Qiagen has secured approval from the Japan’s Ministry of Health Labor and Welfare for 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.
Qiagen TB medical and scientific affairs senior director Masae Kawamura said: “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.
“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).