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Commercial Serodiagnostic Tests for Diagnosis of Tuberculosis: Policy Statement. Geneva: World Health Organization; 2011.

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Commercial Serodiagnostic Tests for Diagnosis of Tuberculosis: Policy Statement.

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4GRADE evidence profiles and final policy recommendations

The GRADE evidence assessment (Tables 1 to 4) confirmed that the quality of evidence for commercial serodiagnostic tests was very low, with harms/risks far outweighing any potential benefits (strong recommendation). It is therefore recommended that these tests should not be used in individuals suspected of active pulmonary or extra-pulmonary TB, irrespective of their HIV status.

  • This recommendation also applies to paediatric TB based on the generalisation of data from adults (while acknowledging the limitations of microbiological diagnosis in children);
  • This recommendation also applies to the use of commercial serodiagnostic tests as add-on tests in smear-negative individuals given the high risk of false-positives and the consequent adverse effects.
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Bookshelf ID: NBK304211
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