Berkeley
-- 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."
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