QIAGEN’s QuantiFERON-TB Gold Plus Gains Approval in Japan
Product News Feb 11, 2018
QIAGEN N.V. announced that Japan’s Ministry of Health Labor and Welfare has approved QuantiFERON®-TB Gold Plus (QFT®-Plus) as an in vitro diagnostic to detect tuberculosis (TB) infection. QFT-Plus is the fourth generation of QIAGEN’s market-leading QuantiFERON-TB technology, combining innovative CD4+/CD8+ design for comprehensive immune response detection with the most flexible blood collection workflow for efficient screening in large-scale TB control programs.
“QuantiFERON-TB Gold Plus sets a new global standard for latent TB testing. The proprietary CD4+/CD8+ T cell technology of QFT-Plus, with the addition of specific CD8+T cell stimulating antigens, has the potential to provide important insights for high-risk patients such as contacts exposed to active TB or HIV-positive persons,” said Dr. Masae Kawamura, Senior Director, TB Medical and Scientific Affairs, at QIAGEN. “In 2015, the Japanese government set a goal to reduce the country’s tuberculosis incidence rate to 10.0 per 100,000 persons by 2020. We are very happy to contribute to achievement of that goal with QFT-Plus becoming an important tool for use in Japan’s comprehensive TB control efforts.”
Japan’s approval of QFT-Plus follows 2017 approval in the United States and successful uptake of the test in more than 75 countries across Europe, the Middle East, Africa, Asia and Latin America, where nearly two million of the new tests have already been used. QFT-Plus builds on the foundation of QuantiFERON-TB Gold® (QFT®), the third generation of QIAGEN’s world-leading interferon gamma release assay (IGRA).
QFT-Plus advances the science of TB testing with innovative antigens that measure the cell-mediated immune response to tuberculosis infection from both CD4+ and CD8+ T cells – providing a broader assessment of TB infection. CD8+ T cells have been shown to play an important role in Mycobacterium tuberculosis immunity. QFT-Plus includes the following new features:
• Optimized CD8+T cell responses – facilitating research on patient risk stratification of latent TB infections developing into active disease. Published evidence underlines the future potential of CD8+ T cells for distinguishing active from latent TB, discerning recent vs. old infections, detecting TB in certain populations such as HIV co-infection and young children, as well as assessing patient responses to TB treatment. No other test is optimized for both CD4+ and CD8+ T cell responses.
• Expanded blood collection options – enabling customers to take control of the TB testing workflow with blood collection options for flexibility in collection and transport. QFT-Plus offers a new standard single-tube collection option that allows larger volumes or remotely collected blood samples to be processed up to 53 hours after venipuncture for flexible transport to the lab. The existing “assay in collection tube” design for immediate stimulation of the blood sample continues to provide a direct draw option with the identical transport times as QuantiFERON-TB Gold (QFT), the third-generation assay.
• High sensitivity and specificity – QFT-Plus has a specificity of >97% and a sensitivity of >94%, producing more accurate results than the century-old tuberculin skin test (TST).
Tuberculosis is a contagious bacterial infection spread primarily through coughing by patients with the active pulmonary form of the disease. In 2016, the World Health Organization (WHO) estimates, there were 10.4 million new cases of active TB worldwide and 1.7 million deaths from TB. In latent tuberculosis infection (LTBI), the bacterium infects a person but produces no symptoms unless it progresses to the active disease. Screening of high-risk individuals and treatment for LTBI play an important role in tuberculosis control efforts in developed and emerging markets around the world.