Kenota 1 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.

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Key information

Conditions

Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunoglobulin E-Mediated Allergic Disorder

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Paul Allergy & Asthma, Saint Paul, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Immunoglobulin E, Obtained From Fingerstick Sample

Diagnostic Test

The Kenota 1 System is intended to be a specialized tool in a professional allergist setting. It will help streamline the patient testing process by bringing quantitative, minimally invasive fingerstick IgE blood testing to the allergy clinic.

Primary outcomes

Total IgE Value

Time frame: One day

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.

Sponsors and collaborators

Lead sponsor

Kenota Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jan 27, 2023
Registry last updated: May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed