Feb. 28, 2018—The U.S. Centers for Disease Control and Prevention issued a notification to U.S. civil surgeons stating it will require the use of FDA-approved interferon gamma release assays for tuberculosis screening. The CDC plans for the change to go into effect Oct. 1. The use of the tuberculin skin test will no longer be allowed for use in immigration screening, including for children under age five.
Qiagen said in a statement that it welcomes the decision by the CDC to use the blood-based test. The company’s QuantiFeron-TB Gold Plus (QFT-Plus) assay, which was approved by the FDA in June 2017, is one of the tests that can be used for screening.
“We look forward to working with the civil surgeons around the U.S. in this transition period since switching from the TB skin test to tests like QFT-Plus can eliminate false-positive results from BCG vaccination used in most countries. This makes the QFT-Plus results more accurate and believable to both the physician and the patient, ” Masae Kawamura, MD, senior director of TB medical and scientific affairs at Qiagen, said in a statement.
QFT-Plus adds CD8 T-cell stimulating antigens to existing CD4 antigens, which provides a broader immune assessment of TB infection.