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1Research Centre, DR. G.M. Taori Central India Institute of Medical Sciences (CIIMS), Nagpur, India
2Centre for Molecular Therapeutics, Australian Institute of Tropical Health and Medicine, James Cook University, Cairns, Australia
©2021, Korean Society of Epidemiology
This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
CONFLICT OF INTEREST
The authors have no conflicts of interest to declare for this study.
FUNDING
None.
AUTHOR CONTRIBUTIONS
Conceptualization: AAH, RSK. Data curation: AAH. Funding acquisition: None. Writing – original draft: AAH. Writing – review and editing: AAH, AK, RSK.
Timeline (year) | Actions/Achievements |
---|---|
1961 | National tuberculosis program (NTP) launched by the government of India |
1992 | Joint review of NTP by government of India, World Health Organization (WHO), and Swedish International Developmental Agency |
1993 | NTP program renamed to Revised National Tuberculosis Control Programme (RNTCP) with implementation of WHO-endorsed Directly-observed Treatment Short Course (DOTS) |
1993-97 | RNTCP with DOTS (WHO) piloted in some states in India |
1997 | RNTCP with DOTS (WHO) launched nationwide by government of India |
2002 | Green light committee established to promote high-quality access to second-line drugs for appropriate use in TB control regimens |
2006 | Complete countrywide coverage achieved by RNTCP- DOTS for TB |
RNTCP become known as RNTCP-2 | |
2007 | RNTCP-2 launched programmatic management of drug-resistant tuberculosis (PMDT) to improve drug-resistant tuberculosis (DR-TB) care in India |
2009 | Rapid molecular tests and line probe assay (LPA) endorsed by WHO |
2010 | Cartridge-based nucleic acid amplification tests (CBNAAT) endorsed by WHO for rapid molecular diagnosis of TB and DR-TB |
Guidelines for PMDT released by government of India | |
2011 | CBNAAT introduced in India |
2012 | National Strategic Plan for Tuberculosis (2012-2017) launched by the government of India |
The government of India prohibited sale of serodiagnostic kits and its use for TB diagnosis | |
TB case notification made mandatory by the government of India | |
Online TB case notification portal “NIKSHAY” launched by RNTCP-2 by government of India | |
2013 | Complete geographic coverage for multidrug-resistant (MDR)-TB achieved by RNTCP-2 |
2014 | Standards of TB care in India released containing universal guidelines for TB care and management for both private and public sectors |
First national drug resistance survey conducted by the government of India | |
2016 | Technical and operational guidelines by RNTCP-2 for TB control in India (updated recommendations to standards for TB care in India) for use of short-term oral regimens and advisory for second line LPA for DR-TB |
MDR regimes with bedaquiline piloted in some states | |
2017 | Revised National Strategic Plan (2017-25) launched by Prime Minister to end TB |
Decentralization of DR-TB services by implementation of guidelines of PMDT | |
Launch of Joint Effort for Elimination of Tuberculosis program under revised NSP to improve quality of TB services in private sector and boost public private partnership | |
2018 | WHO consolidated guidelines for DR-TB including use of short-term/full oral regimen for MDR-TB released and integrated under PMDT by RNTCP-2 |
2019 | Implementation of TrueNAT as rapid molecular assay endorsed under RNTCP-2 |
New guidelines for PMDT released based on WHO recommendation | |
2020 | RNTCP-2 renamed as the National Tuberculosis Elimination Program |
The Indian Council of Medical Research endorsed TrueNAT based on WHO recommendation as mainstay test for universal drug susceptibility testing (DST) in India replacing conventional DST |
Diagnostic test | Manufacturer | Platform/technology | Advantage | Limitation | |
---|---|---|---|---|---|
CBNAAT | |||||
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 | |
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 | |
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 | |||||
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 | |
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 | |
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 | |
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 | |||||
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 | |
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 | |||||
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 |
WHO, World Health Organization; TB, tuberculosis; MTB, Mycobacterium tuberculosis; PCR, polymerase chain reaction; MDR, multidrug-resistance.