Grifols has received the CE mark approval for its new Procleix ArboPlex Assay to screen blood donors for four major arboviruses, chikungunya, dengue, West Nile and Zika viruses.
The Procleix ArboPlex Assay is a nucleic acid test (NAT) that leverages magnetic-based target capture, transcription-mediated amplification (TMA) and chemiluminescence.
It runs on the Procleix Panther System, which automates all aspects of NAT-based blood screening on a single unified platform and detects the RNA sequences of the arboviruses.
Procleix ArboPlex Assay is the first automated NAT specifically validated for screening blood donors to detect four major arboviruses, said the Spanish healthcare company.
Grifols intends to commercialise the assay in all markets accepting the CE mark certification, following any additional registration and notification requirements.
Grifols diagnostic business unit president Antonio Martínez said: “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.
“Certification of this new assay provides a reliable and efficient solution to ensure accurate and consistent results, demonstrating Grifols’ continued commitment to innovating blood screening safety.”
According to the company, chikungunya, dengue, West Nile and Zika viruses are the four most significant arboviruses of concern, all spread through mosquito vectors.
The changes in climate and increasing global connectivity have contributed to the geographic spread and enhanced exposure to arboviruses, which are a major public health concern.
Currently, the risk for arboviruses in blood donors is checked either with a monoplex test, duplex test or through a questionnaire, in which donors’ declaration may temporarily defer.
Grifols said that its Procleix ArboPlex Assay uses plasma or serum samples to detect arboviral RNA, further strengthening its Procleix portfolio for blood donor screening.
The blood banks and collection centres are enabled to decide that deferrals are unnecessary if donors are tested and found negative using the assay.
