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Evaluation of the Xpert MTB Host Response assay for the triage of patients [TB0108]

A triage test with a minimum sensitivity of 90% and specificity of 70%, meeting predefined operational targets, could help reduce underdiagnosis and misdiagnosis of tuberculosis, decrease delays in starting treatment, and lower the cost and infrastructure demands of current gold-standard sputum-based tests in high-burden settings.  Sweeney and colleagues validated a three-gene host blood signature, utilizing blood mRNA to measure markers associated with the host inflammatory response, which can differentiate tuberculosis disease from other conditions. This signature has been developed into an automated, blood-based quantitative PCR test on the GeneXpert platform, generating a TB Score based on the cycle threshold of expressed genes. Early studies from stored samples and interim results from a multisite study suggest that this test may achieve the WHO's target product profile minimum accuracy threshold for a tuberculosis triage test. We aimed to prospectively evaluate the diagnostic...
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