Allergen-specific immunotherapy (ASIT) with fungal extracts has been beset by safety and efficacy problems, which result mainly from qualitative and quantitative variations. Little has been published on the safety and efficacy of these extracts. The objective was to analyze the safety and efficacy of ASIT with an Alternaria alternata extract. A total of 28 patients were selected with rhinitis and/or bronchial asthma because of Alternaria allergy and monosensitization to molds. The patients were randomized to an active ASIT or placebo group, both groups on a conventional immunotherapy schedule (increasing weekly doses until maintenance dose and then monthly doses). Adverse reactions were classified with the European Academy of Allergology and Clinical Immunology system. Clinical efficacy was analyzed for a year with symptom/medication diary cards, peak expiratory flow (PEF) measures, clinical severity score, severity of symptoms (visual analog scale), subjective evaluation of treatment by the patient and the physician, and a quality of life questionnaire. Twenty-three patients completed the study; all reached the established maintenance dose with only two mild adverse reactions in the whole sample. Significant improvements were found after 6 months in respiratory symptoms in the active treatment group, and in all symptoms in both groups. PEF increased significantly in the active treatment group but not in the placebo group. The severity of asthma decreased in the active treatment group, and the severity of rhinitis decreased in both groups. Visual analog scale scores for severity of symptoms improved in all phases in the active treatment group, but only after 12 months in the placebo group. Physicians judged the disease course as significantly better in the active treatment group. ASIT with the A. alternata extract was safe, with clinical improvements after one year of treatment.
BackgroundThe ImmunoCAP ISAC 112 is a fluoro-immunoassay that allows detection of specific IgE to 112 molecular components from 51 allergenic sources. We studied the reliability of this technique intra- and inter- assay, as well as inter-batch- and inter-laboratory-assay.MethodsTwenty samples were studied, nineteen sera from polysensitized allergic patients, and the technique calibrator provided by the manufacturer (CTR02). We measured the sIgE from CTR02 and three patients' sera ten times in the same and in different assays. Furthermore, all samples were tested in two laboratories and with two batches of ISAC kit. To evaluate the accuracy of ISAC 112, we contrasted the determinations of CTR02 calibrator with their expected values by T Student test. To analyse the precision, we calculated the coefficient of variation (CV) of the 15 allergens that generate the calibration curve, and to analyse the repeatability and the reproducibility, we calculated the intraclass coefficient correlation (ICC) to each allergen.ResultsThe results obtained for CTR02 were similar to those expected in 7 of 15 allergens that generate the calibration curve, whereas in 8 allergens the results showed significant differences. The mean CV obtained in the CTR02 determinations was of 9.4%, and the variability of sera from patients was of 22.9%. The agreement in the intra- and inter-assay analysis was very good to 94 allergens and good to one. In the inter-batch analyse, we obtained a very good agreement to 82 allergens, good to 14, moderate to 5 allergens, poor to one, and bad to 1 allergen. In the inter-laboratory analyse, we obtained a very good agreement to 73 allergens, good to 22, moderate to 6 and poor to two allergens.ConclusionThe allergen microarray immunoassay, ISAC 112, is a repeatable and reproducible in vitro diagnostic tool for determination of sIgE beyond the own laboratory.
Background: Plant food allergies associated with lipid transfer protein (LTP) have been widely described in the Mediterranean Basin. Objective: The aim of this work was to describe the clinical profile and pollen sensitization of plant food- allergic patients sensitized to LTP in a non-Mediterranean area. Methods: Patients with clear IgE-mediated symptoms associated with plant foods and a positive skin prick test (SPT) to Pru p 3 were included in a prospective study in the north of Spain. Reported symptoms were analyzed together with a battery of food and pollen SPTs and specific IgE components by ISAC microarray. Cross-inhibition studies were performed by ImmunoCAP with plane tree, mugwort and rPru p 3. Results: Among the 72 patients included, the most frequent food allergy reported was to peaches (69%) followed by nuts (walnuts 55%, peanuts 54% and hazelnuts 43%). Most patients suffered from symptoms with multiple plant foods (a median of 6 foods per patient). Regarding the patients' pollen sensitization, 36% were sensitized to mugwort pollen (72% showing sIgE to Art v 3), 33% to grass pollen and 24% to plane tree pollen (94% with sIgE to Pla a 3). Inhibition studies showed that specific IgEs against mugwort and plane tree pollen are inhibited by Pru p 3 in a strong manner, whereas Pru p 3 was less inhibited by pollen extracts. Conclusions: LTP syndrome occurs in a non-Mediterranean area and is related to multiple sensitizations to foods and pollens such as plane tree and mugwort. In these pollen sensitizations, Pru p 3 seems to be the primary sensitizer.
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