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Infectious Disease Testing for Blood TransfusionsNIH Consensus Development Panel on Infectious Disease Testing for Blood Transfusions
NIH;
Jane F. Desforges, MD;
Freydoon Athari, MD;
E. Shannon Cooper, MD, JD;
Cage S. Johnson, MD;
Stanley M. Lemon, MD;
Karen L. Lindsay, MD;
Jeffrey McCullough, MD;
Kenneth McIntosh, MD;
Robert K. Ross, MD;
Carolyn F. Whitsett, MD;
Janet Wittes, PhD;
Teresa L. Wright, MD;
Harvey J. Alter, MD;
Miriam J. Alter;
Morris A. Blajchman, MD, FRCPC;
Michael P. Busch, MD, PhD;
Ritchard G. Cable, MD;
Roger Y. Dodd, PhD;
Jay S. Epstein, MD;
S. Victor Feinman, MD, BSc (Med), FRCPC;
Raymond Gambino, MD;
Ronald O. Gilcher, MD;
Guillermo A. Herrera, MD;
Paul V. Holland, MD;
F. Blaine Hollinger, MD;
Harold S. Kaplan, MD;
Eve M. Lackritz, MD;
James W. Mosley, MD;
Kenrad E. Nelson, MD;
Lyle R. Petersen, MD, MPH;
Mark A. Popovsky, MD;
Leonard B. Seeff, MD;
Ira A. Shulman, MD;
Cladd Stevens, MD;
Gary E. Tegtmeier, PhD;
Paul R. McCurdy, MD;
Luiz H. Barbosa, DVM;
Robin M. Biswas, MD;
Jane F. Desforges, MD;
Roger Y. Dodd, PhD;
Jerry M. Elliott;
John H. Ferguson, MD;
William H. Hall;
Indira K. Hewlett, PhD;
Paul V. Holland, MD;
Leslye D. Johnson, PhD;
Harvey G. Klein, MD;
George J. Nemo, PhD;
Elaine M. Sloand, MD;
Ellen K. Sommer;
John H. Ferguson, MD;
Claude Lenfant, MD;
Harvey G. Klein, MD;
Anthony S. Fauci, MD
JAMA. 1995;274(17):1374-1379.
Abstract
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Objective.
—To provide physicians and other transfusion medicine professionals with a current consensus on infectious disease testing for blood transfusions.
Participants.
—A nonfederal, nonadvocate, 12-member consensus panel representing the fields of hematology, infectious disease, transfusion medicine, epidemiology, and biostatistics and a public representative. In addition, 23 experts in hematology, cardiology, transfusion medicine, infectious disease, and epidemiology presented data to the consensus panel and a conference audience of 450.
Evidence.
—The literature was searched through MEDLINE and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience.
Consensus.
—The panel, answering predefined consensus questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature.
Consensus Statement.
—The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference.
Conclusions.
—The serum alanine aminotransferase test should be discontinued as a surrogate marker for blood donors likely to transmit posttransfusion non-A, non-B hepatitis infection since specific hepatitis C antibody testing has eliminated more than 85% of these cases. Antibody to hepatitis B core antigen testing should continue as it may prevent some cases of posttransfusion hepatitis B; it may also act as a surrogate marker for human immunodeficiency virus (HIV) infection in donors and may prevent a small number of cases of transfusion-transmitted HIV infection. Syphilis testing should continue until adequate data can determine its effect on the rarity of transfusion-transmitted syphilis. Vigilant public health surveillance is critical in responding to emerging infectious disease threats to the blood supply.
(JAMA. 1995;274:1374-1379)
Author Affiliations
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Panel and Conference Chairperson, Distinguished Professor of Medicine Emerita, Division of Hematology/Oncology, Department of Medicine, New England Medical Center, Boston, Mass; Medical Director, Blood Bank and Donor Services, Department of Pathology, Fairfax Hospital, Falls Church, Va; Laboratory Director, Ochsner Transplant Center, New Orleans, La; Professor of Medicine, Division of Hematology, Department of Medicine, University of Southern California School of Medicine, Los Angeles; Professor and Associate Chairman for Research, Department of Medicine, University of North Carolina, Chapel Hill; Associate Professor of Clinical Medicine, Division of Gastrointestinal and Liver Diseases, Department of Medicine, University of Southern California, Los Angeles; Professor and Associate Chief, Clinical Affairs, Department of Laboratory Medicine and Pathology, Director, Division of Laboratory Medicine and Section of Transfusion Medicine, University of Minnesota Hospital, Minneapolis; Professor of Pediatrics, Harvard Medical School, Chief, Division of Infectious Diseases, Children's Hospital, Boston, Mass; Director, Department of Health Services, San Diego, Calif; Associate Professor, Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Ga; President, Statistics Collaborative, Inc, Washington, DC; Associate Professor of Medicine, University of California, San Francisco. Speakers; "Alanine Aminotransferase and HBcAb as Surrogate Tests for Hepatitis C Transmissibility"; "Residual Risk of Transfusion-Associated Hepatitis" and "ALT and Hepatitis C"; "A Multicenter Randomized Trial to Evaluate the Impact of the Non-A, Non-B Surrogate Tests (ALT and Anti-HBc) Before and After Anti-HCV Testing"; "Incidence of Infectious Disease Markers in Blood Donors: Implications for Residual Risk of Viral Transmission by Transfusion" and "Relationship Between Antibody to Hepatitis B Core Antigen (anti-HBc) and Retrovirus Infections Among Volunteer Blood Donors"; "Value of Testing for Syphilis in Blood Donors"; "Preventing Transfusion-Transmitted Chagas' Disease: The American Red Cross Approach"; "Food and Drug Administration