Effectiveness of GenoType MTBDRsl in excluding TB drug resistance in a clinical trial-Reference-Cited by-同舟云学术

Effectiveness of GenoType MTBDRsl in excluding TB drug resistance in a clinical trial

Published:2021-10-01 Issue:10 Volume:25 Page:839-845
ISSN:1027-3719
Container-title:The International Journal of Tuberculosis and Lung Disease
language:en
Short-container-title:int j tuberc lung dis

Author:

Ejo M.¹,Van Deun A.²,Nunn A.³,Meredith S.³,Ahmed S.³,Dalai D.⁴,Tumenbayar O.⁴,Tsogt B.⁵,Dat P. T.⁶,Ha D. T. M.⁶,Hang P. T.⁶,Kokebu D.⁷,Teferi M.⁸,Mebrahtu T.⁸,Ngubane N.⁹,Moodliar R.¹⁰,Duckworth L.¹⁰,Conradie F.¹¹,Enduwamahoro E.¹²,Keysers J.¹²,De Rijk P.¹²,Mulders W.¹²,Diro E.¹³,Rigouts L.¹⁴,de Jong B. C.¹²,Torrea; G.¹²,on behalf of the STREAM collaborators

Affiliation:

1. Institute of Tropical Medicine, Antwerp, Belgium, University of Gondar, Gondar, Ethiopia, Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium

2. Institute of Tropical Medicine, Antwerp, Belgium, Independent Consultant, Leuven, Belgium

3. Medical Research Council Clinical Trials at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK

4. National Centre of Infectious Diseases, National Tuberculosis Reference Laboratory, Ulaanbaatar, Mongolia

5. Mongolian TB Coalition, Ulaanbaatar, Mongolia

6. Pham Ngoc Thach Hospital, Ho Chi Minh, Vietnam

7. Saint Peter´s TB Specialized Hospital, Addis Ababa, Ethiopia

8. Armauer Hansen Research Institute, Addis Ababa, Ethiopia

9. Doris Goodwin Hospital, Pietermaritzburg, South Africa

10. King Dinuzulu Hospital, Durban, South Africa

11. Sizwe Tropical Disease, Johannesburg, South Africa

12. Institute of Tropical Medicine, Antwerp, Belgium

13. University of Gondar, Gondar, Ethiopia

14. Institute of Tropical Medicine, Antwerp, Belgium, Department of Biomedical Sciences, University of Antwerp, Antwerp, Belgium

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.

Publisher

International Union Against Tuberculosis and Lung Disease

Subject

Infectious Diseases,Pulmonary and Respiratory Medicine

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