Presentation on theme: "Point of Care diagnostics: South Africa’s experience"— Presentation transcript:
1Point of Care diagnostics: South Africa’s experience Lesley ScottDepartment of Molecular Medicine and HaematologyUniversity of the Witwatersrand,and the National Priority Program, NHLSJohannesburg, South AfricaPOC WHO, IAS satellite 30th June 2013
2A perspective on South Africa’s Testing volumes Total Population over 50 Million at last censusEstimated 5.7 million HIV infected individuals of which 1.9 million are receiving ARV therapy. HIV continues to drive these testing needs.Currently Conduct approximately ~ 4 million CD4 tests annually, 2 million viral loads and currently EID assays3rd highest TB cases, 20% worlds reported HIV‐associated TB cases and 4th largest reported numbers of MDR.over 1.4 million GeneXpert tests (2012), smear microscopy load ~5 million smears in 2012, 1.2 million TB cultures in 201230-40% of all public health sector laboratory expenditure for HIV and TBUniversal testing for HIV and screening for TB – the primary objectives being to ensure that all citizens know their HIV and TB status, and to prevent new HIV and TB infections (NSP: 2012/ /2017) . Increase testing requirementsThe NSP has five goals: halving the number of new HIV infections ensuringthatatleast80%ofpeoplewhoareeligiblefortreatmentfor HIV are receiving it (at least 70% should be alive and still on treatment after five years) halving the number of new TB infections and deaths from TB ensuring that the rights of people living with HIV are protected halving the stigma related to HIV and TB.NSP, 2012
3NDOH Healthcare Facilities 256 NHLS labs ~80% population (public sector)NDOH Healthcare FacilitiesOver 7636 health facilities54 different categories of facility45% urban, 45% rural, 0.7% peri-urbanOver 3515 ARV clinicsNew guidelines:On ART: CD4 only at 12 monthsPre-ART: CD4 every 6 months2013/2014:14 million HCT – 2, (14%) expected HIV positive and require CD4.Target to initiate , thus 1 CD4 at 12 months.Residual 1, with CD4 >350c/ul will be monitored 6 monthly (ie 3, CD4 tests).Total CD4 for 2013/14 = 6, : significant scale upNational Department of Health manages health across all 9 provinces; provinces have significant autonomyNational Health Laboratory Service managed from a single headquarters in Johannesburg but services all 9 provinces: Services >80% of total public sector populationResponsible for teaching and research in pathology disciplinesNational Footprint of 265 laboratoriesStrong private sector with at least 5 major players services the insured population: knowledge base weak at a NDoH level on private sector activitiesUniversal testing for HIV and screening for TB – the primary objectives being to ensure that all citizens know their HIV and TB status, and to prevent new HIV and TB infections (NSP: ): massive increase in testing requirements
4Evaluations of POC CD4 Count Within Comprehensive Interventions: linkage to care!! Recently completed pilot evaluations (no comparison arms):HBCT-Plus (Home based counseling and testing, POC CD4 count, facilitated referrals, and follow up home visits)86% initiated ART ≤ 3months in rural KZN RAP (“Rapid Initiation of Antiretroviral Therapy in Pregnancy”)97% initiated ART (91% on same day) in Cape Town Randomized controlled trials now underwayGrand Challenges Canada RCT (“Investigating the feasibility of implementation of multi-disciplinary point-of-care testing in an HIV treatment clinic using a randomised controlled trial”)RapIT (“Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa”)Others?Courtesy Syndey Rosen, NDoH/NHLS POC workshop Pretoria, 24-15th June 2013
5Grand Challenges Canada (POC implementation award, 2011-2014) Feasibility of implementing multi-disciplinary point-of care (POC) testing in an active HIV treatment clinic ( PI: Wendy Stevens )CD4, Creatinine, ALT, Hb, TB (VL, CryAG)Develop a “POCT package”Perform randomized controlled trial (POC vs SOC “2010 guidelines”)Determine costingRecommend policy
6FindingsClinic space to perform “multiple POCT” is variable and limited.POCT requires its own checklist within quality ISO, CLSI and SANAS guidelines : pre-analytical, analytical and post analytical; equipment, safety, storage, waste, test QC, EQA, operator certification, training.SOP’s to include quick reference charts.Training both central and “on-site” test witnessing: more emphasis placed on computer literacy (GeneXpert experience)A “starter kit” (measuring cylinder, squeegee bottle, spill kit, order charts etc to introduce GCLP into clinics.Health system strengthening required for daily clinic workflow issues69% HIV patients require multiple POCT (>3/visit).
