Shirley Owusu-Ofori

Predonation screening of blood donors with rapid tests: implementation and efficacy of a novel approach to blood safety in resource-poor settings.

BACKGROUND:  In sub‐Saharan Africa, the percentage of screened blood is limited to approximately 75 percent for human immunodeficiency virus antibodies (anti‐HIV), 50 percent for hepatitis B surface antigen, and 19 percent for hepatitis C virus antibodies (anti‐HCV), mainly because of costs.

Relative safety of first-time volunteer and replacement donors in West Africa.

BACKGROUND: A significantly higher level of safety between nonremunerated volunteer and replacement donor blood is assumed. This is supported by global data without stratifying between genuine replacement and paid donors, for first‐time or repeat volunteer, or according to age.

A pool of repeat blood donors can be generated with little expense to the blood center in sub‐Saharan Africa

BACKGROUND: In sub‐Saharan Africa, most collected blood originates from accessible and cheaper replacement donors while recruiting and retaining volunteers requires considerable costs not all countries can afford. The Kumasi Teaching Hospital Blood Center and a local FM radio station developed a partnership calling three times a year for donation at the radio station where music, entertainment, and token gifts were available.

Effect of Plasmodium inactivation in whole blood on the incidence of blood transfusion-transmitted malaria in endemic regions: the African Investigation of the Mirasol System (AIMS) randomised controlled trial

BACKGROUND Transfusion-transmitted malaria is a frequent but neglected adverse event in Ghana. We did a randomised controlled clinical trial to assess the efficacy and safety of a whole blood pathogen reduction technology at preventing transfusion transmission of Plasmodium spp parasites. METHODS For this randomised, double-blind, parallel-group clinical trial, eligible adult patients (aged ≥ 18 years) with blood group O+, who required up to two whole blood unit transfusions within 3 days of randomisation and were anticipated to remain in hospital for at least 3 consecutive days after initial transfusion, were enrolled from Komfo Anokye Teaching Hospital in Kumasi, Ghana. The main exclusion criteria were symptoms of clinical malaria, antimalaria treatment within 7 days before randomisation, fever, and haemorrhage expected to require transfusion with up to two units of whole blood during the 3 days following study entry. Eligible patients were randomly assigned 1:1 by computer-generated permuted block randomisation (block size four) list to receive transfusion with either pathogen-reduced whole blood (treated) or whole blood prepared and transfused by standard local practice (untreated). Patients, health-care providers, and data collectors were masked to treatment allocation. Patients in both groups received up to two whole blood unit transfusions that were retrospectively tested for parasitaemia. Pre-transfusion and post-transfusion blood samples (taken on days 0, 1, 3, 7, and 28) were tested for presence and amount of parasite genome, and assessed for haematological and biochemical parameters. The primary endpoint was the incidence of transfusion-transmitted malaria in non-parasitaemic recipients exposed to parasitaemic whole blood, defined as two consecutive parasitaemic post-transfusion samples with parasite allelic matching, assessed at 1-7 days after transfusion. Secondary endpoints included haematological parameters and a safety analysis of adverse events in patients. This study is registered with ClinicalTrials.gov, number NCT02118428, and with the Pan African Clinical Trials Registry, number PACTR201406000777310. FINDINGS Between March 12, 2014, and Nov 7, 2014, 227 patients were enrolled into the study, one of whom was subsequently excluded because she did not meet the inclusion criteria. Of the 226 randomised patients, 113 were allocated to receive treated whole blood and 113 to receive standard untreated whole blood. 223 patients (111 treated and 112 untreated) received study-related transfusions, whereas three patients (two treated and one untreated) did not. 214 patients (107 treated and 107 untreated) completed the protocol as planned and comprised the per-protocol population. Overall, 65 non-parasitaemic patients (28 treated and 37 untreated) were exposed to parasitaemic blood. The incidence of transfusion-transmitted malaria was significantly lower for the pathogen-reduced (treated) patients (1 [4%] of 28 patients) than the untreated group (8 [22%] of 37 patients) in this population (p=0.039). Overall, 92 (41%) of 223 patients reported 145 treatment-related emergent adverse events during the conduct of the study, with a similar incidence of adverse events between groups receiving untreated or treated whole blood. No transfusion-related deaths occurred in the trial. INTERPRETATION Treatment of whole blood with the Mirasol pathogen reduction system for whole blood reduced the incidence of transfusion-transmitted malaria. The primary endpoint of the study was achieved in the population of non-parasitaemic patients receiving parasitaemic whole blood. The safety profile and clinical outcomes were similar across the two treatment groups. FUNDING Terumo BCT Inc.

External Financial Aid to Blood Transfusion Services in Sub-Saharan Africa: A Need for Reflection

Jean-Pierre Allain and colleagues argue that, while unintended, the foreign aid provided for blood transfusion services in sub-Saharan Africa has resulted in serious negative outcomes, which requires reflection and rethinking.

