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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Device: IB10 sphingotest PCT+


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: IB10 sphingotest PCT+|Whole blood in EDTA for procalcitonin POC testing on IB10 sphingotest PCT+ device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Method comparison | 1 day | 
| 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 | Method comparison | 1 day | 
| To establish equivalence of IB10 sphingotest PCT+ measurements in fresh EDTA plasma specimens and frozen EDTA plasma specimens | in vitro stability | 24 hours | 
| To establish the precision of IB10 sphingotest PCT+ measurements in point-of-care setting with respect to frozen EDTA plasma specimens | Point of Care precision Testing | 1 day | 
| 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. | in vitro stability | 1 day |