Abstract
A rapid diagnosis of drug-resistant tuberculosis (TB) is critical for early initiation of effective therapy. Molecular testing with line probe assays (MTBDRplus and MTBDRsl) on culture isolates has been available for some time and significantly reduces the time to diagnosis of drug resistance. However, routine use of this test directly on sputum is less common. As part of enrollment screening procedures for tuberculosis clinical trials conducted in Hanoi, Vietnam, we evaluated the feasibility and performance of line probe assay (LPA) testing directly on sputum samples from 315 participants with no prior history of TB treatment. Test performance characteristics for the detection of rifampin (RIF) and isoniazid (INH) drug resistance as compared to culture-based drug susceptibility testing (DST) reference standard were calculated. LPA demonstrated high sensitivity and specificity for the diagnosis of drug resistance. Scaling up molecular testing on sputum as part of time-sensitive clinical trial screening procedures in high TB burden settings is feasible and will reduce both time to initiation of appropriate therapy and the risk of late exclusions due to microbiologic ineligibility.
Highlights
Tuberculosis (TB) remains a public health threat with an estimated 10 million people diagnosed and 1.3 million deaths worldwide in 2017 alone [1]
A total of 394 participants were screened for enrollment in Study 29X (S29X) and Study 31 (S31)
79 participants were excluded from analyses because of missing reference culture-based drug susceptibility testing (DST) results, missing line probe assay (LPA)
Summary
Tuberculosis (TB) remains a public health threat with an estimated 10 million people diagnosed and 1.3 million deaths worldwide in 2017 alone [1]. The latest report by the World Health Organization highlights improvement in TB diagnostics and shortening the time to initiation of appropriate treatment as key priorities [1]. The recent guidelines recommend drug sensitivity testing in all settings, shifting the paradigm of TB treatment from standardized regimens to individualized therapy [2]. Though rapid molecular tests have been developed to identify DR-TB, questions surrounding their feasibility has limited their use in high TB burden settings. In the context of clinical trial screenings, rapid detection of resistance to rifampin, isoniazid, and fluoroquinolones is essential for identifying eligible study participants. Rapid screening can prevent treating participants with drugs to which their bacteria have resistance, expedites access to curative therapy, and reduces risks for late exclusions, which impact the integrity of the clinical trial
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