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

Nanomix

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Industry

Identifiers

NCT03619109

Nanomix

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

160 participants in 1 patient group

Healthy Volunteers

Description:

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.