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

NCT04529733 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-08-28

No results posted yet for this study

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

Interventions

DEVICE

IB10 sphingotest PCT+

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

Sponsors & Collaborators

  • Nexus DX

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2021-02-28
Completion
2021-03-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529733 on ClinicalTrials.gov