Procalcitonin Test Reference Range Determination (PRO-H)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Mt. Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy normal

Description

Inclusion Criteria:

• Apparently healthy (as determined by a subject questionnaire) males or females, of any race
• >18 years of age
• Willing to voluntarily agree to sign a consent form

Exclusion Criteria:

• Meets the definition for one or more of Systematic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock and/or Multiple Organ Dysfunction Syndrome (MODS) as defined by The American College of Chest Physicians (ACCP) and the Society of Critical Care Medicine (SCCM) consensus conference in 1992.
• Current diagnosis, or history, of any underlying major medical condition such as heart disease, hypertension/hypotension, stroke, renal disease, chronic obstructive pulmonary disorder, diabetes, bleeding disorders, hypercalcitoninemia, HIV, etc.
• Bacterial, fungal or malaria infection within previous 12 months
• Have experienced or undergone trauma, surgery, cardiac shock and/or a burn within previous 3 months
• Current diagnosis of cancer and/or has undergone Immunotherapy which stimulates cytokines in the previous 12 months
• Hospitalization (for >24 hours) within previous 3 months
• Currently pregnant or nursing a child
• Unable, or unwilling, to provide required blood sample for testing
• Non-compliance to the protocol or inclusion criteria
• Investigator believes subject is unsuitable for inclusion in the trial (i.e. has major condition(s) or other reason(s) that could limit their ability to participate in the study; or impact the scientific integrity of the study)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procalcitonin value for healthy reference subjects	Procalcitonin value for each subject will be determined within 2 hours of phlebotomy. At study completion all data obtained will be compiled and a 95th percentile value determined.	Subjects will be followed for duration of one blood draw from one visit only; study enrollment will occur over 21 days.

Collaborators and Investigators

• Sponsor: Response Biomedical Corp.
• Investigators: Principal Investigator: Azar Azad, Mount Sinai Services

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Estimate): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CSP025