Tuberculosis Diagnosis: Improved Blood Test by Qiagen to Hit Shelves

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This kit, which will be sold starting October 9, 2017, is the fourth installment of tuberculosis testing from Qiagen.
This kit, which will be sold starting October 9, 2017, is the fourth installment of tuberculosis testing from Qiagen.

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).

Reference

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.

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