12 April 2019 - - Dutch life science company Qiagen N.V.'s (NYSE: QGEN) QuantiFERON-TB test for detection of latent tuberculosis infections has surpassed 60m tests administered, the company said.

Qiagen said it is continuing to improve and innovate with new automation options for the fourth-generation QuantiFERON-TB Gold Plus (QFT-Plus) test which will continue to drive rapid growth in the conversion of latent TB testing from the century-old technology of tuberculin skin tests to Qiagen's modern, accurate and efficient blood test.

The global fight against tuberculosis, the world's most deadly infectious disease, is a major focus at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2019), taking place April 13-16 in Amsterdam, Netherlands.

Numerous presentations will deal with prevention, diagnosis and treatment of the disease, in its active contagious stage or as a latent infection, in at-risk populations.

Four studies focusing specifically on applications of QFT-Plus will be presented at ECCMID 2019.

Qiagen continues to enhance the ease of use, efficiency and accessibility of QuantiFERON-TB tests:

A read-out kit for QuantiFERON-TB Gold Plus, which was CE-IVD marked in 2018, is rolling out in Europe and other markets as part of DiaSorin's broad menu of tests for its LIAISON chemiluminescent immunoassay platforms.

This efficient automated solution for analysis of QFT-Plus is expected to be available in 2019 in the United States and in 2020 in China. 

DiaSorin has placed more than 7,000 LIAISON instruments in hospitals and laboratories around the world.

Qiagen said it is partnering with two leaders in liquid handling solutions to provide options for automated aliquoting of samples from the single tube option to the QuantiFERON-TB Gold Plus Tubes for analysis with the QFT-Plus assay, for those customers who choose to implement a single tube collection process.

The collaborations integrate the Hamilton Robotics Microlab STAR automated liquid handling workstation into the QFT-Plus assay workflow, or the Tecan Fluent Laboratory Automation workstation to automate the manual step of aliquoting of samples from a single collection device such as Lithium Heparin blood collection tube into the QuantiFERON-TB Gold Plus workflow.

In partnership with Ellume, a digital diagnostics developer, Qiagen is developing QuantiFERON-TB Access (QFTAccess) as a novel workflow dedicated to the needs of low-resource regions with a high disease burden of TB.

The global community has an unmet need for a low complexity, highly accurate test for latent TB designed with a focus on cost efficiency and ease of use that brings the best in class QuantiFERON technology to these settings.

Clinical trials for QFT Access are planned for this year, and commercialization is expected to begin in 2020.

QuantiFERON-TB Gold Plus combines a flexible new blood collection workflow with innovative CD4/CD8 T cell technology to enable the most comprehensive TB immune response detection available.

Now marketed in more than 75 countries, QFT-Plus has been adopted by many organisations such as the International Organization for Migration and the International Panel Physicians Association. 

More than 20 peer-reviewed publications to date have supported the performance of QFT-Plus, and studies underway in 22 countries involve more than 30,000 patients.

Tuberculosis is a contagious bacterial infection spread primarily by coughing of patients with the active pulmonary form of the disease.

In 2017, the World Health Organization estimates, there were 10m new cases of active TB worldwide and 1.6 m deaths from TB.

In latent tuberculosis infection, the bacterium infects a person but produces no symptoms unless it progresses to the active disease.

On a global basis, approximately one out of four people are estimated to have latent TB infection, and about 5-10% of those individuals, if untreated, will progress to active tuberculosis at some point in their lifetimes.