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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal reference ranges of CRP, Procalcitonin, and Lactate for the Nanōmix eLab® System | 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. | One timepoint at enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRP, C-Reactive Protein, Procalcitonin, Lactate, In Vitro Diagnostic Product, IVD