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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 Acknowledgments to: HPV Genotyping - Data summary 25 Jan 2011

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

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) Case detection and cure rates are below WHO targets Ability to integrate services HPV Genotyping - Data summary 25 Jan 2011

5 NHLS TB Laboratory Facilities: 2010/2011
4.7 million smears 1 million cultures LPA On average 22% culture are positive 11% of cultures demonstrate some form of resistance MDR rates: low HPV Genotyping - Data summary 25 Jan 2011

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 24th 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?
Culture generally: symptomatic and smear negative, HIV pos or prior history of TB HPV Genotyping - Data summary 25 Jan 2011

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) HPV Genotyping - Data summary 25 Jan 2011

9 54 NHLS staff members trained prior to world TB day
9

10 National Xpert MTB Results (cumulative March to June)
ICF MTB detected MTB not detected Test failure Total % Positive 2218 12 762 744 15 724 14.11% Non-ICF 6373 26 725 1271 34 369 18.54% 8591 39 487 2015 50 093 17.15% % Total 78.83% 4.02% 100% HPV Genotyping - Data summary 25 Jan 2011

11 National Xpert RIF results: March-June 2011
N = 8591 (MTB detected); 630 RIF Resistance ICF Status Indeterminate No result Resistant Sensitive Total % ICF 15 78 195 1930 2218 8.79 Non-ICF 57 435 5824 6373 6.83 72 135 630 7754 8591 7.33 0.84 1.57 7.33% 90.26% 100% HPV Genotyping - Data summary 25 Jan 2011

12 Geographical Variation
Province MTB Detected MTB Not Detected Test Failure Total % MTB Positive % RIF Eastern Cape 632 3141 148 3921 16.12 7.12 Free State 523 2701 1 3225 16.22 5.93 Gauteng 683 3528 94 4305 15.87 7.32 Kwazulu-Natal 3941 14490 788 19219 20.51 7.13 Limpopo 515 4142 62 4719 10.91 8.16 Mpumalanga 879 4515 557 5951 14.77 8.08 North West 527 2867 72 3466 15.20 9.30 Northern Cape 868 4049 292 5209 16.66 7.03 Western Cape 23 54 78 29.49* - 8591 39487 2015 50093 17.15 % 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
Algorithm development Time to get consensus, ideally before implementation Need to build in flexibility Changes: TB guidelines, request forms, training etc, resistance reporting Training Site 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 rates 3-4%: error codes: 5011 (73%), 5006/7 (16%)(insufficient vol), 2008 (10%) EQA program Verification 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 Challenges and Lessons learned HPV Genotyping - Data summary 25 Jan 2011

15 National Phased Implementation
Cluster randomised trial design: PHASES| PILOT | FULL PILOT|HIGH CASE| GF XPERT | CONTROL | DISTRICTS| ALL LABS 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 FAST SCALE-UP scenario: Full coverage by December 2012 (Ministerial mandate) SLOW SCALE-UP scenario: Full coverage by September 2013

16 Model for instrument placement (Fast scale-up, 10% growth in suspects)
2011/12 2012/13 2013/14 Tests/ day at full capacity Province GX4 GX16 GX48 EC 4 12 10 14 2 2,720 FS 1 5 3 496 GP 13 1,552 KN 6 11 18 36 2,944 LP 7 20 1,056 MP 544 NC 192 NW 656 WC 1,088 TOTAL 65 GX4, 169 GX16, 4GX48 11,248 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 item Cost % of total Cartridge R 70% Calibration R 4.47 2% Staff R 18.77 8% Consumables R 5.02 Waste disposal R 1.92 1% Transport and logistics R 15.33 7% Training and QA R 3.83 Overheads R 19.17 Total R 100% Cost will vary: dependent on implementation rate, exchange global volumes, negotiation, freight Modelled Average per test cost across all scenarios 2011/12 to 2013/14: R $ 26-36 2014/15 to 2016/17: R

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) Scenario Annual 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 $ 280 M $ 121 $ 835 $ 399 M $ 172 $ 912 $ 118 M $ 51 $ 77 +42% 42% 9% TOTL POPULATION: 5.5% SYMPTOMATIC

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
HPV Genotyping - Data summary 25 Jan 2011

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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