Equivalence of the GeneXpert System and GeneXpert Omni System for tuberculosis and rifampicin resistance detection

被引：3

作者：

Georghiou, Sophia B. ^{[1
]}

Alagna, Riccardo ^{[2
]}

Cirillo, Daniela M. ^{[2
]}

Carmona, Sergio ^{[1
]}

Ruhwald, Morten ^{[1
]}

Schumacher, Samuel G. ^{[1
]}

机构：

[1] FIND, Global Alliance Diagnost, Geneva, Switzerland

[2] IRCCS San Raffaele Sci Inst, Milan, Italy

来源：

PLOS ONE | 2021年 / 16卷 / 12期

关键词：

XPERT MTB/RIF ULTRA;

D O I：

10.1371/journal.pone.0261442

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

A laboratory validation study was conducted to assess the equivalence of Xpert MTB/RIF Ultra testing on the GeneXpert System and the GeneXpert Omni System ('Omni') for tuberculosis and rifampicin resistance. High concordance of the two devices was demonstrated for well-characterized clinical samples as well as control materials, with controls tested on Omni at normal and challenging environmental conditions (i.e. 35 degrees C, 90% relative humidity). Equivalence of the Cts for all probes was also shown. Equivalence was demonstrated for the Omni and GeneXpert devices for tuberculosis and rifampicin resistance detection for a diverse range of clinical specimens and environmental conditions.

引用

页数：7

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