Determination of Normal Reference Values of CRP, Procalcitonin, and Lactate Levels for the Nanōmix eLab® System

Healthy Clinical Trial

Official title:

Evaluation of the Levels of C-Reactive Protein, Procalcitonin, and Lactate in a Normal Healthy Population When Tested With the Nanōmix eLab® System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619109
• Other study ID #: Nanomix
• Status: Completed
• Start date: December 22, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: August 2018
• Source: Nanomix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this clinical study is to determine the normal reference range of the Nanōmix eLab® (eLab) C-Reactive Protein, Procalcitonin and Lactate Assay.

Description:

The purpose of this clinical study is to determine the normal reference range of the Nanōmix eLab® (eLab) C-Reactive Protein, Procalcitonin and Lactate Assay, whereby collected blood samples are used to characterize the distribution of C-Reactive Protein (CRP), Procalcitonin (PCT), and Lactate (LAC) in a population of healthy subjects. Approximately 4 mL of whole blood will be collected by venipuncture from normal healthy volunteers and tested with the eLab C-Reactive Protein, Procalcitonin, and Lactate assay within 30 minutes of collection. Following the whole blood test, the sample will be spun down to plasma and a plasma sample will be tested on the eLab with the eLab C-Reactive Protein, Procalcitonin, and Lactate assays within 30 min of the whole blood test. Demographic and health information will also be collected from each participant by having them complete a questionnaire. The test results will be collated to establish the normal range (2.5 - 97.5th percentile) for each analyte. The remaining plasma will be frozen and stored at -80° C.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be 18 years of age or older

• Must have provided written informed consent

• Must self-report as being in good health

Exclusion Criteria:

• Under the care of a physician and currently receiving any therapy

• Obesity (BMI > 35)

• Have had outpatient surgery or been hospitalized in the last 3 months for any reason

• Known to be pregnant or nursing

• Engaged in exertion resulting in an estimated HR>120 bpm for > 5 minutes in the last 4 hours

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Nanomix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanomix eLab® System	To determine the normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanomix eLab® System using Li-Heparinized venous whole blood and Li-Heparinized plasma samples from healthy subjects.System using Li-Heparinized venous whole blood and Li-Heparinized plasma samples from healthy subjects.Nanomix eLab® System.	One timepoint at enrollment