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- W2890721848 abstract "The skin prick test (SPT) has been used as a primary diagnostic tool to detect type I hypersensitivity reactions in individual patients or to screen for atopy in epidemiologic studies.1Heinzerling L.M. Burbach G.J. Edenharter G. Bachert C. Bindslev-Jensen C. Bonini S. et al.GA(2)LEN skin test study I: GA(2)LEN harmonization of skin prick testing: novel sensitization patterns for inhalant allergens in Europe.Allergy. 2009; 64: 1498-1506Crossref PubMed Scopus (285) Google Scholar Studies comparing the SPT to in vitro test systems such as ImmunoCap and total serum IgE have shown that the SPT has the best positive predictive value and the best efficiency to diagnose respiratory atopic diseases.2Tschopp J.M. Sistek D. Schindler C. Leuenberger P. Perruchoud A.P. Wuthrich B. et al.Current allergic asthma and rhinitis: diagnostic efficiency of three commonly used atopic markers (IgE, skin prick tests, and Phadiatop). Results from 8329 randomized adults from the SAPALDIA Study. Swiss Study on Air Pollution and Lung Diseases in Adults.Allergy. 1998; 53: 608-613Crossref PubMed Scopus (135) Google Scholar Furthermore, the SPT gives immediate information for both patients and physicians. Although it is the major diagnostic test for type I immediate hypersensitivity worldwide, such as for allergic rhinitis, asthma, and occupational and food allergy, further developments concerning standardization and ease of application are needed.3Fatteh S. Rekkerth D.J. Hadley J.A. Skin prick/puncture testing in North America: a call for standards and consistency.Allergy Asthma Clin Immunol. 2014; 10: 44Crossref PubMed Scopus (36) Google Scholar, 4Heinzerling L. Mari A. Bergmann K.C. Bresciani M. Burbach G. Darsow U. et al.The skin prick test – European standards.Clin Transl Allergy. 2013; 3: 3Crossref PubMed Scopus (484) Google Scholar A new device, the Skin Prick Test Tape (SPT Tape), could provide a convenient, sterile, and standardized application for both patients and doctors. The SPT Tape is used once only and then discarded. SPT Tapes can be adapted in size and number of allergens; they can hold from 2 up to possibly 8 allergens and 2 control solutions (on both forearms), which can be selected per region, country, or group of allergens (inhalant, food allergens). Furthermore, if preferred, the SPT Tape can be filled by the physician with allergens for individual patient use. Advantages and disadvantages of the SPT Tape versus the SPT are listed in Table I.Table IAdvantages and disadvantages of the SPT Tape vs SPTAdvantages and disadvantagesSPT TapeSPTAdvantages•Sterility of the allergens, 1-time use•Standardization of the allergen panel (international/national standards)•Uniformity of skin penetration depth•No need for keeping patients' arms horizontally fixed•Ease of application for the personnel•Sealed testing chamber, no cross- contamination between allergens•No appearance of needles, ideal for children•Nearly no pain (micro-needles)•Clear labeling of allergens•Currently used by most MDs worldwide•Flexibility, large number of allergens available•Relatively inexpensiveDisadvantages•Costs may be higher than those for conventional SPT•Removal of SPT Tape may be unpleasant in patients with hairy forearms•Not suitable for patients with severe skin disease or those taking certain drugs such as antihistamines and β-blockers•May cause pain for some patients•Unintentional (interindividual) variations described•Requires stock of allergens•Sterility may be at risk when testing many patients with allergen solutions from the same vial•Risk of cross-contamination during the performance of the test•Not suitable for patients with severe skin disease or those taking certain drugs such as antihistamines and β-blockers Open table in a new tab The SPT Tape (international patent application PCT/EP2015/069283) has been designed to facilitate the performance of SPTs in everyday allergy diagnosis. It consists of an aluminum base foil coated with high-density polyethylene, aluminum, and polyamide, which carries 10 chambers, each holding a fleece (polymer) in a ring and 3 micro-needles (2 mm apart from each other). The adhesive tape consists of a double-sided paste layer to bond the cover foil and the base foil to each other, separating the chambers from each other. The SPT Tape tested here consists of 4 small chambers for 1 allergen (100 μL 10 histamine equivalent potency solution of Dermatophagoides pteronyssinus; Soluprick, ALK, Horsholm, Denmark) and 2 control solutions (saline and histamine 10 mg/mL); 1 chamber was left blank. The SPT Tape, using adhesive for medical purposes, was fixed to the forearm; chambers are activated one by one by applying pressure with the finger (for illustration, see Fig 1, A), pushing the allergen-contaminated needles 0.8 to 1 mm into the skin. The middle part of the SPT Tape is removed after 5 minutes; side strips identifying the allergen and solutions are kept in place until wheals are read after 15 minutes (Fig 1, B). To evaluate the bioequivalence of the SPT Tape in comparison with the conventional SPT, and to compare safety and comfort of both procedures, we enrolled 144 subjects (62% women, 38% men, mean age, 34.6 ± 12.5 years), including 72 subjects with and 72 subjects without house dust mite allergy, as evaluated by symptoms and previous allergy test results (specifically, specific IgE to house dust mite [Unicap system, Thermo Fisher Scientific Inc, Uppsala, Sweden] or SPT). In all subjects, the conventional SPT was done on the left forearm according to current guidelines,4Heinzerling L. Mari A. Bergmann K.C. Bresciani M. Burbach G. Darsow U. et al.The skin prick test – European standards.Clin Transl Allergy. 