FDAnews
www.fdanews.com/articles/208438-grifolss-procleix-plasmodium-assay-for-malaria-granted-a-ce-mark

Grifols’s Procleix Plasmodium Assay for Malaria Granted a CE Mark

July 1, 2022

Grifols has received a CE mark for its Procleix Plasmodium assay, a nucleic acid test that detects the presence of Plasmodium, the mosquito-borne parasite that causes malaria.

Designed to improve the safety of blood for transfusions, the automated assay uses a whole blood sample and detects the single-celled organism’s ribosomal RNA (rRNA), which is present in thousands of copies per parasite, providing equivalent sensitivity in individual and pooled samples, the company said.

The chemiluminescent test uses magnetic-based target capture and transcription-mediated amplification in its process.

Grifols said the assay will be available in all markets that accept CE mark certification. 

View today's stories