Devices and assays for diagnosis of viral and bacterial infections

An assay kit comprising:

• a lysis buffer to lyse cells within a nasal mucosal sample and form a single sample solution, wherein the lysis buffer comprises between 0.01% and 5% (w/w) sarkosyl and between 0.1% and 15% (w/w) sucrose, wherein the lysis buffer is adapted to expose antigens from a plurality of pathogens within the nasal mucosal sample;
• a cartridge containing one or more solid phase substrates holding a first binding agent that binds specifically to an antigen specific a first pathogen selected from one of:
• H. influenzae, M. catarrhalis or S. pneumoniae, and a second binding agent that binds specifically to an antigen specific to a second pathogen, wherein the first binding agent and the second binding agent are bound to specific regions of the one or more solid phase substrates of the cartridge;
• one or more conjugation regions within the cartridge, the one or more conjugation regions in fluid communication with the one or more solid phase substrates and comprising an agent that is labeled and that binds specifically to the antigen specific to the first pathogen, and an agent that is labeled and that binds specifically to the antigen specific to the second pathogen;
• one or more sample inlets on the cartridge in fluid communication with the one or more conjugation regions;
• and
• one or more windows through which the specific regions of the one or more solid phase substrates to which the first binding agent and the second binding agent are to be viewed.

An assay kit comprising:

• a lysis buffer to lyse cells within a mucosal sample and form a single sample solution, wherein the lysis buffer comprises between 0.01% and 5% (w/w) sarkosyl and between 0.1% and 15% (w/w) sucrose, wherein the lysis buffer is adapted to expose an antigen specific to a particular type of bacterium and an antigen specific to a particular type of virus in the mucosal sample;
• a cartridge containing one or more solid phase substrates holding a bacterial-binding agent that binds specifically to the antigen specific to the particular type of bacterium but not to the antigen specific to the particular type of virus, and a viral-binding agent that binds specifically to the antigen specific to the particular type of virus but not to the antigen specific to the particular type of bacterium, wherein the bacterial-binding agent and the viral-binding agent are bound to specific regions of the one or more solid phase substrates of the cartridge;
• one or more conjugation regions within the cartridge, the one or more conjugation regions in fluid communication with the one or more solid phase substrates and comprising an agent that is labeled and that binds specifically to the antigen specific to the particular type of bacterium, and an agent that is labeled and that binds specifically to the antigen specific to the particular type of virus;
• one or more sample inlets on the cartridge in fluid communication with the one or more conjugation regions;
• and
• one or more windows through which the specific regions of the one or more solid phase substrates to which the bacterial-binding agent and the viral-binding agent are to be viewed.

A method for concurrently detecting multiple pathogens from a single nasal mucosal sample, the method comprising:

• adding the nasal mucosal sample to a lysis buffer to lyse multiple pathogens within the nasal mucosal sample and form a single sample solution, wherein the lysis buffer comprises between 0.01% and 5% (w/w) sarkosyl and between 0.1% and 15% (w/w) sucrose, wherein the lysis buffer is adapted to expose an antigen specific to a first pathogen and an antigen specific to a second pathogen in the nasal mucosal sample;
• adding the sample solution to a cartridge containing one or more solid phase substrates holding a first binding agent that binds specifically to the antigen specific to the first pathogen but not to the antigen specific to the second pathogen, and a second binding agent that binds specifically to the antigen specific to the second pathogen but not to the antigen specific to the first pathogen, wherein the first binding agent and the second binding agent are bound to specific regions of the one or more solid phase substrates of the cartridge, further wherein the first pathogen is one of:
• H. influenzae, M. catarrhalis or S. pneumoniae;
• and
• contacting the sample solution, either before or after it is added to the cartridge, with an agent that is labeled and that binds specifically to the antigen specific to the first pathogen, and an agent that is labeled and that binds specifically to the antigen specific to the second pathogen.

