Kit and method for earwax self-sampling and the measurement of biomarkers using said earwax in situ

A device for measuring biomarkers from an earwax sample obtained by a sample extraction device, comprising a handle, a head attached to the handle, said head having a sponge holder and a sponge attached to the holder for a sponge for sampling ear wax by inserting it into the ear canal, wherein said device for measuring biomarkers comprises:

• a casing having at least one upper wall wherein the upper wall has a central opening;
• information processing means mounted in an internal portion of the housing;
• at least one screen for presenting information, each connected to the information processing means for presenting results of biomarker measurements;
• one or more biosensors, each placed within the housing, are contactable by the sponge of the sampling device so that said sponge can deposit a sample of ear wax in each biosensor.

A multiplexed lateral flow biosensor comprising:

• a base membrane, elongated, made of a flexible material selected from the set comprising but not limited to vinyl or nitrocellulose, said base membrane is pressure sensitive through an adhesive made of acrylic but non-reactive and stable;
• said base membrane has a first end, a second end, an internal surface and an external surface, where the internal surface may have hydrophilic characteristics, to slow down the diffusion of the earwax sample (hydrophobic), thus guaranteeing the time necessary for the immunohistochemical reaction to be carried out;
• a nitrocellulose membrane of elongated shape, having a first end and a second end and having a test line portion and a control line portion, said nitrocellulose membrane located vertically on the base membrane along the entire length of the same where its first and second end coincides with the first and second end of the base membrane;
• a conjugate pad located vertically on the nitrocellulose membrane at the first horizontal end thereof to contain conjugated tracer antibodies;
• an earwax sample pad is placed vertically above the conjugate pad;
• the sample pad is made of high oil absorption property material, such as natural inorganic substances like sand, clay, or volcanic ash. It can also be made of other natural organic and synthetic materials and must be pre-treated with a buffer solution;
• and an absorbent pad located vertically on the nitrocellulose membrane at a second horizontal end thereof;
• where:
• the earwax diffuses into the sample pad, which also acts as a filter;
• the conjugates to be used (enzymes or antibodies) are dispensed onto the conjugate pad;
• the corresponding capture reagents are dispensed onto the nitrocellulose membrane where the test and control lines are located, respectively;
• labels (tracers) located on the pads and nitrocellulose membrane are included and are made of a material selected but not limited to colloidal gold, carbon or latex;
• and the resulting complexes during the assay move through the principle of capillarity until they are detected on the test line through a pre-deposited detection antibody.