Healthy
Conditions
Keywords
C-Reactive Protein, CRP, Procalcitonin, Lactate, In Vitro Diagnostic Product, IVD
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.
Interventions
None listed
Sponsors
Nanomix
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed