NCT03876535

Performance Evaluation of the Nanomix eLab® CRP, PCT, and LAC Assays With the Nanomix eLab System

A Performance Evaluation of the Nanomix eLab® C-Reactive Protein, Procalcitonin, and Lactate Assays With the Nanomix eLab System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 184 (actual)
• Sponsor: Nanomix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sepsis
• SIRS

Interventions

Type	Name	Description
OTHER	Nanomix eLab® System molecular diagnostic test (non-interventional)	This is not an interventional study. It involves performance equivalence demonstration of a point of care diagnostic system to FDA cleared predicate devices currently used in sepsis and SIRS diagnosis.

Timeline

• Start date: 2018-12-11
• Primary completion: 2019-04-30
• Completion: 2019-08-30
• First posted: 2019-03-15
• Last updated: 2021-08-23

Locations

1 site across 1 country: United States