NCT03619109

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Nanomix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Timeline

• Start date: 2017-12-22
• Primary completion: 2019-02-28
• Completion: 2019-02-28
• First posted: 2018-08-07
• Last updated: 2019-03-14

Locations

1 site across 1 country: United States