Donor Notification Research Articles

Integration of nucleic acid amplification test results into hepatitis C virus supplemental serologic testing algorithms: implications for donor counseling and revision of existing algorithms

The routine use of hepatitis C virus (HCV) nucleic acid amplification testing (NAT) donor screening assays has provided an opportunity for revision of the current HCV supplemental testing algorithm, which requires that recombinant immunoblot assay (RIBA) be performed on every HCV enzyme immunoassay (EIA)-repeat-reactive donation. The FDA has approved variance requests to use a new algorithm that eliminates the need to perform RIBA when HCV NAT results are reactive. Data are provided in support of this new algorithm. HCV EIA (including signal-to-cutoff optical density ratio), RIBA, and NAT data were compiled from 33.2 million donations screened over an approximately 4-year period by the American Red Cross and Blood Systems Laboratories. Further, donations having specific combinations of HCV EIA, RIBA, and minipool (MP) NAT results were evaluated, with more sensitive individual-donation (ID) NAT, to construct improved counseling messages for donors. Of 47,041 EIA-repeat-reactive donations, 49.3 percent were RIBA-positive, 17.1 percent RIBA-indeterminate, and 33.5 percent RIBA-negative. NAT-reactive rates were 79.2, 2.5, and 0.18 percent for RIBA-positive, -indeterminate, and -negative donations, respectively. The new algorithm classified an additional 1 percent of donations as HCV-infected while at the same time detecting all infections classified as HCV-infected under the current algorithm. An additional 2.4 percent of RIBA-positive, MP NAT-nonreactive donations were reactive when a frozen-thawed aliquot was retested by ID NAT. Integrating HCV NAT results with RIBA results for purposes of donor notification allows more appropriate counseling messages to be given to EIA-repeat-reactive donors. The new HCV supplemental algorithm is an acceptable alternative to the current algorithm because it provides equivalent or superior accuracy in formulating donor counseling messages and may also result in reduced costs and more timely notification of infected donors.

Program to Activate the Notification of the Potential Donors

Program to Activate the Notification of the Potential Donors

The donor notification process from the donor's perspective.

Despite large numbers of blood donors being notified of abnormal infectious disease screening results, there has been little scientific study of the effects of this process. With a 28-item questionnaire, an anonymous mail survey was conducted of 4141 blood donors notified of 15 distinct categories of abnormal infectious disease screening and confirmatory test results. The survey had a 42 percent response rate, and 10 percent of the respondents did not recall being notified of their results. Of the 1556 respondents who recalled being notified, 27 percent contacted the blood center for further information, 60 percent discussed their results with a health care provider, and 73 percent of permanently or indefinitely deferred donors correctly understood their deferral status. Confusion and emotional upset were reported in 81 and 75 percent of notified donors, respectively. The notification process appears to achieve most of its aims in the majority of donors. Nevertheless, some donors did not understand that they were ineligible for future donation, and many donors were confused and upset. These data indicate that the adverse impact of notifying donors about abnormal test results needs to be considered when new blood donor screening tests and confirmatory algorithms are being licensed and implemented. Further studies of the effectiveness of newer revised donor notification materials are needed.

Interactions between science, government and media on selection and testing of donors.

The international media attention to "bad blood" has fueled governmental action in countries around the world. Donor selection criteria continue to expand, focusing most recently on the possibility of exclusion due to intranasal cocaine use and, in the US, due to incarceration for more than 72 hours. As newer methods of testing evolve, more deferrals will occur due to improved testing. An emerging area of concern is the non-standardized notification of donors who are ineligible to donate and lack of a centralized listing of such deferred donors. Because of the consequences to recipients, improvements in both donor questioning and testing are necessary. Further studies are needed to understand and improve these processes.

