AIDS Testing
Gerald Schochetman J. Richard George Editors AIDS Testing A Comprehensive Guide to Technical, Medical, Social, Legal, and Management Issues Second Edition Foreword by Walter R. Dowdle With 59 Illustrations Springer Science+Business Media, LLC
Gerald Schochetman, Ph.D. Chief Laboratory Investigations Branch Division of HIV / AIDS National Center for Infectious Diseases Centers for Disease Control and Prevention Atlanta, GA 30333 USA J. Richard George, Ph.D. Chief Developmental Technology Section Laboratory Investigations Branch Division of HIV / AIDS National Center for Infectious Diseases Centers for Disease Control and Prevention Atlanta, GA 30333 USA Library of Congress Cataloging-in-Publication Data AIDS testing: a comprehensive guide to technical, medical, social, legal, and management issues 1 [edited by] G. Schochetman, J.R. George.-2nd ed. p. cm. Includes bibliographical references and index. ISBN 978-1-4612-6927-4 ISBN 978-1-4612-0867-9 (ebook) DOI 10.1007/978-1-4612-0867-9 1. AIDS (Disease)-Diagnosis. 2. Medical screening. 1. Schochetman, Gerald. II. George, J. Richard. [DNLM: 1. Acquired Immunodeficiency Syndrome-diagnosis. 2. HIV Infections-diagnosis. 3. Diagnosis, Laboratory, 4. Ethics, Medical. WD 308 A288468 1994] RC607.A26A3591994 616.97'92075-dc20 DNLM/DLC for Library of Congress 94-7986 CIP Printed on acid-free paper. 1994, 1992 Springer Seience+Business Media New York Originally published by Springer-VerJagNew York, me. in 1994 Softcover reprint of the hardeover 2nd edition 1994 Ali rights reserved. This work may not be translated or eopied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC), exeept for brief excerpts in conneetion with reviews or seholarly analysis. Use in conneetion with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or' dissimilar methodology now known or hereafter developed is forbidden. The use of general descriptive names, trade names, trademarks, etc. in this publication, even if the former are not espeeially identified, is not to be taken as a sign that sueh names, as understood by the Trade Marks and Merchandise Marks Act, may accordingly be used freely by anyone. Further, the use of trade names is for identifieation only and does not constitute endorsement by the Public Health Service or the U.S. Department of Health and Human Services. While the advice and information in this book are believed to be true and accurate at the date of going to press, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Produetion coordinated by Chernow Editorial Serviees, Ine., and managed by Theresa Komak; manufacturing supervised by Gail Simon. Typeset by Best-set Typesetter Ltd., Hong Kong. 987 6 5 4 3 2 1 ISBN 978-1-4612-6927-4
Foreword During the two years since the publication of the first edition of this book, the global spread of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) has continued. HIV was estimated by the World Health Organization (WHO) in 1993 to have infected at least 13 million individuals worldwide, with 1 million infected in the United States. HIV/AIDS in the United States has become the leading cause of death among men 25 to 44 years of age and the fifth leading cause of death among women of the same age group. Prevention of HIV infection remains a global challenge. Testing for HIV is the cornerstone for surveillance and prevention programs and for the provision of appropriate medical care for those who are infected. Such testing is equally essential to the search for effective antivirus drugs and vaccines. This second edition of AIDS Testing incorporates the most current thinking on test methodology and interpretation, some of which has changed considerably over the past two years. This edition also has been expanded to include a section consisting of six chapters on test applications and a section consisting of four chapters on management issues. This edition, like the first, describes in clear terms all the complex elements of testing, including applications, scientific principles, quality assurance, safety, and medical, ethical, and legal considerations. For laboratory workers and epidemiologists involved in surveillance and prevention, this book provides a framework for program direction and quality data. For health care providers who must understand and apply testing for detection, counseling, and caring of HIV-infected persons, this book provides a comprehensive overview of the spectrum of issues related to HIV testing. Tests are discussed in terms of the information they provide and the application of that information for the benefit of the patient. For persons involved in HIV/AIDS research and for all laboratory workers this book serves as a handy reference for the design and safe implementation of quality HIV tests. Since the first edition, notable advances have been made in the use of the polymerase chain reaction (PCR) in a variety of research and clinical settings. The chapter on nucleic acid amplification techniques (e.g., PCR) in this edition reflects these more recent demonstrations of test utility. v
vi Foreword Like per, other laboratory tests for HIV/AIDS and associated host responses will continue to evolve as our knowledge expands and new applications are required. In whatever direction test technology may evolve, the basic scientific principles described in this book for performance of HIV I AIDS tests of high sensitivity, specificity, and quality will remain. Walter R. Dowdle Deputy Director Centers for Disease Control and Prevention
