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

March 13, 2019 updated by: Nanomix

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

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.

Study Overview

Status

Completed

Conditions

Healthy

Detailed 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.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Francisco, California, United States, 94110
    - Zuckerberg San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Cross-Sectional

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Healthy Volunteers No real intervention since samples from volunteers are not tested on Nanōmix eLab™ System near any volunteers. Leftover samples are stored at Sponsor for potential future analysis/ projects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System Time Frame: One timepoint at enrollment	To determine the normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix 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.Nanōmix eLab® System.	One timepoint at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanomix

Investigators

Study Director: Tina Landess, Nanomix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2017

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria