Developing new TB diagnostics:
Needs, challenges and opportunities
Shinichi Takenaka
Stop TB Partnership, Geneva
30 October 2020

References
Global strategy for tuberculosis
research and innovation. WHO;2020
https://apps.who.int/iris/rest/bitstream
s/1312195/retrieve

Global Plan to End TB 20182022 The Paradigm Shift. StopTB Partnership; 2019http://www.stoptb.org/assets/docume
nts/global/plan/GPR_20182022_Digital.pdf

Global tuberculosis report 2020.
WHO; 2020
https://apps.who.int/iris/bitstream/handle/10665/336069/9789240013131eng.pdf?ua=1

GDF’s Diagnostics Catalog. StopTB Partnership; 2020
http://www.stoptb.org/assets/documen
ts/gdf/drugsupply/GDFDiagnosticsCatalog.pdf

www.stoptb.org

Highest priorities in TB diagnostics development include:• a biomarker test: a point-of-care, non-invasive and non-sputum-based highaccuracy test that can detect all forms of TB (TB infection, DS-TB and DR-TB)
in all age groups and subpopulations by identifying characteristic
biomarkers or biosignatures, and which can identify people more likely todevelop TB disease after infection;• a triage test: a point-of-care, simple, low-cost test that can be used by firstcontact health care providers to identify those who need further testing;• a smear replacement test: a more accurate (high sensitivity and specificity)
point-of-care diagnostic test to replace smear microscopy for detecting
pulmonary TB and to monitor treatment response for all subpopulations
and age groups; and• a rapid drug susceptibility test: a test that can be used at the microscopy
centre level of the health care system to select appropriate first lineregimen-based therapy
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R&D priorities include
Stop TB Partnership• Develop rapid and affordable non-sputum-based tests for diagnosis ortriage.
• Develop accurate DST for critical medicines.
• Improve tools for detecting TB infection and testing for risk ofprogression to active disease.
FIND• A user-friendly, low-cost, non-sputum-based rapid test for diagnosing
active TB that can be used for active case-finding and in primary
healthcare facilities.
• Rapid drug-resistance tests that enable treatment regimens to be
tailored to individuals and help to safeguard medicines against AMR.
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Progress in the development of TB diagnostics (1/4)
TECHNOLOGIES ENDORSED BY WHO
Molecular detection of TB and drug resistance▪ Xpert MTB/RIF and Xpert Ultra as the initialdiagnostic test for TB and rifampicin resistance,
Cepheid, USA▪ LPA for the detection of MTB, isoniazid andrifampicin resistance in acid-fast bacilli smear
positive sputum or MTB cultures (FL-LPA), Hain
Lifescience, Germany and Nipro, Japan▪ LPA for the detection of resistance tofluoroquinolones and second-line injectableagents (SL-LPA), Hain Lifescience, Germany▪ TB LAMP for detection of TB, Eiken, Japan▪ Truenat MTB, MTB Plus and MTB-RIF Dx assays
as initial diagnostic tests for TB and rifampicin
resistance, Molbio Diagnostics, India

IGRAs for TB infection▪ T-SPOT.TB, Oxford Immunotec, UK▪ QuantiFERON-TB Gold Plus (QFT-Plus), Qiagen,USA
Culture-based technologies▪ Commercial liquid culture systems and rapid
speciation▪ Culture-based phenotypic DST using 1% critical
proportion in LJ,7H10,7H11 and MGIT mediaMicroscopy▪ Light and light-emitting diode microscopy(diagnosis and treatment monitoring)
Biomarker based assays▪ Alere Determine TB-LAM, Alere, USA for TB
detection in HIV infected people
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Progress in the development of TB diagnostics (2/4)
UNDER EVALUATION BY WHO
Molecular detection of TB and drug resistance▪ Molecular technologies for genotypic drug
resistance testing (including sequencingtechnologies)▪ FluoroType MTBDR, Hain Lifescience, Germany▪ m2000 RealTime MTB System, Abbott, USA▪ BD Max MDR-TB, Becton Dickinson, USA▪ Roche cobas® MTB system, Roche Diagnostics,Switzerland▪ AccuPower TB & MDR RT PCR, Bioneer, Republicof Korea▪ Genoscholar PZA TB II, Nipro, Japan▪ Xpert XDR-TB cartridge, Cepheid, USA

CAD for digital chest radiography▪ CAD4TB, Delft Imaging, Netherlands▪ Lunit INSIGHT CXR, Lunit, South Korea▪ qXR, qure.ai, India▪ DxTB, Deeptek, USA▪ XrayAME, Epcon, Belgium▪ InterRead DR Chest, Inter VISION, China▪ T-Xnet, Artelius, India▪ Dr CADx, Dr CADx, Zimbabwe▪ RediSen, AXIR, South Korea▪ JF CXR-1, JF HEALTHCARE, China
Culture-based drug susceptibility testing▪ SensititreTM MYCOTBI plate; ThermoFisher
Scientific Inc., USA
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Progress in the development of TB diagnostics (3/4)
ON THE MARKET (NOT YET EVALUATED BYWHO)
Molecular detection of TB and drug resistance▪ iCubate System, iCubate, USA▪ Genechip, TB drug resistance array, Capital Bio,China▪ EasyNAT TB Diagnostic kit, Ustar
Biotechnologies, China▪ Amplification-based tNGS assays: Next GenRDST assay, TGen, USA;▪ Deeplex-MycTB assay, GenoScreen, France

IGRAs for TB infection▪ Lioferon TB/LTBI, LIONEX Diagnostics &Therapeutics GmbH, Germany▪ STANDARD E TB-Feron ELISA, SD Biosensor,Republic of Korea▪ Advansure TB IGRA, LG chem, Republic of Korea
Skin tests for TB infection▪ Diaskintest, JSC Generium, Russian Federationwww.stoptb.org

Progress in the development of TB diagnostics (4/4)
TECHNOLOGIES IN DEVELOPMENT
Molecular detection of TB and drug resistance▪ Gendrive MTB/RIF ID, Epistem, UK▪ TruArray MDR-TB, Akkoni, USA▪ INFINITIMTB Assay, AutoGenomics, USA▪ FluoroType XDR-TB assay, Hain Lifescience,
Germany▪ MeltPro TB assay, Zeesan Biotech, China▪ QuantuMDx, POC, UK▪ Truenat MTB-INH/MTB-FQ, Molbio, India▪ AccuPower XDR-TB RT PCR, Bioneer, Republic ofKorea

IGRAs for TB infection▪ Access QuantiFERON®-TB, QIAGEN, USA▪ IP-10 IGRA elisa/lateral flow, rBioPharm,Germany▪ ichroma™ IGRA-TB, Boditech Med Inc., Republicof Korea▪ T-Track(R) TB, Lophius Biosciences GmbH,Germany▪ VIDAS TB-IGRA, bioMérieux, FranceSkin tests for TB infection▪ c-Tb skin test, Serum Institute of India, India▪ EC-Test, Anhui Zhifei Longcom
Biopharmaceutical Co. Ltd, China
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PRICE - GDF’s Diagnostics Catalog -www.stoptb.org

Thanks

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