Detection of Plasmodium spp. in asymptomatic blood donors by the new Brazilian NAT PLUS HIV/HBV/HCV/Malaria Bio-Manguinhos kit.

BACKGROUND: Transfusion-transmitted malaria (TTM) is a public health problem in endemic and nonendemic areas. The Brazilian Ministry of Health (MH) requested the development of a nucleic acid amplification test (NAT) for the detection of Plasmodium spp. in public blood centers to increase blood safety. STUDY DESIGN AND METHODS: The new Brazilian NAT kit named NAT PLUS HIV/HBV/HCV/Malaria Bio-Manguinhos was first implemented in HEMORIO, a public blood center in the city of Rio de Janeiro. Since October 1, 2022, this blood center has been testing all its blood donations for malaria in a pool of six plasma samples to detect Plasmodium spp. by real-time polymerase chain reaction (PCR). RESULTS: Since the implementation of the NAT PLUS platform until February 2023, HEMORIO has successfully received and tested 200,277 donations. The platform detected two asymptomatic donors in the city of Rio de Janeiro, which is a nonendemic region for malaria. Our analyses suggested a malaria from the Amazon region caused by Plasmodium vivax, in the first case, while an autochthonous transmission case by Plasmodium malariae was identified in the rural area of Rio de Janeiro state. DISCUSSION: The NAT PLUS platform detects Plasmodium spp. in plasma samples with sensitivity capable of detecting subpatent infections. This is the first time worldwide that a group developed and implemented molecular diagnosis for Plasmodium spp. to be used by public blood centers to avoid TTM.

Vaccine-induced immune thrombotic thrombocytopenia post COVID-19 booster vaccination in Brazil: a case series.

Background: The emergence of new variants of SARS-CoV-2 has led to the administration of different booster vaccines to mitigate COVID-19. Vaccines with adenoviral vectors have been rarely associated with vaccine-induced immune thrombotic thrombocytopenia (VITT). Objectives: This study aimed to describe 15 cases of VITT after the third and fourth doses of the COVID-19 vaccine in Brazil. Methods: Cases were reported after all kinds of anti-SARS-CoV-2 booster vaccinations between October 17, 2021, and September 4, 2022. Results: Of the 26 suspected cases, 15 cases of VITT were analyzed. Of these, 10 were classified as definite VITT, 2 as probable, 1 as possible, and 2 as unlikely. The estimated frequency of definite, probable, or possible VITT was 0.33 cases per million. Cases were assigned to ChAdOx1 (13 cases), Ad26.COV2.S (1 case), and BNT162b2 (1 case). None of the patients received an adenoviral vaccine as a primary vaccination. The average age of participants was 34 years, and symptoms usually appeared 8 days after vaccination. Headache was the most common symptom, and cerebral veins were the most affected thrombotic site. The overall mortality risk was 53%. Anti-platelet factor 4 enzyme-linked immunosorbent assay serology was positive in 11 out of 15 patients (73.3%), negative in 2 (13.3%), and missing in 2 (13.3%). Conclusion: The study confirms that VITT is linked to the first exposure to adenoviral vector vaccines. Since January 2023, Brazil has recommended preferably COVID-19 messenger RNA vaccines for individuals aged 18 to 39 years. We suggest that, in the current disease scenario, COVID-19 adenovirus vaccines should not be the first choice for individuals aged <50 years who have not received a previous dose of this type of vaccine.

Vaccine-induced immune thrombotic thrombocytopenia after COVID-19 vaccination: Description of a series of 39 cases in Brazil.

