An observational study in Allergy and Immunoglobulin E-Mediated Allergic Disorder, sponsored by Kenota Inc.. Completed at 3 sites in United States. Open to participants aged Up to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Kenota Inc. · Observational
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:
Subjects will be asked to donate two fingerstick whole blood samples and one venous blood draw.
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.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's enrollment of 411 is above the median of 166 across 327 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →This is the only study on the registry with Kenota Inc. as lead sponsor.
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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.
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Exclusion Criteria:
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.
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.
Time frame: One day
Plan to share: No — 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
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Apr 2023, 2 months.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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