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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04529733

Enrollment

300

Registered

2020-08-28

Start date

2020-09-15

Completion date

2021-03-30

Last updated

2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Brief summary

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.

Interventions

DEVICEIB10 sphingotest PCT+

Whole blood in EDTA for procalcitonin POC testing on IB10 sphingotest PCT+ device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings, with corresponding procalcitonin measurements obtained in a ref or clinical laboratory using a comparative assay, with respect to the same EDTA plasma specimens	1 day	Method comparison
To establish the equivalence of IB10 sphingotest PCT+ measurements in EDTA whole blood and plasma specimens, as obtained in point-of-care settings as defined above	1 day	Method comparison
To establish equivalence of IB10 sphingotest PCT+ measurements in fresh EDTA plasma specimens and frozen EDTA plasma specimens	24 hours	in vitro stability
To establish the precision of IB10 sphingotest PCT+ measurements in point-of-care setting with respect to frozen EDTA plasma specimens	1 day	Point of Care precision Testing
To establish the in vitro stability of EDTA whole blood and plasma speciments with respect to procalitonin concentrations as measured by the of IB10 sphingotest PCT+ test.	1 day	in vitro stability

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026