OBJECTIVE: Describe a case series of vaccine-induced immune thrombotic thrombocytopenia (VITT) after COVID-19 vaccination in Brazil that included ChAdOx1 nCoV-19, Ad26.COV2.S and BNT162b2 vaccines, describing their clinical and laboratory characteristics. METHODOLOGY: Descriptive case series study using Bio-Manguinhos/Fiocruz/AstraZeneca Brazil and National Immunization Program/Ministry of Health (NIP/MoH) data on COVID-19 AEFI surveillance. We obtained patient-level data from pharmacovigilance for AEFI surveillance and used both the NIP/MoH and Bio-Manguinhos/Fiocruz pharmacovigilance databases to create the study database. Thirty-nine cases of suspect VITT were included, 36 after ChAdOx1 nCoV-19, one after BNT162b2 and two after Ad26.COV2.S vaccine. All cases were based on meeting the Brighton Collaboration criteria for VITT. The primary outcomes were clinical and laboratory features, site of thrombosis, and anti-PF4 ELISA, when available. RESULTS: Thirty-nine cases met the criteria, 38 of which were classified as level 1 and one as level 3 according to Brighton Collaboration. Most cases had the central nervous system (CNS) as the main site of thrombosis (21/39) and happened after the vaccine first dose (34/39). The median age of the cases was 41 years old (23 to 86 yo). Most of the cases (61.5%) occurred in women. The median interval between vaccination and onset of symptoms was 8 days (0-37 days). The platelet count and D-dimer count had median values of 34,000/µL and 19,235 µg FEU/L, respectively. The ELISA anti-PF4 antibody was positive in 18 samples. The overall mortality rate was 51% and was higher in cases of CNS thrombosis with intracerebral bleeding. CONCLUSION: Our case series shows that Brazilian VITT cases have similar clinical and laboratory profiles as demonstrated in the literature. Brazil has administered more than 300 million doses of COVID-19 vaccines (more than 110 million from ChAdOx1 nCoV-19). VITT seems to be a very rare but serious adverse event following COVID-19 immunization, especially adenoviral vector immunization.

A Large Cohort Study of SARS-CoV-2 Detection in Saliva: A Non-Invasive Alternative Diagnostic Test for Patients with Bleeding Disorders.

Diagnosis of SARS-CoV-2 infections is mostly based on the nasopharyngeal swabs (NPS). However, this collection is invasive and uncomfortable, especially for children and patients with coagulopathies, whose NPS collection often causes bleeding. Thus, the aim of this study was to evaluate the usefulness and accuracy of saliva for the diagnosis of COVID-19 in patients presenting bleeding disorders. Samples of NPS, oropharyngeal swabs (OPS), and saliva were collected simultaneously from 1159 hospitalized patients with hematological diseases and from 524 healthcare workers, both symptomatic and asymptomatic for SARS-CoV-2. All samples were evaluated for SARS-CoV-2 by qRT-PCR. SARS-CoV-2 was detected in NPS, OPS and saliva from 16.9%, 14.4% and 15.6% individuals, respectively. Tests in saliva showed sensitivity, specificity, and overall agreement of 73.3%, 96.9% and 92.7% (=0.74), respectively. Salivary tests had good accuracy (AUC = 0.7) for discriminating negative and positive qRT-PCR for SARS-CoV-2. Higher sensitivity was observed in symptomatic than in non-symptomatic patients, as well as in healthy subjects than in patients with hematological disease, in both OPS and saliva. The mean viral load in NPS was significantly higher than in OPS and in saliva samples (p < 0.001). Saliva is a good diagnostic tool to detect SARS-CoV-2, especially among patients symptomatic for COVID-19, and is a valuable specimen for mass screening of hospitalized patients with hematological diseases, especially for those that with bleeding disorders.

10-year analysis of human immunodeficiency virus incidence in first-time and repeat donors in Brazil.

