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GUIDELINESGUIDELINES FORFOR THETHE DIAGNOSISDIAGNOSIS OFOF LATENTLATENT TUBERCULOSISTUBERCULOSIS INFECTIONINFECTION inin thethe 21st21st CenturyCentury CME Certified Monograph 2nd Edition PO Box 1709 • 225 Warren Street • Newark, NJ 07101-1709 GUIDELINES FOR THE DIAGNOSIS OF LATENT TUBERCULOSIS INFECTION IN THE 21st CENTURY CONTINUING EDUCATION CERTIFIED MONOGRAPH Sponsored by the University of Medicine & Dentistry of New Jersey (UMDNJ), and the New Jersey Medical School Global Tuberculosis Institute Original Release Date: June 2002 • Activity Update: April 1, 2008 • Expiration Date: March 31, 2010 Nursing credit for this activity will be provided through March 31, 2010 This activity is supported by educational grants from Monarch Pharmaceuticals for the first edition release and JHP Pharmaceuticals for the release of the second edition. TARGET AUDIENCE This activity is designed for internists, pediatricians, pulmonologists, infectious disease specialists, public health and preventive medicine specialists, nurses, and other health personnel interested or involved in tuberculosis diagnosis, treatment and prevention of tuberculosis and latent tuberculosis infection. LEARNING OBJECTIVES Upon the completion of this activity, participants should be able to: I Describe the role of tuberculin testing in low prevalence countries I Review how tuberculins are developed, manufactured and validated I Recognize minor disparities in commercially available tuberculins and the necessity of serial testing with the same antigen I Explain the protocol for administering and reading tuberculin skin tests I Correctly interpret repeated tuberculin skin tests I Examine the role of tuberculin reactions produced by cross reactions with non-tuberculous mycobacteria I Differentiate the use of interferon-γ release assays when compared to tuberculin skin testing I Discuss the role of the nurse in the diagnosis of latent TB infection METHOD OF INSTRUCTION Participants should read the learning objectives and the activity in its entirety. After reviewing the material, complete the post-test consisting of a series of multiple-choice questions. Upon completing this activity as designed and achieving a passing score 70% or more on the post-test, participants will receive a continuing education credit letter and test answer key four weeks after receipt of the registration and evaluation materials. Estimated time to complete this activity as designed is 3.5 hours. c1 ACCREDITATION Physicians: UMDNJ–Center for Continuing and Outreach Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing education for physicians. UMDNJ–Center for Continuing and Outreach Education designates this educational activity for a maximum of 3.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity. Nurses: UMDNJ–Center for Continuing and Outreach Education is an approved provider of continuing nursing education by NJSNA, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. This activity is awarded 3.5 contact hours (60 minute CH). Provider approved by the California Board of Registered Nursing, Provider Number CEP 13780. This activity was peer-reviewed for relevance, accuracy of content and balance of presentation by Lee B. Reichman, MD, MPH and Rajita Bhavaraju, MPH; and pilot-tested for time required for participation by Anju Budhwani, MD, Henry S. Fraimow, MD, DJ McCabe, RN, MSN, and Lillian Pirog, RN, PNP. DISCLOSURE In accordance with the disclosure policies of UMDNJ and to conform with ACCME and FDA guidelines, individuals in a position to control the content of this education activity are required to disclose to the activity participants: 1) the existence of any financial interest or other relationships with propriety entities producing health care goods and services, with the exemption of non-profit or government organizations and non-health care related companies, within the past 12 months; and 2) the identification of a commercial product/device that is unlabeled for use or an investigational use of a product/device not yet approved. The faculty and editors listed below have declared that they have no significant financial relationships or affiliations to disclosure: John-Manuel Andriote, MS Kitty Lambregts, MD, PhD, MPH Rajita Bhavaraju, MPH Alfred Lardizabal, MD George Comstock, MD, DrPH Richard Menzies, MD, MSc Karen Galanowsky, RN, MPH Sheldon L. Morris, PhD Elsa Villarino, MD, MPH Lee B. Reichman, MD, MPH is a consultant for and shareholder of Cellestis, Inc. The pilot-testers listed below have declared that they have no significant financial relationships or affiliations to disclosure: Anju Budhwani, MD DJ McCabe, RN, MSN Henry S. Fraimow, MD Lillian Pirog, RN, PNP OFF-LABEL USAGE DISCLOSURE This publication contains information about the test, T-SPOT.TB, which has not been approved by the U.S. Food and Drug Administration for the detection of M. tuberculosis as of the date of this publication. DISCLAIMER The views expressed in this publication are those of the faculty. It should not be inferred or assumed that they are expressing the views of Monarch and JHP Pharmaceuticals, any other manufacturer of pharmaceuticals, or UMDNJ. The drug selection and dosage information provided in this publication are believed to be accurate. However, the reader is urged to consult the full prescribing information on any drug mentioned in this publication for recommended dosage, indications, contraindications, warnings, precautions, and adverse effects before prescribing any medication. This is particularly important when a drug is new or infrequently prescribed. Copyright © 2008 UMDNJ-Center for Continuing and Outreach Education. All rights reserved including translation into other languages. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval systems, without permission in writing from UMDNJ-Center for Continuing and Outreach Education. To review UMDNJ’s privacy policy: http://ccoe.umdnj.edu/general/privacypolicy.html. Please direct continuing education related questions to UMDNJ at 800-227-4852 or email [email protected]. –––––––––––––––––––––– This activity is accessible via Internet Explorer and Netscape browsers. A high speed connection is highly recommended. You must have Adobe Acrobat Reader version 4 or above installed on your computer to view PDF files. If you do not have Acrobat Reader, you can download it for free at Adobe.com. Page composition and typography by Williams Production Group, Annandale, Virginia. GUIDELINES FOR THE DIAGNOSIS OF LATENT TUBERCULOSIS INFECTION in the 21st Century Continuing Education Certified Monograph 2nd Edition Edited by Lee B. Reichman, MD, MPH John-Manuel Andriote, MS (First Edition) Rajita Bhavaraju, MPH (Second Edition) GUIDELINES FOR THE DIAGNOSIS OF LATENT TUBERCULOSIS INFECTION IN THE 21st CENTURY Introduction Lee B. Reichman, M.D., M.P.H. Relevance of the Tuberculin Test in Low-Prevalence Countries Kitty Lambregts, M.D., Ph.D, M.P.H. Developing a Clinical Tuberculin Test: Tuberculin Characteristics, Reactivity and Potency Sheldon L. Morris, Ph.D. Randomized Clinical Trials of Specificities of Commercially Available Tuberculins Elsa Villarino, M.D., M.P.H. Administering and Reading Tuberculin Skin Tests; Interpreting Repeated Tuberculin Skin Tests Richard Menzies, M.D., M.Sc. Tuberculin Sensitivity Produced by Mycobacteria Other than the Mycobacterium Tuberculosis Complex George Comstock, M.D., Dr.P.H. Interferon-γ Release Assay for Detection of Tuberculosis Infection Alfred Lardizabal, M.D. The Role of the Nurse in Diagnosing Latent TB Infection Karen Galanowsky, R.N., M.P.H. A special symposium was held in Miami Beach, Florida. It was chaired by Lee B. Reichman, M.D., M.P.H., and the faculty featured six distinguished authorities on the diagnosis of latent tuberculosis infection. This monograph presents suggested guidelines that emerged from the meeting, which are intended for the practicing clinician, and emphasize the administration and interpretation of tuberculin tests as part of the diagnosis and treatment of latent tuberculosis infection. The symposium and monograph was supported by an unrestricted educational grant from Monarch Pharmaceuticals. Due to unprecedented interest, authors were asked to revise and update chapters for a second edition, which was supported by an unrestricted educational grant from JHP Pharmaceuticals. John-Manuel Andriote was the technical editor of the original monograph. Rajita Bhavaraju revised the 2nd edition. SUGGESTED CITATION To Cite the Entire Monograph Reichman LB, Bhavaraju R, eds.Guidelines for the Diagnosis of Latent Tuberculosis Infection in the 21st Century, 2nd Edition. Newark: New Jersey Medical School Global Tuberculosis Institute, 2008. To Cite a Specific Chapter Menzies R. Interpreting Repeated Tuberculin Skin Tests. pages 38-46. in Reichman LB, Bhavaraju R, eds: Guidelines for the Diagnosis of Latent Tuberculosis Infection in the 21st Century, 2nd Edition. Newark: New Jersey Medical School Global Tuberculosis Institute, 2008. Dedication to George Comstock, M.D., Dr.P.H. George Comstock, M.D., Dr.P.H. passed away on July 15, 2007 after a long illness. We were particularly gratified that even though quite ill, Dr. Comstock saw fit to bring his chapter, “Tuberculin Sensitivity
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