Method and device for discriminating between viral and bacterial infections

A method for discriminating between a bacterial infection and a viral infection in a subject, the method comprising the steps of:

• (a) providing a sample from the subject;
• (b) providing a point-of-care assay device comprising:
• (i) a sample application zone;
• (ii) a detection zone with detection reagents consisting of a first detection reagent with binding affinity to Mx-B-protein (Mx-B), a second detection reagent with binding affinity to C-reactive Protein (CRP), a third detection reagent with binding affinity to procalcitonin (PCT), and a fourth detection reagent with binding affinity to bactericidal/permeability-increasing protein (BPI);
• and
• (iii) a test window configured to allow observation of the test results;
• (c) applying the sample to the sample application zone of the assay device;
• (d) observing the absence or presence of detectable reagent-marker complexes in the test window of the assay device to determine whether the sample contains Mx-B, CRP, PCT, and/or BPI;
• and
• (e) determining the infection status of the subject,
• wherein the patient is determined to have a viral infection when (i) Mx-B is present and (ii) CRP, PCT, and BPI are absent;
• wherein the patient is determined to have a bacterial infection when (i) Mx-B is absent, (ii) CRP and/or PCT is present, and (iii) BPI is present;
• wherein the patient is determined to have a mixed viral and bacterial infection when (i) Mx-B is present and (ii) CRP, PCT, or BPI are present.