Screening for human immunodeficiency virus type 1 and 2 in a Turkish blood donor population

Objectives: To determine the prevalence of human immunodeficiency virus-1 and -2 infection in voluntary blood donors at a university hospital in the third largest city of Turkey and to evaluate the HIV testing strategy for notifying blood donors. Methods: Between July 1995 and August 1997, 36,373 voluntary blood donors who met the criteria for donating blood were tested for the presence of HIV-1 and -2 antibodies by using an automated enzyme-linked fluorescent immunoassay. Repeatedly reactive samples were subjected to a different enzyme-linked immunosorbent assay (ELISA) and a line immunoassay (LIA) for the detection of antibodies. Results: Of the 36,373 samples tested 72 were found to be repeatedly reactive or borderline by the first screening enzyme immunoassay (EIA). None of the 72 samples was reactive by the second EIA. These samples were further tested by LIA: 64 were negative on the line immunoassay and 8 were indeterminate. Three of eight donors who had indeterminate results by LIA were tested for HIV-1 DNA by polymerase chain reaction (PCR) and were found to be negative. One additional donor with an indeterminate LIA was found to be negative by EIA and LIA during the 6-month follow-up period. Conclusion: Donor questioning, repeat EIA testing, LIA testing, and HIV-1 DNA analysis did not confirm evidence for HIV infection among this blood donor population. Blood donor notification of test results according to the World Health Organization (WHO) strategy III was found to be an appropriate approach.

Hepatitis B surface antigenemia in blood donors following vaccination

Detection of hepatitis B surface antigen (HBsAg) in recently vaccinated adults has not previously been reported. Transient detectable HBsAg has been observed in newborn infants immunized with a recombinant hepatitis B vaccine. Over a 1-year period, eight HBsAg-positive blood donors mentioned during donor notification that they had been vaccinated for hepatitis B virus 1 to 3 days before donation. Follow-up tests for HBsAg, antibodies to HBsAg, and antibodies to hepatitis B core antigen were performed 3 to 37 weeks after immunization. Four months later, a group of 19 donors who were coworkers received hepatitis B vaccination and then donated blood the next day. The coworkers were observed for duration of antigenemia. A total of nine cases of transient, confirmed (neutralizable) antigenemia occurred in healthy individuals who donated blood 1 to 3 days following vaccination with a recombinant hepatitis B vaccine. Follow-up testing showed no evidence of infection by hepatitis B virus. One (5.3%) of 19 blood donors vaccinated as a group had antigenemia at Day 1 but not on Days 2 and 3 following immunization. Individuals recently vaccinated for hepatitis B may test positive for HBsAg and become permanently disqualified as blood donors. Therefore, blood collection centers should consider temporary deferral of potential donors who recently received hepatitis B vaccine.

Blood donor counselling for HIV: Results of amulti-country feasibility study

A qualitative characterisation study was conducted by the World Health Organisation's Global Programme on AIDS, and the International Federation of Red Cross and Red Crescent Societies, in six developing countries in order to determine the feasibility of introducing blood donor counselling into procedures for blood donation at blood transfusion sites. After careful preparation of consultants, in-country visits were made to include structured discussions with key BTS and Red Cross, and national AIDS programme staff, and donors, and observations of relevant facilities. Necessary resources, management requirements, obstacles to and options for blood donor counselling were explicated, together with information on the role of HIV testing in motivating blood donation, and problems associated with this and with donor notification. Blood donor counselling is seen as feasible, provided minimum conditions can be established to ensure appropriate standards and availability of resources.

IMMUNOHEMATOLOGY: Immune Cytopenias and Screening Blood Donors for Immune Response to Infection

One of the most remarkable aspects of screening blood donors for evidence of their immune response to infectious agents is the size and scope of the undertaking. Some 3 million patients a year in America require transfusions, which are provided by about 13 million donations. Against this background, screening in the interests of ensuring transfusion safety for patients also represents a massive public health intervention from the standpoint of notifying and counseling donors about positive test results. For some markers, particularly HBsAg, anti-HIV, and anti-HCV, this is vitally important information. The chronic carrier of hepatitis B can be warned about possible health outcomes and close contacts can be offered vaccination. Many donors found to be truly positive for HIV antibodies were infected unwittingly and otherwise might not have been made aware of their infection. It is possible that similar benefits will accrue in the notification of donors found to be truly positive for antibodies to HCV. Many of these donors also were infected unwittingly. As better understanding of the value of treatment for the HCV-infected patient emerges, particularly with the use of interferon, early treatment of asymptomatic individuals may enable them to escape long-term complications of HCV infection. Although some progress is being made toward the viral inactivation of products for transfusion, particularly clotting factor concentrates, it is highly likely that the mainstay of transfusion safety will continue to be screening donors for markers of infectious disease. As was pointed out earlier, careful consideration must be given to the usefulness of additional donor screening. This is particularly true for rarely transmitted infectious diseases in which screening will result in further attrition of the donor base as a result of nonspecific test results.

