Multi-Center Study Confirms Value of QIAGEN’s QuantiFERON®-TB Gold Plus

QIAGEN N.V. has announced a major published study evaluating its novel QuantiFERON^®-TB Gold Plus, the fourth-generation of QIAGEN’s industry-leading test for tuberculosis (TB) infection. Results of the multi-center study, published ahead of print in the peer-reviewed European Respiratory Journal on February 12, confirmed that QuantiFERON-TB Gold Plus demonstrates excellent performance, with a diagnostic sensitivity estimated at 88% and a specificity of 97%. Notably, among subjects co-infected with HIV and TB, the QuantiFERON-TB Gold Plus result was positive in all of them, demonstrating 100% sensitivity in this challenging patient population.

“This publication by leading European experts provides the medical community with independent confirmation of the excellent performance of QuantiFERON-TB Gold Plus as demonstrated in our validation and registration studies,” said Dr. Masae Kawamura, Senior Director of Medical and Scientific Affairs for QIAGEN. “Introduced in Europe in 2015, QuantiFERON-TB Gold Plus helps clinicians get accurate, reliable results to detect latent TB infection and to protect vulnerable patients from active TB. The authors also noted the potential value of additional clinical information provided by the proprietary CD8 T-cell technology in QuantiFERON TB-Gold Plus.”

The study of QuantiFERON TB-Gold Plus was led by Dr. Daniela Cirillo, Director of the Supranational Reference Laboratory at the San Raffaele Scientific Institute in Milan, and included leading experts from six sites across Europe. The investigators assessed the sensitivity and specificity of QuantiFERON-TB Gold Plus by testing 225 people, 119 patients with active TB and 106 low-risk control subjects. The active TB group consisted of patients with TB that was confirmed microbiologically (either by nucleic acid amplification or culture) and included immunocompromised individuals, such as people living with HIV infection.

The authors also commented on the CD8 T-cell technology of QuantiFERON-TB Gold Plus, the only test for TB infection that offers the ability to distinguish between CD4 and CD8 T-cell responses. The investigators found a statistically significant difference in responses for the two T-cell types and suggested further studies. “The novel CD8 technology is providing interesting signals on potential additional interpretation of the TB infection spectrum and risk assessment. Studies are needed to further explore this,” Dr. Cirillo said. Around 20 studies of QuantiFERON-TB Gold Plus have been initiated to date, and QIAGEN expects further publications in 2016.

QIAGEN partners with governments and health organizations around the world to fight tuberculosis – and continues to develop innovative new technologies. QuantiFERON-TB Gold is the modern standard for accuracy in latent TB infection diagnosis – faster, less labor-intensive and more accurate than the tuberculin skin test. QuantiFERON-TB-Gold’s clinical reliability and simpler administration enhance the accuracy of screening and improve the cost-effectiveness of TB control. In 2015 QIAGEN launched QuantiFERON-TB Gold Plus in Europe and other markets as a fourth-generation test with CE-IVD marking. To date, more than 20 million tests using QuantiFERON-TB technology have been distributed globally.