Digital Device Reading Skin Prick Test
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital skin test reading device.
- Who it may be relevant to
- Registry conditions: Allergy Skin Prick Test Reading. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sensitivity and Specificity Study of Electromedical Device Nexkin DSPT and Manual Measurement of Hives in Allergy Skin Prick Tests
Overview
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.
Interventions
- Device Digital skin test reading device
The device to be studied measures optically the size of the wheals from skin tests (SPT) performed for the diagnosis of allergen sensitization.
Primary outcome measures
- Measurement of the histamine (positive control) wheal by healthcare professional [Time frame: At enrollment]
- Measurement of the NaCl (negative control) wheal by healthcare professional [Time frame: At enrollment]
- Measurement of the histamine (positive control) wheal by digital device [Time frame: At enrollment]
- Measurement of the NaCl (negative control) wheal by digital device [Time frame: At enrollment]
Secondary outcome measures (1)
- Measure of the time involved in the complete reading and recording of the results [Time frame: At enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Switzerland · 1 center
- Inselspital, Bern University Hospital, University of Bern — Bern
Identifiers
NCT: NCT06743737 · 2024-D0059