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Challenges and Progress with Diagnosing Pulmonary Tuberculosis in Low- and Middle-Income Countries
Communication

Feasibility of Direct Sputum Molecular Testing for Drug Resistance as Part of Tuberculosis Clinical Trials Eligibility Screening

1
Santa Clara Valley Medical Center, San Jose, CA 95128, USA
2
UCSF Center for Tuberculosis, San Francisco, CA 94110, USA
3
University of California, San Francisco, CA 94143, USA
4
Vietnam National Tuberculosis Programme/UCSF Research Collaboration, Hanoi, Vietnam
5
National Reference Laboratory, National Lung Hospital, Hanoi, Vietnam
6
Hanoi Lung Hospital, Hanoi, Vietnam
7
Stanford Healthcare ValleyCare, Pleasanton, CA 94588, USA
*
Author to whom correspondence should be addressed.
Received: 24 April 2019 / Revised: 25 May 2019 / Accepted: 27 May 2019 / Published: 30 May 2019
(This article belongs to the Special Issue Diagnosis and Treatment of Tuberculosis)
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. View Full-Text
Keywords: MTBDRplus; MTBDRsl; line probe assay; tuberculosis; DR-TB; Hain test; diagnostics; clinical trials; molecular testing MTBDRplus; MTBDRsl; line probe assay; tuberculosis; DR-TB; Hain test; diagnostics; clinical trials; molecular testing
MDPI and ACS Style

Alipanah, N.; Shete, P.B.; Nguyen, H.; Nguyen, N.V.; Luu, L.; Pham, T.; Nguyen, H.; Nguyen, P.; Tran, M.C.; Pham, N.; Phan, H.; Phillips, P.P.J.; Cattamanchi, A.; Nahid, P. Feasibility of Direct Sputum Molecular Testing for Drug Resistance as Part of Tuberculosis Clinical Trials Eligibility Screening. Diagnostics 2019, 9, 56. https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics9020056

AMA Style

Alipanah N, Shete PB, Nguyen H, Nguyen NV, Luu L, Pham T, Nguyen H, Nguyen P, Tran MC, Pham N, Phan H, Phillips PPJ, Cattamanchi A, Nahid P. Feasibility of Direct Sputum Molecular Testing for Drug Resistance as Part of Tuberculosis Clinical Trials Eligibility Screening. Diagnostics. 2019; 9(2):56. https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics9020056

Chicago/Turabian Style

Alipanah, Narges, Priya B. Shete, Hanh Nguyen, Nhung V. Nguyen, Lien Luu, Thuong Pham, Hung Nguyen, Phuong Nguyen, Minh C. Tran, Nam Pham, Ha Phan, Patrick P.J. Phillips, Adithya Cattamanchi, and Payam Nahid. 2019. "Feasibility of Direct Sputum Molecular Testing for Drug Resistance as Part of Tuberculosis Clinical Trials Eligibility Screening" Diagnostics 9, no. 2: 56. https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics9020056

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