Regional
Universal molecular screening for malaria in Brazil: from transfusion safety innovation to integrated surveillance
Jacqueline Viana de Carvalho Ruas
Ministry of Health, Brazil
Luciana Maria de Barros Carlos
Ministry of Health, Brazil
Denise Menezes Brunetta
Ceará Hematology and Hemotherapy Center, Brazil
Bárbara de Jesus Simões
Ministry of Health, Brazil
Arthur Lobato Barreto Mello
Ministry of Health, Brazil
Marcelo Addas de Carvalho
University of Campinas, Brazil
João Paulo Baccara de Araújo
Bio-Manguinhos Institute of Technology, Brazil
Antonio Gomes Pinto Ferreira
Bio-Manguinhos Institute of Technology, Brazil
Patrícia Alvarez da Silva Baptista
Bio-Manguinhos Institute of Technology, Brazil
Malaria remains a challenge for transfusion safety in Brazil. Although transmission occurs predominantly through the bite of infected Anopheles mosquitoes, transfusion-transmitted malaria is recognized and may involve asymptomatic donors with low parasitemia. The greatest disease burden is concentrated in the Amazonian Region, but the occurrence of infections in the Extra-Amazonian Region increases the complexity of donor selection and highlights the limitations of strategies based exclusively on epidemiological history and clinical manifestations.
Brazil’s experience with nucleic acid testing (NAT) is closely linked to the national public policy for technological development in hemotherapy. NAT complements serological screening of blood donors through the direct detection of nucleic acids from infectious agents. Following national development by researchers at Bio-Manguinhos/Fiocruz, testing for HIV and HCV was implemented in 2013 for blood services linked to the Brazilian Unified Health System (SUS), followed by the incorporation of HBV. The strategy used Brazil’s public blood service network, centralizing NAT testing in strategically located laboratories, with daily logistics for the shipment of samples and results. This enabled coverage of all blood collections performed by SUS, which account for 80% of blood collections in Brazil. Based on epidemiological assessments and discussions with specialists and the blood service network, the need to incorporate malaria as the fourth target of Brazilian NAT was established through the development of a new testing platform, called NAT Plus.
Figure 1. Timeline of Brazilian NAT: national development, incorporation of HIV/HCV/HBV, development of NAT Plus, start of malaria implementation in 2022, and regulatory consolidation in 2026
The NAT Plus platform sought to increase sensitivity for the detection of Plasmodium spp. while simultaneously modernizing donor eligibility criteria. A pilot study conducted at the Amazonas State Blood Center (HEMOAM) in 2018, involving approximately 2,900 samples, identified a malaria NAT-detectable sample from a donor who subsequently developed clinical disease, providing important proof of principle for the new target.
Implementation in the Brazilian Blood Service Network
Implementation of NAT Plus for HIV/HBV/HCV/Malaria in SUS services began in 2022, with progressive expansion. The platform was designed to integrate molecular detection of Plasmodium spp. into the routine already established for HIV, HBV and HCV, making use of the national testing infrastructure, sample transportation flows and quality assurance mechanisms developed throughout Brazil’s experience with NAT implementation.
The national strategy, funded by the Ministry of Health, combines kit production by Bio-Manguinhos/Fiocruz, centralized processing at NAT Testing Sites, sample transportation logistics and monitoring through the Multicenter NAT System Manager (GSM-NAT). The current network of 13 NAT Testing Sites provides integrated logistical coverage for 100% of public and private blood services affiliated with SUS.
The incorporation of malaria represented more than the addition of a new analytical target. It also enabled a review of the donor epidemiological risk approach. Ordinance GM/MS No. 11,685, of July 2, 2026, updated the regulatory framework for hemotherapy and consolidated the mandatory requirement for molecular screening for malaria, linking testing to updated donor eligibility criteria. Among the advances is the reduction to 30 days of the deferral period related to travel to or residence in transmission areas, when the criteria established by the regulation apply.
Results and main findings
Between September 2022 and June 2026, 9,350,211 samples were processed on the NAT Plus platform, including 1,660,563 in the first half of 2026. During this period, molecular screening detected 131 asymptomatic malaria-reactive donations identified in 20 Brazilian states and the Federal District.
Figure 2. Geographic distribution of the 131 NAT detections of malaria in asymptomatic blood donors, by Brazilian state, September 2022 to June 2026.
P. vivax was the most frequent species, with 60 detections (45.8%), followed by P. malariae, with 39 (29.8%), P. falciparum, with 9 (6.9%), and P. ovale, with 1 (0.8%); in 22 samples (16.8%), the species was not identified. The North Region accounted for 56 detections, but one of the most relevant findings occurred outside the Amazon: 34 of the 39 P. malariae cases were identified in the South and Southeast Regions.
Figure 3. Distribution of Plasmodium species identified by NAT Plus in blood donors, September 2022 to June 2026
These results demonstrate the ability of molecular screening to intercept donations from asymptomatic individuals and reveal a species profile that is not always evident through surveillance based on clinical cases. The identification of P. malariae in donors from the South and Southeast Regions is particularly relevant to transfusion safety and to understanding the silent circulation of the parasite. Lessons learned and integration with surveillance Brazil’s experience shows that a nationwide NAT strategy depends not only on the analytical performance of the assay, but also on a coordinated network integrating technology, logistics, information systems, external quality assurance, and communication between blood services and epidemiological surveillance. NAT adds a layer of protection to transfused blood by detecting infections that may escape clinical, epidemiological and laboratory assessment of the donor.
At the same time, NAT findings should be interpreted as complementary to—and not equivalent to—epidemiological surveillance records. NAT assesses a selected population of blood donors, predominantly asymptomatic, with transfusion safety as its primary purpose. In national surveillance, the SIVEP-Malária epidemiological surveillance system, used in the Amazonian Region, and SINAN, used in the Extra-Amazonian Region, record and monitor cases according to their respective epidemiological workflows. Therefore, differences in species distribution between these sources should not be interpreted as a direct comparison of prevalence.
This complementarity, however, is valuable. Molecular identification of Plasmodium in donors may signal silent circulation, support epidemiological investigations, and strengthen the interface between hemovigilance and surveillance of communicable diseases. With the inclusion of malaria, Brazil became a pioneer in adopting universal molecular screening for this infection in blood donors, transforming a laboratory innovation into an integrated tool for transfusion safety and public health.
Final message
The incorporation of malaria into Brazilian NAT represents the evolution of a national technological development policy initiated more than two decades ago. The accumulated experience demonstrates that universal molecular screening can simultaneously enhance recipient protection, modernize donor selection criteria, and generate complementary information for epidemiological surveillance. This strategy provides national coverage, laboratory quality, information integration, and support for the continuous analysis of epidemiological patterns identified among donors.
Key References
1. Brazil. Law No. 10,205, of March 21, 2001. Regulates §4 of Article 199 of the Federal Constitution and provides for the National Policy on Blood, Blood Components and Blood Products.
2. Rocha D, et al. The Brazilian experience of nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus infections in blood donors. Transfusion. 2018.
3. Brazil. Ministry of Health. Consolidation Ordinance GM/MS No. 5, of September 28, 2017.
4. Brazil. Ministry of Health. Ordinance GM/MS No. 11,685, of July 2, 2026.
5. Brazil. Ministry of Health. Multicenter NAT System Manager (GSM-NAT).