BACKGROUND AND OBJECTIVES: Incidence in first-time and repeat blood donors is an important measure of transfusion-transmitted HIV infection (TT-HIV) risk. This study assessed HIV incidence over time at four large blood centres in Brazil. MATERIALS AND METHODS: Donations were screened and confirmed using serological assays for HIV from 2007 to 2016, and additionally screened by nucleic acid testing from 2011 forward. Limiting antigen (LAg) avidity testing was conducted on HIV seroreactive samples from first-time donors to classify whether an infection was recently acquired. We calculated incidence in first-time donors using the mean duration of recent infection and in repeat donors using classical methods. Time and demographic trends were assessed using Poisson regression. RESULTS: Over the 10-year period, HIV incidence in first-time donors was highest in Recife (45·1/100 000 person-years (105 py)) followed by São Paulo (32·2/105 py) and then Belo Horizonte (23·3/105 py), and in repeat donors was highest in Recife (33·2/105 py), Belo Horizonte (27·5/105 py) and São Paulo (17·0/105 py). Results from Rio de Janeiro were available from 2013 to 2016 with incidence in first-time donors of 35·9/105 py and repeat donors from 2011 to 2016 of 29·2/105 py. Incidence varied by other donor demographics. When incidence was considered in 2-year intervals, no significant trend was evident. Overall residual risk of TT-HIV was 5·46 and 7·41 per million units of pRBC and FFP transfused, respectively. CONCLUSION: HIV incidence in both first-time and repeat donors varied by region in Brazil. Clear secular trends were not evident.

Seroprevalence of anti-SARS-CoV-2 among blood donors in Rio de Janeiro, Brazil.

OBJECTIVE To estimate the seroprevalence of antibodies to SARS-CoV-2 among blood donors in the state of Rio de Janeiro, Brazil. METHODS Data were collected on 2,857 blood donors from April 14 to 27, 2020. This study reports crude prevalence of antibodies to SARS-CoV-2, population weighted prevalence for the state, and prevalence adjusted for test sensitivity and specificity. Logistic regression models were used to establish the correlates of SARS-CoV-2 prevalence. For the analysis, we considered collection period and site, sociodemographic characteristics, and place of residence. RESULTS The proportion of positive tests for SARS-Cov-2, without any adjustment, was 4.0% (95%CI 3.3-4.7%), and the weighted prevalence was 3.8% (95%CI 3.1-4.5%). We found lower estimates after adjusting for test sensitivity and specificity: 3.6% (95%CI 2.7-4.4%) for the non-weighted prevalence, and 3.3% (95%CI 2.6-4.1%) for the weighted prevalence. Collection period was the variable most significantly associated with crude prevalence: the later the period, the higher the prevalence. Regarding sociodemographic characteristics, the younger the blood donor, the higher the prevalence, and the lower the education level, the higher the odds of testing positive for SARS-Cov-2 antibody. We found similar results for weighted prevalence. CONCLUSIONS Our findings comply with some basic premises: the increasing trend over time, as the epidemic curve in the state is still on the rise; and the higher prevalence among both the youngest, for moving around more than older age groups, and the less educated, for encountering more difficulties in following social distancing recommendations. Despite the study limitations, we may infer that Rio de Janeiro is far from reaching the required levels of herd immunity against SARS-CoV-2.

Optimisation and control of the supply of blood bags in hemotherapic centres via Markov decision process with discounted arrival rate.

Running a cost-effective human blood transfusion supply chain challenges decision makers in blood services world-wide. In this paper, we develop a Markov decision process with the objective of minimising the overall costs of internal and external collections, storing, producing and disposing of blood bags, whilst explicitly considering the probability that a donated blog bag will perish before demanded. The model finds an optimal policy to collect additional bags based on the number of bags in stock rather than using information about the age of the oldest item. Using data from the literature, we validate our model and carry out a case study based on data from a large blood supplier in South America. The study helped achieve an overall increase of 4.5% in blood donations in one year.

Blood components requests at an orthopedic hospital: a critical survey

Abstract Introduction The correct completion of the blood components request form is the starting point to ensure good transfusion care. Many guidelines have been developed to search for hemoglobin values that trigger the need for transfusion and show the importance of Patient Blood Management, a scientific evidence-based approach in processes where transfusion is a possibility, such as in elective surgeries. Objective The cross-sectional study aimed to analyze the transfusion requests at a complex orthopedic hospital over a one-year period. Method The completion quality was classified as Good, Regular, Bad or Very Bad, according to the information given by the physician. Transfusion medicine professionals analyzed the transfusion indication reported on the request form and classified it as Correct, Not based on Patient Blood Management (PBM), in accordance or not with the institutional Maximum Surgical Blood Order Schedule, Impossible to evaluate due to lack of information on the form, and Incorrect. Results The study categorized the completion quality of 2011 requests as Good (8.80%), Regular (9.30%), Bad (72.75%) and Very Bad (9.15%). Analysis of the indications revealed that 54.90% of the requests were in accordance with the current blood transfusion recommendations, and on 23.12% of the forms this field had not been filled out. Conclusion The majority of blood components (63%) requests are in tune with current blood transfusion recommendations, despite the great number of incorrectly completed forms; nevertheless, it is mandatory to reach much better appropriateness rates.

