Now FDA-approved for use on patients as young as 6 years old! Reference Manual truetest.com 800.878.3837 l © 1988 -2018 SmartPractice • All rights reserved. SmartPractice, T.R.U.E. TEST and associated logos are registered trademarks of SmartHealth, Inc. This manual is furnished with T.R.U.E. TEST® (Allergen Patch Test) purchased by a licensed medical professional, and may be used or copied as needed in accordance with patient care. In all other cases, this manual may not be duplicated or reproduced in any printed or digital media for distribution or sale without the written consent of the publisher SmartPractice. TT69010P 82310_0118 © 2018 SmartPractice • All rights reserved. SmartPractice, T.R.U.E. TEST and associated logos are registered trademarks of SmartHealth, Inc. Table of Contents Physician Manual Disclaimer........................................................................................................................................................v T.R.U.E. TEST (Allergen Patch Test) Shipping and Handling .....................................................................................................vi Introduction Contact Dermatitis is Common and Costly ................................................................................................................................1.1 Allergic or Irritant Contact Dermatitis? .......................................................................................................................................1.1 Why Patch Test? ............................................................................................................................................................................1.2 T.R.U.E. TEST (Allergen Patch Test) Features and Benefits .......................................................................................................1.3 T.R.U.E TEST Case Presentations ................................................................................................................................................1.5 T.R.U.E. TEST Quick Reference Guide ........................................................................................................................................ 2.1 Clinical Indications and Contraindications Indications for Use ........................................................................................................................................................................3.1 Contraindications .........................................................................................................................................................................3.2 Precautions ....................................................................................................................................................................................3.2 Warnings ........................................................................................................................................................................................3.4 Potential Adverse Events .............................................................................................................................................................3.5 Application of T.R.U.E. TEST Pretest Considerations .................................................................................................................................................................4.1 Patient History Including Allergies and Exposures ....................................................................................................................4.2 T.R.U.E. TEST Panel Application ..................................................................................................................................................4.3 Patient History and Data Forms Patient Dermatology and Allergy History Form .........................................................................................................................5.1 T.R.U.E. TEST Standard Data Collection Form ...........................................................................................................................5.4 Interpretation of T.R.U.E. TEST Results Interpreting and Recording Reactions to T.R.U.E. TEST Allergens ..........................................................................................6.1 Differential Diagnosis - Positive Reactions .................................................................................................................................6.3 Diagnostic Path for Positive Reactions .......................................................................................................................................6.5 Differential Diagnosis - Negative Reactions ...............................................................................................................................6.6 Diagnostic Path for Negative Reactions .....................................................................................................................................6.8 Differential Diagnosis - Doubtful or Minimal Reactions ............................................................................................................6.9 Diagnostic Path for Doubtful or Minimal Reactions ..................................................................................................................6.9 Differential Diagnosis - Irritant Reactions ...................................................................................................................................6.10 iii 800.878.3837 l truetest.com Allergen Components in T.R.U.E. TEST (Physician Information) Chart of Common Sources ..........................................................................................................................................................7.1 Allergen Information: Panel 1.3 Panel 2.3 Panel 3.3 1. Nickel Sulfate ............................................ 7.3 13. p-tert-Butylphenol Formaldehyde Resin 7.11 25. Diazolidinyl Urea ..................................... 7.19 2. Wool Alcohols ........................................... 7.3 14. Epoxy Resin ............................................. 7.11 26. Quinoline Mix ......................................... 7.19 3. Neomycin Sulfate ..................................... 7.4 15. Carba Mix ................................................ 7.12 27. Tixocortol-21-Pivalate ............................ 7.20 4. Potassium Dichromate ............................. 7.4 16. Black Rubber Mix ................................... 7.13 27. Gold Sodium Thiosulfate ....................... 7.21 5. Caine Mix… .............................................. 7.5 17. Cl+ Me- Isothiazolinone ........................ 7.13 29. Imidazolidinyl Urea ................................. 7.21 6. Fragrance Mix ........................................... 7.5 18. Quaternium-15 ....................................... 7.14 30. Budesonide ............................................. 7.22 7. Colophony................................................. 7.7 19. Methyldibromo Glutaronitrile. .............. 7.15 31. Hydrocortisone-17-Butyrate .................. 7.22 8. Paraben Mix .............................................. 7.7 20. p-Phenylenediamine .............................. 7.15 32. Mercaptobenzothiazole ......................... 7.23 9. Negative Control ...................................... 7.8 21. Formaldehyde ........................................ 7.16 33. Bacitracin ................................................. 7.23 10. Balsam of Peru .......................................... 7.9 22. Mercapto Mix .......................................... 7.16 34. Parthenolide ............................................ 7.24 11. Ethylenediamine Dihydrochloride ........ 7.10 23. Thimerosal ............................................... 7.17 35. Disperse Blue 106 ................................... 7.24 12. Cobalt Dichloride ................................... 7.10 24. Thiuram Mix ............................................ 7.18 36. 2-Bromo-2-Nitropropane-1,3-Diol ........ 7.25 Patch composition .......................................................................................................................................................................7.2 Patch Test Coding and Reimbursement Guide Coding for Evaluation and Management (E/M) Services ..........................................................................................................8.1 Patch Test Coding ........................................................................................................................................................................8.2 Patch Test Reimbursement ..........................................................................................................................................................8.2 Claim Denials and Appeals .........................................................................................................................................................8.3 Patient Information about T.R.U.E. TEST and Contact Allergens Questions and Answers about T.R.U.E. TEST .............................................................................................................................9.1 Reading Labels to Identify Allergens ..........................................................................................................................................9.3 A Negative Test Result .................................................................................................................................................................9.4