Original article

Ahead-of-Print

Improving blood safety: NAT-based detection of Plasmodium spp. in blood donors in endemic area of Brazil

Authors

Key words: malaria, NAT Plus assay, hemovigilance, screening, blood screening
Publication Date: 2025-11-28

Abstract

Background -  Transfusion-transmitted malaria remains a significant challenge in endemic areas and is a leading cause of blood donation deferral. Rigorous clinical and molecular screening is essential to ensure the safety of blood components. The presence of low-density Plasmodium spp. parasitemia in asymptomatic individuals can compromise transfusion safety and perpetuate disease transmission. This study aimed to describe malaria positivity detected by the NAT PLUS HIV/HBV/HCV/Malaria kit (Bio-Manguinhos), as well as to characterize the epidemiological profile of blood donors and the main deferral causes at a reference blood center in the Brazilian Amazon.

Materials and methods - This was a retrospective observational study using secondary data from the HemoSys database, which included sociodemographic variables, clinical screening, and self-reported malaria history from blood donors. Cases of clinical malaria were investigated among NAT PLUS-positive donors within six months before and after the reactive donation.

Results - A total of 67,114 blood donors tested using the NAT PLUS assay were included. The median age was 35 years (IQR 25-43), with a predominance of male donors (65.1%). Most self-identified as mixed race (80.5%) and had completed high school (53.3%). Malaria-related factors accounted for 2.6% of deferrals (No.=27,434). Malaria positivity detected by NAT PLUS assay was 0.01% (8/67,114), with all reactive donors being asymptomatic at screening. Most positive cases (6/8) occurred during the low-transmission period (rainy season). One donor (12.5%) developed symptomatic malaria (P. falciparum), confirmed by thick blood smear and notified in the SIVEP-Malaria system shortly after donation.

Discussion - Individuals testing positive for Plasmodium spp. by NAT PLUS assay may progress to clinical malaria post-donation, posing risks to both donor health and transfusion safety. The frequent absence of information on malaria exposure during clinical screening highlights the need for standardized protocols and molecular testing to improve early identification of at-risk donors in endemic regions.

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Authors

Anne Cristine Gomes de Almeida - Programa de Pós-Graduação em Ciências aplicadas à Hematologia (PPGH-UEA). Universidade do Estado do Amazonas, Manaus, Amazonas, Brazil.

Ana Carolina Shuan Laco - Programa de Pós-Graduação em Medicina Tropical (PPGMT-UEA). Universidade do Estado do Amazonas, Manaus, Amazonas, Brazil. https://orcid.org/0009-0002-0718-7018

Maewia Gomes Rodrigues - Fundação Hospitalar de Hematologia e Hemoterapia do Amazonas (HEMOAM). Manaus, Amazonas, Brasil https://orcid.org/0009-0001-2238-539X

Vitória Gabrielly Godinho de Siqueira - Programa de Pós-Graduação em Ciências aplicadas à Hematologia (PPGH-UEA). Universidade do Estado do Amazonas, Manaus, Amazonas, Brazil.

Fransuellem Batista de Moura Brito - Instituto Leônidas & Maria Deane (ILMD- Fiocruz Amazônia). Manaus, Amazonas, Brazil. https://orcid.org/0009-0007-3625-8870

Cynara Melo Gato - Fundação Hospitalar de Hematologia e Hemoterapia do Amazonas (HEMOAM). Manaus, Amazonas, Brasil

Jady Shayenne Mota Cordeiro - Programa de Pós-Graduação em Medicina Tropical (PPGMT-UEA). Universidade do Estado do Amazonas. Manaus, Amazonas, Brazil.

José Marcelo Hipólito Carneiro - Fundação Hospitalar de Hematologia e Hemoterapia do Amazonas (HEMOAM). Manaus, Amazonas, Brazil.

Sergio Roberto Lopes Albuquerque - Programa de Pós-Graduação em Ciências Aplicadas à Hematologia (PPGH-UEA). Universidade do Estado do Amazonas. Manaus, Amazonas, Brasil. Fundação Hospitalar de Hematologia e Hemoterapia do Amazonas (HEMOAM). Manaus, Amazonas, Brasil. https://orcid.org/0000-0002-1581-1135

Yury Oliveira Chaves - Fundação Hospitalar de Hematologia e Hemoterapia do Amazonas (HEMOAM). Manaus, Amazonas, Brasil. Instituto Leônidas & Maria Deane (ILMD- Fiocruz Amazônia). Manaus, Amazonas, Brazil.

Maria de Fátima Ferreira da Cruz - Instituto Oswaldo Cruz (IOC/Fiocruz), Rio de Janeiro, Brazil.

Patrícia Alvarez Baptista - Institute of Technology in Immunobiology Bio-Manguinhos, Fundação Oswaldo Cruz/Fiocruz. Rio de Janeiro, Brasil.

Marcelo Addas de Carvalho - Universidade Estadual de Campinas (UNICAMP). Campinas, São Paulo, Brasil. https://orcid.org/0000-0003-0178-6191

Andrea Monteiro Tarragô - Programa de Pós-Graduação em Ciências Aplicadas à Hematologia (PPGH-UEA). Universidade do Estado do Amazonas. Manaus, Amazonas, Brasil. Fundação Hospitalar de Hematologia e Hemoterapia do Amazonas (HEMOAM). Manaus, Amazonas, Brasil. Programa de Pós-graduação em Imunologia Básica e Aplicada (PPGIBA). Universidade Federal do Amazonas. Manaus, Amazonas, Brasil.

Gisely Cardoso de Melo - Programa de Pós-Graduação em Ciências Aplicadas à Hematologia (PPGH-UEA), Universidade do Estado do Amazonas, Manaus, Amazonas, Brazil; Programa de Pós-Graduação em Medicina Tropical (PPGMT-UEA), Universidade do Estado do Amazonas, Manaus, Amazonas, Brazil; Fundação de Medicina Tropical Doutor Heitor Vieira Dourado. Manaus, Amazonas, Brazil

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