An assay kit for concurrently detecting H. influenzae, M. catarrhalis, S. pneumoniae, influenza A, and Influenza B in a mucosal sample, the assay kit comprising:

• a lysis buffer to lyse cells within the mucosal sample and form a single sample solution, wherein the lysis buffer comprises between 0.01% and 5% (w/w) sarkosyl and between 0.1% and 15% (w/w) sucrose, wherein the lysis buffer is adapted to expose antigens specific to the H. influenzae, M. catarrhalis and S. pneumoniae cells and antigens specific to influenza A and influenza B viruses in the mucosal sample;
• a cartridge containing one or more solid phase substrates holding:
• a first bacterial-binding agent that binds specifically to a first bacterial antigen specific to H. influenzae but not M. catarrhalis, S. pneumoniae, influenza A or influenza B;
• a second bacterial-binding agent that binds specifically to a second bacterial antigen specific to M. catarrhalis but not H. influenzae, S. pneumoniae, influenza A or influenza B;
• a third bacterial-binding agent that binds specifically to a third bacterial antigen specific to S. pneumoniae but not M. catarrhalis, H. influenzae, influenza A or influenza B;
• a first viral-binding agent that binds specifically to a fourth viral antigen specific to influenza A but not H. influenzae, M. catarrhalis, S. pneumoniae or influenza B;
• and a second viral-binding agent that binds specifically to a second viral antigen specific to influenza B but not H. influenzae, M. catarrhalis, S. pneumoniae or influenza A, wherein the first bacterial-binding agent, the second bacterial-binding agent, the third bacterial-binding agent, the first viral-binding agent and the second viral-binding agent are bound to specific regions of the one or more solid phase substrates in the cartridge;
• one or more conjugation regions within the cartridge, the one or more conjugation regions in fluid communication with the one or more solid phase substrates and comprising a fourth agent that is labeled and that binds specifically to the first bacterial antigen, a fifth agent that is labeled and that binds specifically to the second bacterial antigen, a sixth agent that is labeled and that binds specifically to the third bacterial antigen, a seventh agent that is labeled and that binds specifically to the first viral antigen, and an eighth agent that is labeled and that binds specifically to the second viral antigen;
• one or more sample inlets on the cartridge in fluid communication with the one or more conjugation regions;
• and
• one or more windows through which the specific regions of the one or more solid phase substrates to which the first bacterial-binding agent, the second bacterial-binding agent, the third bacterial-binding agent, the first viral-binding agent and the second viral-binding agent are bound are to be viewed.

A method for concurrently detecting H. influenzae, M. catarrhalis, S. pneumoniae, influenza A, and influenza B from a mucosal sample, the method comprising:

• adding the mucosal sample to a lysis buffer to lyse cells within the mucosal sample and form a single sample solution, wherein the lysis buffer comprises between 0.01% and 5% (w/w) sarkosyl and between 0.1% and 15% (w/w) sucrose;
• adding the sample solution to a cartridge containing one or more solid phase substrates holding a first bacterial-binding agent that binds specifically to a first bacterial antigen specific to H. influenzae but not M. catarrhalis, S. pneumoniae, influenza A or influenza B;
• a second bacterial-binding agent that binds specifically to a second bacterial antigen specific to M. catarrhalis but not H. influenzae, S. pneumoniae, influenza A or influenza B;
• a third bacterial-binding agent that binds specifically to a third bacterial antigen specific to S. pneumoniae but not M. catarrhalis, H. influenzae, influenza A or influenza B;
• a first viral-binding agent that binds specifically to a first viral antigen specific to influenza A but not H. influenzae, M. catarrhalis, S. pneumoniae or influenza B;
• and a second viral-binding agent that binds specifically to a second viral antigen specific to influenza B but not H. influenzae, M. catarrhalis, S. pneumoniae or influenza A, wherein the first bacterial-binding agent, the second bacterial-binding agent, the third bacterial-binding agent, the first viral-binding agent and the second viral-binding agent are bound to specific regions of the one or more solid phase substrates in the cartridge;
• and
• contacting the sample solution, either before or after it is added to the cartridge, with a fourth agent that is labeled and that binds specifically to the first bacterial antigen, a fifth agent that is labeled and that binds specifically to the second bacterial antigen, a sixth agent that is labeled and that binds specifically to the third bacterial antigen, a seventh agent that is labeled and that binds specifically to the first viral antigen, and an eighth agent that is labeled and that binds specifically to the second viral antigen.