Baseline assessment findings of the Africa Society for Blood Transfusion Step-Wise Accreditation Programme in 10 sub-Saharan African countries, 2016-2018.

BACKGROUND AND OBJECTIVES: The accreditation of blood services promotes continuous quality improvement in blood and transfusion services. The Africa Society for Blood Transfusion (AfSBT) conducted 20 baseline assessments of National Blood Transfusion Services (NBTS) or blood banks as part of the Step-Wise Accreditation Programme (SWAP) in 10 sub-Saharan African (SSA) countries from 2016 to 2018. This paper aims to elucidate the process and findings of the baseline assessments. MATERIALS AND METHODS: This is a descriptive study of 20 baseline assessments of NBTS. Eleven sections of the AfSBT assessment were reviewed, and 48 out of 68 standards and 356 out of 466 criteria were assessed. Each standard was assigned a value of 1 if it was fully achieved, 0.5 if partially achieved and 0 if not achieved. We defined average section scores >75% as having 'met AfSBT Standards', ≤25% as not meeting standards, 26%-50% as needs major improvement, and 51%-75% as needs some improvement and >75% as meets standards. RESULTS: The AfSBT SWAP standards were met in 4 out of the 11 sections: donor management, blood collection, component production and compatibility testing. Three sections were determined to need some improvement (quality system; handling, transport and storage and testing of donated blood), and three sections were determined to need major improvement (haemovigilance, blood administration and national blood service accreditation). One section (receipt, ordering, and issuing of blood) did not meet standards. CONCLUSION: Despite improvements in the quality of blood services in SSA over the past two decades, governments may consider the importance of prioritizing investments in NBTS, ensuring these institutions meet international accreditation standards that are aligned with safe blood transfusion services.

New HIV infections from blood transfusions averted in 28 countries supported by PEPFAR blood safety programs, 2004-2015.

BACKGROUND: To quantify the impact of the US President's Emergency Plan for AIDS Relief (PEPFAR) on the risk of HIV transmission through infected blood donations in countries supported by PEPFAR blood safety programs. METHODS: Data reported to the World Health Organization Global Database on Blood Safety were analyzed from 28 countries in sub-Saharan Africa (SSA), Asia, and the Caribbean during 2004-2015. We used the Goals model of Spectrum Spectrum System Software, version 5.53, to perform the modeling, assuming laboratory quality for HIV testing had 91.9% sensitivity and 97.7% specificity irrespective of testing method based on results of two external quality assurance and proficiency testing studies of transfusion screening for HIV in SSA blood centers. We calculated the number of new HIV infections from the number of transfusions and the prevalence of HIV infection acquired from blood transfusions with infected blood donations. We determined the impact of laboratory testing programs by estimating the number of new HIV infections averted since PEPFAR implementation. RESULTS: Assuming that HIV testing would not be performed in any of these countries without PEPFAR funding, the number of new HIV infections acquired from blood transfusions averted by laboratory testing increased over time in all 28 countries. The total number of HIV infections averted was estimated at 229 278 out of 20 428 373 blood transfusions during 2004-2015. CONCLUSION: Our mathematical modeling suggests a positive impact achieved over 12 years of PEPFAR support for blood safety. Standardized HIV testing of donated blood has reduced the risk of HIV transmission through blood transfusions in SSA, Asia, and the Caribbean.

Evaluation of the WHO global database on blood safety.

OBJECTIVE: While the Global Database on Blood Safety (GDBS) helps to monitor the status of adequate and safe blood availability, its presence alone does not serve as a solution to existing challenges. The objective of this evaluation was to determine the GDBS usefulness in improving the availability of adequate safe blood and its ability to function as a surveillance system. METHODS: The GDBS was evaluated using methods set out by the Centers for Disease Control and Prevention (CDC) Guidelines for assessing surveillance systems. Six recommended tasks were used to evaluate if the GDBS met the requirements of a surveillance system in a public health context. RESULTS: The majority of stakeholders engaged with GDBS found it was unique and useful. The GDBS answered all six questions essential for determining a blood safety surveillance system's usefulness. The GDBS fully met the needs to six of the eleven attributes used for evaluating the usefulness of a surveillance system. CONCLUSION: The GDBS is a unique global activity that provides vital data on safety of blood transfusion services across countries and regions. However, aspects of the GDBS such as timeliness of reporting and improvement of WHO Member States national blood information systems could enhance its effectiveness and potential to serve as a global surveillance system for blood safety.

