The World Health Organisation (WHO) would be issuing guidelines recommending against the use of serology tests for tuberculosis because they may be causing more harm than good in high burden countries.
This is the first negative recommendation to be made by the WHO, a release issued in Accra and copied to the Ghana News Agency on Thursday said.
The unusually strong warning is based on more than six years of work by Research and Training in Tropical Diseases (TDR) and its partners at the McGill University, University of California, the Institute of Tropical Medicine, New York University and the Statens Serum Institute.
TDR, a Special Programme for Research and Training in Tropical Diseases, is a global programme of scientific collaboration that helps to coordinate, support and influence global efforts to combat a portfolio of major diseases of the poor and disadvantaged.
The release said while manufacturers market their tests as filling an important niche in point-of-care tuberculosis diagnostics, the commercial serology tests, which were sold in scores of countries, were “inaccurate and useless”.
Established in 1975, TDR based in Geneva, Switzerland, is executed by the WHO and sponsored by the United Nations Children’s Fund (UNICEF), United Nations Development Programme (UNDP) and the World Bank.
TDR commissioned two systematic reviews on serological tests that were published in 2007 and in collaboration with the Institute of Tropical Medicine, at Antwerp, conducted a laboratory-based evaluation of 19 rapid serological tests for TB, published in 2008.
This evaluation found out that none of the assays were of sufficient quality to replace smear microscopy as a diagnostic, while many tests had false results.
The expert group, according to the release, endorsed the findings from an updated systematic review since the TDR report in 2008 and essentially concluded that the negative policy guidance should be preceded based on the fact that the performance characteristics of these tests were far below expectation.
In addition, the quality of the data was so weak and bad that it warranted a recommendation against the use of these tests.