Clinical trial NCT05702671: Kenota 1 CWS Method Comparison Validation Study
Official title: Clinical Validation Study of Point of Care Kenota 1 System and Total Immunoglobulin E Test Kit Using the CWS Method Comparison Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Immunoglobulin E-Mediated Allergic Disorder
Keywords: Point of Care
Total Immunoglobulin E (tIgE) level in blood
Fingerstick
Kenota 1 System
Kenota 1 Device
Allergy Clinics
Allergist
Lead sponsor: Kenota Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 411
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total IgE Value
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: St. Paul Allergy & Asthma
state: Minnesota
city: Chapel Hill
country: United States
facility: Allergy Partners of Chapel Hill
state: North Carolina
city: Virginia Beach
country: United States
facility: Children's Specialty Group
state: Virginia
Study officials:
affiliation: Kenota Health
name: Christopher Harder, PhD
role: PRINCIPAL_INVESTIGATOR
References: