Global Tuberculosis Report -- 2012.pdf

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evised as a result of the introduction of new technologiesin which culture and DST are invariably performedtogether. In 2011, 19 of the 36 countries in the combinedlist of 22 high TB burden countries and 27 high MDR-TB burden countries did not reach the target (Table 6.1).Of these 36 countries, 9 reported more than 1 laboratoryper 5 million population using line probe assays – a highthroughputtool used at central and regional levels to rapidlydetect resistance to rifampicin and, in some cases,isoniazid. These numbers are changing quickly, as laboratorystrengthening efforts including EXPAND-TB (seeSection 6.3) come to fruition.Quality-assured DST is critical to ensure accuratedetection of drug resistance for subsequent treatmentdecisions and to avoid false diagnoses. External qualityassessment schemes for DST appear to be comprehensivelyinstalled more commonly than those for microscopy.While 42% of countries claim to have a comprehensivescheme for microscopy (as stated above), 71% of the 115low- and middle-income countries and territories indicatingcapacity for DST reported an external quality assessmentscheme encompassing all DST laboratories.The target for culture and DST capacity of 1 laboratoryper 5 million population is likely to be reviseddownwards in future following the introduction of theWHO-recommended automated nucleic amplificationassay Xpert ® MTB/RIF (Cepheid, Sunnyvale, CA, USA).Xpert MTB/RIF technology (see Box 6.1) can detectrifampicin resistance-conferring mutations, has sensitivityfor TB detection equivalent to that of solid culture, andcompared with culture methods it can be used at lowerlevels of the laboratory network. Importantly, however,culture will remain essential for testing of susceptibilityto drugs other than rifampicin, and is currently the onlytool available for monitoring the response to treatment ofthe growing number of patients being treated for MDR-TB. Ongoing evaluation of evidence on the use of XpertMTB/RIF and its impact on the workload of other laboratorydiagnostics, including microscopy, culture and DST,will allow for refinement of the current targets.While a number of countries report suboptimal capacityto detect TB and drug resistance, patients in manyparts of the world still access laboratory testing by seekingcare in the private sector. The quality of diagnosticservices in this sector is highly variable, and some privatepractitioners continue to use diagnostic tests thatare not recommended by WHO. In addition, in some settingslaboratories in the public sector that are not underthe auspices of the national TB control programme alsodiagnose TB without necessarily following recommendedguidelines and quality assurance procedures. Collaborationbetween national TB control programmes and alllaboratories offering TB diagnosis is therefore critical toensure that national guidelines are followed, that appropriatediagnostic tests are used, and that patients diagnosedwith TB are notified to the national TB controlprogramme and receive proper care. In 2011, 15 of 36high burden countries reported some level of collaborationwith laboratories in the private sector; 17 reportedcollaboration with laboratories in the public sector.6.3 Strengthening TB laboratories globally,regionally and nationallyOne of the main prerequisites for strengthening TB laboratorycapacity in countries is dynamic policy reform,adapting WHO guidelines on TB diagnostics into nationalTB control programme guidelines. Table 6.2 presentsthe uptake of selected WHO policy guidance at global,regional and country levels, focusing on the 36 countriesin the combined list of 22 high TB burden countries and27 high MDR-TB burden countries.All reporting high MDR-TB burden countries and 85%of reporting countries globally had incorporated intotheir national guidelines the WHO policy guidance onconventional phenotypic DST by 2011. Countries in theAfrican Region have the lowest uptake (69%).Incorporation of policy guidance on liquid cultureis highly variable, ranging from as low as 45% in theEastern Mediterranean Region to 84% in the EuropeanRegion. Globally, uptake of policy on line probe assays isrelatively low (44%) for all countries; only 17% of countriesin the Region of the Americas reported incorporationof the guidance in their national guidelines.Although recommended by WHO only in December2010, WHO’s policy guidance on Xpert MTB/RIF hasbeen incorporated into national guidelines by one third(33%) of reporting countries; two thirds (64%) of thehigh TB burden countries and half (50%) of the highMDR-TB burden countries have already incorporated theassay in their revised diagnostic policies.The EXPAND-TB project is a global initiative of multiplepartners that aims to strengthen laboratory capacityfor detecting drug-resistant TB and establish rapid diagnosticsin 27 countries. Launched in 2008, the project isa collaboration among WHO, the Global Laboratory Initiative(GLI), FIND and the Global Drug Facility, fundedby UNITAID and other partners. As shown in Figure 6.1,the participating countries are at various stages of projectimplementation: 17 were in the final phase of routinetesting and monitoring as of July 2012, compared with6 in July 2011. Given the time required to establish thenecessary infrastructure for central level laboratoriescapable of using liquid culture and line probe assays, theEXPAND-TB project is now coming to fruition in the routinedetection and reporting of drug-resistant TB cases.Several of the countries participating in the project havereported considerable increases in the numbers of drugresistantcases during recent years (Figure 6.2).The WHO/GLI TB Supranational Reference Laboratory(SRL) Network is another driving force in strengtheningGLOBAL TUBERCULOSIS REPORT 2012 69
