Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting

Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting

To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical laboratory using a comparative assay, with respect to the same subset of human EDTA plasma specimens.

Inclusion Criteria:

• Subject is able and willing to provide written informed consent

• Subject is 18 years of age or older

• Subject is presenting with symptoms suggestive of bacterial infection

• Subject is presenting with two or more of the following symptoms suggestive of systemic inflammatory response syndrome (SIRS):

  • Body temperature less than 36°C (96.8°F) or greater than 38°C (100.4°F);
  • Heart rate greater than 90 beats per minute;
  • Respiratory rate greater than 20 breaths per minute, or an arterial partial pressure of carbon dioxide (pCO2) less than 4.3 kPa (32 mmHg);
  • White blood cell count less than 4,000 cells/mm3 (4 x 109 cells/L) or greater than 12,000 cells/mm3 (12 x 109 cells/L);
  • A normal white blood cell count with the presence of greater
  • than 10% immature neutrophils.

Exclusion Criteria:

• Subjects less than 18 years of age;
• Subjects who do not present with a minimum of two symptoms suggestive of SIRS, as defined above
• Subjects unable or unwilling to provide written informed consent