Reactivity of genotype-specific recombinant proteins of human erythrovirus b19 with plasmas from areas where genotype 1 or 3 is endemic

ABSTRACT Human erythrovirus (parvovirus) B19 (B19) is a common human pathogen. The recent discovery of three genotypes, 1 to 3, raised issues related to the ability of genotype-specific antigens to cross-react with antibodies elicited by other genotypes. This study assessed antibody capture and immunoglobulin G (IgG) cross-reactivity between genotype 1 and genotype 3 recombinant antigens and analyzed the potential gain of adding VP1 protein to VP2 capsid antigen. Plasma samples from genotype 1- or genotype 3-infected populations were blindly tested with blindly prepared reagents. The IgG reactivity was assessed with baculovirus-expressed VP2 or VP1 and VP2 recombinant genotype 1 or genotype 3 proteins in a standardized enzyme immunoassay (EIA). A high degree of agreement (>95%) between EIA results was observed, with Spearman correlation coefficient and kappa reliability coefficient results of ≥0.95 for samples from the United Kingdom and ≥0.77 for samples from Ghanaian children, respectively. Most discrepant results were related to equivocal reactivity. The addition of VP1 to VP2 capsids did not significantly impact antibody detection. These data suggest that the currently available genotype-1-based IgG EIA is suitable to detect antibody to B19 genotype 3 in Ghanaian children. However, samples from the Ghanaian adult population exhibited atypical results in the assay, possibly due to the high levels of nonspecific IgG antibodies found in adults living in this region. Within these limitations, the study demonstrates that genotype 1 and genotype 3 antigens are equally effective in detecting either antibody species.

Prevalence of persistent and latent viruses in untreated patients infected with HIV-1 from Ghana, West Africa.

Only limited epidemiological data, pertaining to the prevalence of common persistent viruses has been reported in Ghana. This study was conducted to determine the prevalence of persistent viruses in individuals with untreated HIV‐1 infection and uninfected blood donors. Paired plasma and cellular samples from HIV‐negative blood donors, asymptomatic HIV and symptomatic/AIDS cohorts were screened by multiplex PCR then qPCR for parvovirus B19 (B19V), hepatitis B virus (HBV), GB virus‐C (GBV‐C), cytomegalovirus (CMV), Epstein–Barr virus (EBV), human herpesvirus‐8 (HHV‐8) and varicella‐zoster virus (VZV). IgG antibodies specific to each target virus were tested to determine exposure rates. No evidence of viraemia was found for B19V and VZV in any group. Prevalence of GBV‐C plasma viraemia was significantly higher in asymptomatic and symptomatic HIV infection (16.7%) and (16.2%) than in blood donors (4%) P < 0.005. Occult HBV infection was significantly more frequent in symptomatic HIV infection (10.9%) compared to asymptomatic HIV (3.6%) and blood donors (1.6%) P < 0.005. Although there was a high background of EBV viraemia in cellular fractions of blood donors (8.3%), it was significantly higher in asymptomatic (44.6%) and symptomatic HIV (14.6%) P < 0.0001. For CMV, the significantly increased prevalence of viraemia was only observed in the plasma fraction of the symptomatic HIV‐1/AIDS patients (7.6%) compared to asymptomatic individuals (1.8%) and blood donors (0.8%) P ≤ 0.001. The background seroprevalence in blood donors was high for B19V (≥64%), HBV (≥70%), CMV and EBV (≥90%) and was significantly increased in HIV infections for HBV, CMV, VZV (symptomatic HIV), and HHV‐8 (asymptomatic and symptomatic HIV). J. Med. Virol. 81:1860–1868, 2009.

Predonation testing of potential blood donors in resource-restricted settings

Clark and coworkers caution against adopting predonation screening practices lest they be inexpertly applied or delay a move toward nationalized blood transfusion services. Indeed, under the guidance of WHO-led programs, many countries in Sub-Saharan Africa, such as Uganda, have made significant strides toward establishing sustainable volunteer blood donor programs. I cannot help but wonder, however, whether the two programs have to be mutually exclusive. In Fall 2003, I had the honor of serving the CDC in assessing the status of blood transfusion in Tanzania in anticipation of the current administration announcing the PEPFAR (President’s Emergency Package for AIDS Relief) package that includes

Effects of transfusion on human erythrovirus B19-susceptible or -infected pediatric recipients in a genotype 3-endemic area

42 million to help 14 emerging countries establish blood transfusion services. A visit to the public hospital that serves nearly 2 million people in Dar Es Salaam revealed a blood bank that had few units on its shelves, and they were all directed donor units. At present, plans are under way to establish four zonal transfusion centers, which should greatly relieve the dearth of available safe blood. I also had the opportunity to visit a mission hospital in a remote area of Tanzania that had neither electricity nor refrigeration (http://www.iambi.org/). The hospital had implemented rapid screening (Determine HIV-1 and -2, Abbott Laboratories, Abbott Park, IL) and observed that 11 percent of prospective blood donors were HIV-seropositive. It took 15 hours to travel approximately 250 miles from Dar Es Salaam because most of the roads were not paved and many crossed over dry stream beds. In the rainy season, the hospital is inaccessible by any convenient route. Even if the zonal centers were fully stocked in the near future, the needs of the majority of the country’s population would not be addressed, because most citizens live in rural regions. During my travels, I passed many signs for “Money Maker” irrigation pumps, a simple

Fostering repeat donations in Ghana

50 stair-stepper device that allows subsistence farmers to become cash crop farmers. The developers of this technology, ApproTEC, have been so successful that there is a Harvard Business School case study describing their contributions. Simply put, ApproTEC, with its advocacy for providing simple and appropriate technology into the hands of users in resource-limited setting, has had greater and more sustainable impact on the East African economy than many more expensive and well-intentioned international relief programs. By analogy, organizations like PATH (Program for Appropriate Technology in Healthcare), have helped develop extremely sensitive, yet simple, blood screening strips for HIV that approach the sensitivity of Western blot tests, yet do not require refrigeration, extensive training, or other equipment. Because there are parallel needs, I would encourage international aid programs to support both the establishment of national transfusion services and innovative programs, such as those of J.-P. Allain, MD, MBA, and colleagues, that fill a much-needed niche. We should not let the perfect be the enemy of the good. Jed B. Gorlin, MD Memorial Blood Centers Minneapolis, Minnesota 55404 e-mail: jed@mbc.org