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

NCT04529733 | Unknown DMC FDA Device

• 1 other identifier: B10-08
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

IB10 sphingotest PCT+ DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nexus DX: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 28, 2020
• Study Start: September 15, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 30, 2021
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share