CBNAAT |
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Commercial GeneXpert (Xpert MTB/RIF assay) |
Cepheid, Sunnyvale, USA |
Automated real-time PCR |
WHO-endorsed front-line test for simultaneous detection of MTB complex and resistance to drug rifampicin in less than 2 hr |
Expensive; Detection of mono-resistance; Reduced sensitivity in smear negative and paucibacillary samples |
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Xpert® MTB Ultra |
Cepheid, Sunnyvale, USA |
Automated real-time PCR |
WHO-endorsed. ultra-large cartridge and additional MTB target for improved sensitivity for MTB detection in paucibacillary sample |
Expensive; Detection of mono-resistance; Reduced specificity compared to GeneXpert cartridge |
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Xpert® MTB/XDR |
Cepheid, Sunnyvale, USA and the Foundation for Innovative New Diagnostics, USA |
Automated real-time PCR |
Detection of MTB and drug resistance against multiple second-line drugs |
Announced, under WHO evaluation; Not available for commercial use |
Line probe assay |
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GenotypeMTBDRplus V1 |
Hains Lifesciences, Germany |
Manual/Automated hybridization assay |
WHO-endorsed assay for detection of MDR (resistance to frontline drugs isoniazid and rifampicin) |
Requires culture or smear positive sample to rule out MDR |
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GenoType MTBDRsl version 1.0 |
Hains Lifesciences, Germany |
Manual/Automated hybridization assay |
WHO-endorsed assay for ruling out MDR; Offers resistance detection to second line drugs |
Requires culture or smear positive sample to rule out MDR |
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GenoType MTBDRsl version 2.0 |
Hains Lifesciences, Germany |
Manual/Automated hybridization assay |
Offers resistance detection to second line drugs and injections |
Reduced sensitivity in smear negative samples |
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GenoscholarTM NTM+MDRTB II |
NIPRO, Japan |
Manual/Automated hybridization assay |
WHO-endorsed assay for differentiation of MTB species along with detection of MDR |
Reduced sensitivity in smear negative samples |
TrueNatTM
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TrueNatTM MTB |
Molbio Diagnostics/ Bigtec Labs, India |
Real-time microchip-based PCR system |
Battery-operated point-of-care system for quantitative detection and diagnosis of MTB in 35 min |
Reduced sensitivity in smear negative samples |
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TrueNatTM MTB Plus |
Molbio Diagnostics/ Bigtec Labs, India |
Real-time microchip-based PCR system |
Quantitative detection of MTB and resistance to rifampicin in 35 min |
Reduced sensitivity in smear negative samples |
Commercial LAMP assay |
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Loopamp MTBC Detection Kit |
Eiken Chemical Company Ltd., Japan |
Manual point-of-care PCR assay |
WHO-endorsed point-of-care PCR assay performed without thermal cycler; Results in less than 1 hr |
Lower sensitivity than conventional PCR assays |