Analytical and clinical performance characteristics of the Abbott RealTime MTB RIF/INH Resistance, an assay for the detection of rifampicin and isoniazid resistant Mycobacterium tuberculosis in pulmonary specimens

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• 作者：Joshua Kostera ; ^{joshua.kostera@abbott.com" class="auth_mail" title="E-mail the corresponding author} ; Gregor Leckie ^{Gregor.Leckie@abbott.com" class="auth_mail" title="E-mail the corresponding author} ; Ning Tang ^{Ning.Tang@abbott.com" class="auth_mail" title="E-mail the corresponding author} ; John Lampinen ^{John.Lampinen@abbott.com" class="auth_mail" title="E-mail the corresponding author} ; Magdalena Szostak ^{magdalena.szostak@abbott.com" class="auth_mail" title="E-mail the corresponding author} ; Klara Abravaya ^{Klara.B.Abravaya@abbott.com" class="auth_mail" title="E-mail the corresponding author} ; Hong Wang ^{Hong.Wang@abbott.com" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Mycobacterium ; Rifampicin ; Isoniazid ; Sensitivity ; Specificity ; Reflex
• 刊名：Tuberculosis
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：101
• 期：Complete
• 页码：137-143
• 全文大小：500 K

文摘

Clinical management of drug-resistant tuberculosis patients continues to present significant challenges to global health. To tackle these challenges, the Abbott RealTime MTB RIF/INH Resistance assay was developed to accelerate the diagnosis of rifampicin and/or isoniazid resistant tuberculosis to within a day. This article summarizes the performance of the Abbott RealTime MTB RIF/INH Resistance assay; including reliability, analytical sensitivity, and clinical sensitivity/specificity as compared to Cepheid GeneXpert MTB/RIF version 1.0 and Hain MTBDRplus version 2.0. The limit of detection (LOD) of the Abbott RealTime MTB RIF/INH Resistance assay was determined to be 32 colony forming units/milliliter (cfu/mL) using the Mycobacterium tuberculosis (MTB) strain H37Rv cell line. For rifampicin resistance detection, the Abbott RealTime MTB RIF/INH Resistance assay demonstrated statistically equivalent clinical sensitivity and specificity as compared to Cepheid GeneXpert MTB/RIF. For isoniazid resistance detection, the assay demonstrated statistically equivalent clinical sensitivity and specificity as compared to Hain MTBDRplus. The performance data presented herein demonstrate that the Abbott RealTime MTB RIF/INH Resistance assay is a sensitive, robust, and reliable test for realtime simultaneous detection of first line anti-tuberculosis antibiotics rifampicin and isoniazid in patient specimens.