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.

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Device: IB10 sphingotest PCT+

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nexus DX

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2020
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): March 30, 2021

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: B10-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No