Method and device for the detection of traumatic brain injuries

TBI/mTBI Biomarker detection method using a Point-of-Care in vitro diagnostic (IVD) medical device for mTBI/IBL specific biomarker detection by means of spatially resolved ECL quantitative multi-analyte immunoassays (SR-ECLIA), including an optic module, a detachable single-use analytical cartridge, and a mobile base station,

• wherein the cartridge is adapted to receive a sample to analyze through a sample inlet port (201) and to mix it with first biomarker(s)-specific ligands L1 coupled with an electrochemiluminescent detection label, and comprises a sensor unit including one or multiple electrodes pre-functionalized with second biomarker(s)-specific ligands L2 with which the mixed solution is reacted to form a sandwich immunoassay complex, wherein each of the first biomarker(s)-specific ligands L1 can be immobilized at a different, separate location on the conductive electrode surface (s) and being adapted to apply a potential to the pre-functionalized electrode(s) and trigger an ECL reaction between the reagents producing an ECL signal pattern to be acquired by a detector unit (130), and
• wherein the mobile base station is adapted to receive the cartridge via a cartridge interface and to apply a potential to the pre-functionalized electrode(s) to trigger an ECL reaction between the reagents in the sensor unit (207, and comprises a detector unit (130) for detecting said ECL signal pattern generated in the sensor unit (207) of the cartridge (101), being connected to the sensor unit (207) via an optic path (132) crossing a first window (133) on the station interfacing with the cartridge (101) via a second window on the cartridge (134), and
• characterized in that
• the optical module is less than 5 cm in length and comprises at least two lenses with a focal distance of less than 30 mm and numerical apertures of at least 0.6, aligned between the sensor unit and the detector unit to quantitatively transfer in a lightproof way the generated light from the sensor to the detector while maintaining spatial resolution of the light pattern, so as to permit for a maximum photon collection efficiency through said dedicated windows on the device and cartridge comprising steps of:
• obtaining a biological sample from a human subject and performing the sample processing steps to assess TBI/mTBI biomarker(s) potentially present in the biological sample;
• binding of one or a plurality of biomarkers present in the biological sample with biomarker(s)-specific ligands coupled with an electrochemiluminescent detection label (L1/ECL) to form a biomarker(s)-L1/ECL complex(es);
• binding of said biomarker(s)-L1/ECL complex(es) in the sensor unit to the conductive electrode surface functionalized with a plurality of biomarker(s)-specific ligands (L2) to form a sandwich immunoassay complex(es) (L1/ECL-biomarker(s)-L2), wherein each of the ligands L2 can be immobilized at a different, separate location on the conductive electrode surface;
• washing step;
• adding an ECL buffer solution;
• detecting of ECL signal for each biomarker by applying potential to the sensor unit to trigger ECL read-out and correlating it to the concentration of biomarker(s) present in the biological sample.