainly due to logistical (and political) reasons, the supply of patients at Star-shl ultimately fell short of expectations. Fortunately, the patient flow was significantly greater in the other participating centres and a total of 143 patients were able to participate. The breath test scored well: with a cut-off point, retrospectively chosen on the basis of the test results, COVID-19 could be excluded with sufficient certainty (high negative predictive value).
The results led to the rapid deployment of the test for validation in a rapid test lane at the Amsterdam Municipal Health Service (GGD). Star-shl had no role in this second phase. Ultimately, after testing 1,800 patients, the conclusion was that the SpiroNose can exclude coronavirus infection with enough certainty in three quarters of cases.
As a screening instrument, the test now appears to be gaining a definite place in the COVID-19 diagnostic arsenal.
In the meantime, the Dutch Ministry of Public Health, Welfare and Sport (VWS) has ordered hundreds of devices, which will initially be used in the GGD’s test lanes.
Star-shl and Breathomix are investigating whether cooperation in COPD and asthma diagnostics could also be of added value after the COVID-19 pandemic.