This project supports the development of a non-invasive diagnostic tool for malaria, focusing on validating the link between VOCs (volatile organic compounds) and malaria infection using thermodynamic sensors. This technology aims to provide rapid, painless alternatives to blood-based diagnostics, enabling malaria detection without invasive sampling.

Trace Sensing has already identified six potential VOC biomarkers based on published literature specific for malaria. Two of these are part of the company's existing library and can already be detected in purified form by the TRACE-E device, while the others are under active evaluation. To confirm the suitability of the selected VOC biomarkers for diagnosing malaria and strengthen the detection algorithm, high-quality, robust clinical data from well-characterized biological specimens are required. In partnership with Gondar University in Ethiopia, breath samples will be collected from individuals (12 years and older) suspected of having malaria presenting at two health clinics. PCR performed on blood samples will serve as reference method to confirm infection status, while non-invasive clinical breath tests will be performed using the TRACE-E device.

The resulting data will confirm whether the six candidate malaria VOC biomarkers can be detected in patient breath, and if other VOC biomarkers can be detected as well. This study will therefore act as a malaria VOC biomarker confirmation study.

Inclusion Criteria:

Aged 12 years or older

Presenting at the study site with fever (37.5 degrees and above)

Freely agreeing to participate by providing informed consent (and assent, if applicable)

Exclusion Criteria:

Presence of symptoms and signs of severe illness and/or central nervous system infections.

Presenting with any condition that prevents adequate breath collection:

Asthma

Chronic Obstructive Pulmonary Disease (COPD)

Severe respiratory illness

Inability to follow instructions

Patient lacking capacity to provide informed consent.

Prior antimalarial treatment within the last 14 days.

The study population consists of individuals aged 12 years and older presenting to outpatient clinics in Gondar, Ethiopia with suspected malaria.