The objective of this study is to determine the biologic activity of a Secale cereale 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. Four concentrations of Secale cereale 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
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
35
4 concentrations of Secale cereale 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 Universitario La Paz
Madrid, Madrid / Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla / Andalucía, 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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