Effectiveness of GenoType MTBDRsl in excluding TB drug resistance in a clinical trial.
Int J Tuberc Lung Dis
; 25(10): 839-845, 2021 10 01.
Article
in En
| MEDLINE
| ID: mdl-34615581
ABSTRACT
OBJECTIVES:
To assess the performance of the GenoType MTBDRsl v1, a line-probe assay (LPA), to exclude baseline resistance to fluoroquinolones (FQs) and second-line injectables (SLIs) in the Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB 1 (STREAM 1) trial.METHODS:
Direct sputum MTBDRsl results in the site laboratories were compared to indirect phenotypic drug susceptibility testing (pDST) results in the central laboratory, with DNA sequencing as a reference standard.RESULTS:
Of 413 multidrug-resistant TB (MDR-TB) patients tested using MTBDRsl and pDST, 389 (94.2%) were FQ-susceptible and 7 (1.7%) FQ-resistant, while 17 (4.1%) had an inconclusive MTBDRsl result. For SLI, 372 (90.1%) were susceptible, 5 (1.2%) resistant and 36 (8.7%) inconclusive. There were 9 (2.3%) FQ discordant pDST/MTBDRsl results, of which 3 revealed a mutation and 5 (1.3%) SLI discordant pDST/MTBDRsl results, none of which were mutants on sequencing. Among the 17 FQ- and SLI MTBDRsl-inconclusive samples, sequencing showed 1 FQ- and zero SLI-resistant results, similar to frequencies among the conclusive MTBDRsl. The majority of inconclusive MTBDRsl results were associated with low bacillary load samples (acid-fast bacilli smear-negative or scantily positive) compared to conclusive results (P < 0.001).CONCLUSION:
MTBDRsl can facilitate the rapid exclusion of FQ and SLI resistances for enrolment in clinical trials.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Tuberculosis, Multidrug-Resistant
/
Mycobacterium tuberculosis
Type of study:
Diagnostic_studies
Limits:
Humans
Language:
En
Journal:
Int J Tuberc Lung Dis
Year:
2021
Document type:
Article
Affiliation country:
Bélgica