The global burden of infections with human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) is substantial with 38 million people living with HIV, 257 million with HBV and 71 million with HCV. Altogether, these viral infections result in around 2 million deaths per year[1, 2]. Viral load (VL) determination of these viruses in plasma samples has shown to be essential in managing patients infected with these viruses. VL testing has been reliably performed for over 20 years by (semi)-automated molecular workflow platforms as for example Cobas Ampliprep/Cobas Taqman (Roche Diagnostics) (CAP/CTM) and m2000 SP/RT (Abbott molecular). Analysis of VLs has been used not only to detect active infections, but also to monitor the effect of antiviral treatment or to detect potential development of antiviral resistance of these viruses[3], [4], [5].

Some years ago more advanced platforms such as the Cobas6800/8800 (Roche Diagnostics) and Panther (Hologic) have been introduced for VL testing of HIV-1, HCV and HBV infections and for screening of blood products. Recently, two additional platforms became available, the Abbott Alinity m to replace their m2000 system and the NeuMoDx 96/288 systems (Qiagen, Hilden, Germany). These new molecular platforms are highly efficient, flexible and fully-automated, provide a sample-in-result-out format, enable random access and can be bidirectionally linked to laboratory information systems. Importantly, these platforms have been designed to not only run assays for viral detection in plasma but an increasing portfolio of diagnostic tests for other pathogens has been launched or are under development. Based on the medium-size sample throughput of the medical microbiology department of the Leiden University Medical Center (LUMC), the Alinity m and NeuMoDx 288 were considered interesting candidates to further automate the molecular diagnostic workflow. In addition, the accompanying CE-IVD marked assays enable compliance to the European Union (EU) In Vitro Diagnostic Regulations[6]. The throughput of the NeuMoDx 288 platform is 288 samples per 8 hour shift, with a time to result of the first samples of 60 minutes for DNA targets and 80 minutes for RNA targets[7]. The throughput of the Alinity m platform is approximately 300 samples every 8 hours with a time to first result of 115 minutes for both DNA and RNA targets[8].

Despite the availability of international standards, comparative studies between different diagnostic platforms have shown variation in the determined VL in the same samples[9], [10], [11]. The aim of the current study is comparative analysis of the clinical performance of the new real-time PCR assays for VL testing of HIV, HBV and HCV on the Alinity m and the NeuMoDx 288 platforms.