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

NCT03876535 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 184

Last updated 2021-08-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Nanomix

    lead INDUSTRY

Principal Investigators

  • Tina Landess · Nanomix

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2019-04-30
Completion
2019-08-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876535 on ClinicalTrials.gov