The approval will let Qiagen and DiaSorin offer streamlined laboratory automation for latent TB screening
Image: Qiagen and DiaSorin secure FDA approval for new TB test. Photo: Courtesy of stockdevil/FreeDigitalPhotos.net
Qiagen and DiaSorin have received the US Food and Drug Administration’s (FDA) approval for the use of QuantiFERON-TB Plus (QFT-Plus) on DiaSorin’s LIAISON platforms for latent tuberculosis (TB) detection.
The approval will let Qiagen and DiaSorin offer streamlined laboratory automation for latent TB screening, supporting the conversion from tuberculin skin tests to modern blood-based QuantiFERON technology.
The automated workflow on LIAISON platforms offers QuantiFERON customers, a flexible option for all throughput ranges. LIAISON customers are also offered a new assay option with significant growth potential, with the embedding of QuantiFERON assays in the assay menu of DiaSorin’s LIAISON analyzers.
The workflow combines Qiagen’s standard QuantiFERON-TB Gold Plus Blood Collection Tubes (QFT-Plus BCT, containing the core QuantiFERON technology) with DiaSorin’s newly launched LIAISON QuantiFERON-TB Plus detection assay.
DiaSorin Group CEO Carlo Rosa said: “Today we made a step further in our strategy to drive the conversion to the most advanced solution available in the market for the detection of latent tuberculosis.
“LIAISON QuantiFERON-TB Gold Plus Test, already available in Europe since September 2018, is now available in the United States on the LIAISON family platforms and we believe this solution for laboratories will furtherly strengthen our positioning as a specialty player.”
Qiagen and DiaSorin have been working together since 2017
The collaboration between Qiagen and DiaSorin began in 2017 to develop new tests for the LIAISON family of analyzers based on Qiagen’s assay technologies.
Additional tests based on QuantiFERON technology, which offer a efficient way to detect asymptomatic infections and other risks that may not be detected with standard diagnostic technologies, have been planned to be adopted to the LIAISON platforms.
Besides, QIAGEN is partnering with two major players in liquid handling solutions to offer options for automated pre-analytical processing for customers who implement the single-tube collection process for QFT-Plus.
QIAGEN’s QuantiFERON-TB Gold (QFT) and QFT-Plus tests are blood tests for latent TB. QuantiFERON-TB Gold Plus is registered in over 75 countries in North America, Europe, Asia, Africa and Latin America.