Performance Evaluation of the Nanomix eLab® CRP, PCT, and LAC Assays With the Nanomix eLab System
Completed
Conditions studied: Sepsis, SIRS
In brief
The performance of the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays will be demonstrated during a method comparison study in which venous whole blood and plasma samples are used. eLab results will be compared to an FDA cleared predicate device. Demographic information will be collected for the subject. Venous blood will be collected in 2 Li-heparinized tubes (2-4ml per tube). One tube will be used for testing at the site and the second tube will be processed to plasma for storage and subsequent shipment to a designated testing site. Whole blood samples will be tested on the eLab C-Reactive Protein, Procalcitonin, and Lactate test as soon as possible after collection; testing on whole blood must be completed within 30 minutes of collection. A predicate Lactate test will also be run as soon as possible after collection; testing of WB on the predicate must be completed within 30 minutes of collection. Plasma will be separated from the whole blood via centrifugation within 30 minutes of collection and tested on the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays and started on predicate CRP and PCT devices (If available at the site) within 30 minutes of the eLab whole blood test. The remainder of the plasma specimen and plasma from the second collection tube will be frozen within one hour of collection, then stored at approximately -20 degrees C or colder.
Key facts
- Study ID
- NCT03876535
- Run by
- Nanomix
- People needed
- 184
- Starts
- 2018-12-11
- Expected to finish
- 2019-08-30
- Last updated by the study team
- 2021-08-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must be 18 years of age or older
- Must have provided written informed consent
- Admitted to ICU, Emergency Department or other medical wards for acute illness and observation of infection and meeting SIRS criteria (such as elevated heart rate, tachypnea, hypotension, fever, hypothermia, or elevated respiratory rate)
You may not qualify if…
- Pregnant or nursing
- Admitted to ICU after trauma
- Admitted to ICU after surgery
- Cardiogenic shock
Where it is running
- UCSF- San Francisco General Hospital — San Francisco, California, United States
Full record on ClinicalTrials.gov
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