Molecular diagnostics firm Qiagen has received the US Food and Drug Administration (FDA) approval for its fourth-generation blood test developed to detect latent tuberculosis (TB) infection.
The new QuantiFERON-TB Gold Plus (QFT-Plus) test features CD8+ technology, which is expected to improve the insights into the immune system's response to TB infection.
Initially launched last year, the test is currently available in more than 75 countries across the Middle East, Europe, Africa, Asia, and Latin America.
Qiagen Molecular Diagnostics business area senior vice-president and head Thierry Bernard said: “We can now bring a range of very attractive clinical and workflow benefits to customers who have helped us to create the market-leading latent TB testing franchise.”
The firm has incorporated CD8+ T cell response data into the test to allow research on the risk stratification of infections that may develop into active disease.
The response data is expected to provide researchers with new information by measuring a wider range of immune response.
Reportedly, CD8+ T cells may play an important role in differentiating active and latent TB, and recent and old infections. It will also help detect the infection in risk populations and assess the response to treatment.
The test includes an option for standard single-tube blood collection to facilitate sample processing for up to 53 hours after venipuncture, without affecting the test accuracy.
The approval is based on the evidence from nine independent peer-reviewed publications that confirmed QFT-Plus’ performance, which is being further validated in additional studies being conducted across 22 countries in approximately 30,000 patients.