Adventitious Virus Detection For Viral Safety Testing With The QIAseq xHYB MAP/HAP/RAP Panel

By Matthew Fosbrink, Megan Zais, Dylan Barbera, and Jonathan Shaffer

Ensuring viral safety remains a critical requirement in biopharmaceutical development, particularly as products grow more complex and timelines continue to compress. This application note explores a modern, molecular approach to adventitious virus detection using hybrid capture–based targeted sequencing aligned with ICH MAP, RAP, and HAP testing expectations. It examines how hybrid capture–based targeted sequencing compares to traditional in vitro, in vivo, and shotgun metagenomic methods, with a focus on sensitivity, specificity, and genome coverage at low viral copy numbers. Real-world performance data demonstrate the ability to confidently detect multiple viral targets down to 10 copies, while maintaining uniform coverage and tolerance to sequence variation. By reducing reliance on animal-based assays and improving detection efficiency, this approach supports more robust viral safety strategies for cell banks, raw materials, and biopharmaceutical products. The workflow also demonstrates substantial enrichment over shotgun sequencing, enabling sensitive detection with fewer sequencing reads and lower per-sample costs.

Find out how targeted sequencing can strengthen adventitious agent testing workflows.