Approach to Testing"; "Posttransfusion Transaminitis Seronegative for Hepatitis A, B, and C: Is There Yet Another Posttransfusion Viral Hepatitis?"; "Overview of Testing Blood for Markers of Infectious Disease"; "Using Alanine Aminotransferase Testing More Effectively"; "Syphilis as a Surrogate Marker for HIV, Hepatitis B Virus, and Hepatitis C Virus"; "The Effect of Indirect Markers of Infectious Diseases on Blood Transfusion Safety: Overview"; "PCR-Based Analysis of Sera From Patients With Negative Tests for HCV Antibodies and Abnormal ALT, Hepatitis B Core Antibody, or Both"; "Human Error: More Tests at What Risk?"; "Residual Risk of Transfusion-Associated HIV Transmission"; "Indirect Tests for Transfusion-Transmitted Diseases" and "Recipient Outcomes Associated With Donors Screened by ALT and Anti-HBc Assays: The Transfusion-Transmitted Viruses Study"; "Incident Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Infections in Transfused Cardiac Surgery Patients: Infection Rates During Different Methods of Donor Screening"; "Comparing Surrogate Lifestyle Tests and HIV p24 Antigen Testing With Regard to Transfusion Safety"; "Alanine Aminotransferase Test to Predict Hepatitis C Virus Seroconversion"; "Long-Term Hepatitis Morbidity and Mortality"; "Preventing Transfusion-Transmitted Chagas' Disease: The Los Angeles County/University of Southern California Experience"; "HIV and Hepatitis: Compared and Contrasted"; "Antibodies to Hepatitis B Core Antigen As a Surrogate Test for Hepatitis C or a Specific Test for Occult Hepatitis B Infection in Blood Donors."; Chairperson, Chief, Bone Marrow Transplantation Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md; Deputy Chief, Transfusion Medicine Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md; Chief, Laboratory of Hepatitis, Division of Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md; Panel and Conference Chairperson, Distinguished Professor of Medicine Emerita, Division of Hematology/Oncology, Department of Medicine, New England Medical Center, Boston, Mass; Head, Transmissible Diseases Department, Holland Laboratory, American Red Cross, Rockville, Md; Program Analyst, Office of Medical Applications of Research, National Institutes of Health, Bethesda, Md; Director, Office of Medical Applications of Research, National Institutes of Health, Bethesda, Md; Director of Communications, Office of Medical Applications of Research, National Institutes of Health, Bethesda, Md; Laboratory Chief, Division of Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Md; Clinical Professor of Medicine, Division of Hematology/Oncology, University of California at Davis Medical Center, Medical Director/Chief Executive Officer, Sacramento (Calif) Medical Foundation Blood Center; Chief, Enteric Diseases Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md; Chief, Department of Transfusion Medicine, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Md; Chief, Transfusion Medicine Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md; Special Assistant to the Director, AIDS Coordinator, Office of the Director, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md; Public Affairs Specialist, Communications and Public Information Branch, Office of Prevention, Education, and Control, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md.; Director; National Heart, Lung, and Blood Institute, National Institutes of Health; Chief; National Institute of Allergy and Infectious Diseases, National Institutes of Health
Footnotes
NIH Consensus Development Conferences are convened to evaluate available scientific information and resolve safety and efficacy issues related to a biomedical technology. The resultant NIH Consensus Statements are intended to advance understanding of the technology or issue in question and to be useful to health professionals and the public.
NIH Consensus Statements are prepared by a non-advocate, nonfederal panel of experts, based on (1) presentations by investigators working in areas relevant to the consensus questions during a 2-day public session, (2) questions and statements from conference attendees during open discussion periods that are part of the public session, and (3) closed deliberations by the panel during the remainder of the second day and morning of the third day. This statement is an independent report of the panel and is not a policy statement of the NIH or the federal government.
Preparation and distribution of this statement is the responsibility of the Office of Medical Applications of Research of the National Institutes of Health. Free copies of this statement and bibliographies prepared by the National Library of Medicine are available from the Office of Medical Applications of Research, Federal Bldg, Room 618, National Institutes of Health, 7550 Wisconsin Ave MSC 9120, Bethesda, MD 20892 (William H. Hall) or the NIH Consensus Program Information Service by 24-hour voice mail at (800) NIH-OMAR (644-6627). Full-text versions of all these statements are also available on-line through the NIH Information Center Bulletin Board System at (800) NIH-BBS1 (644-2271) and through the Internet using gopher (gopher://gopher.nih.gov/Health and Clinical Information), file transfer protocol (ftp://public.nlm.nih.gov/hstat/nihcdcs), or the World Wide Web (http:// text.nlm.nih.gov/nih/nih.html).
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