QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) welcomes the publication of a new systematic evaluation that underlines the unique benefits of the company's own test technology for the detection of tuberculosis (TB). The study confirms the leading position of QIAGEN in tuberculosis screening, which is based on the Interferon-Gamma Release Assay (IGRA) QuantiFERON-TB Gold Plus. The test is unique on the market because it includes two primary blood collection tubes - TB1 and TB2 - and can thus detect the reaction of CD4 T cells in TB1 and additionally the reaction of CD8 T cells in TB2.

The meta-analysis of QuantiFERON tests was carried out by Universitas Padjadjaran, Indonesia, and published in the journal Clinical Chemistry and Laboratory Medicine (CCLM).¹ In the systematic evaluation, which takes into account 17 studies with a total of 4,050 subjects, a higher release of interferon gamma (IFN-γ) was detected in the QuantiFERON-TB Gold This confirms the important role that CD8 T cells play in the comprehensive immunological assessment of TB infections.

A subgroup analysis in certain population groups showed that the differences in IFN-γ release between the TB2 and TB1 tubes were significantly greater in subjects with active TB than in subjects with latent TB. The medical professional community has long been looking for ways to distinguish between active TB and latent infections in order to be able to classify patients into risk groups. The result of the study shows a significant response of CD8 T cells in subjects with active TB and could be related to the increased TB bacterial load in these subjects.

The study also highlighted the possible benefit of the TB2 tube for CD8 detection in certain risk groups such as immunocompromised people and in particular people with a CD4 T cell deficiency. It provided additional insights into the medical relevance of the detection of the response of CD4 and CD8 T cells for the diagnosis of TB (including the disease) - a unique selling point of QuantiFERON

"In order to prevent the spread of TB, it is crucial to be able to detect TB infections in risk groups. This also plays an important role in the ambitious goals of the World Health Organization's "EndTB" strategy - in particular in reducing TB-related deaths by 90% by 2030 compared to 2015," says Dr. Davide Manissero, M.D., Chief Medical Officer of QIAGEN. "Based on the results of this large systematic evaluation, it should be further examined what role the Quanti The results also encourage us to constantly invest in our diagnostic products and to further improve them. In this way, we want to create added value for patients and respond to the needs of the medical professional."

Tuberculosis is a bacterial infectious disease that is mainly spread by the cough of those affected by the active, pulmonary form of the disease. The World Health Organization (WHO) expects more than 10 million new cases of active TB worldwide and 1.6 million deaths from TB in 2021. The screening of risk groups and the treatment of TB infections play an important role in TB control both in the USA and many European countries as well as in other industrialized countries and emerging countries.

QuantiFERON-TB Gold Plus is the world's leading IGRA blood test and is used millions of times a year. The test is a better alternative to the outdated tuberculin skin test. This is less meaningful for people with BCG vaccination - a common vaccination in countries with a high TB disease burden - and for people who do not appear for the second doctor's appointment to evaluate the test. QuantiFERON-TB Gold Plus supports patients and medical staff worldwide: Only a single doctor's appointment is necessary for blood collection, with a shortened waiting time for the result.

QuantiFERON-TB Gold Plus uses an optimized workflow and works with whole blood samples instead of purified lymphocytes - and is thus different from other IGRA tests. To combat the global TB epidemic, the international guidelines of the Centers for Disease Control and Prevention (CDC) and the WHO recommend the use of blood tests such as QuantiFERON-TB Gold Plus in all areas.