The objective of this study is to determine the biologic activity of a Poa pratensis 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 Poa pratensis 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
31
Four concentrations of Poa pratensis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
C.E. Virgen de la Cinta - Hospital Juan Ramón Jiménez
Huelva, Andalusia, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 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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