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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | 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. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Tina Landess | Nanomix | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | San Francisco | California | 94110 | United States |
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Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Sponsor for potential future analysis/ projects.