dmcanzi@watserv1.waterloo.edu (David Canzi) (12/12/90)
Medical News for November 5, 1990 to November 13, 1990
Copyright 1990: USA Today/Gannett National Information Network
Reproduced with Permission
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Nov. 5, 1990
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Center for Disease Control Reports
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Morbidity and Mortality Weekly Report
Friday November 23, 1990
Current Trends
Surveillance for HIV-2 Infection in Blood Donors --
United States, 1987-1989
In collaboration with CDC, blood collection agencies are conducting
ongoing surveillance for human immunodeficiency virus type 2 (HIV-2) infection
among U.S. blood donors. Through December 1989, no blood donors with HIV-2
infection had been detected. This report summarizes findings of recent HIV-2
surveillance by the American Red Cross Blood Services (ARCBS) and the New York
Blood Center (NYBC).
To examine the potential for HIV-2 infection in blood supplies, the ARCBS
and the NYBC tested stored frozen serum (collected from January 1987 to
December 1989) that had previously tested repeatedly reactive by the HIV-1
enzyme immunoassay (EIA) (serum from persons with HIV-2 infection often cross-
reacts with HIV-1 EIA (1,2)). The ARCBS tested 24,826 samples (approximately
95% of all specimens at the ARCBS that tested repeatedly reactive by the HIV-1
EIA). Of these, 93% were identified from routine HIV-1 screening of
approximately 18 million regular, directed (i.e., recipient specifies donor),
and autologous blood donations from all ARCBS collection facilities; 7% were
identified from testing of nondonor samples referred for HIV-1 confirmatory
testing. The NYBC tested 3314 specimens that were repeatedly reactive by the
HIV-1 EIA and indeterminate by HIV-1 Western blot. These samples were
identified from approximately 2 million donations.
The ARCBS and the NYBC screened donors with the licensed Abbott* (North
Chicago, Illinois) and Dupont/Biotech (Wilmington, Delaware) whole-virus
lysate HIV-1 EIAs, respectively. Serum samples repeatedly reactive by HIV-1
EIA were tested with a whole-virus lysate HIV-2 EIA (Genetic Systems, Seattle,
Washington) that was recently licensed by the Food and Drug Administration
(FDA). Of the 24,826 ARCBS samples, 2426 (9.8%) were also repeatedly reactive
by the HIV-2 EIA (Table 1). Of these, 86% were HIV-1 positive by Western blot
at the time of initial donor screening. Of the 3314 NYBC samples, 48 (1.5%)
had repeatedly reactive HIV-2 EIA results.
Twenty-six blinded HIV-2-positive control specimens**, 141 HIV-1 EIA-
negative control specimens, and 2415 specimens from ARCBS and NYBC that tested
repeatedly reactive by the HIV-2 EIA were sent to CDC for further testing with
investigational HIV-1 and HIV-2 EIA peptide assays (Genetic Systems, Seattle,
Washington). (An additional 59 specimens from ARCBS and NYBC had insufficient
quantity of serum for further testing.) Specimens with positive HIV-2 peptide-
assay results were also tested by an investigational whole-virus lysate HIV-2
Western blot (Genetic Systems, Seattle, Washington). Specimens with positive
HIV-1 and HIV-2 peptide results were also tested with an HIV-1 Western blot
(Dupont/Biotech, Wilmington, Delaware) at CDC.
A specimen was considered to have HIV-2 antibody if the HIV-2 Western blot
result was reactive by World Health Organization criteria (3). No blood-donor
specimens had HIV-2 antibody.
Reported by: CT Fang, PhD, AE Williams, PhD, Jerome H Holland Laboratory,
American National Red Cross, Rockville, Maryland. MCJ Rios, C Bianco, New York
Blood Center, New York City. Div of HIV/AIDS, Center for Infectious Diseases,
CDC.
Editorial Note: ARCBS accounts for greater than or equal to 50% of the blood
donations in the United States (4). Sixty percent to 90% of serum samples from
persons with HIV-2 infection are reactive by the Abbott whole-virus lysate
HIV-1 EIA (1,2), which is used for donor screening by the ARCBS. Therefore, by
testing blood donations that were repeatedly reactive by the HIV-1 EIA
(approximately 0.13% of greater than 18 million), the ARCBS study would have
detected greater than or equal to 60% of donations potentially containing HIV-
2 antibody. However, among approximately 18 million ARCBS donations, no blood
donors with HIV-2 infection were detected.
