BACKGROUND:  Mycobacterium tuberculosis is one of the major infectious diseases in the world. There are approximately 2 billion people infected and about 2 million people that die from tuberculosis each year. Animals are also affected by this infectious disease. Current diagnosis may take up to weeks or months, and involves clinical presentation, X-ray evidence, and/or culture from an infected site. One of the tuberculosis tests is the tuberculin skin test, which requires two patient visits since the test needs two days from the time the tuberculin is injected into the skin until the time the test is read. The tuberculin skin test does not provide information as to the current activity of tuberculosis, such as whether it is currently active or inactive, nor do the related Quantiferon tests conducted on a blood sample. In the majority of people who have positive tuberculin skin tests or blood Quantiferon tests, the disease is inactive. There is a need for a new test that requires only a sample of the patient's serum and a single patient visit. There is also a need for this test to be able to monitor the treatment of tuberculosis and indicate active tuberculosis.

INNOVATION:  UCLA researchers at have identified a novel diagnostic assay to detect active tuberculosis (both pulmonary and extra-pulmonary) in humans and animals. This new rapid and inexpensive tuberculosis test is positive only when tuberculosis is active. As well, the test can monitor the treatment of tuberculosis. Failure to notice a drop in the level of molecule measured by the test can determine when a tuberculosis treatment is not working. This assay requires only a patient's blood or serum sample. The ability to distinguish between inactive and active disease can reduce the burden of culling all domesticated animals with a positive Quantiferon or skin test. Now, only animals with active tuberculosis will be culled, resulting in a huge economic benefit, especially in developing nations.

POTENTIAL APPLICATIONS 

• Detect active tuberculosis, including both pulmonary and extra-pulmonary tuberculosis, in humans and animals
• Monitor the treatment of tuberculosis to determine if treatment is successful or not, and indicate whether a change in antibiotic therapy is needed

ADVANTAGES

• Rapid and inexpensive detection of active tuberculosis
• Distinguishes between active and inactive tuberculosis
• Only the patient's blood or serum sample is required
• Test requires only one patient visit
• Monitors tuberculosis treatment through the drop in the test level of the molecule measured and provides early indication of multi-drug resistant tuberculosis
• Reduce the burden and economic impact that the agriculture industry faces in culling domesticated animals

DEVELOPMENT-TO-DATE:  The tuberculosis assay has been tested in vitro and in vivo in humans and in animals.

Reference: UCLA Case No. 2008-449