NEW YORK – Qiagen said on Monday that its QuantiFeron-TB Gold Plus (QFT-Plus) assay for tuberculosis diagnosis has been approved by China's National Medical Products Administration.
The new approval is for diagnosing both latent and active TB infections and builds on prior regulatory approvals for QFT-Plus in the US and other countries around the world, including CE-IVD marking. QFT-Plus also improves upon a previous generation of the QuantiFeron test that received Chinese regulatory approval by enabling even more accurate detection of infection, including in immunocompromised people, Qiagen said.
QuantiFeron-TB Gold Plus is an interferon-gamma release assay (IGRA), an immunoassay that uses blood samples to test for interferon-gamma molecules released from T cells that have come into contact with TB bacteria. Testing requires one patient visit and produces a result in 20 minutes after sample incubation.
In China, all available IGRA tests including QFT-Plus are licensed to rule out active TB. Other countries generally use these tests to detect latent TB, in which infected individuals have the potential to develop active disease.
"QuantiFeron TB-Gold Plus is much easier for our laboratory technicians to use than other tests — it doesn't require complicated lab technology and is easily scalable for the kind of high-throughput testing we need," Gao Lei, a professor at the Institute of Pathogen Biology at the Chinese Academy of Medical Sciences, said in a statement. "The world needs new technologies and methods to contest TB, and Qiagen's IGRA technology is playing a crucial role here."
In a January policy statement from the World Health Organization, QFT-Plus and a relatively new IGRA from Chinese firm Beijing Wantai were found to have comparable performance to previously WHO-recommended IGRAs for TB detection, which include Qiagen's prior-generation QuantiFeron tests and PerkinElmer's Oxford Immunotec T-Spot.TB assay, prompting WHO to note that its recommendations are valid for the new tests.
WHO also noted that, based on available data, Qiagen's QiaReach QuantiFeron-TB (a point-of-care version of the test developed with Australian company Ellume), SD Biosensor's Standard E TB-Feron ELISA, and the Oxford Immunotec T-Spot.TB 8 with T-Cell Select could not be adequately compared with previously recommended IGRAs and thus require further evaluation.