Expired Study
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San Francisco, California 94110


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03619109


Primary Contact:

Study Director
Tina Landess
Nanomix


Backup Contact:

N/A


Location Contact:

San Francisco, California 94110
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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