Sex Differences in HIV Testing - 20 PEPFAR-Supported Sub-Saharan African Countries, 2019.

Despite progress toward controlling the human immunodeficiency virus (HIV) epidemic, testing gaps remain, particularly among men and young persons in sub-Saharan Africa (1). This observational study used routinely collected programmatic data from 20 African countries reported to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) from October 2018 to September 2019 to assess HIV testing coverage and case finding among adults (defined as persons aged ≥15 years). Indicators included number of HIV tests conducted, number of HIV-positive test results, and percentage positivity rate. Overall, the majority of countries reported higher HIV case finding among women than among men. However, a slightly higher percentage positivity was recorded among men (4.7%) than among women (4.1%). Provider-initiated counseling and testing (PITC) in health facilities identified approximately two thirds of all new cases, but index testing had the highest percentage positivity in all countries among both sexes. Yields from voluntary counseling and testing (VCT) and mobile testing varied by sex and by country. These findings highlight the need to identify and implement the most efficient strategies for HIV case finding in these countries to close coverage gaps. Strategies might need to be tailored for men who remain underrepresented in the majority of HIV testing programs.

Proficiency Testing of Viral Marker Screening in African Blood Centers - Seven African Countries, 2017.

A 2014 report evaluating accuracy of serologic testing for transfusion-transmissible viruses at African blood center laboratories found sensitivities of 92%, 87%, and 90% for detecting infections with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), respectively (1). Following substantial investments in national blood transfusion service (NBTS) laboratories, in 2017 investigators tested proficiency at 84 blood center laboratories (29 NBTS and 55 non-NBTS) in seven African countries. A blinded panel of 25 plasma samples was shipped to each participating laboratory for testing with their usual protocols based on rapid diagnostic tests (RDTs) (2) and third and fourth generation enzyme immunoassays (EIA-3 and EIA-4). Sensitivity and specificity were estimated using separate regression models that clustered assays by laboratory and adjusted for assay type and NBTS laboratory status. Mean specificities were ≥95% for all three viruses; however, mean sensitivities were 97% for HIV-positive, 76% for HBV-positive, and 80% for HCV-positive samples. Testing sensitivities for all viruses were high when EIA-3 assays were used (≥97%). Lower sensitivities for HBV-positive samples and HCV-positive samples were associated with assay types other than EIA-3, used primarily by non-NBTS laboratories. Proficiency for HIV testing has improved following international investments, but proficiency remains suboptimal for HBV and HCV testing. In sub-Saharan African blood centers, the quality of rapid tests used for HBV and HCV screening needs to be improved or their use discouraged in favor of EIA-3 tests.

Trends and Gaps in National Blood Transfusion Services - 14 Sub-Saharan African Countries, 2014-2016.

Ensuring availability of safe blood products through recruitment of voluntary, nonremunerated, blood donors (VNRDs) and prevention of transfusion-transmissible infections (TTIs), including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis, is important for public health (1,2). During 2004-2016, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) provided approximately $468 million in financial support and technical assistance* to 14 sub-Saharan African countries† with high HIV prevalence to strengthen national blood transfusion services (NBTSs)§ and improve blood safety and availability. CDC analyzed these countries' 2014-2016 blood safety surveillance data to update previous reports (1,2) and summarize achievements and programmatic gaps as some NBTSs begin to transition funding and technical support from PEPFAR to local ministries of health (MOHs) (2,3). Despite a 60% increase in blood supply since 2004 and steady declines in HIV prevalence (to <1% among blood donors in seven of the 14 countries), HIV prevalence among blood donors still remains higher than that recommended by the World Health Organization (WHO) (4). PEPFAR support has contributed to significant reductions in HIV prevalence among blood donors in the majority of PEPFAR-supported countries, and linking donors who screen HIV-positive to confirmatory testing and indicated treatment, as well as further reducing TTIs, remains a public health priority (5).

Diagnoses and ordering practices driving blood demand for treatment of anemia in Tanzania.

