Test to distinguish viral-only from bacterial infection or viral/bacterial coinfection using a respiratory swab

A method for detecting a viral-only or a bacterial-associated respiratory infection in a patient, the method comprising:

• a. analyzing a respiratory sample from the patient to determine a level of at least one respiratory virus infection-associated molecule and a level of at least one bacterial respiratory infection-associated molecule by measuring protein, wherein the at least one respiratory virus infection-associated molecule comprises FAM160A1 and the at least one bacterial respiratory infection-associated molecule comprises SEP15;
• and
• b. comparing the level of the at least one respiratory virus infection-associated molecule and the level of the at least one bacterial respiratory infection-associated molecule with a predetermined reference level for the at least one respiratory virus infection-associated molecule and a predetermined reference level of the at least one bacterial respiratory infection-associated molecule, respectively;
• wherein if the level of the at least one respiratory virus infection-associated molecule is above the respective reference level, the patient is determined to have a respiratory viral infection;
• and
• if the level of the at least one bacterial respiratory infection-associated molecule is above the respective reference level, the patient is determined to have a bacterial-associated respiratory infection.

A method of treating a patient exhibiting symptoms of a respiratory infection, the method comprising:

• a. analyzing a respiratory sample from the patient to determine a level of at least one respiratory virus infection-associated molecule and a level of at least one bacterial respiratory infection-associated molecule and a level of a housekeeping gene by measuring mRNA, wherein the at least one respiratory virus infection-associated molecule comprises FAM160A1 and the at least one bacterial respiratory infection-associated molecule comprises SEP15;
• b. normalizing the level of the at least one respiratory virus infection-associated molecule and the level of the at least one bacterial respiratory infection-associated molecule to the level of the housekeeping gene to determine a normalized level of the at least one respiratory virus infection-associated molecule and a normalized level of the at least one bacterial respiratory infection-associated molecule;
• and
• c. comparing the normalized level of the at least one respiratory virus infection-associated molecule and the normalized level of the at least one bacterial respiratory infection-associated molecule with a predetermined reference level for the at least one respiratory virus infection-associated molecule and a predetermined reference level of the at least one bacterial respiratory infection-associated molecule, respectively;
• wherein if the normalized level of the at least one respiratory virus infection-associated molecule is above the respective reference level, the patient is treated for a respiratory viral infection;
• and
• if the normalized level of the at least one bacterial-associated molecule is above the respective reference level, the patient is treated for a bacterial respiratory infection.

A method of treating a patient exhibiting symptoms of a respiratory infection, the method comprising:

• a. analyzing a respiratory sample from the patient to determine a level of at least one respiratory virus infection-associated molecule and a level of at least one bacterial respiratory infection-associated molecule by measuring protein, wherein the at least one respiratory virus infection-associated molecule comprises FAM160A1 and the at least one bacterial respiratory infection-associated molecule comprises SEP15;
• and
• b. comparing the level of the at least one respiratory virus infection-associated molecule and the level of the at least one bacterial respiratory infection-associated molecule with a predetermined reference level for the at least one respiratory virus infection-associated molecule and a predetermined reference level of the at least one bacterial respiratory infection-associated molecule, respectively;
• wherein if the normalized level of the at least one respiratory virus infection-associated molecule is above the respective reference level, the patient is treated for a respiratory viral infection;
• and
• if the normalized level of the at least one bacterial-associated molecule is above the respective reference level, the patient is treated for a bacterial respiratory infection.

A method of determining whether a subject who tests positive for the presence of a bacterial or viral respiratory pathogen is a carrier or if the pathogen is part of a disease process, the method comprising:

