Table Of ContentAIDS 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. J. Richard George, Ph.D.
Chief Chief
Laboratory Investigations Branch Developmental Technology Section
Division of HIV/ AIDS Laboratory Investigations Branch
National Center for Infectious Diseases Division of HIV/ AIDS
Centers for Disease Control and National Center for Infectious Diseases
Prevention Centers for Disease Control and
Atlanta, GA 30333 Prevention
USA 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
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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 applica
tions and a section consisting of four chapters on management issues.
This edition, like the first, describes in clear terms all the complex ele
ments 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 infor
mation 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 perfor
mance 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 v
Contributors 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 52
Jay S. Epstein
5. Detection of HIV Infection Using Serologic Techniques 62
J. Richard George and Gerald Schochetman
6. Quality Control for HIV Testing 103
Bruce J. McCreedy and J. Richard George
7. HIV Culture 129
Mark A. Rayfield
8. Direct Detection of HIV Infection Using Nucleic
Amplification Techniques 141
Gerald Schochetman and John J. Sninsky
9. Use of Flow Cytometry to Enumerate Lymphocyte
Populations in HIV Disease 170
Janet K.A. Nicholson and Alan L. Landay
10. Prognostic Indicators for Progression of HIV Disease 196
C. Robert Horsburgh Jr.
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 Preven
tion, Atlanta, GA 30333, USA
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,
Atlanta, GA 30333, USA
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, Atlanta, GA 30333, USA
Carol A. Ciesielski, M.D., Surveillance Branch, Division of HIV/AIDS,
Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
Lynda S. Doll, Ph.D., Division of HIV/AIDS, National Center for In
fectious 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 Preven
tion, Atlanta, GA 30333, USA
Nancy 1. Haley, Ph.D., Director, Insurance Testing Laboratory, Metro
politan Life Insurance Company, Elmsford, NY 10523, USA
Thomas L. Hearn, M.S., Public Health Program Practice Office, Centers
for Disease Control and Prevention, Atlanta, GA 30333, USA
Walid Heneine, Ph. D., Division of Viral and Rickettsial Diseases,
National Center for Infectious Diseases, Centers for Disease Control and
Prevention, Atlanta, GA 30333, USA
Priscilla Holman, National AIDS Information and Education Program,
Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
C. Robert Horsburgh, Jr. M.D., Division of HIV/AIDS, National Center
for Infectious Diseases, Centers for Disease Control and Prevention,
Atlanta, GA 30333, USA
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,
Atlanta, GA 30333, USA
Jonathan E. Kaplan, M.D., Division of HIV/AIDS, National Center
for Infectious Diseases, Centers for Disease Control and Prevention,
Atlanta, GA 30333, USA
Aleaghan B. Kennedy, M.P.H., Division of HIV/AIDS, National Center
for Infectious Diseases, Centers for Disease Control and Prevention,
Atlanta, GA 30333, USA
Rima F. Khabbaz, M.D., Division of Viral and Rickettsial Diseases,
National Center for Infectious Diseases, Centers for Disease Control and
Prevention, Atlanta, GA 30333, USA
Fred Kroger, Director, National AIDS Information and Education
Program, Centers for Disease Control and Prevention, Atlanta, GA
30333, USA
