Performance Evaluation of the Nanomix eLab® CRP, PCT, and LAC Assays With the Nanomix eLab System
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/17/2019 |
| Start Date: | December 11, 2018 |
| End Date: | April 30, 2019 |
| Contact: | Tina Landess |
| Email: | tlandess@nano.com |
| Phone: | (510) 428-5300 |
A Performance Evaluation of the Nanomix eLab® C-Reactive Protein, Procalcitonin, and Lactate Assays With the Nanomix eLab System
The performance of the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays will be
demonstrated during a method comparison study in which prospectively collected 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.
demonstrated during a method comparison study in which prospectively collected 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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Pregnant or nursing
- Admitted to ICU after trauma
- Admitted to ICU after surgery
- Cardiogenic shock
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