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QIAGEN’s QuantiFERON-TB Gold Plus shows unique clinical value with CD8 technology

QIAGEN’s QuantiFERON-TB Gold Plus shows unique clinical value with CD8 technology in new meta-analysis of tuberculosis screening
  • First-of-its-kind systematic review on the clinical relevance of test values from the QuantiFERON-TB Gold Plus TB1 and TB2 blood collection tubes has been published

  • Study including 4,050 subjects highlights the value of the TB2 tube and the detection of CD8 T-cell responses for immunocompromised patients, a key risk group for TB disease

  • Higher interferon-gamma production difference between TB2 and TB1 tubes in active TB compared to latent TB subjects suggests stronger CD8 T-cell response

Venlo, the Netherlands, June 15, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) welcomes the publication of a new, systematic review highlighting the unique value of its proprietary tuberculosis (TB) testing technology. The study highlights QIAGEN’s continued leadership in TB infection screening, centered on QuantiFERON-TB Gold Plus test, an interferon-gamma release assay (IGRA). The test is unique to the market in featuring two primary blood collection tubes – TB1 and TB2 – enabling detection of responsive CD4 T-cells in TB1, and additionally, CD8 T-cell responses in TB2.


The meta-analysis on QuantiFERON testing was conducted by Universitas Padjadjaran, Indonesia, and published in Clinical Chemistry and Laboratory Medicine (CCLM)[1]. The systematic review, based on 17 studies and including 4,050 subjects, showed a higher level of interferon-gamma (IFN-γ) production in the QuantiFERON-TB Gold Plus TB2 tube than in the TB1 tube, confirming the important role of CD8 T-cells for a broad immune assessment of TB infection.


Subgroup analysis in specific populations revealed that the difference of IFN-γ production between the TB2 and TB1 tubes was significantly higher in active TB disease subjects than in those with latent TB. The ability to differentiate active TB disease from latent infection has long been sought by the medical community to help stratify patient risk. This result likely reflects a significant CD8 T-cell response in active TB subjects and may be related to the increased tuberculosis bacterial load in these individuals.


The study also highlighted the potential benefit of the TB2 tube for CD8 detection in certain high-risk populations, such as immunocompromised patients, and especially those having CD4 T-cell deficiency. It provided additional insights into the medical relevance for detection of both CD4 and CD8 T-cell responses in the context of diagnosis of TB infection (including disease), a feature unique to the QuantiFERON-TB Gold Plus assays.


“Identifying TB infection in high-risk individuals is critical to preventing the spread of TB. It plays a vital role in achieving the World Health Organization's ambitious EndTB strategy goals, particularly in reducing TB-related deaths by 90% by 2030, compared to 2015 levels,” said Dr. Davide Manissero, M.D., Chief Medical Officer of QIAGEN. “The results of this large systematic review warrant further exploration of the role of patient stratification that QuantiFERON TB testing could offer. It also validates our broader strategy of continual investment and improvement of our diagnostic products with the aim to bring increased value to patients and to address the needs of the medical community.”


Tuberculosis is a contagious bacterial infection spread primarily by coughing of patients with the active pulmonary form of the disease. The World Health Organization (WHO) estimated that there were more than 10 million new cases of active TB worldwide and 1.6 million deaths from TB in 2021. Screening of high-risk individuals and treatment for TB infection plays an important role in TB control efforts in the U.S. and many European countries, as well as in other developed and emerging markets around the world.


QuantiFERON-TB Gold Plus is the world’s leading IGRA blood test, with millions of tests performed annually. It has established itself as a superior alternative to the dated TB skin test (TST), which is less effective in identifying TB infection in people who have received BCG vaccination, which is common for patients from high-TB-burden countries, and in patients who may be unlikely to return for TST interpretation. QuantiFERON-TB Gold Plus has helped patients and providers globally by reducing the number of visits to a single blood draw with a faster turnaround time.


QuantiFERON-TB Gold Plus sets itself apart from other IGRA tests with a streamlined workflow and the use of whole blood samples, not purified lymphocytes. International guidance from the CDC and the WHO support the use of blood tests like QuantiFERON-TB Gold Plus in all settings as part of the fight to end the global TB epidemic.


More information about TB testing and QuantiFERON-TB Gold Plus is available at https://www.qiagen.com/End-TB.




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