Taken from:

TDR for Research on Diseases of Poverty

http://apps.who.int/tdr/svc/news-events/news/tb-test-alert


Commercial TB test alert: TDR research leads to an unusual warning
from WHO

    * TDR news item, 14 January 2011

The World Health Organization (WHO) will be issuing guidelines
recommending against the use of serology tests for tuberculosis
because they may be doing more harm than good in high-burden
countries, according to The Lancet. This is the first negative
recommendation to be made by the WHO. The unusually strong warning is
based on more than six years of work by TDR and its partners at the
McGill University (Montreal), University of California (San
Francisco), the Institute of Tropical Medicine (Antwerp), New York
University and the Statens Serum Institut (Copenhagen).

While manufacturers market their tests as filling an important niche
in point-of-care tuberculosis diagnostics, in fact, the commercial
serology tests, which are sold in scores of countries, are
"inaccurate and useless," Madhukar Pai, co-chair of the STOP TB
Partnership, told The Lancet.

TDR commissioned two systematic reviews on serological tests that were
published in 2007 and also, along with the Institute of Tropical
Medicine, Antwerp, conducted a laboratory-based evaluation of 19
rapid serological tests for TB, published in 2008. This evaluation
found that none of the assays were of sufficient quality to replace
smear microscopy as a diagnostic. Many tests had false results.

In 2010, TDR commissioned an update of the systematic reviews. The
findings were identical to the 2007 reviews. TDR and the Stop TB
Department at WHO co-convened an Expert Group Meeting to review the
findings and discuss the implications for policy.

“The expert group endorsed the findings from an updated systematic
review since the TDR report in 2008 and essentially concluded that we
should proceed with negative policy guidance based on the fact that
the performance characteristics of these tests were way below what
one would want and also because the quality of the data were so weak
and so bad that it warranted a recommendation against the use of
these tests”, Karin Weyer, Stop TB coordinator of diagnostics and
laboratory strengthening told The Lancet. “We quickly discovered that
manufacturers of these commercial serodiagnostics simply change the
name of the test frequently and re-market and re-sell the same test
under a new brand name," she said.

At the same time, said Weyer, WHO has approached the negative guidance
carefully, so as not to discourage future research and innovation.

For further information contact:

Dr Andy Ramsay -See:

http://apps.who.int/tdr/svc/news-events/news/tb-test-alert

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