Dual-centre evaluation of the FluoroType MTBDR version 2 assay for detection of Mycobacterium tuberculosis complex and resistanceconferring mutations in pulmonary and extrapulmonary samples from Denmark, Germany and Sierra Leone

被引：0

作者：

Svensson, Erik ^{[1
]}

Ketelsen, Hannah ^{[2
]}

Andres, Sonke ^{[2
]}

Folkvardsen, Dorte Bek ^{[1
]}

Hillemann, Doris ^{[2
]}

Conteh, Ousman ^{[3
]}

Norman, Anders ^{[1
]}

Niemann, Stefan ^{[4
,5
]}

Lillebaek, Troels ^{[1
,6
]}

Kuhns, Martin ^{[2
]}

机构：

[1] Statens Serum Inst, Int Reference Lab Mycobacteriol, WHO Supranatl Reference Lab, Copenhagen, Denmark

[2] Leibniz Lung Ctr, Res Ctr Borstel, Natl & WHO Supranatl Reference Lab Mycobacteria, Borstel, Germany

[3] Lakka Govt Hosp, Natl TB Reference Lab, Freetown, Sierra Leone

[4] Partner Site Hamburg Lubeck Borstel Riems, German Ctr Infect Res DZIF, Hamburg, Germany

[5] Leibniz Lung Ctr, Res Ctr Borstel, Mol & Expt Mycobacteriol, Borstel, Germany

[6] Univ Copenhagen, Dept Publ Hlth, Copenhagen, Denmark

来源：

CLINICAL MICROBIOLOGY AND INFECTION | 2024年 / 30卷 / 08期

关键词：

FluoroType MTBDR; inhA; Isoniazide resistance; katG; Mycobacterium tuberculosis; PCR; Rifampicin resistance; rpoB; fabG1;

D O I：

10.1016/j.cmi.2024.04.006

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Objectives: We evaluated the ability of FluoroType MTBDR version 2 (FTv2; Hain Lifescience), a secondstep real-time PCR assay, to simultaneously detect Mycobacterium tuberculosis complex (MTBC) DNA and mutations conferring resistance to rifampicin (RIF) and isoniazid (INH), in pulmonary and extrapulmonary samples from patients and compared them with corresponding cultures. Methods: FTv2 MTBC was evaluated on 1815 and 432 samples from Denmark (DK) and Germany (DE), respectively. RIF and INH resistance mutations were assessed in the German samples and 110 samples from Sierra Leone and subsequently compared to phenotypic antimicrobial susceptibility testing and a composite reference DNA (CRD) based on the GenoType MTBDR line-probe assay and Sanger sequencing or whole-genome sequencing. Results: Of the 584 (557 smear-negative) Danish and 277 (85 smear-negative) German sputum samples, 42 (16) and 246 (54) were culture positive, and 44 (18) and 222 (35) were FTv2 positive, providing an FTv2 sensitivity and speci ficity of 0.86 (0.63) and 0.98 (DK), 0.90 (0.65) and 1.00 (DE), respectively. The count, sensitivities, and speci ficities for all pulmonary samples were 1434, 0.79, and 0.99 (DK) and 347, 0.86, and 1.00 (DE), respectively; for extrapulmonary samples, 381, 0.33, 0.99 (DK) and 83, 0.50, and 1.00 (DE). The valid count, sensitivity, and speci ficity compared with CRD for detecting resistance mutations were RIF 355, 0.99, 0.96, and INH 340, 1.00, and 0.98, respectively. Discussion: FTv2 reliably detects MTBC DNA in pulmonary and extrapulmonary samples and detects resistance mutations for INH and RIF resistance in inhA promoter, katG, and rpoB genes. Erik Svensson, Clin Microbiol Infect 2024;30:1055 (c) 2024 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

引用

页码：1055 / 1060

页数：6