NEW YORK (360Dx) – Qiagen said on Monday after the close of the market that it has received regulatory approval from Health Canada for its QuantiFeron-TB Gold Plus (QFT-Plus) in vitro diagnostic test for latent tuberculosis infection.
QFT-Plus features antigens that measure the cell-mediated immune response to TB infection from both CD4 and CD8 T cells, providing a broader assessment of TB infection.
The assay also features a 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.
In peer-reviewed studies QFT-Plus has achieved a sensitivity of 94 percent and specificity of 97 percent.
The Health Canada approval of QFT-Plus follows its 2017 approval by the US Food and Drug Administration. Qiagen noted that the assay has also seen uptake in more than 75 countries across Europe, the Middle East, Africa, Asia, and Latin America, and that more than 2 million tests have been performed.
"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," Masae Kawamura, senior director for TB medical and scientific affairs at Qiagen, said in a statement. "Fully implementing TB elimination strategies in Canada will require testing that is both patient- and doctor-centered. QFT-Plus fulfills this need, as well as providing better surveillance capacity to tuberculosis programs with its electronic results."