First 4-in-1 Nucleic Acid Test for Arbovirus Screening to Reduce Risk of Transfusion-Transmitted Infections

Arboviruses represent an emerging global health threat, exacerbated by climate change and increased international travel that is facilitating their spread across new regions. Chikungunya, dengue, West Nile, and Zika viruses are the four most significant arboviruses of concern, all being transmitted by mosquito bites. In 2023 alone, dengue virus accounted for over five million cases and 5,000 deaths worldwide. Traditionally, assessing the risk of arboviruses in blood donors has relied on single-pathogen tests, dual-pathogen tests, or donor history questionnaires, with those having traveled to or lived in areas endemic for arboviruses being temporarily deferred. Now, an in vitro nucleic acid test that can detect all four types of arboviruses can help minimize the risk of blood transfusion-transmitted infections.

The new Procleix ArboPlex Assay from Grifols (Barcelona, Spain) is an automated nucleic acid test (NAT) specifically validated for screening blood donors to detect chikungunya, dengue, West Nile and Zika viruses. The assay utilizes magnetic-based target capture, Transcription-Mediated Amplification (TMA), and chemiluminescence to detect the presence of RNA sequences of the four arboviruses in plasma and serum samples of human donors. The Procleix technology ensures high sensitivity and specificity in pathogen detection which is crucial for reducing the transmission risk from blood transfusions, particularly from asymptomatic donors. With this assay, blood banks and collection centers can reconsider deferrals for donors who test negative, ensuring a safer blood supply.

Image: The Procleix ArboPlex Assay has received the CE mark (Photo courtesy of Grifols)

The Procleix ArboPlex Assay runs on the Procleix Panther System, Grifols' NAT platform that automates the entire NAT-based blood screening process on a single, integrated platform. This fully automated system optimizes operational efficiency and offers the highest result throughput per square meter without the need for batch processing. The Procleix Panther System also eliminates the need for batch processing and combines walk-away freedom with intuitive design for ease of use. The Procleix ArboPlex Assay has obtained the CE mark under the In Vitro Diagnostic Regulation (IVDR), the first for a NAT specifically validated for screening blood donors to detect four major arboviruses.

“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, demonstrating Grifols’ continued commitment to innovating blood screening safety.”