Blood components requests at an orthopedic hospital: a critical survey.

INTRODUCTION: The correct completion of the blood components request form is the starting point to ensure good transfusion care. Many guidelines have been developed to search for hemoglobin values that trigger the need for transfusion and show the importance of Patient Blood Management, a scientific evidence-based approach in processes where transfusion is a possibility, such as in elective surgeries. OBJECTIVE: The cross-sectional study aimed to analyze the transfusion requests at a complex orthopedic hospital over a one-year period. METHOD: The completion quality was classified as Good, Regular, Bad or Very Bad, according to the information given by the physician. Transfusion medicine professionals analyzed the transfusion indication reported on the request form and classified it as Correct, Not based on Patient Blood Management (PBM), in accordance or not with the institutional Maximum Surgical Blood Order Schedule, Impossible to evaluate due to lack of information on the form, and Incorrect. RESULTS: The study categorized the completion quality of 2011 requests as Good (8.80%), Regular (9.30%), Bad (72.75%) and Very Bad (9.15%). Analysis of the indications revealed that 54.90% of the requests were in accordance with the current blood transfusion recommendations, and on 23.12% of the forms this field had not been filled out. CONCLUSION: The majority of blood components (63%) requests are in tune with current blood transfusion recommendations, despite the great number of incorrectly completed forms; nevertheless, it is mandatory to reach much better appropriateness rates.

Seroprevalence of anti-SARS-CoV-2 among blood donors in Rio de Janeiro, Brazil

ABSTRACT OBJECTIVE To estimate the seroprevalence of antibodies to SARS-CoV-2 among blood donors in the state of Rio de Janeiro, Brazil. METHODS Data were collected on 2,857 blood donors from April 14 to 27, 2020. This study reports crude prevalence of antibodies to SARS-CoV-2, population weighted prevalence for the state, and prevalence adjusted for test sensitivity and specificity. Logistic regression models were used to establish the correlates of SARS-CoV-2 prevalence. For the analysis, we considered collection period and site, sociodemographic characteristics, and place of residence. RESULTS The proportion of positive tests for SARS-Cov-2, without any adjustment, was 4.0% (95%CI 3.3-4.7%), and the weighted prevalence was 3.8% (95%CI 3.1-4.5%). We found lower estimates after adjusting for test sensitivity and specificity: 3.6% (95%CI 2.7-4.4%) for the non-weighted prevalence, and 3.3% (95%CI 2.6-4.1%) for the weighted prevalence. Collection period was the variable most significantly associated with crude prevalence: the later the period, the higher the prevalence. Regarding sociodemographic characteristics, the younger the blood donor, the higher the prevalence, and the lower the education level, the higher the odds of testing positive for SARS-Cov-2 antibody. We found similar results for weighted prevalence. CONCLUSIONS Our findings comply with some basic premises: the increasing trend over time, as the epidemic curve in the state is still on the rise; and the higher prevalence among both the youngest, for moving around more than older age groups, and the less educated, for encountering more difficulties in following social distancing recommendations. Despite the study limitations, we may infer that Rio de Janeiro is far from reaching the required levels of herd immunity against SARS-CoV-2.

