Actionable diagnostic information at the time of patient examination is more often than not unavailable in crucial time dependent situations.  For example, for patients with suspected infection, knowledge of whether the infection is bacterial or viral is crucial in order to determine whether or not antibiotics should be prescribed. 

Yet this information is typically unavailable to the physician, because current methodology relies on time consuming culture methods to determine the source of infection.  Aside from the length of time required for the infecting organism to grow, results for any test sent to a central laboratory will typically not be available for hours, even if ordered on a stat basis.

Consequences of lack of actionable diagnostic information are that in the case of infection, physicians are left with a "Hobson's choice" --  treat with antibiotics and risk creating more antibiotic resistant organisms if the problem is not bacterial, or don't treat with antibiotics and risk a worsening condition for a  patient with a bacterial infection, perhaps even to the extent of sepsis and septic shock. 

Even in the extreme case, when an infection has led to sepsis, immediate lack of a quantitative assessment of the degree of sepsis can limit the use of sepsis fighting drugs because of a physician’s concerns about side effects of these drugs.

A solution for actionable diagnostic information at all points of care is a small portable device capable of providing quantitative information about white blood cell count, differentials, cell surface markers, and plasma protein levels.  Further, this device must be CLIA waived to enable its use in all settings without the need for trained laboratory personnel. 

A simple cartridge-based system with the capabilities described above has many diagnostic applications.  We intend to focus on three applications that have significant societal and economic cost such that a successful device will provide a major improvement in patient care and a reduction in health care costs.  The three applications are:

• infection/sepsis characterization and detection,
  
• urinary tract infection detection and simple monitoring of HIV progression, and
  
• treatment by measurement of CD4 concentration.

Our approach is based on a cost and medically effective point of care technology.  The key element of this technology is a disposable cartridge that can perform a variety of tests on a small sample of blood and produce results in minutes, thereby providing the physician with actionable diagnostic information at the point of care. 

Our earlier work on the National Space Biomedical Research Institute (NSBRI) funded project has demonstrated the promise of a simple cartridge and reader system capable of white blood cell counting and differentiation as well as cell surface marker analysis and plasma protein quantitation.