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Taking the first steps Xpert MTB/RIF Implementation in public sector in South Africa: Lessons Learned Wendy Stevens Molecular Medicine and Haematology.

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Presentation on theme: "Taking the first steps Xpert MTB/RIF Implementation in public sector in South Africa: Lessons Learned Wendy Stevens Molecular Medicine and Haematology."— Presentation transcript:

1 Taking the first steps Xpert MTB/RIF Implementation in public sector in South Africa: Lessons Learned Wendy Stevens Molecular Medicine and Haematology University of the Witwatersrand & NHLS 1 Acknowledgments to:

2 GeneXpert Technology (Cepheid) throughput/ 8hr day GX4 GX16 FiND, 2010 GX48 (Infinity)

3 Automated Real-time PCR Rapid (2 hours) Cartridge based Result Positive/negative TB Resistance yes/no to Rifampicin Low contamination risk Boehme,C et al NEJM 2010

4 Disease Burden in South Africa 20% worlds reported HIV associated TB cases and 2nd largest reported numbers of MDR 70%-80% TB suspects infected with HIV Overall TB rates 980/100,000 –Mining populations 2500/100,000 –Correctional Services 4500/100,0000 Increasingly smear negative (8-10% positivity) and extra- pulmonary TB(16%) WHO Strong Recommendation: The new automated DNA test for TB should be used as the initial diagnostic test in individuals suspected of MDR-TB or HIV/TB (i.e. all SA TB suspects) 4

5 NHLS TB Laboratory Facilities: 2010/ million smears 1 million cultures LPA N=244

6 Phase 1 rollout High burden, TB Intensified Case Finding campaign districts Limited Pilot in all 9 provinces Selection: volumes, district selected 25 sites, 30 instruments 20 GX4, 9 GX16, 1 GX48 Placement by world TB day: March 24 th 11% national coverage based on 2010 smears/2.0 2 smears at diagnosis to be replaced by one Xpert MTB/RIF (Phased approach) (microscopy centre based)

7 Where should Xpert be placed within TB diagnostic algorithm? 7

8 Methodology: March-June 2011 Site needs assessment: 25 sites –Hoods, space, network points, power, A/C, HR, checklist developed Training –80 laboratory technologists : intensive 2 day centralised training –-microscopists currently first cadre –SOP driven LIMS interfacing (pilot) –A Lab-Track LIS interface was developed to automatically report: Lab number, cartridge number, TB detected/not, RIF detected/not. A verification program (fit for purpose) for placement and calibration of each module –[MOPE147] Development of implementation plan, budget and National TB Costing Model (NTCM) 8

9 54 NHLS staff members trained prior to world TB day

10 National Xpert MTB Results (cumulative March to June) ICF MTB detected MTB not detected Test failure Total % Positive ICF % Non- ICF % Total % % Total 17.15%78.83%4.02%100% 10 N =

11 National Xpert RIF results: March-June 2011 ICF Statu s Indeterminate No result ResistantSensitiveTotal% ICF Non- ICF Total % %90.26%100% N = 8591 (MTB detected); 630 RIF Resistance

12 Geographical Variation Province MTB Detected MTB Not Detected Test FailureTotal % MTB Positive % RIF Eastern Cape Free State Gauteng Kwazulu-Natal Limpopo Mpumalanga North West Northern Cape Western Cape * - Total %7.33 %

13 TB GeneXpert Positivity: eThekwini District in KZN Average smear positive rates for same period 2010 and 2011: 8%-9%

14 Challenges and Lessons learned ChallengesLessons Learned Algorithm developmentTime to get consensus, ideally before implementation Need to build in flexibility Changes: TB guidelines, request forms, training etc, resistance reporting TrainingSite needs assessment At least 2 days, several individuals at each site Better on site, Include GLP, safety, computer literacy Focus on sample preparation Clinician training critical Workflow issues problematic on large instruments Regulatory issues Costing implementation & modelling future costs Numerous sources for input Need to model future Opportunity for costing and reviewing current TB service Error rates3-4%: error codes: 5011 (73%), 5006/7 (16%)(insufficient vol), 2008 (10%) EQA programVerification program : DCS Frequency? Per module? Need for negative controls for larger analysers? Electricity, temperature, waste disposal, cartridge storage UPS, A/C (if>30C) Cartridges fairly bulky (2-28C) Safety Biohazard hood for infinity and GX16

