Qiagen and DiaSorin have secured approval from the US Food and Drug Administration (FDA) to use QuantiFERON-TB Plus (QFT-Plus automated screening solution) on the latter’s LIAISON platforms for detecting latent tuberculosis (TB).

With the FDA approval, Qiagen and Diasorin can perform laboratory automation for latent TB screening, which will support the conversion from tuberculin skin tests to the blood-based QuantiFERON technology.

The automated workflow on LIAISON platforms is said to be a flexible option for all throughput ranges for QuantiFERON customers. Furthermore, a new assay option with significant growth potential for LIAISON customers is said to be offered through the embedding of QuantiFERON assays in the assay menu of DiaSorin’s LIAISON analyzers.

The workflow will pair up Qiagen’s standard QuantiFERON-TB Gold Plus Blood Collection Tubes (QFT-Plus BCT which contains the core QuantiFERON technology) and DiaSorin’s recently launched LIAISON QuantiFERON-TB Plus detection assay.

Carlo Rosa – DiaSorin Group CEO said: “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 began their collaboration in 2017 to develop new tests for the LIAISON family of analyzers based on the former’s assay technologies.

Additional tests based on QuantiFERON technology have been planned to be adopted to the LIAISON platforms, which are expected to offer an efficient way to detect asymptomatic infections and other risks which may not be detected using standard diagnostic technologies.

Apart from the collaboration, QIAGEN is partnering with two major liquid handling solutions providers to offer options for automated pre-analytical processing for customers who use single-tube collection process for QFT-Plus.

QuantiFERON-TB Gold and QFT-Plus tests are blood tests for latent TB developed by the Netherlands-based QIAGEN.

Thierry Bernard – Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area said: “We are pleased to announce FDA approval of the LIAISON QuantiFERON-TB Gold Plus Test for use on the LIAISON platform and the broad-based initiation of our launch for this new automation option in the United States. The validation of the QuantiFERON technology with the LIAISON platforms further reinforced the clinical profile of QuantiFERON-TB Gold Plus.

“QFT-Plus users are gaining access to the LIAISON’s powerful, highly flexible automation for all throughput segments, as well as to LIAISON’s broad menu of more than 100 tests. The LIAISON workflow for QFT-Plus was introduced in Europe in 2018 and is planned for China in 2020.

“Combined with front-end automation options for liquid handling, the LIAISON workflow for QFT-Plus delivers significant gains in turnaround time and efficiency.”

  Carlo Rosa, DiaSorin, FDA, Food and Drug Administration, LIAISON platforms, Netherlands, Qiagen, QuantiFERON technology, QuantiFERON-TB Plus, Thierry Bernard, tuberculosis, US Food and Drug Administration