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

NCT03876535 | Completed

• 1 other identifier: Nanomix-010s
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Estimates of bias relative to an FDA cleared predicate device using CLSI EP9-A3 as a guideline.

  An analysis of the results from 150-200 subjects collected across the three (3) sites will be performed to accomplish the analytical comparison endpoints. If the analysis requires more samples to cover the assay range, then, the study may be continued and more subjects enrolled. A minimum of 25 percent of the samples must have values near the clinical significant concentration. In order to meet this requirement up to 10 % of samples may be spiked. Clinical significant concentrations for CRP are defined as values greater than 10 mg/L; PCT values greater than 0.5 ng/mL and LAC values greater than 2 mmol/L.

  One timepoint at enrollment

Interventions

Nanomix eLab® System molecular diagnostic test (non-interventional) OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Volunteers from medical wards presenting with acute illness, observation of infection and meeting SIRS criteria.

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

Sponsors & Collaborators

• Nanomix: lead

Study Sites (1)

UCSF- San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Sponsor for future analysis/ projects.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tina Landess

  Nanomix

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: December 11, 2018
• Primary Completion: April 30, 2019
• Study Completion: August 30, 2019
• Last Updated: August 23, 2021

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)