BOX 6.1Rolling out Xpert MTB/RIF globallyIn December 2010, WHO recommended use of the Xpert ® MTB/RIF (Cepheid, Sunnyvale, CA, USA) assay for the rapid and simultaneousdetection of TB and rifampicin resistance using the GeneXpert platform. The test entails fewer biosafety and human resource requirements thanconventional culture or DST. Furthermore, its sensitivity for detecting TB is signifi cantly higher than that of microscopy, particularly in patientswith HIV infection.By the end of June 2012, Xpert MTB/RIF had been rolled out in 67 of the 145 countries eligible to purchase instruments and cartridges atconcessional prices. 1.1 million test cartridges and 3602 GeneXpert instrument modules had been procured, with technical and fi nancialassistance from many partners and donors. South Africa has led the adoption of the technology and intends to use it countrywide as areplacement for microscopy for the diagnosis of TB; as of June 2012, the country accounted for 37% of the modules and 53% of the cartridgesprocured globally. The most up-to-date data on procurement and country-specifi c site locations and plans, together with WHO guidancedocuments on use of the test, are available on a dedicated WHO website. 1To gain evidence on Xpert MTB/RIF for the refi nement of its global policy guidance, WHO has been systematically collecting data from earlyimplementers of Xpert MTB/RIF on the tests conducted and algorithms used, the effects of introducing the technology on laboratory workload,and operational and logistic challenges encountered. 2 As of July 2012, 31 sites in 12 countries had contributed data. Systematic collection ofcomplementary laboratory and patient indicators is also underway by partners including TBCARE I, TB REACH, the South Africa National HealthLaboratory Services and Médecins Sans Frontières. Operational research projects, including those inventoried by the TREAT-TB initiative, 3 areexpected to yield further critical information on the impact and cost effectiveness of Xpert MTB/RIF in various diagnostic algorithms.Scaling up use of the Xpert MTB/RIF assay globally is expected to be greatly accelerated by a drop in the price per test from US$ 16.86 toUS$ 9.98, following execution of a novel fi nancing agreement between the manufacturer (Cepheid) and the Bill & Melinda Gates Foundation,the United States Agency for International Development (USAID), the United States President’s Emergency Plan for AIDS Relief (PEPFAR)and UNITAID in August 2012. The catalytic effect of the price reduction on such global scale-up will be complemented by a US$ 25.9 milliongrant from UNITAID to WHO’s Stop TB Department and the Stop TB Partnership. The new three-year TBXpert project will provide the XpertMTB/RIF technology to 21 recipient countries by linking a broad network of implementing partners with existing initiatives for TB laboratorystrengthening, using innovative approaches to expand access to vulnerable populations in the public and private sectors.FIGURE B6.1.1Progress in the roll-out of Xpert MTB/RIF, by July 2012GeneXpertmodules ordered01–45–2425–4950–99≥ 100Not eligible for preferential pricingNot applicable1www.who.int/tb/laboratory/mtbrifrollout2More detail on this initiative can be found at: www.who.int/tb/features_archive/xpert_use_web/3http://xrmt.treattb.org/70 WHO REPORT 2012 GLOBAL TUBERCULOSIS CONTROL
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GLOBALTUBERCULOSISREPORT2012
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ContentsAbbreviationsivAcknowledgem
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AcknowledgementsThis report on glob
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WHO Western Pacific RegionShalala A
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Executive SummaryThe World Health O
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CHAPTER 1IntroductionBOX 1.1Basic f
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TABLE 1.1 Targets for the scale-up
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TABLE 1.2 Reporting of data in the
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BOX 2.1Uncertainty in estimates of
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TABLE 2.2 Estimated burden of disea
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FIGURE 2.5 Estimated TB incidence r
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FIGURE B2.2.1Reporting of notificat
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FIGURE 2.8Estimated TB incidence ra
Page 28 and 29: FIGURE 2.11 Countries (in blue) for
Page 30 and 31: FIGURE 2.12 Trends in estimated TB
Page 32 and 33: ● producing and widely disseminat
Page 34 and 35: FIGURE 2.16 Progress in global cove
Page 36 and 37: BOX 2.6Efforts by the Task Force to
Page 38 and 39: CHAPTER 3TB case notificationsand t
Page 40 and 41: BOX 3.1 1Definitions of TB casesDef
Page 42 and 43: TABLE 3.3 Contribution of public-pr
Page 44 and 45: BOX 3.4Integrating community-based
Page 46 and 47: TABLE 3.4 Estimates of the case det
Page 48 and 49: TABLE 3.5 Treatment success for new
Page 50 and 51: CHAPTER 4Drug-resistant TBKEY FACTS
Page 52 and 53: FIGURE 4.2 Percentage of new TB cas
Page 54 and 55: BOX 4.1Frequencies of resistance to
Page 56 and 57: FIGURE 4.6 Number of MDR-TB cases e
Page 58 and 59: FIGURE 4.7Notified cases of MDR-TB
Page 60 and 61: egimens globally, providing more su
Page 62 and 63: 5.1 Funding for TB care and control
Page 64 and 65: TABLE 5.2 NTP budgets, available fu
Page 66 and 67: FIGURE 5.5Trends in domestic and do
Page 68 and 69: FIGURE 5.6Domestic funding as a per
Page 70 and 71: FIGURE 5.8Cost per TB patient succe
Page 72 and 73: FIGURE 5.10 Total cost and unit cos
Page 74 and 75: ● The 14 countries not included i
Page 76 and 77: on public health by an external Exp
Page 80 and 81: TABLE 6.2 Incorporation of WHO poli
Page 82 and 83: FIGURE 6.3The Supranational Referen
Page 84 and 85: of TB disease by 65%, irrespective
Page 86 and 87: FIGURE 7.3Percentage of TB patients
Page 88 and 89: BOX 7.1Accelerating progress in pro
Page 90 and 91: TABLE 7.2 Assumptions used to estim
Page 92 and 93: FIGURE 8.1 The development pipeline
Page 94 and 95: sputum specimens and TB isolates fr
Page 96 and 97: cal trial sites and building labora
Page 98: new TB vaccine candidate. A Phase I
Page 102 and 103: This annex explains the methods tha
Page 104 and 105: 2011. On average, 15 data points we
Page 106 and 107: may suffer from biases. These biase
Page 108 and 109: TABLE A1.3Parameter estimates used
Page 110 and 111: 5. Estimates of TB prevalence, 1990
Page 112: the Republic of Moldova, Romania, t
Page 116 and 117: AFGHANISTANPopulation 2011 32 milli
Page 118 and 119: BRAZILPopulation 2011 197 millionHI
Page 120 and 121: CHINAPopulation 2011 1 348 millionH
Page 122 and 123: ETHIOPIAPopulation 2011 85 millionH
Page 124 and 125: INDONESIAPopulation 2011 242 millio
Page 126 and 127: MOZAMBIQUEPopulation 2011 24 millio
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NIGERIAPopulation 2011 162 millionH
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PHILIPPINESPopulation 2011 95 milli
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SOUTH AFRICAPopulation 2011 50 mill
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UGANDAPopulation 2011 35 millionHIG
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VIET NAMPopulation 2011 89 millionH
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ANNEX 3Regional profiles
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WHO REGION OF THE AMERICASPopulatio
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WHO EUROPEAN REGIONPopulation 2011
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WHO WESTERN PACIFIC REGIONPopulatio
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SUMMARY BY WHO REGIONTable A4.1 Est
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MORTALITY (EXCLUDING HIV) PREVALENC
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NEW AND RELAPSENOTIFICATION RATE aY
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-% OF TB PATIENTS WITHKNOWN HIV STA
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AFRICAN REGIONTable A4.1 Estimates
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INCIDENCE (INCLUDING HIV) INCIDENCE
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NEW AND RELAPSENOTIFICATION RATE aY
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NEW AND RELAPSENOTIFICATION RATE a1
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TREATMENT SUCCESS (%) a1995-2010YEA
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YEARTOTALCONFIRMEDCASES OFMDR-TB aE
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MALEYEAR 0-14 15-24 25-34 35-44 45-
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REGION OF THE AMERICASTable A4.1 Es
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% OF COHORTTREATMENT SUCCESS (%) a1
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MALEFEMALEYEAR 0-14 15-24 25-34 35-
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EASTERN MEDITERRANEAN REGIONTable A
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EUROPEAN REGIONTable A4.1 Estimates
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SOUTH-EAST ASIA REGIONTable A4.1 Es
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SMEAR LABS % OF SMEARPER 100K LABS
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Estimates of mortality, prevalence
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YEARPOPULATION(MILLIONS)MORTALITY (
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YEARPOPULATION(MILLIONS)INCIDENCE (
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YEARPOPULATION(MILLIONS)INCIDENCE (
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SMEAR LABS % OF SMEARPER 100K LABS
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