Method and device for combined detection of viral and bacterial infections

A method for analyzing a sample for a presence of MxA and C-reactive protein, comprising the steps of:

• a) collecting a fresh, fingerstick whole blood sample;
• b) transferring the sample to a sample analysis device comprising:
• i) a first lateral flow chromatographic test strip comprising:
• a first reagent zone for detecting a low level intensity of C-reactive protein comprising at least one first reagent specific to C-reactive protein such that, when the sample contacts the first reagent, a first labeled complex forms if the low level intensity of C-reactive protein is present is greater than a threshold concentration in the sample;
• a second reagent zone comprising at least one second reagent specific to detect an intensity MxA such that, when the sample contacts the second reagent, a second labeled complex forms if MxA is present in the sample;
• and
• a first detection zone comprising a first binding partner which binds to the first labeled complex indicative of detecting a bacterial marker being in the sample, wherein the threshold concentration to obtain a positive visual result for the low level intensity of C-reactive protein in the first detection zone of the first lateral flow chromatographic test strip is equal to or greater than a serum equivalent of approximately 6-15 mg/L of C-reactive protein;
• and
• a second binding partner which binds to the second labeled complex indicative of detecting a viral marker being present in the sample;
• an
• ii) a second lateral flow chromatographic test strip parallel in a lateral flow direction to the first lateral flow chromatographic test strip, comprising:
• at least one third reagent zone for detecting a high level intensity of C-reactive protein comprising:
• at least one third reagent specific to C-reactive protein, wherein the third reagent only detects a level of intensity C-reactive protein that is higher in intensity than the low level of intensity of C-reactive protein detected by the first reagent, such that, when the sample contacts the third reagent, a third labeled complex forms if the high level intensity of C-reactive protein is present in the sample;
• and
• a second detection zone comprising a third binding partner which binds to the third labeled complex wherein the threshold concentration to obtain a positive result for the high level of intensity of C-reactive protein in the second reagent zone of the second lateral flow chromatographic test strip is equal to or greater than a serum equivalent of approximately 60-100 mg/L;
• wherein the second lateral flow chromatographic test strip does not comprise reagent and detection zones for detecting MxA;
• and
• c) analyzing the sample for a presence of the low level intensity of C-reactive protein, MxA, and the high level intensity of C-reactive protein;
• wherein the fresh fingerstick whole blood sample is transferred to the sample analysis device and analyzed, such that a result is obtained in 20 minutes or less.