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Protocol: The diagnostic performance of novel skin-based in vivo tests for TB infection compared to blood-based in vitro interferon-gamma release assays: A systematic review and meta-analysis

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Protocol for systematic review and meta-analysis performed to evaluate performance of novel antigen-based skin tests for Tuberculosis infection screening.
The tests evaluated included C-Tb, Diaskintest, EC skin-test and DPPD. Objectives related to test performance and included; 1) test agreement with IGRA or TST; (2) test sensitivity in those with microbiologically-confirmed active TB and specificity in those at low risk of TB infection; (3) association between index test result and proximity of exposure among case contacts; (4) predictive value of index test for incident TB; (5) efficacy of preventive therapy based on test result.
Searches were performed in English, Russian and Chinese in multiple databases and manufacturers were contacted for additional studies. Pooling of results was performed where possible in groups defined by their age, underlying co-morbidity and TB status (eg. microbiologically confirmed, under investigation etc).

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New Diagnostics Working Group

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