Digital Device Reading Skin Prick Test

Sensitivity and Specificity Study of Electromedical Device Nexkin DSPT and Manual Measurement of Hives in Allergy Skin Prick Tests

Skin prick tests (SPTs), or intraepidermal tests, are the first diagnostic approach for people with a suspected allergy. SPTs are very simple, safe and quick. They are cheap tests and are very useful as a screening test for allergy, especially in diseases like bronchial asthma, rhinoconjunctivitis, food/drug allergy and anaphylaxis. Together with the clinical history, SPTs allow to draw conclusions on allergies based on the sensitization pattern.

Nevertheless, the technique itself has evolved very little and continues to be performed entirely manually. This has a few drawbacks that limit the utility of the tests, in many cases limiting them to a purely qualitative assessment.

In comparison to standard practice (manual measurement), the digital skin test reading device Nexkin DSPT can provide the following benefits for project participants: Automates and digitizes the test reading, provides test results in digital format, reduces variability and subjectivity and greater consistency of diagnosis, reduces manual tasks allowing health professionals providing quantitative instead of qualitative results and avoiding potential human errors and allows a faster workflow, resulting in shorter patient visits.

The aim of this study is to validate the clinical utility of the electromedical skin test reading device Nexkin DSPT regarding its use in allergology clinics for the reading of skin prick allergy tests. The overall purpose of the study is to determine the sensitivity and specificity of skin prick tests (SPT) performed using the current practice of the fully manual SPT procedure and those performed using the Nexkin SPT DSPT (digital) procedure and to compare the sensitivity and specificity of both methods.

Study Overview

• Status: Recruiting
• Conditions: Allergy Skin Prick Test Reading
• Intervention / Treatment: Device: Digital skin test reading device

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Bern University Hospital, University of Bern
    • Contact: Lukas Jörg; Phone Number: +41 31 632 22 69; Email: aip@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients with a food or aeroallergy who require a SPT in the routine allergy workup are invited to participate in the study.

Description

Inclusion Criteria:

Patients who will undergo skin prick tests with panels of aeroallergens and/or foods.

Over 18 years of age. The patient or their representative has given consent to participate in the study.

The patient must not have taken an antihistamine in the last 5 days.

Exclusion Criteria:

Patients who are evaluated by more than 40 prick tests. Patients who have taken an antihistamine within the previous 5 days. Patients who are being treated with antidepressants or other drugs with an antihistamine effect.

Patients who suffer severe atopic dermatitis with forearm involvement. Patients with dermographism. Patients who are evaluated by intradermal testing. Pregnant women or women suspected to be pregnant. Vulnerable patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of the histamine (positive control) wheal by healthcare professional	At enrollment
Measurement of the NaCl (negative control) wheal by healthcare professional	At enrollment
Measurement of the histamine (positive control) wheal by digital device	At enrollment
Measurement of the NaCl (negative control) wheal by digital device	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of the time involved in the complete reading and recording of the results	Minutes and seconds of procedure (testing & recording of results) will be recorded for both the manual procedure and the procedure using the digital device	At enrollment

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: sitem-insel AG Bern
• Investigators: Principal Investigator: Elnaz Arjmand, Inselspital, Bern / sitem-Insel AG

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 2024-D0059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No