Xpert MTB/XDR: a 10-Color Reflex Assay Suitable for Point-of-Care Settings To Detect Isoniazid, Fluoroquinolone, and Second-Line-Injectable-Drug Resistance Directly from Mycobacterium tuberculosis-Positive Sputum-Reference-Cited by-同舟云学术

Xpert MTB/XDR: a 10-Color Reflex Assay Suitable for Point-of-Care Settings To Detect Isoniazid, Fluoroquinolone, and Second-Line-Injectable-Drug Resistance Directly from Mycobacterium tuberculosis-Positive Sputum

Published:2021-02-18 Issue:3 Volume:59 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Cao Yuan¹,Parmar Heta¹,Gaur Rajiv L.²,Lieu Deanna²,Raghunath Shobana²,Via Nova²,Battaglia Simone³,Cirillo Daniela M.³^ORCID,Denkinger Claudia⁴,Georghiou Sophia⁴,Kwiatkowski Robert²,Persing David²,Alland David¹^ORCID,Chakravorty Soumitesh¹²

Affiliation:

1. New Jersey Medical School, Rutgers University, Newark, New Jersey, USA

2. Cepheid Inc., Sunnyvale, California, USA

3. San Raffaele Hospital, Milan, Italy

4. Foundation for Innovative New Diagnostics, Geneva, Switzerland

Abstract

We describe the design, development, analytical performance, and a limited clinical evaluation of the 10-color Xpert MTB/XDR assay (CE-IVD only, not for sale in the United States). This assay is intended as a reflex test to detect resistance to isoniazid (INH), fluoroquinolones (FLQ), ethionamide (ETH), and second-line injectable drugs (SLIDs) in unprocessed sputum samples and concentrated sputum sediments which are positive for Mycobacterium tuberculosis .

Funder

Foundation for Innovative New Diagnostics

German Federal Ministry of Education and Research

Dutch Ministry of Foreign Affairs

Australian Department of Foreign Affairs and Trade

HHS | NIH | National Institute of Allergy and Infectious Diseases

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.02314-20