The objective of this study is to determine the biological activity of Artemisia vulgaris allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house reference preparation (IHRP).
This is an open, unblinded and non-randomized biological assay. Tehe study design is a slight modification of the recommendations proposed by the Nordic Guidelines. Four concentrations of Artemisia vulgaris 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
30
Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Hospital de La Agencia Valenciana de Salud Vega Baja
Orihuela, Alicante, Spain
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Time frame: 15-20 min after aplication
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