BACKGROUND: Resource-limited countries in Africa experience blood shortages. Understanding clinical drivers of blood demand can inform strategies to increase blood availability. STUDY DESIGN AND METHODS: From a national representative sample of 42 hospitals in Tanzania, patient records and requests for whole blood (WB) and red blood cells (RBCs) to treat anemia were analyzed using data collected prospectively from June through September 2013. Abstracted data included cause of anemia, number of requested units, clinical signs, and pretransfusion hemoglobin (Hb) levels. Weighted projections of nationwide drivers of blood demand for the year, 2013, were calculated. Mean posttransfusion Hb levels were estimated, and blood requests were assessed for clinical appropriateness. RESULTS: Malaria was the leading driver of blood demand for anemia among children, accounting for 67% (55,949 units; standard deviation [SD], 1911 units) of projected units requested for children in 2013. Maternal hemorrhage was the leading driver of blood demand for anemia among adults, accounting for 21% (31,321 units; SD, 963 units) of projected units requested. Seventeen percent (26,133 units; SD, 1013 units) of projected requested units were deemed inappropriate. Adults with severe anemia had a mean Hb level of 3.7 g/dL and a mean of 1.6 WB or RBC units per request, resulting in an estimated mean posttransfusion Hb level of 5.3 g/dL. CONCLUSIONS: Strategies to prevent and treat underlying causes of anemia and decrease inappropriate blood requests will likely increase blood availability. Restrictive blood ordering practices seen in adults with severe anemia suggests undertreatment of anemia and may result in an underestimation of the national blood demand.

Estimating Tanzania's National Met and Unmet Blood Demand From a Survey of a Representative Sample of Hospitals.

Estimating blood demand to determine collection goals challenges many low-income countries. We sampled Tanzanian hospitals to estimate national blood demand. A representative sample based on probability proportional to size sampling of 42 of 273 (15%) Tanzanian transfusing hospitals was selected. Blood bank registers, patient medical records, and blood component disposition records were reviewed prospectively from June to September 2013 to determine the number of components requested and the number and proportion issued, not issued due to nonavailability, and not issued for other reasons. Data were estimated for an annual national estimate. Of an estimated 278 371 components requested in 2013, 6648 (2.4%) were not issued due to nonavailability, 34 591 (12.4%) were not issued for other reasons, and 244 535 (87.8%) were issued. Of these 278 371 components, 86 753 (31.2%) were requested by adult medical, 74 499 (26.8%) by pediatric medical, and 57 312 (20.6%) by obstetric units. In these 3 units, the proportion of units not issued due to nonavailability was 1.8%. Private (4.1%) and large (6%) hospitals had the largest proportion of units not issued because of nonavailability. Of 244 535 issued components, 91 690 (37.5%) were collected, tested, and issued from blood banks that are not part of the Tanzania National Blood Transfusion Services (TNBTS). Nearly 98% of blood component demand was met. However, a large portion of the blood supply for the hospitals came from non-TNBTS blood banks. TNBTS could increase availability of safe blood through assuring the quality of donor selection and donation testing at non-TNBTS blood banks.

Molecular epidemiology of hepatitis B virus infection in Tanzania.

Despite the significant public health problems associated with hepatitis B virus (HBV) in sub-Saharan Africa, many countries in this region do not have systematic HBV surveillance or genetic information on HBV circulating locally. Here, we report on the genetic characterization of 772 HBV strains from Tanzania. Phylogenetic analysis of the S-gene sequences showed prevalence of HBV genotype A (HBV/A, n=671, 86.9 %), followed by genotypes D (HBV/D, n=95, 12.3 %) and E (HBV/E, n=6, 0.8 %). All HBV/A sequences were further classified into subtype A1, while the HBV/D sequences were assigned to a new cluster. Among the Tanzanian sequences, 84 % of HBV/A1 and 94 % of HBV/D were unique. The Tanzanian and global HBV/A1 sequences were compared and were completely intermixed in the phylogenetic tree, with the Tanzanian sequences frequently generating long terminal branches, indicating a long history of HBV/A1 infections in the country. The time to the most recent common ancestor was estimated to be 188 years ago [95 % highest posterior density (HPD): 132 to 265 years] for HBV/A1 and 127 years ago (95 % HPD: 79 to 192 years) for HBV/D. The Bayesian skyline plot showed that the number of transmissions 'exploded' exponentially between 1960-1970 for HBV/A1 and 1970-1990 for HBV/D, with the effective population of HBV/A1 having expanded twice as much as that of HBV/D. The data suggest that Tanzania is at least a part of the geographic origin of the HBV/A1 subtype. A recent increase in the transmission rate and significant HBV genetic diversity should be taken into consideration when devising public health interventions to control HBV infections in Tanzania.