7Nurses perform multiple POC, daily QC and EQA as accurately as laboratory testing. Multiple POC’s (CD4, Hb, ALT, Creat) could be performed accurately on 1 finger stick (8% required >1 finger stick).100% of patients said they prefer either one (65.5%) or two finger sticks (34.5%) over a venepuncture specimen.68.8% would be willing to have up to 3 finger sticks before having a blood draw.Earliest time a POCT performed was 09:30, (median11:00 and the latest 12:24).Median time taken from the time the nurse started the first POCT to the time taken to start the last POCT varied depending on the number and type of tests requested.When CD4 requested, tests took ~1hr47min,No CD4 requested, ~6min - 14minutes. These time measurements did not include acting on result or any connectivity.
8+ Human resources CLINIC DUTIES Patient registration History taking POC DUTIES (pre-analytical, analytical, post-analytical)Additional finger prick/venepunctureSample labellingInstrument QC testingInstrument maintenanceTesting:ALT, Creat, lactacte, Hb: <2minutesPIMA = 20 minutesXpert MTB/RIF =2 hoursResult recording/printing/reportingExternal quality assessment (EQA)Infection controlSpill cleaningWaste disposalAdditional skills:PhlebotomyTesting performed from blood tubes (pipetting skills)Additional duties:Operator certification and on-going monitoringManaging test failures, instrument downtimeStock controlSpecimen storageHuman resourcesCLINIC DUTIESPatient registrationHistory takingPhysical examCounsellingRapid testing (HIV, pregnancy)Phlebotomy – lab testsTreatmentReturn visit booking+Who will perform POCT?Task Shifting – management of task shifting from lab staff to clinical staffRegulation and certification around scope of work?
9TB screening (questionnaire) RCT at 3 remote PHCN=3000HCT/PICTHIV PositiveHIV NegativePIMACD4> 350CD4< 350ALTTB screening (questionnaire)HemoglobinNegativePositiveGeneXpertCreatinineSOC participantsConsent and Finger-stick x1Venipuncture: HIV test confirmation +PIMA in POCUse stored blood from tests aboveSputumPOC participantsAdherence counselingART start(same day)VenipunctureTB screeningReturn in one weekCD4<3501-4 weeks laterFollow up for 6 or 12 monthsN=1000N=480N=316N=50N= 288CD4>350
10Outcome measuresPrimary: Proportion of patients retained in care at 6/12 and 12/12Secondary:Time taken from HCT to initiation of ART in both armsProportion of patients in each arm experiencing an OI (including TB) in the follow-up periodProportion of patients experiencing treatment interruptions in each groupDetermine cost effectiveness of POC testing vs Standard of Care (SOC)Preliminary results before study end (dedicated staff)GCC RB OsihCategoryPOCSOCP-valueInitiation112740.01Mean CD4 values if less than 350194.6 cells/mm3166.4 cells/mm3TB symptoms present132 (52.4%)123 (55.9%)Time to initiation (Mean)4.1 days16.9 daysTime to initiation (Median)1 day20 daysAs per 2010 guidelines
11TAT: 3 clinics North West Province 75% of specimens are collected (once/day courier) from the clinic and received at laboratory within one day;Patient initiated SOC85% lab tests completed by lab within one day;72% printed results stamped in the clinic within one day.Without connectivity in clinics, POCT will lose National dataTAT: 3 clinics North West ProvincePatient initiated day 1 with POC , same day 72% lab results returned to clinicPOC placement with staff versus treatment guideline timeline change to initiate day 1 or day 7 to compliment clinic work flow.
12Beyond the LIS: Our experience at POC: Laboratory information system (LIS): instant data stream to central “powerhouse data repository”Result reportingBillingProgram M&ECentral data warehouseNational dataBeyond the LIS: Our experience at POC:Manual entry transcription errorsBoth clinic sites had transcription errors (1%; n=5/480):Incorrect assay result recordedAssay result recorded under incorrect test.
