Evaluation of the Levels of C-Reactive Protein, Procalcitonin, and Lactate in a Normal Healthy Population When Tested With the Nanōmix eLab® System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Nanomix
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System
Time Frame: 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.