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. 2019 May 30;9(2):56.
doi: 10.3390/diagnostics9020056.

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

Narges Alipanah  1   2   3 , Priya B Shete  4   5 , Hanh Nguyen  6 , Nhung Viet Nguyen  7   8 , Lien Luu  9 , Thuong Pham  10 , Hung Nguyen  11   12 , Phuong Nguyen  13 , Minh Chi Tran  14 , Nam Pham  15   16 , Ha Phan  17   18 , Patrick P J Phillips  19   20 , Adithya Cattamanchi  21   22 , Payam Nahid  23   24   25
Affiliations

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

Narges Alipanah et al. Diagnostics (Basel). .

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.

Keywords: DR-TB; Hain test; MTBDRplus; MTBDRsl; clinical trials; diagnostics; line probe assay; molecular testing; tuberculosis.

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Conflict of interest statement

The authors declare no conflict of interest.

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