MBS Clinical Validation

Testcases and Publications

Detecting Relevant Pathogens

Sampling Lower Respiratory Tract

Treatment Changing Results

Detection Pathogens

Patient-Friendly

Detecting Pathogens

Clinically relevant

AIM

Detecting pathogens in exhaled breath from COPD patients admitted to the hospital and assess clinical relevance.

RESULTS

Providing a sample from the site of infection with results within the "golden", allowing for directed therapy.

CONCLUSION

Providing a sample from the site of infection with results within the "golden", allowing for directed therapy.

Origin of Data

Proof-of-Concept study 2019; Assessment of COPD patients admitted with an exacerbation.

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Patient-Friendly Sampling for Fast Diagnosis

Better sample, lower burden!​

AIM

Diagnose causation of acute lower respiratory infections, such as Community Acquired Pneumonia and Exacerbations in patients with Chronic Respiratory Disease.

RESULTS

Providing a sample from the site of infection with results within the "golden", allowing for directed therapy.

CONCLUSION

Proof-of-Concept study 2019; Assessment of COPD patients admitted with an exacerbation.

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Monitoring CF Patients

Unambiguous Diagnosis is Hampered by Conventional Sampling Methods

Better sample, lower burden!​

SARS-CoV-2 Contagiousness

AIM

Demonstrate detection of aerogenic SARS-CoV-2 by a low tech disposable and user-friendly bedside device suitable for application in patients with respiratory distress.

STUDY

49 hospitalized COVID-19 patients were sampled in time by using the modular breath sampler to measure SARS-CoV-2 RNA load in exhaled air. These samples were compared to SARS-CoV-2 RNA load of nasopharyngeal-throat-swabs and saliva.

RESULTS

Exhaled air sampling using the modular breath sampler has proven feasible in a clinical COVID-19 setting and demonstrated viral detection in 25% of the patients. Moreover, the absence of any association between SARS-CoV-2 positivity in exhaled air samples and viral load in nasopharyngeal throat swab and saliva samples makes contamination from the upper airway unlikely.

CONCLUSION

This study shows the feasibility of sampling exhaled air from hospitalized COVID-19 patients for the presence of SARS-CoV-2 RNA. The modular breath epidemiological studies to determine the best proxy of SARS-CoV-2 contagiousness.
Moreover, the absence of any association between SARS-CoV-2 positivity in exhaled air samples and viral load in nasopharyngeal throat swab and saliva samples makes contamination from the upper airway unlikely.

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About

Xheal Diagnostics B.V. is a start-up company and spin-off of the Radboudumc focussed sampling innovations for the lower respiratory tract. Our proprietary exhaled breath sampling technology enables a timely and better diagnosis of lung infections and hence improves patient care.

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