Evaluation of a p21e-spiked western blot (immunoblot) in confirming human T-cell lymphotropic virus type I or II infection in volunteer blood donors. The Retrovirus Epidemiology Donor Study Group.

Current algorithms for the serologic confirmation of human T-cell lymphotropic virus type I and II (HTLV-I/II) antibody reactivity are complicated. We evaluated the performance of an HTLV-I Western blot (immunoblot) spiked with recombinant p21e protein (p21e WB) as an alternative to current confirmatory methods. These methods include the HTLV-I viral lysate Western blot and either a radioimmunoprecipitation assay or a p21e enzyme-linked immunosorbent assay. Five hundred fifty nine blood donations obtained from five U.S. blood centers and classified as HTLV-I/II seropositive (n = 149) or seroindeterminate (n = 410) by routine testing methods were further evaluated by PCR for proviral DNA and by the p21e WB. On the basis of serologic and PCR testing, 155 donations were classified as HTLV-I/II infected. The sensitivity of the p21e WB was 97.4%, slightly exceeding that of routine confirmatory testing. The specificity of the p21e WB was 97.5%, as determined by testing of 404 seroindeterminate samples that were negative in the PCR. The positive predictive value of the p21e WB was 94%. In contrast, the specificity and positive predictive value of routine confirmatory testing were both 100%. Follow-up sampling of presumptive p21e WB false-positive donors substantiated the absence of HTLV-I/II infection. Although the p21e WB used in this study has high sensitivity and may be useful as a confirmatory assay in epidemiologic research studies, it may not be ideal as a confirmatory test for the notification of blood donors.

Donor notification and counseling-management of blood donors with positive test results

Donor notification and counseling-management of blood donors with positive test results

ＨＣＶ抗体陽性献血者への通知と追跡調査 （Ｉ）

Recently the notification and a follow-up study on HCV seropositive blood donors were focused from the standpoint of both blood center and its customer.From September, 1990 to September, 1991 the notification of 540 cases (53.4%) out of 1, 011 blood donors (0.89%) with anti-C100-3 reactive result according to the criteria of the notification described in the text and the follow-up study of 198 cases (36.7%) having a medical examination were performed for the first attempt in Japanese Red Cross Blood Centers.The follow-up study over 198 cases along checking with other HCV associated markers, such as anti-GOR, the 2nd-generation agglutination method (PHA), the 2nd-generation recombinant immunoblot assay (RIBA-II) and also with a rutine blood examination gave the following results clearly.1) The results of RIBA-II were good correlated to the findings of blood test and liver function test in contrast to the O. D. values of anti-C100-3 ELISA kit.2) Of them, 88 cases (44.4%) had past history of blood tranfusion and/or operation and 38 cases (19.2%) had family history of liver diseases.3) More than 70% of 198 cases had abnormal findings either on ALT levels, ultra sonography, or ICG retention test. Of them, 74 cases were defined as chronic hepatitis C.4) All of 17 cases who had liver biopsies, demonstrated chronic hepatitis in histology.5) Necessity of the notification and education of blood donors with anti-HCV reactive result was confirmed strictly.

Segmenting blood donors by their perceptions and awareness about blood donation.

A battery of 26 items was used to assess blood donors' perceptions on donor eligibility, blood testing, and notification procedures. An analysis of these items from a mail survey of 392 California blood donors resulted in the identification of four clusters of differing perceptions regarding four aspects of the blood collection process. Three of the four segments identified exhibited moderate to strong degrees of skepticism regarding blood donation. Implications for the continued encouragement and maintenance of donor pools are discussed.

