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.

[1] Darmawan, Guntur et al: “Comparison of interferon-gamma production between TB1 and TB2 tubes of QuantiFERON-TB Gold Plus: a meta-analysis” Clinical Chemistry and Laboratory Medicine (CCLM), 2023. https://doi.org/10.1515/cclm-2023-0293


QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of March 31, 2023, QIAGEN employed more than 6,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations, markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.
Category: Corporate

CONTACT: John Gilardi QIAGEN N.V. +49 2103 29 11711 [email protected] Phoebe Loh QIAGEN N.V. +49 2103 29 11457 [email protected] Thomas Theuringer QIAGEN N.V. +49 2103 29 11826 [email protected] Daniela Eltrop QIAGEN N.V. +49 2103 29 11676 [email protected] 

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