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

NCT ID: NCT03876535

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 184 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-11
• Study Completion Date: 2019-08-30

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanomix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tina Landess

Role: STUDY_DIRECTOR

Nanomix

Locations

UCSF- San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

Nanomix-010s

Identifier Type: -

Identifier Source: org_study_id