15 National Phased Implementation FAST SCALE-UP scenario: Full coverage by December 2012 (Ministerial mandate) SLOW SCALE-UP scenario: Full coverage by September 2013 FAST SCALE-UP | July 2011 | Dec 2011 | Sept 2011 | Mar 2011 | Dec 2011 | Dec 2012 SLOW SCALE-UP | July 2011 | Dec 2011 | Sept 2011 | Mar 2012 | Mar 2013 | Sept 2013 PHASES| PILOT | FULL PILOT|HIGH CASE| GF XPERT | CONTROL | DISTRICTS| ALL LABS

16 Model for instrument placement (Fast scale-up, 10% growth in suspects) 2011/122012/132013/14 Tests/ day at full capacity Province GX4GX16GX48GX4GX16GX48GX4GX16GX48 EC ,720 FS GP ,552 KN ,944 LP ,056 MP NC NW WC ,088 TOTAL65 GX4, 169 GX16, 4GX4811,248 Initiated at current microscopy centres, volumes based on adjusted smear per patient, throughput of analysers. CAPITAL : $21 M

17 Recurrent cost Cost per MTB/RIF test (including hidden costs) Cost itemCost% of total CartridgeR % CalibrationR 4.472% StaffR % ConsumablesR 5.022% Waste disposalR 1.921% Transport and logisticsR % Training and QAR 3.832% OverheadsR % TotalR % Modelled Average per test cost across all scenarios 2011/12 to 2013/14: R $ /15 to 2016/17: R Cost will vary: dependent on implementation rate, exchange global volumes, negotiation, freight

18 National TB Cost Model To estimate implementation costs for NHLS lab network To inform national-level budget requirements ( ) To estimate the incremental national health service cost of replacing the existing pulmonary TB diagnostic algorithm with a new algorithm incorporating Xpert MTB/RIF molecular technology, under routine care conditions and at costs incurred by the government (Excel-based population level decision model) (HER0) Built into Rollout BMGF study: cluster randomised trial design (phase 3a and b) : to verify modelling and assess impact ( Aurum Institute)

19 Programme cost: Total and per case cost in 2013 [2011 USD] (Fast scale-up, 10% growth, SA at 50% of global volume, purchase) ScenarioAnnual cost Cost per suspect Cost per case 1) Cost of diagnosis only Baseline$ 105 M$ 45$ 312 Xpert scenario$ 160 M$ 69$ 367 Difference to Baseline$ 55 M$ 24$ 54 % change+53% +17% 2) Cost of diagnosis and outpatient treatment Baseline$ 280 M $ 121$ 835 Xpert scenario$ 399 M $ 172$ 912 Difference to Baseline$ 118 M $ 51$ 77 % change+42% 42%9%

20 Conclusions I Pilot demonstrated feasibility of implementation Significantly increased early detection of MTB Significantly increased screening for potential MDR cases Significant changes to National TB program envisaged Facilitating HIV/TB integration at laboratory, clinic and programmatic level Expensive algorithm which may well have to be modified as confidence in technology and data emerges

21 Infinity Installation in Prince Msheyni in KZN: truly a team effort

22 Acknowledgements NHLS NPP program NDoH: Drs Mametje, Pillay, Mvusi, Barron NTBRL: Drs Erasmus and Coetzee CHAI SA HERO team, G. Meyer –Rath, K. Bistline Right to care: Ian Sanne MM&H: Prof Scott, N. Gous, B. Cunningham USAID South Africa CDC for funding and support FIND Aurum Institute

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