HIV Antibody Screening and Confirmatory Testing of Italian Blood Donors

During the first year (1986) of blood donor screening for antibody to HIV, 201,750 subjects were tested in 40 blood banks of Lombardia (Italy). All sera repeatedly positive by ELISA were submitted to our reference center for confirmation by Western blot (WB). Only 40 (0.02%) of 286 repeatedly reactive donors were positive by WB, whereas another 45 (0.022%) gave atypical antibody reactivities on WB, mainly directed against HIV core proteins. Of the 16 donors with inconclusive WB results followed for 4-12 months, 3 developed a full-blown antibody response, 5 maintained the anti-core reactivity throughout the follow-up period, and 8 lost all reactivities. The use of recombinant env and core antigen ELlSAs seems to decrease the proportion of sera with inconclusive WB reactions, and to identify as true positive all seroconverting donors in advance of the WB test. The large majority (35 out of 40) of WB-positive donors and all seroconverters for antibody to HIV admitted to belong to a group at risk for AIDS. Among the 19 first-time donors with HIV infection, we found 3 subjects with serological evidence of LAV-2 infection. We describe also the diagnostic and ethical issues when a donor notification policy is based on WB confirmatory procedures.

Anti-HTLV III ELISA and Western Blot Testing in a Blood Donor Population: Implications for Donor Notification

We have evaluated the western blot (WB) test for distinguishing anti-HTLV III ELISA-positive donors who have likely been exposed to HTLV III from those that are false positives. Of 1,955 donors, 26 were positive for anti-HTLV III by ELISA testing. Only 6 (23%) were positive by WB: 5 of these 6 were male homosexuals with multiple partners and 5 of 6 had low Th/Ts ratios. The WB-positive donors gave the highest absorbance values in the anti-HTLV III ELISA assay. The immunologic abnormalities in the WB-positive donors suggest that they should be notified of their test results. We conclude that basing a donor notification policy on WB results is the optimum public health strategy for blood banks at the present time.

Screening Blood: Public Health and Medical Uncertainty

Use of the human T-lymphotropic virus type III (HTLV-III) antibody screening test for reducing the risk of contracting acquired immunodeficiency syndrome (AIDS) through blood transfusion has raised ethical issues regarding notification and confidentiality. It has also raised longterm questions about mass screening mandatory reporting of positive results to public health officials behavioral change and public health interventions under conditions of medical uncertainty. Initially blood banks resisted mandatory notification of antibody-positive donors on the grounds that it established a clinical relationship between donor and blood bank and also might encourage people to come to blood centers solely to get their tests results. Now that other agencies have had time to set up alternative sites for HTLV-III antibody testing blood banks will begin to inform people about their positive antibody status. Names of seropositive individuals will be kept in the American Red Cross confidential national deferral registry. Those who test positive on a single test only will not be notified and their names will not be entered in the national registry but their names will be kept in a local registry and subsequent donations will be discarded. A troubling question concerns whether to notify past recipients of blood from donors who are now seropositive. Most blood banks have adopted a policy of not notifying such recipients since it is not known whether the donor had antibodies at the time of the index donation. Because of the psychological trauma associated with notification blood centers and alternative test sites plan to offer counseling to seropositive persons. More compelling evidence of a public health threat than presently exists will be required to justify mass screening of all those at risk of contracting or spreading AIDS. Such testing would threaten the civil liberties of the persons tested.

Technique d'hémagglutination passive inverse appliquée à la détection de l'antigène HBs

In this report we present an evaluation of the sensitivity, specificity and ability to detect HBs Ag carriers of a new reversed passive hemagglutination test, using immunochemically purified chimpanzee anti HBs bound to stabilized human erythrocytes. The method was shown to have a sensitivity equal (within one two fold dilution) to that of the Ausria I 125 ratio immuno assay, and in a double blind comparison detected essentially the same number of Hbs Ag containing specimens among volunteer blood donors. The method therefore provides an economical method for the third generation testing of blood donors. The methodology which has been described incorporates a definitive specificity test in which serum drawn before and after immunization of chimpanzees with purified HBs Ag is compared for its ability to neutralize the hemagglutination reaction. The use of serum from the same animal for this purpose avoids the theoretical possibility that antiglobulin antibodies directed at subclass determinants such as Gm of Inv could be differentially inhibited due to possible subclass differences in the blocking sera employed. A reliable test for specificity of HBs Ag screening results is essential to avoid false notification of donors that they are carriers of hepatitis B virus.