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

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.

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