Effects of preanalytical factors on hemoglobin measurement: A comparison of two HemoCue® point-of-care analyzers.

BACKGROUND: In field studies, hemoglobin (Hb) is often measured using a battery-operated, portable HemoCue® hemoglobinometer. METHODS: We compared the performance of 2 HemoCue® models (Hb-201+ and Hb-301) and investigated effects of preanalytical factors on Hb results by simulating unfavorable field conditions. RESULTS: The Hb-301 produced 2.6% higher results compared to the Hb-201+. Hb had to be measured within 1min of filling the Hb-301 cuvette to avoid artificially elevated concentrations (1.3% per min). The Hb-301 cuvettes withstood elevated temperature (37°C) and humidity (72%) for 3weeks, while the Hb-201+ cuvettes degraded within 10min under those conditions. Both cuvette types withstood elevated temperature for 3weeks. Properly-collected venous and capillary blood produced comparable results. Pooled capillary blood produced comparable results to the second and third but not the fourth drop of blood (3.3% lower). Blood could be stored for ≤4days at 10-30°C before Hb-201+ measurement, but only for 1day at 10-23°C before Hb-301 measurement (≤1% change in Hb). CONCLUSIONS: Higher Hb results obtained with the Hb-301 may influence the interpretation of anemia prevalence in health surveys. While the Hb-301 performed better in high humidity conditions, the Hb-201+ provided more user flexibility regarding delayed Hb reading.

Effects of delayed sample processing and freezing on serum concentrations of selected nutritional indicators.

BACKGROUND: Environmental conditions during sample processing, shipping, and storage are often suboptimal, particularly in less developed countries. We used samples from US volunteers to investigate the effects of delayed whole blood (WB) processing and delayed freezing of serum on selected nutritional indicators. METHODS: WB tubes (n = 35) were either stored at 32 degrees C for up to 3 days before serum separation or centrifuged within 2 h of collection; serum samples were stored at 11 degrees C for up to 14 days to simulate delayed shipping. We assessed analyte stability by comparing results with data from optimally prepared/stored serum samples (<2 h on the clot, frozen at -70 degrees C) and by using clinical-acceptability criteria based on combined analytical imprecision and intraindividual biologic variability. RESULTS: Clinically acceptable changes in concentration varied from 3%-15%. Delayed WB processing did not unacceptably affect concentrations of carotenoids and vitamins B(12), D, and E; however, we obtained clinically unacceptable changes for ferritin (+9%), soluble transferrin receptor (sTfR) (+5%), and folate (-30%) after 1 day, and for vitamin A (-10%) after 3 days. Delayed freezing of serum did not affect concentrations of ferritin, sTfR, carotenoids, and vitamins A, B(12), and E; however, we obtained clinically unacceptable changes for vitamins C (-20%) and D (+7%) after 7 days and for folate after 14 days (-22%). CONCLUSIONS: Despite substantial delays in WB processing or in the freezing of serum samples, most nutritional indicators showed remarkable stability. This information is important for both the design of field studies and the use of residual samples subjected to suboptimal preanalytical factors.

A randomized, 4-month mango and fat supplementation trial improved vitamin A status among young Gambian children.

Supplementation with carotene-rich fruits may be an effective and sustainable approach to prevent vitamin A deficiency. To test the effectiveness of mango supplementation, 176 Gambian children, aged 2 to 7 y, were randomly assigned to one of four treatments: 75 g of dried mango containing approximately 150 micro g retinol activity equivalents with (MF) or without (M) 5 g of fat, 5 d/wk for 4 mo or 60,000 micro g of vitamin A (A) or placebo (P) capsule at baseline. After 4 mo, plasma beta-carotene was greater in both the M (P < 0.05) and MF (P = 0.07) groups compared with the P group. After controlling for baseline plasma retinol, elevated acute phase proteins and age, plasma retinol concentrations in the A and MF, but not M, groups were higher than in the P group at the end of the study (P < 0.01). Increases in retinol concentrations, however, were small in both groups. These results support the use of dietary supplementation with dried mangoes and a source of fat as one of several concurrent strategies that can be used to help maintain vitamin A status of children in developing countries where there is a severe seasonal shortage of carotenoid-rich foods.