Regional
NAT-based assay to increase blood safety and prevent transfusion-transmitted malaria in Brazil
Malaria is a vector-borne infection caused by intracellular protozoan parasites of the genus Plasmodium. The World Health Organization (WHO) Global Technical Strategy aims to reduce at least 90% of malaria cases and mortality rates by 20301. Between 2000 and 2023, more than 23 million cases and approximately 12,000 deaths have been reported in the region of the Americas. However, since 2015, the case incidence has decreased by 10%. Concerning Brazil, malaria incidence was reduced by less than 25%, like countries of Ecuador and the Bolivarian Republic of Venezuela2, in this same period. Malaria transmission in endemic and non-endemic areas is related to the Anopheles vector species. Most of cases are present in the Brazilian Amazon region. Nonetheless, the extra-Amazon region registered 1% of malaria total cases2. Several factors might impact the occurrence of malaria in countries under-development like Brazil. Poverty, deforestation and population mobility contribute to its persistence. Also, malaria is typically transmitted in tropical and subtropical areas, which means that climatic factors including temperature and rainfall impact where malaria exists. 3
Recent demographic trends highlight the growing importance of middle-aged and elderly individuals as key contributors to the blood supply. Globally and in Hong Kong, the aging population has become increasingly vital, with relaxed eligibility criteria enabling more elderly individuals to donate. While this inclusivity helps stabilizing the blood supply, it also introduces challenges, as older donors may present with chronic conditions such as hypertension, hyperlipaemia, etc. Therefore, RNs must adapt their health assessment techniques to address these issues, ensuring donor safety and optimizing the donation process.
Malaria is transmitted to humans through the bite of infected female Anopheles mosquitoes. However, other forms of transmission can also occur through blood transfusions, organ transplantation, congenital pathway or work accident by contaminated needles4. Transfusion-transmitted malaria (TTM) is acquired via asymptomatic blood donors and takes place through blood elements transfusion from a malaria infected donor to a recipient who consequently might have several clinical symptoms, especially for immuno-compromised people5. An interesting point is that TTM involves blood with direct release of malaria parasites into the recipient's circulation, resulting in high-risk consequences. Considering important advances in molecular techniques, nucleic acid amplification tests (NAT) are essential to ensure blood safety with a sensitive detection of low-density malaria infections6. NAT may contribute to malaria reduction and represent an important strategy for its elimination, providing an epidemiological approach worldwide.
In 2004, based on a Brazilian Ministry of Health demand, Bio-Manguinhos (FIOCRUZ) was consulted about the possibility of developing national technology to produce a NAT of HIV and HCV. In December 2010, NAT multiplex kit HIV/HCV was registered in Brazilian Health Regulatory Agency (ANVISA). This NAT was considered a pioneered governmental propose that represented a technological innovation in Brazilian public health. A posteriorly inclusion of HBV screening was made in November 2014. With NAT HIV/HCV/HBV kit, viruses’ immunological window was reduced, thus increasing transfusion safety7.
As exposed, a lower number of malaria cases occur in the extra-Amazonia region2. However, a lack of data about the prevalence of asymptomatic blood donors is a concern in non-endemic places. In view of this prerogative, a reliable NAT screening for HIV, HBV, HCV and Plasmodium spp. (malaria) was nationally developed and authorized by the ANVISA in March 2022. This molecular test uses an automated platform with high-throughput screening and traceability (up to 552 blood bags per routine) and can reduce the period of ineligibility for blood donors who have been in endemic areas from 12 months to 1 month8.
From 2022 to February 2025, a total of 4,948,262 samples were analyzed by Brazilian NAT PLUS system. A prevalence of 0,0015% (74/4,948,262) from Plasmodium spp. was observed. As expected, Brazilian North region had most positive malaria cases (43.2%) followed by South (28.3%), Southeast (17.6%), Northeast (9.5%) and Midwest (1.4%). Until now, Plasmodium spp. typing was done for 42 samples with the following findings: 54.8% were P. vivax, 35.7% were P. malariae and 9.5% were P. falciparum. It is important to highlight that all other four Brazilian regions had notified malaria cases and reinforces its occurrence in urban areas across Brazil. Migrants and travelers are considered important groups for Plasmodium spp. spread. This data is helping the Brazilian Ministry of Health to strengthen the National Malaria Elimination Plan. The NAT project demonstrated the high capacity of Bio-Manguinhos/FIOCRUZ itself in promoting a molecular test with sensitivity to detect low density infections9. Notably, NAT PLUS system represents a major technological advancement in response to “Global Technical Strategy for Malaria 2016-2030” 1.
References
- World Health Organization (WHO). Global Technical Strategy for Malaria 2016-2030. 2015. Available online: https://www.who.int/ (accessed on 25 March 2025).
- World Health Organization (WHO). World Malaria Report. 2024. Available online: https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2024 (accessed on 25 March 2025).
- Centers for Disease Control and Prevention (CDC). 2024. Available online: https://www.cdc.gov/malaria/data-research/index.html (accessed on 26 March 2025).https://www.rcpath.org/profession/publications/college-bulletin/april-2023/restore.html
- Rosso F, Agudelo Rojas OL, Suarez Gil CC, Lopez Vargas JA, Gómez-Mesa JE, Carrillo Gomez DC, Meza Ramirez L, Caicedo Rusca LA. Transmission of malaria from donors to solid organ transplant recipients: A case report and literature review. Transpl Infect Dis. 2021 Aug;23(4):e13660.
- Verra F, Angheben A, Martello E, Giorli G, Perandin F, Bisoffi Z. A systematic review of transfusion-transmitted malaria in non-endemic areas. Malar J. 2018 Jan 16;17(1):36
- World Health Organization (WHO). Nucleic acid amplification-based diagnostics. 2024. Available online: https://www.who.int/ (accessed on 26 March 2025).
- Rocha D, de Melo GC, Carneiro JMH, Ribeiro M, Ribeiro S, de Godoy DT, Costa E, de Almeida ACG, de Andrade EF, Abrahim CMM, Fraiji NA, Ferreira AGP, Monteiro WM, Brindeiro R, Tanuri A, de Lacerda MVG, Alvarez P. Use of a NAT-based assay to improve the surveillance system and prevent transfusion-transmitted malaria in blood banks. Malar J. 2020 Jul 31;19(1):275.
- Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Kit NAT Plus HIV/HBV/HCV/Malária Bio-Manguinhos. 2022. Available online: https://www.bio.fiocruz.br/ (accessed on 26 March 2025).
- Costa E, Rocha D, Lopes JIF, Andrade E, Cardoso P, Ribeiro M, Fontana-Maurell M, Vicentino ARR, Calazans AR, Arruda MB, Mesquita CA, Ferreira AGP, Amorim Filho L, Alvarez P. Detection of Plasmodium spp. in asymptomatic blood donors by the new Brazilian NAT PLUS HIV/HBV/HCV/Malaria Bio-Manguinhos kit. Transfusion. 2024 Mar;64(3):501-509.