Devices and assays for diagnosis of sinusitis

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

• a lysis buffer to lyse cells within the sample and form a single sample solution, wherein the lysis buffer comprises between 0.01% and 5% (w/w) of an anionic surfactant and between 0.1% and 15% (w/w) of an osmotic agent, wherein the anionic surfactant of the lysis buffer comprises sarkosyl and wherein the osmotic agent of the lysis buffer comprises sucrose;
• a cartridge containing a solid phase substrates holding a first agent that binds specifically to a first antigen specific to H. influenzae but not M. catarrhalis or S. pneumoniae, a second agent that binds specifically to a second antigen specific to M. catarrhalis but not H. influenzae or S. pneumoniae, and a third agent that binds specifically to a third antigen specific to S. pneumoniae but not M. catarrhalis or H. influenzae, wherein the first, second and third agents are bound to specific regions of the solid phase substrate;
• and
• a conjugation region within the cartridge, conjugation region in fluid communication with the solid phase substrate and comprising a fourth agent that is labeled and that binds specifically to the first antigen, a fifth agent that is labeled and that binds specifically to the second antigen, and a sixth agent that is labeled and that bind specifically to the third antigen;
• a sample inlet on the cartridge in fluid communication with the conjugation region;
• and
• one or more windows exposing the specific regions of the solid phase substrate to which the first second and third agents are bound.

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

• adding the sample to a lysis buffer to lyse cells within the sample and form a single sample solution, wherein the lysis buffer comprises both an anionic surfactant and an osmotic agent, wherein the lysis buffer comprises between 0.01% and 5% (w/w) of the anionic surfactant and between 0.1% and 15% (w/w) of the osmotic agent, wherein the anionic surfactant comprises sarkosyl and wherein the osmotic agent comprises sucrose;
• adding the sample solution to a cartridge containing one or more solid phase substrates holding a first agent that binds specifically to a first antigen specific to H. influenzae but not M. catarrhalis or S. pneumoniae, a second agent that binds specifically to a second antigen specific to M. catarrhalis but not H. influenzae or S. pneumoniae, and a third agent that binds specifically to a third antigen specific to S. pneumoniae but not M. catarrhalis or H. influenzae, wherein the first, second and third agents 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 antigen, a fifth agent that is labeled and that binds specifically to the second antigen, and a sixth agent that is labeled and that bind specifically to the third antigen.

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

• adding the sample to a lysis buffer to lyse cells within the sample and form a single sample solution, wherein the lysis buffer comprises between 0.01% and 5% (w/w) of the anionic surfactant and between 0.1% and 15% (w/w) of the osmotic agent, wherein the anionic surfactant comprises sarkosyl and wherein the osmotic agent comprises sucrose;
• adding the sample solution to a cartridge containing a solid phase substrate holding a first agent that binds specifically to a first antigen specific to H. influenzae but not M. catarrhalis or S. pneumoniae, a second agent that binds specifically to a second antigen specific to M. catarrhalis but not H. influenzae or S. pneumoniae, and a third agent that binds specifically to a third antigen specific to S. pneumoniae but not M. catarrhalis or H. influenzae, wherein the first, second and third agents are bound to specific separate regions of the solid phase substrate;
• contacting the sample solution with a fourth agent that is labeled and that binds specifically to the first antigen, a fifth agent that is labeled and that binds specifically to the second antigen, and a sixth agent that is labeled and that bind specifically to the third antigen;
• and
• optically identifying through a window in the cartridge that the fourth agent has bound to the first antigen, the fifth agent has bound to the second antigen, or the sixth agent has bound to the third antigen.