title: Analytical and clinical performance of Abbott RealTime MTB, an assay for detection of Mycobacterium tuberculosis in pulmonary specimens.
abstract: Nucleic acid amplification test (NAAT)-based assays provide fast and sensitive results compared to conventional TB tests. The performance of the new Abbott Molecular MTB assay for the qualitative detection of MTB complex using the automated m2000™ system or manual sample preparation is summarized in this paper. The assay detects eight MTB complex subspecies. The observed limit of detection (LOD) when used to test an MTB H37Rv panel was 2.45 colony forming units (cfu)/mL, while the claimed assay LOD with this MTB strain is 17 cfu/mL. No cross reactivity, or carryover were observed in the study. The clinical sensitivity of the assay was 93% overall; 99% in smear positive, culture positive specimens, and 81% in smear negative, culture positive samples. The clinical specificity was 97%. The inhibition rate in the study was 0.34%. The data suggest that Abbott RealTime MTB is a reliable, robust and sensitive assay for the molecular detection of MTB.
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: ning.tang@abbott.com.
authors.forename: Ning
authors.initials: N
authors.lastname: Tang
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: andrea.frank@abbott.com.
authors.forename: Andrea
authors.initials: A
authors.lastname: Frank
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: vihanga.pahalawatta@abbott.com.
authors.forename: Vihanga
authors.initials: V
authors.lastname: Pahalawatta
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: john.lampinen@abbott.com.
authors.forename: John
authors.initials: J
authors.lastname: Lampinen
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: anke.coblenz-korte@abbott.com.
authors.forename: Anke
authors.initials: A
authors.lastname: Coblenz-Korte
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: chad.dunn@abbott.com.
authors.forename: Chad
authors.initials: C
authors.lastname: Dunn
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: cheng.li@abbott.com.
authors.forename: Cheng
authors.initials: C
authors.lastname: Li
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: gavin.cloherty@abbott.com.
authors.forename: Gavin
authors.initials: G
authors.lastname: Cloherty
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: klara.b.abravaya@abbott.com.
authors.forename: Klara
authors.initials: K
authors.lastname: Abravaya
authors.affiliation: Abbott Molecular, Des Plaines, IL, USA. Electronic address: gregor.leckie@abbott.com.
authors.forename: Gregor
authors.initials: G
authors.lastname: Leckie
mesh_terms: D001431:Bacteriological Techniques; D015169:Colony Count, Microbial; D004269:DNA, Bacterial / Q000235:genetics*; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans; D057230:Limit of Detection; D009169:Mycobacterium tuberculosis / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D021141:Nucleic Acid Amplification Techniques; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology
chemical_list: D004269:DNA, Bacterial
keywords: Co-infection; Inactivation; Mycobacterium; Reproducibility; Respiratory; Sensitivity; Specificity