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

Nexus DX

Status

Unknown

Conditions

Sepsis

Treatments

Device: IB10 sphingotest PCT+

Study type

Interventional

Funder types

Industry

Identifiers

NCT04529733

B10-08

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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