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

Completed

• Conditions: Healthy

• Registration Number: NCT03619109
• Lead Sponsor: Nanomix

Brief 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.

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 Timeline

• Study Start: 2017-12-22
• Status Verified: 2018-08
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-07
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System	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.

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States