Seroprevalence of IgG and IgM anti-SARS-CoV-2 among voluntary blood donors in Rio de Janeiro, Brazil

Background: In Brazil, mathematical models for derivingestimates and projections of COVID-19 cases have been developed without data on asymptomatic SARS-CoV-2 infection. We estimated the seroprevalence of antibodies to SARS-CoV-2 among blood donors in the State of Rio de Janeiro. Methods: Data were collected on 2,857 blood donors from April 14 to 27, 2020. We report the crude prevalence of antibodies to SARS-CoV-2, the weighted prevalence by the total state population, and adjusted prevalence estimates for test sensitivity and specificity. To establish the correlates of SARS-CoV-2 prevalence, we used logistic regression models. The analysis included period and site of blood collection, sociodemographic characteristics, and place of residence. Results: The proportion of SARS-Cov-2 positive tests without any adjustment was 4.0% (95% CI 3.3-4.7%), and the weighted prevalence was 3.8% (95% CI 3.1-4.5%). Further adjustment by test sensitivity and specificity produced lower estimates, 3.6% (95% CI 2.7-4.4%) and 3.3% (95% CI 2.6-4.1%), respectively. The variable most significantly associated with the crude prevalence was the period of blood collection: the later the period, the higher the prevalence. Regarding socio-demographic characteristics, the younger the blood donors, the higher the prevalence, and the lower the educational level, the higher the odds of a positive SARS-Cov-2 antibody. Similar results were found for the weighted prevalence. Discussion: Although our findings resulted from a convenience sample, they match some basic premises: the increasing trend over time, since the epidemic curve in the state is still on the rise; the higher prevalence among the youngest who are more likely to circulate; and the higher prevalence among the less educated as they have more difficulties in following the social distancing recommendations. Despite the study limitations, it is possible to infer that protective levels of natural herd immunity to SARS-CoV-2 are far from being reached in Rio de Janeiro. (AU)

Cenário mundial do fracionamento industrial de plasma e da produção de hemoderivados / World scenario of industrial plasma fractioning and blood derivates production

A produção de hemoderivados no mundo se iniciou nos anos 40, depois que o químico americano Edwin Cohn desenvolveu uma técnica de precipitação das proteínas plasmáticas pelo álcool. Desde então, a indústria tem passado por diversas fases, das quaisa primeira foi o boom da produção de albumina em pequenos laboratórios. Depois, surgiram os fatores de coagulação liofilizados para o tratamento da hemofilia e as imunoglo-bulinas intravenosas. O aparecimento da AIDS e a comprovação de que ela era transmitida pelos hemoderivados, nos anos 80, trouxeram no seu bojo uma transformação radical, com a introdução de métodos de inativação viral e a obrigação de a indústria cumprir compadrões de qualidade cada vez mais rígidos. O surgimento dos fatores de coagulação recombinantes modificou preços e estratégia dos centros de fracionamento de plasma, hoje focados principalmente na produção de imunoglobulina. A tendência da indústria de hemoderivados tem sido o de consolidações e fusões, criando grandes grupos econômicos que controlam o setor e que dependem cada vez mais do plasma em centros de doação remunerada, disseminados nos Estados Unidos. O Brasil entrou recentemente para o rol dos países com indústrias de hemoderivados, com a criação da Hemobrás, empresa estatalpertencente ao governo federal, cujo objetivo central é aproveitar o plasma disponível no país e reduzir a dependência externa por hemoderivados.

The hemoderivative production started in the 1940s, after the American chemistEdwin Cohn developed a alcohol–based plasmatic–protein precipitation technique. Since then, industry has gone through many phases, being the boom of albumin production in small labs the first one. After that, lyophilized coagulation factors appeared for the treatment of hemophilia and intravenous immunoglobulin. AIDS appearing and the verification that it was transmitted by hemoderivatives, in the 1980s, made present a radical transformation that introduced viral inactivation methods and the industry’s obligation of complying with higher quality standards. The appearance of recombinant coagulation factors modified both prices and strategies of plasma fractionation centers, focused nowadays in imunnoglobulin production. Hemoderivative industry is following a consolidation and fusion tendency, creating big economical groupswhich control the sector and depend more and more on plasma from paid donation center, popular in The United States. Brazil has recently entered to the list of countries with hemoderivative industries after the creation of Hemobrás, whose main goal is to use the plasma available in the country to reduce the dependance on imported hemoderivatives.