Contents Foreword by Walter R. Dowdle Contributors v xi Part 1. Introduction 1. Testing for Human Retrovirus Infections: Medical Indications and Ethical Considerations 1 John W. Ward 2. Biology of Human Immunodeficiency Viruses 15 Gerald Schochetman 3. Immunology of HIV Infection 32 Alison C. Mawle and J. Steven McDougal Part 2. Laboratory Issues of Testing 4. FDA Regulation of HIV-Related Tests and Procedures Jay S. Epstein 5. Detection of HIV Infection Using Serologic Techniques J. Richard George and Gerald Schochetman 6. Quality Control for HIV Testing Bruce J. McCreedy and J. Richard George 7. HIV Culture Mark A. Rayfield 8. Direct Detection of HIV Infection Using Nucleic Amplification Techniques Gerald Schochetman and John J. Sninsky 9. Use of Flow Cytometry to Enumerate Lymphocyte Populations in HIV Disease Janet K.A. Nicholson and Alan L. Landay 10. Prognostic Indicators for Progression of HIV Disease C. Robert Horsburgh Jr. 52 62 103 129 141 170 196 VII
VIII Contents 11. Testing for Other Human Retroviruses: HTLV-I and HTLV-II 206 Rima F. Khabbaz, Walid Heneine, and Jonathan E. Kaplan Part 3. Applications 12. HIV Testing in Blood Banks 224 Michael P. Busch 13. HIV Testing for Organ and Tissue Transplantation 237 R.J. Simonds 14. Programs for Routine, Voluntary HIV Counseling and Testing of Patients in Acute-Care Hospitals 245 Robert S. Janssen and Elizabeth A. Bolyard 15. HIV Testing for Life Insurance 252 Nancy J. Haley and Barry S. Reed 16. HIV Infection in Children 266 Martha F. Rogers and Gerald Schochetman 17. Molecular Epidemiology of AIDS 284 Barbara II. Bowman and Thomas J. White Part 4. Psychosocial and Legal Issues 18. HIV Counseling and Testing: What Is It and How Well Does It Work? 302 Lynda S. Doll and Meaghan B. Kennedy 19. Legal Aspects of AIDS: The Chasm Between Public Health Practices and Societal Norms 320 Ann N. James 20. HIV Education in the Workplace 328 Fred Kroger and Priscilla Holman Part 5. Management Issues 21. Standards of Laboratory Practice for HIV Testing 337 Thomas L. Hearn 22. HIV Biosafety: Guidelines and Regulations 346 Jonathan Y. Richmond 23. Management of Occupational Exposure to HIV 361 Denise M. Cardo, Kenneth G. Castro, Jacquelyn A. Polder, and David M. Bell
Contents ix 24. Preventing HIV Transmission in Health Care Settings 376 Carol A. Ciesielski and David M. Bell Glossary 391 Index 399
Contributors David M. Bell, M.D., Hospital Infections Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA Elizabeth A. Bolyard, R.N., M.P.H., Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Barbara H. Bowman, Ph. D., Roche Molecular Systems Inc., Alameda, CA 94501, USA Michael P. Busch, M.D., University of California, San Francisco, and Department of Scientific Services, Irwin Memorial Blood Center, San Francisco, CA 94118, USA Denise M. Cardo, M.D., Hospital Infections Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Kenneth G. Castro, M.D., Division of Tuberculosis Elimination, National Center for Prevention Services, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Carol A. Ciesielski, M.D., Surveillance Branch, Division of HIV/AIDS, Centers for Disease Control and Prevention, Lynda S. Doll, Ph.D., Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA Jay S. Epstein, M.D., FDA ICBERIOBRR, Office of Blood Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA XI
xii Contributors J. Richard George, Ph. D., Chief, Developmental Technology Section, Laboratory Investigations Branch, Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Nancy 1. Haley, Ph.D., Director, Insurance Testing Laboratory, Metropolitan Life Insurance Company, Elmsford, NY 10523, USA Thomas L. Hearn, M.S., Public Health Program Practice Office, Centers for Disease Control and Prevention, Walid Heneine, Ph. D., Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Priscilla Holman, National AIDS Information and Education Program, Centers for Disease Control and Prevention, C. Robert Horsburgh, Jr. M.D., Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Ann N. James, Ph.D., J.D., lenkens & Gilchrist, Houston, TX 77002, USA Robert S. Janssen, M.D., Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Jonathan E. Kaplan, M.D., Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Aleaghan B. Kennedy, M.P.H., Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Rima F. Khabbaz, M.D., Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Fred Kroger, Director, National AIDS Information and Education Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
Contributors xiii Alan L. Landay, Ph.D., Director of Clinical Immunology, Office of Consolidated Laboratory Services, Rush-Presbyterian St. Luke's Medical Center, Chicago, IL 60612, USA Alison C. Mawle, Ph.D., Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Bruce f. McCreedy, Ph.D., CMB Division, Roche Biomedical Laboratories, Research Triangle, NC 27709, USA J. Steven McDougal, M.D., Chief, Immunology Branch, Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Janet K.A. Nicholson, Ph.D., Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Jacquelyn A. Polder, B.S.N., M.P.H., Hospital Infections Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Mark A. Rayfield, Ph.D., Laboratory Investigations Branch, Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Barry S. Reed, M. D., J.D., Medical Department, Metropolitan Life Insurance Company, New York, NY 10010, USA Jonathan Y. Richmond, Ph. D., Director, Office of Health and Safety, Centers for Disease Control and Prevention, Martha F. Rogers, M.D., Chief, Epidemiology Branch, Division of HI VI AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Gerald Schochetman, Ph.D., Chief, Laboratory Investigations Branch, Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, R.J. Simonds, M.D., Epidemiology Branch, Division of liiv/aids, National Center for Infectious Diseases, Centers for Disease Control and Prevention,
xiv Contributors John J. Sninsky, Ph.D., Roche Molecular Systems, Inc., Alameda, CA 94501, USA John W. Ward, M.D., Chief, Surveillance Branch, Division of HIV/ AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Thomas J. White, Ph. D., Vice President, Roche Molecular Systems, Inc., Alameda, CA 94501, USA