Key messages
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The Xpert MTB/RIF assay is a landmark development in tuberculosis diagnostics and yet it does not fulfil requirements as a point-of-care assay
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One Xpert MTB/RIF test on sputum detects 90% of pulmonary tuberculosis (99% of smear-positive disease and about 75% of smear-negative disease)
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High sensitivity of Xpert MTB/RIF for rifampicin resistance is accompanied by some false-positive results (which might be reduced by the new G4 version of the assay) and confirmatory drug sensitivity testing is needed
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Despite substantial price discounting and relative simplicity of use, implementation of the Xpert MTB/RIF assay is hindered by several factors
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Studies of clinical and programmatic effects and associated cost-effectiveness of the Xpert MTB/RIF assay are needed
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Greater funding for research and development for a simple, low-cost, accurate point-of-care assay is needed