Serological tests for the diagnosis of active tuberculosis: relevance for India.

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dc.contributor.authorSteingart, Karen R
dc.contributor.authorRamsay, Andrew
dc.contributor.authorDowdy, David W
dc.contributor.authorPai, Madhukar
dc.date.accessioned2012-08-13T06:24:05Z
dc.date.available2012-08-13T06:24:05Z
dc.date.issued2012-05
dc.description.abstractDiagnostic tests for active tuberculosis (TB) based on the detection of antibodies (serological tests) have been commercially available for decades, although no international guidelines have recommended their use. An estimated 1.5 million serological TB tests, mainly enzyme-linked immunosorbent assays, are performed in India alone every year, mostly in the private sector. The cost of serological tests in India is conservatively estimated at US $15 million (825 million) per year. Findings from systematic reviews on the diagnostic accuracy of serological tests for both pulmonary and extra-pulmonary TB suggest that these tests are inaccurate and imprecise. A cost-effectiveness modelling study suggests that, if used as a replacement test for sputum microscopy, serology would increase costs to the Indian TB control sector approximately 4-fold and result in fewer disability-adjusted life years averted and more false-positive diagnoses. After considering all available evidence, the World Health Organization issued a strong recommendation against the use of currently available commercial serological tests for the diagnosis of TB disease. The expanding evidence base continues to demonstrate that the harms/risks of serological tests far outweigh the benefits. Greater engagement of the private sector is needed to discontinue the use of serological tests and to replace these tests with WHO-endorsed new diagnostics in India. The recent ban on import or sale of TB serological tests by the Indian health ministry is a welcome step in the right direction.en_US
dc.identifier.citationSteingart Karen R, Ramsay Andrew, Dowdy David W, Pai Madhukar. Serological tests for the diagnosis of active tuberculosis: relevance for India. Indian Journal of Medical Research. 2012 May; 135(5): 695-702.en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/140267
dc.language.isoenen_US
dc.source.urihttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3401705/en_US
dc.subjectAntibodyen_US
dc.subjectdiagnosisen_US
dc.subjectsensitivity and specificityen_US
dc.subjectserologyen_US
dc.subjecttuberculosisen_US
dc.subject.meshAntibodies, Bacterial
dc.subject.meshHumans
dc.subject.meshSensitivity and Specificity
dc.subject.meshSerology --methods
dc.subject.meshSerologic Tests --methods
dc.subject.meshTuberculosis --diagnosis
dc.subject.meshWorld Health Organization
dc.subject.meshAndrographis --chemistry
dc.subject.meshAnimals
dc.subject.meshDiabetes Mellitus --diagnosis
dc.subject.meshDiabetes Mellitus --immunology
dc.subject.meshDiabetes Mellitus, Type 2 --diagnosis
dc.subject.meshDiabetes Mellitus, Type 2 --immunology
dc.subject.meshDisease Models, Animal
dc.subject.meshAdjuvants, Immunologic
dc.subject.meshRats
dc.subject.meshStreptozocin
dc.titleSerological tests for the diagnosis of active tuberculosis: relevance for India.en_US
dc.typeArticleen_US
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