NCT02591121

Procalcitonin Test Reference Range Determination

Clinical Evaluation To Determine The Expected Values Distribution Of Procalcitonin For The RAMP® Procalcitonin Test In A Healthy Reference Population (PRO-H)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Response Biomedical Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Prospective, single-centre study in healthy volunteers to establish a reference range for the RAMP Procalcitonin (PCT) test. The primary objective of this study is to establish the reference range for measurement of PCT levels using the RAMP Procalcitonin test.

Detailed description

Healthy volunteers who meet eligibility criteria and have provided informed consent will be enrolled in this study. Each participant will be required to donate 1 blood sample via standard venipuncture into an EDTA (lavender top) tube for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. Sample collection will take place within a single clinical session. The maximum trial duration for each participant is one clinic session.

Conditions

• Healthy

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-10-29
• Last updated: 2015-11-16

Locations

1 site across 1 country: Canada