2013; 3: 3Crossref PubMed Scopus (484) Google Scholar, 5Position Statement. Allergy skin testing. Board of Directors. American Academy of Allergy and Immunology.J Allergy Clin Immunol. 1993; 92: 636-637Abstract Full Text PDF PubMed Scopus (56) Google Scholar and the SPT Tape was placed on the right forearm. Subjects were included from 2 allergy centers: The First Affiliated Hospital of Guiyang Medical College and the Medical University Affiliated Hospital of Guizhou, China. The Ethics committees of the 2 hospitals approved this study. All subjects met the inclusion criteria, voluntarily agreed to participate, and signed the informed consent. Patients taking antihistamines or other drugs interfering with the testing were excluded from the study. The SPT Tape loaded with allergens was kept at 2°C to 8°C. The conventional SPT was performed in parallel on the same subject. After marking the place of testing for each solution with a pen on the skin, a drop each of identical positive and negative solutions as well as of the D pteronyssinus allergen extract was applied to the skin of the left forearm. With the help of a single-head metal lancet per drop (ALK), the skin was pricked through each drop, and test results were interpreted 15 minutes after application. A positive SPT or SPT Tape result was defined as a wheal of greater than or equal to 3 mm longest diameter for both methods.6Konstantinou G.N. Bousquet P.J. Zuberbier T. Papadopoulos N.G. The longest wheal diameter is the optimal measurement for the evaluation of skin prick tests.Int Arch Allergy Immunol. 2010; 151: 343-345Crossref PubMed Scopus (45) Google Scholar All tests were readable and could be evaluated. All histamine SPT results were positive; all saline test results were negative and not different from the blanks. The concordance of results for the allergen (D pteronyssinus), calculated as the sum of positive and negative observations in agreement between the 2 methods, was 100%. The wheal diameter of the histamine reaction was about 1 mm larger with the SPT Tape (7.4 ± 1.7 mm) compared with that with the conventional SPT (6.3 ± 1.5 mm; P < .01; Fig 2). There were no significant differences in the wheal diameters for the saline (0.4 ± 0.6 vs 0.3 ± 0.7 mm; P > .05) or the house dust mite reactions (3.6 ± 3.5 vs 3.8 ± 4.1 mm; P > .05). The SPT Tape induced significantly less pain (visual analog scale [VAS] score) than the conventional SPT (0.0 [0.0-2.0] vs 2.0 [0.0-4.0]; P < .00); 98% of all subjects and 99% of the investigators preferred the SPT Tape over the conventional SPT. Adverse events were not recorded for both techniques; local tolerability was very good. The SPT uses the presence and the degree of cutaneous reactivity to an allergen as a surrogate marker for the degree of sensitization within target organs,7Bousquet J. Lebel B. Dhivert H. Bataille Y. Martinot B. Michel F.B. Nasal challenge with pollen grains, skin-prick tests and specific IgE in patients with grass pollen allergy.Clin Allergy. 1987; 17: 529-536Crossref PubMed Scopus (68) Google Scholar that is, nose, eyes, gut, and lung. More than 20 different allergens can be tested in parallel using both forearms, rendering the SPT a cheap, easy-to-handle, and rapid diagnostic tool. However, cross-contamination between allergens during application and testing has been noted. Repeatability of the SPT is dependent on the individual investigator, and different investigators will induce skin reactions of different sizes.8Malling H.J. Allesen-Holm P. Karved L.S. Poulsen L.K. Proficiency testing of skin prick testers as part of a quality assurance system.Clin Transl Allergy. 2016; 21: 36Crossref Scopus (6) Google Scholar And finally, sterility may be at risk when testing many patients with allergen solutions from the same vial. The SPT Tape overcomes critical points of the conventional SPT by standardizing the application procedure, easing the reading of results (by the side strips), avoiding cross-contamination by separating allergens in different chambers, guaranteeing sterility, and finally easing the handling of the SPT for the patient, who remains free in moving around, and the physician, sparing personnel (as he or she can apply the test himself or herself within short time), room (patient can return to waiting area), and finally costs. Especially children, not any more exposed to visible needles and pain sensations, may appreciate this SPT Tape system. We here have shown that the SPT Tape delivered bioequivalent results to the conventional SPT for the diagnosis of house dust mite allergen sensitization. The SPT Tape was significantly less painful and clearly preferred over the conventional SPT by nearly all patients. Further tests with various allergens should be performed to establish the possible role of the SPT Tape in daily allergy practice." @default.
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- W2890721848 title "Comparison of a new Skin Prick Test Tape with the conventional skin prick test" @default.
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