More than 10 million people contract TB each year with the disease killing 1.7 million people annually. Bacterial culture is still commonly used to diagnose TB and to identify drug-resistant TB cases in much of the world.
Bacterial culture tests can take several weeks to provide a final result and are unable to detect a substantial fraction of individuals with active TB disease. More recently developed molecular tests can reduce the time required for TB diagnosis, but also can have poor ability to detect certain manifestations of TB disease and are not useful in monitoring patient responses to anti-TB therapy.
Researchers at the Tulane, School of Medicine https://medicine.tulane.com have performed multiple preclinical studies to develop an effective test with Tony Hu, MD, Director of the Center of Cellular and Molecular Diagnosis, leading the project.
Tulane is now partnering with researchers at Baylor College of Medicine https://www.bcm.edu along with the company NanoPin Technologies Inc. https://www.nanopintech.com to screen the diagnostic performance of this test in a large population of patients with and without active TB.
According to Tony Hu, “Our test has several advantages over currently existing TB tests, including the gold-standard of bacterial culture. It requires only a small blood sample and can directly measure TB-derived proteins to detect all forms of TB.”
The current test can also indicate the severity of the infection and response to treatment, using a streamlined approach suitable for high throughput operation in clinical settings. The test uses equipment already approved by FDA for other assays, but can also run on portable instruments suitable for use in resource-limited or extreme settings encountered during military and humanitarian missions.
The research effort is being funded with a $3.8 million grant from the Army Medical Research Acquisition Activity Office https://www.usamraa.army.mil through their Peer Reviewed Medical Research Program within the Department of Defense https://www.defense.gov.