Grifols Procleix ArboPlex Assay receives CE mark
This is the first four-in-one nucleic acid test for arbovirus screening
8 Apr 2024
Grifols, a producer of plasma-derived medicines and innovative diagnostic solutions, has announced its new Procleix ArboPlex Assay® has obtained the CE mark under the In Vitro Diagnostic Regulation (IVDR). This is a first for an automated nucleic acid test (NAT) specifically validated for screening blood donors to detect four major arboviruses: chikungunya, dengue, West Nile and Zika viruses.
These are the four most significant arboviruses of concern, all spread through mosquito vectors. Changes in climate and increasing global connectivity have made the geographic spread of – and growing exposure to – arboviruses a major public health concern.
Further strengthening the Grifols Procleix portfolio for blood donor screening, the Procleix ArboPlex Assay uses plasma or serum samples to detect arboviral RNA. Currently, risk for arboviruses in blood donors is evaluated either with a monoplex test, duplex test, or through a questionnaire in which donors who declare having traveled to or prior residence in arbovirus-endemic areas are temporarily deferred. Blood banks and collection centers could decide that deferrals are unnecessary if donors were tested and found negative using the Procleix ArboPlex Assay.
Reliably detect the presence of RNA
The Procleix ArboPlex Assay is a NAT that uses magnetic-based target capture, transcription-mediated amplification (TMA) and chemiluminescence to detect the presence of RNA sequences of four arboviruses (chikungunya virus, dengue virus RNA, West Nile virus RNA, and Zika virus) in plasma and serum from human 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. The assay runs on the Procleix Panther System, an automated NAT instrument from Grifols.
Automate NAT-based blood screening
The Procleix Panther System automates all aspects of NAT-based blood screening on a single, integrated platform, and is capable of delivering the highest result throughput per square meter. It eliminates the need for batch processing and combines walk-away freedom with intuitive design for ease of use.