The objective of this study is to determine the biologic activity of a Dermatophagoides pteronyssinus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines. Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
42
This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dichloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.
Hospital de Denia (Marina Salud)
Denia, Alicante, Spain
Complexo Hospitalario Universitario A Coruña (Hospital Abente y Lago)
A Coruña, Spain
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Time frame: Test sites should be inspected and recorded 15-20 min after application
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