Ann Clin Microbiol 2025;28(3):16. Current status of mycobacterial identification in clinical laboratories in Korea
| Assay | Type | Gene | Target | Manufacturer, headquarters |
|---|---|---|---|---|
| Amplified Mycobacterium Tuberculosis Direct (AMTD) test | isothermal transcriptase-mediated amplification assay | 16S rRNA gene | Detection of MTBC | Hologic, Canada |
| AdvanSure TB/NTM real-time PCR kit | Real-time PCR | IS6110 insertion sequence for MTBC ITS regions for NTM | Differentiation TB/NTM | Invitros, South Korea |
| PowerChek MTB/NTM real-time PCR kit | Real-time PCR | IS6110 insertion sequence for MTBC ITS regions for NTM | Differentiation TB/NTM | KogeneBiotech, South Korea |
| Anyplex MTB/NTM real-time PCR kit | Real-time PCR | IS6110 and mpb64 for MTBC 16S rRNA gene for NTM | Differentiation TB/NTM | Seegene, South Korea |
| Real-Q MTB & NTM kit | Real-time PCR | IS6110 insertion sequence for MTBC ITS regions for NTM | Differentiation TB/NTM | BioSewoom, South Korea |
| NextGene MTB/NTM Detection Kit | Real-time PCR | IS6110 and mpb64 for MTBC 16S rRNA gene for NTM | Differentiation TB/NTM | EONE Biotech Co, South Korea |
| The NeoPlex TB/NTM Detection Kit | Real-time PCR melting curve analysis | IS6110 insertion sequence for MTBC 16S rRNA gene for NTM | Differentiation TB/NTM / Identification of five NTM | GeneMatrix, South Korea |
| COBAS TaqMan MTB | Real-time PCR fully-automated system | 16S rRNA gene, esx gene | Detection of MTBC | Roche, Switzerland |
| COBAS MTB-RIF/INH | Real-time PCR fully-automated system | rpoB gene for rifampicin resistance katG gene and inhA promoter region for isoniazid resistance | Detection of resistance for rifampicin and isoniazid | Roche, Switzerland |
| Xpert MTB/RIF | Nested real-time PCR fully-automated system | rpoB gene for MTBC and rifampicin resistance | Detection of MTBC and Rifampicin resistance | Cepheid, U.S |
| Xpert MTB/RIF Ultra | Nested real-time PCR fully-automated system | IS1081 and IS6110 for MTBC rpoB gene for rifampicin resistance | Detection of MTBC and Rifampicin resistance | Cepheid, U.S |
| BD MAX MDR-TB | Real-time PCR fully-automated system | IS6110 and IS1081 insertion sequence rpoB gene for rifampicin resistance katG gene and inhA promoter region for isoniazid resistance | Detection of MTBC and Rifampicin and isoniazid resistance | Becton-Dickinson, U.S |
Abbreviations: PCR, polymerase chain reaction; MTBC, Mycobacterium tuberculosis complex; NTM, nontuberculous mycobacteria; TB, tuberculosis.