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Table. 1.

Table. 1.

Nucleic acid based MTB complex tests

Trade NameFDA No.ClassMethodTargetSensitivitySpecificity
Mycobacterium tuberculosisXpert MTB/RIF AssayK143302Class IIaReal-time PCRrpoB93.8% (439/468)d, 94.7% (18/19)e98.7% (620/628)d, 99.0% (404/408)e
Amplified Mycobacterium tuberculosis Direct TestP940034Class IIbTranscription mediated amplification (TMA) and Hybridization protection assay (HPA)rRNA93.2% (109/114)98.8% (414/419)
Amplicor Mycobacterium tuberculosis testP940040Class IIcPCR, Hybridization16S rRNA95% (134/141)100% (48/48)
SNAP M. tuberculosis complexK900292Class INAAT, DNA probeNRNRNR
BDProbetec ETMycobacterium tuberculosis complex culture identification kitK000884Class INAAT, DNA probe16S-23SrRNA ITS99.6% (226/227)95.6% (473/495)
Accuprobe Mycobacterium tuberculosis complex TestK896493Class ILine probe AssayNR99.2%99.9%
Rapid Diagnostic System for Mycobacterium tuberculosisK871795Class ILine probe AssayNRNRNR
Rapid Identification Test for Mycobacterium tuberculosis complexK862614Class ILine probe AssayNRNRNR

a, b, and c are for Class II documents from FDA. The source of documents were provided by FDA [9], [10], and [11], respectively. Abbreviations: NR, Not reported in document; d, a sensitivity for MTB complex; e, a sensitivity for Rifampin assay.

Korean J Clin Lab Sci 2018;50:20-8
© 2018 Korean J Clin Lab Sci