13Increasing access to results: SMS printers SMS printers to improve turn-around-time of results back to facilities from the labsBeneficial in remote, far-reaching areas where no internet access is availableSMS is automaticallygenerated from the lab’s LISResult printed on paperand to be stored in patient’sfileInitial roll-out in 2009:Currently 1990 SMS printers in the field nationwide (~4500 DoH facilities)Services available for: CD4 Count, HIV VL, EID, GeneXpert TB and TB Microscopy.Dashboard
15Centralised data for decentralised testing POC Device #1POC Device #2POC Device #3POC Device #4Host LIS/HISUniversal POC Devices Interface Program / Data Management SystemHL7/ASTM /POCT1-ABi-directional CommunicationPOCT1-AASTMHL7Proprietary
16Feasibility of multi-disciplinary Point-of-Care Testing
17Available Options for Connectivity ProductInstrument InterfacingTraining and CertificationQC and instr. ManagementPatient HistoryResult ManagementClinical InformationVisit ManagementAegisPOCExtensiveYesNoPOCceleratorCobas ITLimitedIdenticareDevelopmentTherapy EdgeNoneeKAPAInstrument and Data ManagementPatient Management
18Dashboard Middleware PIMA connectivity: PIMA modem required for FTP-PUSHLIS mechanism can be developed to interface results from CSV fileTwo components: Dashboard and Middleware SolutionsDashboard contains a small subset of the full features of the middleware solutionsDashboard is unlinked from patient informationDashboards are instrument / manufacturer specificMiddleware solutions are vendor & instrument neutral.PIMA connectivity:
19Cepheid/NHLS Remote Monitoring Operational dashboard for real-time monitoring of results, errors, resistance and positivity ratesPre-configured on all newly installed GeneXpertsCompare results per country, province, district, sub-district, laboratory.Break down of error rates per error code and % increase / decrease over a time period.User Workshop held 5-9th November to improve usabilityand facilitate design changes, Johannesburg
20Current GeneXpert Placements National policyRoll out March 2011, testing at smear microscopy labs>1mil tests to date.Gx at POC: NTCM=too costly,2 ½ staff required for 15 patients same day treatmentPhase 2Phase 3Testing centres: 175Analysers: 242Clinic placements: 20Gx4: 77Gx16-8: 1Gx16: 162GX48: 1GX80-48: 1
21POCT not an easy decision for South Africa Both a national policy and legal framework required.NDoH/NHLS combined POCT workshop (24-25th June 2013): output to form a national advisory body to focus on POCT.POCT “an extension of the lab tiered network”Focus on CD4, Cryptococcal antigen testing <100CD4 cells/ulInvestigate POCT for NCD’sDetermine the place of VLAddress lack of regulation issuesAddress connectivity as a critical component for quality POCTCombine efforts on modeling the place and cost for POCT.Address gaps in research – especially linkage to care (HIV and TB) and improve health systems.
23In the interim: 62 CD4 labs – current footprint Proposed CD4 service delivery modelNHLS CD4 testing laboratories (Red),Proposed community laboratories (Green),POC/mini-lab sites (Yellow)in reference to the NDOH clinics (blue)
24Is South Africa ready for (multiple) POCT? Clinic space is varied and limitedNurses can perform multiple POCT duties but time is limited. Need a new cadre of POCT staffMore studies needed:Full economic costingCost-effectiveness (incl. multiple POCT)Cost of deployment and logisticsCost of quality assuranceAddress economic scale and new guidelines: Hb, ALT, cr, CD4 at once for 7 day initiationSame day initiation impact (HCT + adherence + LTH + HIV resistance) yet unknown: takes more than a rapid CD4 count
25Acknowledgments National Department of Health NHLS National Priority Program staff (led by Prof Wendy Stevens and Dr. Leigh BerrieNHLS POCT working groupGCC team and clinical partnersFunders: Clinton Foundation, CDC, PEPFAR, Grand Challenges CanadaProfessor Scott and R&D Development teamSouth African Cryptococcal Screening Programme: Nelesh GovenderHERO: Professor Sydney Rosen, Dr. Lawrence Long, Kate SchnippelConnectivity working group (Brad Cunningham)CD4 working team (Prof. Debbie Glencross), viral load (Dr. Sergio. carmona)Special thanks to Trevor Peter, Maurine Murtagh, Rosanna Peeling, Tim Tucker,Ilesh Jani. Mozambique program