• a. analyzing a respiratory sample from the subject to determine a level of at least one respiratory virus infection-associated molecule, a level of at least one bacterial respiratory infection-associated molecule, and a level of a housekeeping gene by measuring mRNA, wherein the at least one respiratory virus infection-associated molecule comprises FAM160A1 and the at least one bacterial respiratory infection-associated molecule comprises SEP15;
• b. normalizing the level of the at least one respiratory virus infection-associated molecule and the level of the at least one bacterial respiratory infection-associated molecule to the level of the housekeeping gene to determine a normalized level of the at least one respiratory virus infection-associated molecule and a normalized level of the at least one bacterial respiratory infection-associated molecule;
• and
• c. comparing the normalized level of the at least one respiratory virus infection-associated molecule and the normalized level of the at least one bacterial respiratory infection-associated molecule with a predetermined reference level for the at least one respiratory virus infection-associated molecule and a predetermined reference level of the at least one bacterial respiratory infection-associated molecule, respectively;
• wherein if the normalized level of the at least one respiratory virus infection-associated molecule is above the respective reference level, the subject is determined to have a respiratory viral infection;
• if the normalized level of the at least one bacterial respiratory infection-associated molecule is above the respective reference level, the subject is determined to have a bacterial-associated respiratory infection;
• if the normalized level of the at least one respiratory virus infection-associated molecule is above the respective reference level and the level of the at least one bacterial respiratory infection-associated molecule is above the respective reference level, the subject is determined to have both a respiratory viral infection and a bacterial respiratory infection;
• and
• if neither the level of the at least one respiratory virus infection-associated molecule nor the level of the at least one bacterial respiratory infection-associated molecule is above the respective reference level, the subject is determined to be a carrier.

A method of determining whether a subject who tests positive for the presence of a bacterial or viral respiratory pathogen is a carrier or if the pathogen is part of a disease process, the method comprising:

• a. analyzing a respiratory sample from the subject to determine a level of at least one respiratory virus infection-associated molecule and a level of at least one bacterial respiratory infection-associated molecule by measuring protein, wherein the at least one respiratory virus infection-associated molecule comprises FAM160A1 and the at least one bacterial respiratory infection-associated molecule comprises SEP15;
• and
• b. comparing the level of the at least one respiratory virus infection-associated molecule and the level of the at least one bacterial respiratory infection-associated molecule with a predetermined reference level for the at least one respiratory virus infection-associated molecule and a predetermined reference level of the at least one bacterial respiratory infection-associated molecule, respectively;
• wherein if the level of the at least one respiratory virus infection-associated molecule is above the respective reference level, the subject is determined to have a respiratory viral infection;
• if the level of the at least one bacterial respiratory infection-associated molecule is above the respective reference level, the subject is determined to have a bacterial respiratory infection;
• if the level of the at least one respiratory virus infection-associated molecule is above the respective reference level and the level of the at least one bacterial respiratory infection-associated molecule is above the respective reference level, the subject is determined to have both a respiratory viral infection and a bacterial respiratory infection;
• and
• if neither the level of the at least one respiratory virus infection-associated molecule nor the level of the at least one bacterial respiratory infection-associated molecule is above the respective reference level, the subject is determined to be a carrier.

A method of detecting a bacterial-associated respiratory infection in a subject, the method comprising:

• a. analyzing a respiratory sample from the subject to determine a level of at least one bacterial respiratory infection-associated molecule and a level of a housekeeping gene by measuring mRNA, wherein the at least one bacterial respiratory infection-associated molecule comprises SEP15;
• b. normalizing the level of the at least one bacterial respiratory infection-associated molecule to the level of the housekeeping gene to determine a normalized level of the at least one bacterial respiratory infection-associated molecule;
• and
• c. comparing the normalized level of the at least one bacterial respiratory infection-associated molecule with a predetermined reference level of the at least one bacterial respiratory infection-associated molecule;
• wherein if the normalized level of the at least one bacterial respiratory infection-associated molecule is above the respective reference level, the subject is determined to have a bacterial-associated respiratory infection.

A method of detecting a bacterial-associated respiratory infection in a subject, the method comprising:

• a. analyzing a respiratory sample from the subject to determine a level of at least one bacterial respiratory infection-associated molecule by measuring protein, wherein the at least one bacterial respiratory infection-associated molecule comprises SEP15;
• and
• b. comparing the level of the at least one bacterial respiratory infection-associated molecule with a predetermined reference level for the at least one bacterial respiratory infection-associated molecule;
• wherein if the level of the at least one bacterial respiratory infection-associated molecule is above the respective reference level, the subject is determined to have a bacterial respiratory infection.