title: 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.
abstract: 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.
authors.affiliation: Abbott Molecular, 1300 Touhy Ave, Des Plaines, IL 60018, USA. Electronic address: joshua.kostera@abbott.com.
authors.forename: Joshua
authors.initials: J
authors.lastname: Kostera
authors.affiliation: Abbott Molecular, 1300 Touhy Ave, Des Plaines, IL 60018, USA. Electronic address: Gregor.Leckie@abbott.com.
authors.forename: Gregor
authors.initials: G
authors.lastname: Leckie
authors.affiliation: Abbott Molecular, 1300 Touhy Ave, Des Plaines, IL 60018, USA. Electronic address: Ning.Tang@abbott.com.
authors.forename: Ning
authors.initials: N
authors.lastname: Tang
authors.affiliation: Abbott Molecular, 1300 Touhy Ave, Des Plaines, IL 60018, USA. Electronic address: John.Lampinen@abbott.com.
authors.forename: John
authors.initials: J
authors.lastname: Lampinen
authors.affiliation: Abbott Molecular, 1300 Touhy Ave, Des Plaines, IL 60018, USA. Electronic address: magdalena.szostak@abbott.com.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Szostak
authors.affiliation: Abbott Molecular, 1300 Touhy Ave, Des Plaines, IL 60018, USA. Electronic address: Klara.B.Abravaya@abbott.com.
authors.forename: Klara
authors.initials: K
authors.lastname: Abravaya
authors.affiliation: Abbott Molecular, 1300 Touhy Ave, Des Plaines, IL 60018, USA. Electronic address: Hong.Wang@abbott.com.
authors.forename: Hong
authors.initials: H
authors.lastname: Wang
mesh_terms: D000995:Antitubercular Agents / Q000494:pharmacology* / Q000627:therapeutic use; D015169:Colony Count, Microbial; D024901:Drug Resistance, Multiple, Bacterial / Q000235:genetics; D006801:Humans; D007538:Isoniazid / Q000494:pharmacology* / Q000627:therapeutic use; D008826:Microbial Sensitivity Tests / Q000379:methods; D009154:Mutation; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000254:growth & development / Q000302:isolation & purification*; D012293:Rifampin / Q000494:pharmacology* / Q000627:therapeutic use; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology
chemical_list: D000995:Antitubercular Agents; D007538:Isoniazid; D012293:Rifampin
keywords: Isoniazid; Mycobacterium; Reflex; Rifampicin; Sensitivity; Specificity