Patch Test Products & Reference Manual 2018 7 Patch Test Products & Reference Manual 2018 DISTRIBUTOR MB Diagnostics AB Chemotechnique ©2017 Chemotechnique MB Diagnostics AB ©2017 Chemotechnique MB Diagnostics rev 20171128 Chemotechnique MB Diagnostics AB Modemgatan 9 | SE-235 39 | Vellinge | Sweden Tel +46 40 466 077 | www.chemotechnique.se President’s message With 2017 coming to an end, I look back at the past year with a sense of fulfillment. I reflect on the challenges overcome, the accomplishments achieved and the advancements made in the field of contact allergy. Entering 2018, our full hapten range is registered as pharmaceuticals in Canada following a lengthy regulatory process. The approved registration, the first in history, is a testament to the superior quality of the Chemotechnique products. This accomplishment has been achieved through the tireless work performed by our laboratory staff and from our North American distributor Dormer Laboratories and their consultants. I take this opportunity to extend my appreciation not only to the people involved but to all people fighting to overcome varying regulatory hurdles that are being imposed onto Patch Testing around the world, thereby limiting its beneficial expansion. The notion that an increasing number of patients previously undiagnosed are now experiencing an enhanced quality of life through the diagnosis of contact allergy assures me that Patch Testing remains as relevant as ever before, and I am of the firm belief that Patch Testing is, and will continue to be, a procedure worth fighting for. Always at your service, Bo Niklasson CEO and President Chemotechnique MB Diagnostics AB 1 The Chemotechnique crew at the ESCD in Manchester 2016 Patch Test Products authorized by the ICDRG Distributed Worldwide Production: Chemotechnique MB Diagnostics AB Printing: Exakta 2017 Revised: November 2017 © 2017 Chemotechnique MB Diagnostics AB Chemotechnique MB Diagnostics AB Modemgatan 9 | SE-235 39 | Vellinge Sweden | Tel +46 40 466 077 www.chemotechnique.se 2 Table of Contents Table of Contents President’s message ......................................................................1 Chemotechnique ............................................................................4 Contact Allergy ..............................................................................6 Patch Test Products .......................................................................8 • IQ Ultra™ ..........................................................................10 • IQ Ultimate™ ................................................................... .11 • Patch Test Accessories ...................................................12 • Spot Tests .........................................................................13 • Patch Test Haptens ..........................................................14 • Hapten Series ............................................................16 • International Baseline Series ............................17 • International Screening Series ..........................17 Patch Test Instructions ................................................................21 Featured topics .............................................................................24 Clinical information ......................................................................26 FAQ ................................................................................................32 Compostion of International Baseline Series ..............................33 Compostion of International Screening Series .........................53 List of Haptens ..............................................................................78 Hapten Information .....................................................................103 Catalogue amendments .............................................................210 • Catalogue amendments January 2018 .........................213 3 Chemotechnique the Trusted name in Patch Testing Chemotechnique - The trusted name in Patch Testing Chemotechnique MB Diagnostic AB (“Chemotechnique”) has provided Patch Test solutions since 1981 and is proudly recognized as the Trusted name in Patch Testing. Chemotechnique is a Sweden based company with global reach through world-wide distribution. Research and Development With emphasis on R&D and working in close cooperation with contact dermatitis research groups such as the International Contact Dermatitis Research Group (ICDRG), the European Environmental and Contact Dermatitis Research Group (EECDRG) and the North American Contact Dermatitis Group (NACDG), Chemotechnique ensures an ideally composed product line-up. Highest quality products Chemotechnique offers a complete range of high quality Patch Test Products including Patch Test Haptens, Patch Test Units as well as Patch Test Accessories and Spot Tests. Our haptens are produced in Sweden under strict pharmaceutical control following the GMP quality management system audited by the Swedish Medical Products Agency. Certified by the ISO 13485 and ISO 9001 Quality Management systems the Chemotechnique high quality products and reliable service will aid you in the diagnosis of contact allergy in your patients. Online resources Visit the continually updated www.chemotechnique.se website to access the Chemotechnique online resources including an extensive Hapten Database, patch testing Video Instructions, Patch test record forms, Patient information sheets and much more. Create a free account today! 4 the Trusted name in Patch Testing Countries (in blue) in which Chemotechnique offers local distribution www.chemotechnique.se for both desktop and mobile 5 Contact Allergy 1 out of 10 is sensitized to nickel Contact Allergy & Allergic Contact Dermatitis (ACD) Contact Allergy is the result of specific immune responses caused by antigens. Unlike allergens (such as pollens and animal proteins) causing other forms of allergy, the culprits of Contact Allergies, haptens, are not antigens by themselves. Haptens (typically small, chemically reactive molecules with low molecular weight) need to penetrate the horny layer of the skin in order to conjugate to epidermal and dermal proteins forming “hapten-carrier complexes” with antigenic properties capable of causing contact allergy. Examples of widely recognized haptens include nickel, formaldehyde and other preservatives in cosmetics. Allergen Contact allergy is the state of being sensitized to a hapten. Sensitization to Stratum a hapten occurs when the accumulated corneum exposure to the hapten surpasses a Hapten certain threshold. This threshold is individual and varies greatly, some will develop an allergy the first time encountering the hapten while others withstand a life time of exposure without becoming sensitized. The median prevalence of contact allergy to at least one hapten is around 25% in the general population. Allergic Contact Dermatitis (ACD) is a disease of the skin that can emerge in people that are exposed to specific haptens after having developed contact allergy to them. Once allergic, the subject might respond with skin inflammation (redness, flaking skin or blisters) whenever exposed. Individuals handling haptens as part of their 6 Contact Allergy Introduction profession run a higher risk of developing ACD. ACD accounts for 20% of all reported work related skin diseases. Occupational fields with high occurrences of ACD include (but are not limited to) hairdressing, construction work, cleaning and health care. Chronic once developed, and with no known cure, contact allergy is of major distress for those affected. Diagnosis While contact allergy cannot be treated it can be diagnosed; by Patch Testing and not by Skin Allergy Testing (such as skin prick testing - used for the diagnosis of, for instance, respiratory allergies). Knowing what hapten is causing the allergic reactions helps the patient stay clear of that specific hapten, avoiding ACD and thereby effectively improving the quality of life for the individual. The indication for Patch Testing is to test all patients in whom contact allergy is suspected or needs to be ruled out, regardless of age or anatomical site of dermatitis. Chemotechnique provides all tools required to perform patch tests the IQ way - the gold standard for diagnosing contact allergy. In order to perform a diagnostic Patch Test, two crucial components are required; Patch Test Haptens and Patch Test Units. Patch Test Haptens The hapten preparations used in patch testing should ideally be specifically developed for patch testing purposes. The Patch Test Haptens manufactured by Chemotechnique are standardized and prepared by mixing high purity fine particle ground raw material with high purity grade white petrolatum using state of the art technology. Patch Test Units To ensure that the hapten remains in direct contact with the skin for the time required (48h) to create a standardized controlled reaction, a Patch Test Unit is needed. A Patch Test Unit is composed of sets of chambers mounted on an adhesive tape. The purpose of the patch test chambers is to provide a defined areai in which the skin will be exposed to the haptens during the testing. 7 Patch Test Products IQ Chamber with hapten IQ Patch Test Chambers The Inert Quadrate (IQ) chambers are the most technologically advanced patch test chambers ever developed. The laminated tape/foam/filter paper construction results in a comfortable chamber providing a unique closed-cell and leak-free system which defines a test area. The quadrate shape allows