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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; SIRS
• Intervention / Treatment: Other: Nanomix eLab® System molecular diagnostic test (non-interventional)

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • UCSF- San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nanomix
• Investigators: Study Director: Tina Landess, Nanomix

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Nanomix-010s

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No