Systematic Review Series on TB Diagnostics
Immunodiagnostic Tests
Serological tests for the diagnosis of TB
Serological (i.e., humoral, antibody-mediated) tests are widely available, although no guideline recommends their use for the diagnosis of TB. In contrast, blood-based tests for cellular immune response (i.e., T-cell based interferon-gamma release assays) have been recommended for use in certain countries. Currently, in low-income countries, where diagnostic tests are rarely subjected to regulatory review or approval, test manufacturers and distributors are marketing dozens of different antibody detection commercial kits. The extent of their use is largely unknown; however, companies report sales volumes between 3,000 and 300,000 tests per year.
Serological tests would seem to offer the potential to improve TB diagnosis as currently performed, as some of the test formats are suitable for resource-limited areas. Major advantages of these tests are their speed (in some cases results may be available within minutes because of the point-of-care format) and potential simplicity compared with microscopy. However, the question is: do they work?
- Commercial serological antibody detection tests for the diagnosis of pulmonary tuberculosis: a systematic review
Steingart KR, Henry M, Laal S, Hopewell PC, Ramsay A, Menzies D, Cunningham J, Weldingh K, Pai M
PLoS Medicine, 2007;Vol. 4, No. 6, e202
[download article]
- A systematic review of commercial serological antibody detection tests for the diagnosis of extrapulmonary tuberculosis
Steingart KR, Henry M, Laal S, Hopewell PC, Ramsay A, Menzies D, Cunningham J, Weldingh K, Pai M
Thorax, 2007 Oct;62(10):911-8
[download abstract]
- Commercial serological tests for the diagnosis of tuberculosis: do they work?
Steingart KR, Ramsay A, Pai M
Future Microbiology, 2007;2:355-9
[PubMed citation]
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