Kenota 1 CWS Method Comparison Validation Study

Clinical Validation Study of Point of Care Kenota 1 System and Total Immunoglobulin E Test Kit Using the CWS Method Comparison Validation Study

The goal of this Method Comparison Study is to compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods. The main questions it aims to answer are:

• Are the Kenota 1 Devices easy to use by untrained operators at a clinic environment?
• Do tIgE results provided by the Kenota 1 Devices match the results provided by the FDA-cleared Phadia ImmunoCAP System?

Subjects will be asked to donate two fingerstick whole blood samples and one venous blood draw.

Study Overview

• Status: Completed
• Conditions: Allergy; Immunoglobulin E-Mediated Allergic Disorder
• Intervention / Treatment: Diagnostic test: Total Immunoglobulin E, Obtained From Fingerstick Sample

Detailed Description

The Method Comparison Study will compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms. comprising three types of samples and two testing methods.

Arm (A): Fresh fingerstick whole blood will be collected and tested on Kenota 1 Devices at three CLIA-Waived sites (CWSs).

Arm (B): Venous plasma will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.

Arm (C): Venous plasma will be collected at the CWSs and tested on Phadia instruments (ImmunoCAP) at the central lab site.

Arm (D): Venous whole blood will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.

The first method for this study is the Kenota 1 System, which will be used across Three (3) U.S. CWSs. At each CWS, 120 subjects will be recruited and will be asked to donate fingerstick blood and venous blood.

Three (3) untrained operators at each site will be running the freshly collected fingerstick blood samples on the Kenota 1 Devices provided at the site (Testing Arm A). Site operators will also process and store the collected venous blood and venous plasma samples as instructed, and ship them to the central lab for further testing.

The second method for this study involves testing at a Central US Laboratory as a CLIA-regulated laboratory.

At the central lab, at least one trained lab operator will run frozen venous plasma (testing Arm B) and frozen venous whole blood (testing Arm D) collected from all subjects using the Kenota 1 Devices provided at the central lab. As the comparator method, one lab operator will run a second set of frozen plasma samples collected from all subjects on the Phadia ImmunoCAP System (testing Arm C).

The Method Comparison Validation Study is expected to be completed within two months and will be run in conjunction with the Multi-Site Reproducibility Validation Study. All testing will include a daily External Control session on each device used, ensuring the devices are performing as expected.

• Study Type: Observational
• Enrollment (Actual): 411

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55116
      • St. Paul Allergy & Asthma
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Allergy Partners of Chapel Hill
  • Virginia
    • Virginia Beach, Virginia, United States, 23456
      • Children's Specialty Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study population will be selected from existing and new patients visiting the allergist clinic, as well as individuals from the clinic such as volunteering staff members.

Description

Inclusion Criteria:

• Ages <80 years
• From all Ethnic/Racial backgrounds

Exclusion Criteria:

- Individuals with skin damage, burns or scars at the site of venipuncture on both arms

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total IgE Value	Tests performed on the Kenota 1 Devices will provide tIgE values in kU/L for each test. These values will be compared directly with the tIgE results produced by the comparator method, Phadia ImmunoCAP system, which are also in kU/L. The Slope, Intercept and Correlation Coefficient will be calculated and used to determine if overall proportional bias of Kenota 1 fresh fingerstick whole blood is less than 10% compared to the comparator method.	One day

Collaborators and Investigators

• Sponsor: Kenota Inc.
• Investigators: Principal Investigator: Christopher Harder, PhD, Kenota Health

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2023
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): April 7, 2023

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Point of Care; Total Immunoglobulin E (tIgE) level in blood; Fingerstick; Kenota 1 System; Kenota 1 Device; Allergy Clinics; Allergist
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Hypersensitivity, Immediate; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: DOC_K1M_0096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No participant personal data will be shared. The information collected will only be in the Informed Consent Form and will be kept at the Site only for maximum of 3years

Drug and device information, study documents

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