A professor at Texas A&M Health Science Center College of Medicine created a new low-cost tuberculosis test that is meant to increase the speed and accuracy of the disease diagnosis. Using a new chemical compound to identify the bacteria that causes tuberculosis, the researchers expect to provide physicians with the ability to make a preliminary diagnosis within minutes.
Jeffrey Cirillo, Ph.D., professor at the Texas A&M Health Science Center College of Medicine, in collaboration with Texas A&M spinoff company GBDbio, which is engaged in the creation and distribution of global infectious disease diagnostics, and researchers from Stanford University, identified a new chemical compound that can locate the bacteria responsible for tuberculosis, and is thought to be as accurate as tests that usually take months. The test works using a fluorescent substrate with which the device locates an enzyme produced by the bacteria BlaC.
This is the first device that is able to identify the indicator of the bacteria’s presence and use it for diagnosis. TB REaD is the battery-powered, portable tabletop device that analyzes sputum samples combined with the reactive substance to detect any fluorescence and deliver the diagnosis in about 10 minutes. “It’s simple. Take a sputum sample, treat it with the solution and put it inside the reader,” Cirillo explained. “A camera inside looks for a reaction between the sample and solution that produces light. No light, no infection.”
The results of the first human clinical trial data were published in a recent issue of the journal Angewandte Chemie. The researchers concluded that the new test is able to diagnose tuberculosis with an 86 percent sensitivity and 73 percent specificity, which is even better that the widely used test throughout the world, smear microscopy, which detects tuberculosis with a 50 to 60 percent sensitivity.
Another significant difference lies in costs. While the latest FDA-approved model costs more than $20,000, the target price tag on Cirillo’s test is less than $1,000 for the reader and less than $5 per test. The new test also requires little technical expertise or resources, and takes about 30 minutes to perform, which means that it may be a helpful field diagnosis resource.
“Interrupting disease transmission will require early and accurate detection paired with appropriate treatment,” Cirillo said. “Our new, rapid point-of-care TB test dramatically reduces the current delays in diagnosis with incredible accuracy, accelerating appropriate treatment and reducing the death rate of the highly infectious disease. We’re looking at a low-cost, easy-to-use test that has the potential to eradicate TB.”
Cirillo also noted that the preventable disease kills 50 percent of its patients, which means three people every minute, making it the second leading cause of mortality from infectious diseases in the world. The scientist believes that the device can undercut the diagnostic methods and reduce the number of untreated patients, a common scenario in countries lacking infrastructure or resources to efficiently screen and follow up with infected patients. It also can be expanded to the identification of other respiratory diseases and infectious agents.
The research team is currently performing the later stages of clinical trials and expects to commercialize it in the next 18 months. The project, which is being conducted for six years, had already been published in the journal Nature: Chemistry and was supported by the Foundation for Innovative New Diagnostics, the Clinton Health Access Initiative and the Wellcome Trust.