Clinical evaluation of the cobas® MTB-RIF/INH reagent and the cobas® 6800 for the detection of isoniazid and rifampicin resistance.

Humans Indicators and Reagents Isoniazid / pharmacology Microbial Sensitivity Tests Mycobacterium tuberculosis Rifampin / pharmacology Sensitivity and Specificity Tuberculosis, Multidrug-Resistant / diagnosis
Isoniazid Mutation Real-time polymerase chain reaction Resistance Rifampicin

Journal

Tuberculosis (Edinburgh, Scotland)
ISSN: 1873-281X
Titre abrégé: Tuberculosis (Edinb)
Pays: Scotland
ID NLM: 100971555

Informations de publication

Date de publication:
05 2022
Historique:
received: 11 10 2021
revised: 09 03 2022
accepted: 15 03 2022
pubmed: 4 4 2022
medline: 3 6 2022
entrez: 3 4 2022
Statut: ppublish

Résumé

We aimed to validate the performance of a newly developed real-time PCR assay using cobas® MTB-RIF/INH reagent on the cobas® 6800 system for detecting isoniazid (INH) and rifampicin (RIF) resistance, using Japanese Mycobacterium tuberculosis (MTB) isolates. In total, 119 mock sputum specimens spiked with resistant MTB were tested using the cobas® MTB-RIF/INH reagent. The whole genomes of all MTB isolates were sequenced by MiSeq and analysed for mutations/indels causing drug resistance. All isolates were tested for phenotypic drug susceptibility, then MTB negative sputa were collected and pooled to prepare mock sputum specimens for the study. The sensitivity and specificity for INH resistance at a concentration equal to 3 × the limit of detection were 77.8% and 90.0%, respectively; those for RIF resistance were 91.8% and 93.5%, respectively. The sensitivities for INH and RIF were statistically different (P = 0.014), but not the specificities (P = 0.624). Twenty-two false-susceptible and two false-resistant results were obtained in INH; meanwhile, six false-susceptible and three false-resistant results were obtained in RIF. False-resistance for INH and RIF was mainly due to disputed mutations. The cobas® MTB-RIF/INH reagent showed better performance than other rapid molecular tests.

Identifiants

DOI: 10.1016/j.tube.2022.102199 PMID: 35367868
pubmed: 35367868
pii: S1472-9792(22)00036-1
doi: 10.1016/j.tube.2022.102199
pii:
doi:

Substances chimiques

Indicators and Reagents 0
Isoniazid V83O1VOZ8L
Rifampin VJT6J7R4TR

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

102199

Informations de copyright

Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

Akio Aono (A)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan.

Yoshiro Murase (Y)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan.

Masaaki Minegishi (M)

Clinical laboratory, National Hospital Organization Tokyo Hospital, Kiyose, Tokyo, Japan.

Shuichi Ohtawa (S)

Clinical laboratory, National Hospital Organization Tokyo Hospital, Kiyose, Tokyo, Japan.

Masatoshi Yano (M)

Clinical laboratory, National Hospital Organization Tokyo Hospital, Kiyose, Tokyo, Japan.

Kinuyo Chikamatsu (K)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan.

Yoshiko Shimomura (Y)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan.

Makiko Hosoya (M)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan.

Yuriko Igarashi (Y)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan.

Yuta Morishige (Y)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan.

Hiroyuki Yamada (H)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan.

Akiko Takaki (A)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan.

Kenichi Togashi (K)

Roche Diagnostics KK, Shinagawa, Tokyo, Japan.

Mikako Hiura (M)

Roche Diagnostics KK, Shinagawa, Tokyo, Japan.

Satoshi Mitarai (S)

Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose, Tokyo, 2048533, Japan. Electronic address: mitarai@jata.or.jp.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Clinical evaluation of the cobas® MTB-RIF/INH...
questionsmedicales.fr › Actions chimiques et utilisations › Utilisations spécialisées de produits chimiques › Produits chimiques de laboratoire › Indicateurs et réactifs › Clinical evaluation of the cobas® MTB-RIF/INH...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Pyridines › Acides isonicotiniques › Isoniazide › Clinical evaluation of the cobas® MTB-RIF/INH...
questionsmedicales.fr › Techniques d'investigation › Évaluation préclinique de médicament › Tests de sensibilité microbienne › Clinical evaluation of the cobas® MTB-RIF/INH...
questionsmedicales.fr › Bactéries › Bactéries à Gram positif › Bâtonnets à Gram positif › Bâtonnets asporogènes à Gram positif › Bâtonnets asporogènes réguliers à Gram positif › Mycobacteriaceae › Mycobacterium › Mycobacterium tuberculosis › Clinical evaluation of the cobas® MTB-RIF/INH...
questionsmedicales.fr › Composés polycycliques › Composés macrocycliques › Lactames macrocycliques › Rifamycine › Rifampicine › Clinical evaluation of the cobas® MTB-RIF/INH...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Sensibilité et spécificité › Clinical evaluation of the cobas® MTB-RIF/INH...
questionsmedicales.fr › Infection › Infections bactériennes et mycoses › Infections bactériennes › Infections bactériennes à Gram positif › Infections à Actinomycetales › Infections à Mycobacterium › Tuberculose › Tuberculose multirésistante › Clinical evaluation of the cobas® MTB-RIF/INH...