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Automated Nucleic Acid Test (NAT) System Screens Blood Donors for Malaria

By LabMedica International staff writers
Posted on 10 Jun 2022
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Image: Procleix Plasmodium Assay is the first nucleic acid test for malaria blood screening to receive CE mark (Photo courtesy of Grifols)
Image: Procleix Plasmodium Assay is the first nucleic acid test for malaria blood screening to receive CE mark (Photo courtesy of Grifols)

Plasmodium is a mosquito-borne parasite that causes malaria and is responsible for more than 240 million infections and 620,000 deaths annually. The protozoan parasite creates a significant risk for both blood safety and availability. Screening blood donors can reduce the risk of transfusion-transmitted malaria (TTM) and enhance blood availability by reducing the number of donors rejected and deferred due to malaria risk. Now, a nucleic acid test (NAT) for blood donor screening detects the presence of Plasmodium to improve blood safety.

Grifols’ (Barcelona, Spain) Procleix Plasmodium Assay, designed for NAT, uses magnetic-based target capture, Transcription-Mediated Amplification (TMA) and chemiluminescence to detect the presence of specific ribosomal RNA sequences of five species of Plasmodium parasites that cause malaria in humans (P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) in whole blood specimens from blood donors. The high sensitivity and specificity of the Procleix technology enables pathogen detection to reduce the risk of transfusing infected blood or blood components, even when the donor does not exhibit symptoms and traditional screening techniques are not able to detect the presence of the pathogen, or the antibodies against it. The assay runs on the widely adopted Procleix Panther System, an automated NAT instrument from Grifols.

Currently, risk for malaria in blood donors is typically evaluated using a questionnaire in which donors who declare having traveled to or prior residence in malaria-endemic areas are temporarily deferred. Blood banks and collection centers could decide that deferrals could be unnecessary if donors were tested and found negative using the Procleix Plasmodium Assay. The assay has obtained the CE mark, the first for an automated NAT system specifically validated for screening blood donors for malaria, and will be available in all markets accepting the CE mark certification.

"We are excited to announce the CE mark certification of an additional Procleix assay, demonstrating Grifols' continued commitment to transfusion safety," said Antonio Martínez, President, Grifols Diagnostic Business Unit. "Certification of the Procleix Plasmodium Assay enhances the ability of blood banks in Europe to provide safer blood transfusions."

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