Low complexity TB infection screening test
QIAGEN has partnered with Ellume to develop a new version of a QuantiFERON-based tuberculosis (TB) test dedicated and tailored to the needs of low-resource regions with a high disease burden of TB. The new testing solution, QuantiFERON-TB Access (QFT Access), is designed to pair ultrasensitive digital detection of TB infection with a complete workflow created with a focus on cost efficiency and ease of use. TB screening and prevention in these settings is necessary for achieving the goals of the World Health Organization's END TB strategy to reduce TB deaths by 90% and TB incidence by 80% by 2030. QuantiFERON-TB Access is a room temperature stable assay for TB infection utilizing 1 ml of whole blood in a single tube containing innovative and TB-specific CD4 and CD8 T cell stimulants. Interferon gamma is detected in the plasma with a single-use, ultra-sensitive digital detection device with onboard data storage and analysis. Results are available in less than 20 min post incubation and can be displayed on a reusable eHub with battery backup, reducing the requirements for a computer, equipment calibration and maintenance. QFT Access will accommodate single user throughput that is scalable from a single test up to at least 20 tests per hour. The low complexity design requires only 5 minutes of hands-on time, reduces overall costs per result and will aid in the diagnosis of TB infection in high-burden low-resource settings.