The Netherlands-based molecular diagnostic giant, Qiagen, announced on October 5, 2017, the marketing of an improved blood test for tuberculosis (TB) infection, QuantiFERON-TB Gold Plus (QFT-Plus).1 This kit, which will be sold starting October 9, 2017, is the fourth installment in TB testing from Qiagen, 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.”
In addition, QFT-Plus includes the following improvements over previous versions:
- Optimization for the detection of CD8 T-cell responses, allowing it to discriminate active vs latent TB (ie, recent vs old infections), detect TB in patients with HIV, and assess response to TB treatment.
- Flexibility in both collection, with a single-tube blood collection option allowing for direct draw, and transport, with processing time up to 53 hours after venipuncture.
- High sensitivity (>94%) and specificity (>97%).
“The proprietary CD4+/CD8+ T cell technology of QFT-Plus has the potential to provide important insights for high-risk patients such as contacts exposed to active TB or HIV-positive persons while maintaining high specificity,” said Masae Kawamura, MD, senior director, TB Medical and Scientific Affairs, Qiagen, in a company press release.1 “In the United States, test accuracy has never been more important as the country aggressively fights to end [TB] through recent policy-driven expansion of targeted testing and preventive treatment. It is currently estimated that 93% of the TB disease in the U.S. comes from the 13 million-person reservoir of latent TB infection,” she added.
The US Food and Drug Administration approved QFT-Plus last June,2 after completion of 2 clinical trials assessing its efficacy (ClinicalTrials.gov identifiers: NCT02142894 and NCT02256839).
QIAGEN launches fourth-generation QuantiFERON®-TB Gold Plus in the U.S. [press release]. Germantown, Maryland: QIAGEN. Updated October 5, 2017. Accessed October 6, 2017.