A previously reported study from San Francisco that used a similar
methodology for 942 donor samples reactive by the HIV-1 EIA also failed to
identify donors seropositive for HIV-2 antibody (5). Although the San
Francisco study and the study reported here may have failed to detect persons
with HIV-2 infection whose serum samples did not cross-react on the HIV-1 EIA,
these findings suggest that from 1987 through 1989. HIV-2 infection in U.S.
blood donors was extremely rare. In a previous study of 8503 blood donors
randomly selected from three areas of the United States in 1988, no donors
with HIV-2 infection were detected (6).
Eighteen persons with HIV-2 infection in the United States have been
reported to CDC. All of the 15 for whom historical information is available
had recently immigrated from West Africa, had sexual contact with West
Africans, or had traveled to West Africa. One person was a volunteer blood
donor (7) who was born in the United States and had traveled to West Africa;
she donated blood in 1986 before the HIV-2 surveillance project began. Because
she had a reactive HIV-1 EIA, her blood was not transfused.
Based on the low prevalence of HIV-2 in the United States and the failure
to detect HIV-2 infections in large blood-donor surveys, routine HIV-2 donor
screening with HIV-2-specific assays from 1987 through 1989 would have
detected few, if any, additional donations from persons infected with HIV-2.
For these reasons, the Blood Products Advisory Committee of the FDA has
recommended and the FDA has determined that routine HIV-2 screening of blood
and plasma donated for use in transfusion is not necessary (8). (Moreover,
recent immigrants from West Africa or persons who are sexual contacts of West
Africans have been requested to defer from donating blood (9).) FDA will
reevaluate and update the recommendations for donor deferral and screening of
blood donors for HIV-2 based on additional surveillance reports and new
technologic developments, such as licensed combination tests for the detection
of antibodies to both HIV-1 and HIV-2. CDC and collaborating blood collection
agencies will continue surveillance for HIV-2 in U.S. blood donors and other
selected populations.
References
1. George JR, Rayfield MA, Phillips S, et al. Efficacies of U.S. Food and Drug
Administration-licensed HIV-1-screening enzyme immunoassays for detecting
antibodies to HIV-2. AIDS 1990;4:321-6.
2. Schumacher RT, Howard J, Ayres L, Pista A, Avillez F, Garrett P. Cross-
reactivity of anti-HIV-2 positive serum in U.S. FDA licensed screening tests
for anti-HIV-1 (Abstract). VI International Conference on AIDS. Vol 3. San
Francisco, June 20-24, 1990:245.
3. World Health Organization. Recommendations for the interpretation of HIV-2
Western blot results. Wkly Epidemiol Rec 1990;65:69-76.
4. Petersen LR, Dodd R, Dondero TJ. Methodologic approaches to surveillance of
HIV infection among blood donors. Public Health Rep 1990;105:153-7.
5. Busch MP, Petersen LR, Schable C, Perkins HA. Monitoring blood donors for
HIV-2 infection by testing anti-HIV-1 reactive sera. Transfusion 1990;30:184-
7.
6. CDC. AIDS due to HIV-2 infection--New Jersey. MMWR 1988;37:33-5.
7. O'Brien TR, Schable CA, Polon C, et al. HIV-2 infections in the United
States (Abstract). VI International Conference on AIDS. Vol 2. San Francisco,
June 20-24, 1990:245.
8. Parkman PD. Use of Genetic Systems HIV-2 EIA (Memorandum to all registered
blood establishments). Bethesda, Maryland: Food and Drug Administration,
Center for Biologics Evaluation and Research, 1990.
9. Parkman PD. Recommendations for the prevention of human immunodeficiency
virus (HIV) transmission by blood and blood products (Memorandum to all
registered blood establishments). Bethesda, Maryland: Food and Drug
Administration, Center for Biologics Evaluation and Research, 1990.
* Use of trade names is for identification only and does not imply endorsement
by the Public Health Service, the U.S. Department of Health and Human
Services, the American National Red Cross, or the New York Blood Center.
** As determined by all of the following: 1) either a nonreactive or weakly
reactive HIV-1 peptide EIA, 2) a strongly reactive HIV-2 peptide EIA, 3) a
reactive HIV-2 Western blot, and 4) an indeterminate HIV-1 Western blot.
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Volume 3, Number 36 December 5, 1990
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Editor: David Dodell, D.M.D.
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David Canzi