Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion:

Description

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, 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.

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

Keywords

Healthy C-Reactive Protein CRP Procalcitonin Lactate In Vitro Diagnostic Product IVD Calcitonin

Eligibility

You can join if…

Open to people ages 18 years and up

  • Must be 18 years of age or older
  • Must have provided written informed consent
  • Must self-report as being in good health

You CAN'T join if...

  • 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

Location

  • Zuckerberg San Francisco General Hospital
    San Francisco California 94110 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nanomix
ID
NCT03619109
Study Type
Observational
Last Updated
August 28, 2018