Grifols, a global 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 the first 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.
With the dengue virus alone, there were more than 5 million cases and 5,000 deaths reported globally in 2023.1
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 travelled to or prior residence in arbovirus-endemic areas are temporarily deferred.
Blood banks and collection centres could decide that deferrals are unnecessary if donors were tested and found negative using the Procleix ArboPlex Assay.
“With its 4-in-1 arbovirus test feature, the Grifols Procleix ArboPlex Assay has the ability to speed up and overall improve donor screening laboratory efficiency,” said Antonio Martínez, president of Grifols Diagnostic Business Unit. “Certification of this new assay provides a reliable and efficient solution to ensure accurate and consistent results.”
The Procleix ArboPlex Assay will be available in all markets accepting the CE mark certification after completion of any additional registration and notification requirements.
