Clinical trial NCT06743737: Digital Device Reading Skin Prick Test
Official title: Sensitivity and Specificity Study of Electromedical Device Nexkin DSPT and Manual Measurement of Hives in Allergy Skin Prick Tests
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergy Skin Prick Test Reading
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: sitem-insel AG Bern
First posted: 2024-12-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of the histamine (positive control) wheal by healthcare professional
timeFrame: At enrollment
measure: Measurement of the NaCl (negative control) wheal by healthcare professional
timeFrame: At enrollment
measure: Measurement of the histamine (positive control) wheal by digital device
timeFrame: At enrollment
measure: Measurement of the NaCl (negative control) wheal by digital device
timeFrame: At enrollment
Secondary outcomes:
measure: Measure of the time involved in the complete reading and recording of the results
timeFrame: At enrollment
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital, University of Bern
Study officials:
affiliation: Inselspital, Bern / sitem-Insel AG
name: Elnaz Arjmand
role: PRINCIPAL_INVESTIGATOR
References: