StrengtheningLabCapacityforTBDiagnosisandCareinLMICs

RaisingtheBar

June20,2018AdvancedTBDiagnosticsCourseMcGillUniversity,Montreal

KathleenEngland,PhDMScTBDiagnosticsAdvisor

MSFAccessCampaign,Geneva

Deep Diagnostics By Alice Street

“thepieceshowshowtheglobalhealthcommunitysystematicallypromotedempiricalorsyndromictreatmentinlowincomesettings,becausebuildingareasonablelabinfrastructurewasconsideredtoodifficultandexpensive,andsyndromictreatmentwasconsideredenoughforimpoverishedsettings”-M.Pai

URL:https://limn.it/deep-diagnostics/

•  1990’spushforRDTs•  Seriouslyneglectinginvestmentsinlaboratories•  Improvementoflabsandstrengtheningsystemsisstillconsideredtooexpensiveand

difficultbymostgovernmentsanddonors.-StigmatizingandDemotivating•  Majorimpact=Donordrivenimplementation–Silos,whichfragmentcareandmoved

awayfromintegratedpatientcentricservices.

TIMEFORCHANGE–RAISETHEBAR!•  Focusonbuildingstrongerintegratedlabnetworks•  BalancetheuseofRDTswithmorereliablelaboratorytests•  Establishcomprehensivediagnosticservices

1stEdition•  Generallabtestforroutinepatientcarerequireforcommunicableandnoncommunicablediseases.

•  DiseasespecificIVDsfordetection,diagnosis,andmonitoring(HIV,TB,Malaria,HBV/HCV,HPV,Syphilis)

WhattoolsareWhere?WhattoolsareNeeded?WhohasAccess?

NetworkAssessments

CantheEDLdrivenetworkstrengtheningandcapacitybuilding?

WhatisCapacityBuilding?

TTT

echnologies

ests

raining

LabStrengthening?

Skillsdevelopment

Standardization(SOPs)

Quality(QMS)

WhatisMissing?

SystemsIntegration

PrivateSectorPatientPerspective

Environment&Infrastructure

CLEANTemperatureHumidityControls

•  Inthe21stCenturytheseessentialfeaturesareaMUSTforlabsateverylevelofahealthcaresysteminordertoprovideaccurateandreliablediagnosticservices

.•  ItistimetopushGovernmentstoInvestinLaboratoryServicesforQualityCare

•  RAISEtheBARtoprovidetheFOUNDATIONforlaboratoriestosupportmedicalcare.

RapidInformationTransfer21stCenturyDataManagement&Reporting

DEVICE

Patient EHR

Doctor/HCW

MoH

DataLINKAGESConnectivity&LIMS

DXCONNECTIVITY

NETWORK

EHR

Ø GxAlerthasthelargestglobalfleetconnectingavarietyofinstruments

In41countries.

Ø Others•  C360(Cepheid)•  Data-To-Care(Savics)•  BlueFrontier(FIND)

WHOTBReportingtoolsdonotcollectinformationonLIMSimplementationorprogressofe-linkagesoflabdatatoEHRs.

*2017WHOTBReportData(216counties)

CollectionSites

VariousTransportModes

SpecimenReferralLinkages-IntegratedTransport-

HC

HC

HC HC

HC

Hub&Spoke

ZonalCourierSystems

ZoneA

ZoneB

ZoneC

ZoneD(warm/lush)

VariousModelsVariousModalitiesVariousSpecimens

14countrysurveyonspecimenreferral

(unpublishedsurvey,K.England,2015)•  WHOReportingtooldoesnotcollectinformationonspecimenreferralnetworksorlinkagestotesting.

RecentMSFSurvey2017(16countries):•  10/14(71%)reportedhaveaspecimenreferralsystem•  3indicatedtheirsystemwereefficient•  Only2statedplanstoinvest

QualifiedHumanResources1)NeedforSpecialists:•  Microbiologists•  MolecularBiologists•  InformationSystemsSpecialists•  Bioengineers•  InstrumentationSpecialists•  MedicalTechnologists•  DataManagers•  Supply&ProcurementOfficers•  QualityOfficers•  BioSafetyOfficers•  LabManagers•  NetworkCoordinators

2)UniversityEngagementforcurriculumdevelopmenttosupportnationalprogramsneedsbybuildingthecadreofskilledlaboratoriansthroughqualitydegree/certificateprograms.

3)Transitionawayfromdonordriventrainingandestablishnationalmechanismswithintheeducationsystem(MinistryofEducation)thataremoresustainable.

4)InvestinHR:provideequitablewagesandbenefitstokeepexperiencedstaff.

LabWasteManagementWhatarewedoingwithlabwaste?

NotincludedinWHOreporting.

EngagingPrivateSectorLabsWheredopatientsseekcare?

•  13-countriesinanalysis•  ~60%seekinitialcareinPrivateSector•  Microscopycoveragelimitedatentrylevels•  Xpertcoveragewasnotevaluated

•  NeedToEnsurePrivateSectorLabshaverecommendedtoolsforTB.

-  DiagnosticAlgorithms-  XpertMTB/RIF-  Linkagestofollow-ontestinglikeDST-  PatientMonitoring

EngagingPrivateSectorLabsAffordability

[Ponnuduraietal.(2018)JournalofEpidemiologyandGlobalHealth]

NeedforGovernmentRegulationsonPricing

IntegratedLabServices1)  BeginswithHIVandTBprograms

•  TestingforTBexpandedtoARTcenters•  TestingforHIVimplementedatTBcenters•  Increasedcoordinationofcommoninterventions•  Sharingresourcesforcommoninitiatives•  Increasedcooperationtoprovidepatientcenteredcare

2)  IntegrateHealthServices•  PatientFocus•  Eliminationofparallelprograms•  Buildingcooperativestrategies•  Linkingpublicandprivatesector•  PoolResources(GlobalFundTransition)

3)IntegrationofSystems•  Laboratory•  DataManagement•  Procurement&Distribution•  Specimenreferral•  Community-basedsupport

TB$

HIV$HCV$

MCH$MAL$

NCD$

NTD$

IntheMSF16countrysurvey(2017)–XpertNetworkResources•  94%ofcountriesrelyonGFtosupportXpertNetwork•  67%relyonGFandadditionaldonorstosupport95%ofnetworkactivities.•  Only6countriesnoted“some”domesticallocation.•  50%willfacesubstantialchangesduetoGFtransitioning.

TBDiagnosticsWherearewetoday?

WHATISMISSING??

RoutineADSMTesting:Patientmonitoringtoimprovetreatment

outcomes

WHOEndTBStrategy

PatientdiagnosedwithRR-TB(XpertMTB/RIF=initialtest)

SL-LPAdirect

Noresult

80%interpretable 20%uninterpretable

PerformCulture

InitiatetheshorterMDR-TBregimen

FQ-S/SLID-S FQ-R/SLID-S FQ-S/SLID-R FQ-R/SLID-R

InitiateoptimisedlongerMDR-TBregimen

2ndlinecDSTinhighprevalenceFQ/SLID

SL-LPAIndirecttesting

ü  XpertMTB/RIFü  2ndLineLPAü  2ndlinecDST

XpertCapacityStudy-30HBTBCountriesTheWHOExceltoolforcalculatingcountry-specifictargetsfor

laboratorystrengtheningandcapacitybuilding

Pulmonary,bacteriologicallyconfirmed Newcases: 124'604 Relapsecases: 3'637Pulmonary,cliniciallydiagnosed Newcases: 45'009 Relapsecases: 3'795Extrapulmonary Newcases: 43'549 Relapsecases: 1'654Totalnewcasesnotified 213'162 Totalrelapsecasesnotified: 9'086Previouslytreatedcases,excludingrelapses 1'673Totalcasesnotified 223'921%ofTBcasesthatarechildren 0.042 %ofTBcasesthatareadult: 0.958%ofTBcasesthatareHIV-positive 0.020 %ofTBcasesthatareHIV-negative/unknown: 0.980HIV-positivepeopleclinicallyscreenedforTB 13'500

PlannednumberofRR/MDR-TBcasestobedetected(andtreated): 5'300

Calculationofcountry-specifictargetsformicroscopy,WRDs(includingXpertMTB/RIF),culture/DSTcapacityValuesin red shouldbeenteredoradjustedwhenpossiblebasedonactualcountrydataandpractices

TBepidemiology

XpertMTB/RIFAnnualnumberofXpertMTB/RIFtests

ForPLHIVwithsignsandsymptomsofTB: 4'100

ForchildrenwithsignsandsymptomsofTB: 56'000

Forpeopleatriskofhavingdrug-resistantTB: 59'200

ForpreviouslyuntreatedHIV-negativeadultswithsignsandsymptomsofTB:

1'170'200

ForTBcasesforDSTpurposes(excludingthosegettingXpertMTB/RIFasinitialtest):

0

TotalannualnumberofXpertMTB/RIFtests 1'290'000

TargetnumberofGeneXpertmodules 1344

•  InitialTestforALL•  MaxTestingCapacity

@4tests/module/day240workdays/yr

11/30(37%)countriesneedmoremodulesAlthoughweknownotificationratesarelow,thefirststepistorecognizetheneedsinordertotestcurrentrates.

AngolaChina

DRCongoEthiopiaIndia

IndonesiaKenya

MozambiqueMyanmarNigeriaPNG

SouthAfricaThailandZimbabwe

BangladeshDPRKoreaPakistanPhilippinesRussiaVietNam

CambodiaSierraLeone

BrazilCentralAfr.Rep.Congo

LesothoLiberiaNamibiaURTanzaniaZambia

AzerbaijanBelarusKazakhstanKyrgyzstanPeruRep.MoldovaSomaliaTajikistanUkraineUzbekistan

BotswanaCameroon

ChadGhana

Guinea-BissauMalawi

SwazilandUganda

LPAin-countryNoLPA=(17%)

No2ndlineLPA(25%)

•  WHOreportingtoolsdonotspecificallyrequestinformationoninstrumentcapacity,annual2nd-lineLPAtestingrates,orresults.(FQ,SLIs)

•  Noforecastingtoolfor2nd-lineLPA(mostcountriesdonotknowprevalenceofFQorSLIresistance).

•  Nodataonimplementation/usewithinnationalalgorithms?

WHO2017Reportingdata

AngolaChina

DRCongoEthiopiaIndia

IndonesiaKenya

MozambiqueMyanmarNigeriaPNG

SouthAfricaThailandZimbabwe

BangladeshDPRKoreaPakistanPhilippinesRussiaVietNam

CambodiaSierraLeone

BrazilCentralAfr.Rep.Congo

LesothoLiberiaNamibiaURTanzaniaZambia

AzerbaijanBelarusKazakhstanKyrgyzstanPeruRep.MoldovaSomaliaTajikistanUkraineUzbekistan

BotswanaCameroon

ChadGhana

Guinea-BissauMalawi

SwazilandUganda

2ndLinecDSTInCountryNoneExternal

WHO2017Reportingdata

WHOHASACCESS?HowwillSequencingfitin?

PushforQualityQMSimplementationandprogress

ImplementationofQMSandprogresstowardsaccreditationofNTRLsinAfrica-Albertetal.(2017)AJLM

TBSLMTAprogramin10countries,37labssince2013

FINDSurveyConductedinAfricanRegion•  47/49NTRLSfromWHOAfricanRegion•  21labs(43%)receivedTBSLMTA/SLMTA•  10ActivelyusingGLItool•  28.6%NTRLshaveaccreditationinterventionsinstrategicplans.

EQAprograms- 95.8%formicroscopy-  60.4%for1stlinecDST-  25.0%for2ndlinecDST-  22.9%moleculartesting

NEEDtoinvestinQUALITY

RaiseYourBar•  NetworkAssessments•  EstablishaNationalEDL•  BuildStrongerSystems•  InvestinHRSolutions•  PushIntegration•  Link-InPrivateSector•  BetterForecasting•  SetDiagnosticTargets•  EnsureQuality•  IncreaseDomesticInvestment•  UnderstandthePatientPerspective