In a head-to-head matchup between a new blood-based tuberculosis (TB) test and the traditional tuberculin skin test, researchers from the University of California, Berkeley, and the Mahatma Gandhi Institute of Medical Sciences in India found that the two methods of detecting latent TB infection are equally good.
The results of the study, to be published in a special June 8 theme issue on tuberculosis in the Journal of the American Medical Association, mean that switching to the more expensive blood test may not be necessary for people in India.
“Our study is the first time this blood test has been evaluated in India, where TB is highly endemic,” said Dr. Madhukar Pai, a post-doctoral fellow in epidemiology at UC Berkeley’s School of Public Health and lead author of the paper. “It’s also the largest study of its kind among health care workers, a group that is at high risk for occupational TB.”
There are about 9 million new cases of TB each year, and a large proportion of the disease burden is in developing countries. Most people infected with TB contain the infection, and it remains latent. In some individuals, the infection progresses to active disease.
The tuberculin skin test, in which the skin is pricked with antigens from Mycobacterium tuberculosis, had stood alone for more than 100 years as the method for detecting latent TB infection.
However, many health professionals consider the skin test crude, said Pai, because it is unable to clearly distinguish between people who have received a vaccine against TB from those who have a true infection. Moreover, the skin test requires the patient to return three days after the skin prick so that a health worker can measure the resulting bump on the skin.
Having a test that allows health care officials to confirm a true TB infection is important because a positive test can lead to a six-month treatment of daily anti-TB drugs for the patient.
Pai said the development of a more advanced assay that uses specific TB antigens to detect levels of interferon-gamma, a protein released by the immune cells of people infected with tuberculosis, was greeted with a measure of excitement among health officials.
The test, called QuantiFERON-TB-Gold, has been approved by the U.S. Food and Drug Administration. Unlike the skin test, the interferon-gamma test requires only one visit by the patient, and its results do not rely upon the subjective interpretation of a health worker.
However, the new test requires special lab facilities, making it more expensive than the old skin test. The skin test, in turn, involves more personnel time because it requires health care workers to deal with a patient twice. “The new test may turn out to be more cost-effective in developed nations like the United States where labor costs are higher,” said Pai.
For this study, researchers analyzed the results of 726 health care workers from the Mahatma Gandhi Institute, a rural hospital in Sevagram, India, that treats about 300 tuberculosis patients a year. The workers were tested with both the traditional TB skin test and the interferon-gamma assay.
About half of the workers tested positive for latent TB infection. The researchers found a high level of agreement – 81.4 percent – between the two tests. Surprisingly, previous TB vaccination had little impact on the results of either test.
Pai notes that other studies in North America and Europe have shown that the interferon-gamma test outperformed the skin test. “It’s important to keep both tests on the menu so that health professionals can choose what’s best for their target population,” said Pai. “For high-burden, low-resource countries such as India, the skin test might still have value.”
From UC Berkeley