Experience with implementation of Xpert MTB/RIF in India Dr K S Sachdeva Addl. DDG (TB), Government of India
Background Two ongoing projects being implemented in India, under RNTCP by FIND Gene Xpert feasibility and Impact study Collect evidence on the feasibility and impact of introducing CBNAAT at decentralized labs on TB and Rifampicin resistance detection EXPANDx TB CBNAAT project Establish 12 CBNAAT labs for Rif DST to supplement the capacity of the existing reference lab network of NTP in difficult areas
Xpert Feasibility and Impact study EXPANDx TB Xpert project Rural - 3,370,324 (7) Urban 2,862,482 (5) Tribal - 1,611,537 (4) Urban Slum - 602,328 (1) Hilly - 260,000 (1) Population 8,7 Mill (18 sites)
Aim Gene Xpert feasibility and Impact study o Collect evidence on the feasibility and impact of introducing CBNAAT for the detection of TB and Rifampicin resistance Objectives o Feasibility: Establish the feasibility of decentralized deployment of routine CBNAAT testing all pulmonary TB & DR-TB suspects in selected geographic areas o Impact: Assess the impact of decentralized deployment of routine CBNAAT testing of all pulmonary TB suspects on diagnosis of TB & DR-TB Approach o Programmatic demonstration with before/after comparison from same sites; Phased implementation
Gene Xpert feasibility and Impact study Feasibility Outcomes Infrastructure requirements Test failure rates under field conditions Effect of operating temperature & Electrical power requirements Minimum training needs Description quality assurance requirements Impact Outcomes Detection of TB & DR-TB cases Delay and treatment outcomes HIV-TB & paediatric cases Referral from the private sector Cost effectiveness modelling Feasibility and costs of solar powered back-up
Project Timelines APW by WHO to FIND in Sept, 2011 for 2 Study year project conceived, funding approved by USAID March, 2010 Protocol approved and 18 projects sites finalized by NTP, Jan, 2012 Ethical approval, 10 th March, 2012 First site operational, 24 March, 2012
Project design Project sites Unit of implementation: RNTCP TB Unit- Approx. 500,000 population 18 TB Units identified by programme at Diverse settings; Pop.8.7 million Baseline Data collection: 2-3 months for 14 sites Four sites directly started CBNAAT for early feasibility assessment Preparatory activities Training Referral linkages with all public health facilities Air Cond, Power Back-up, security aspects addressed Intervention Same day sputum specimen transportation All pulmonary TB & DR TB suspects offered single CBNAAT test Rx based on CBNAAT result CBNAAT-detected RIF-resistant patients referred for 2 nd line treatment; specimen sent to reference lab for confirmatory DST
All project sites provided with: Air-conditioning Preparatory Activities 2 hours power back-up for CBNAAT equipment Maximum and Minimum temperature gauges Training Existing staff used to operate CBNAAT One day to lab staff on CBNAAT testing & to field staff on project protocol Specimen transportation Specific specimen transportation mechanism developed for each site Transportation cost covered under the project Quality assurance Panel testing using GLI Xpert MTB-Rif panel
Rapid Scale Up 7000 Total monthly TB suspects tested across sites 6000 5000 4000 3423 15 sites 4046 16 sites 4397 18 sites 5297 18 sites 5113 18 sites 5074 18 sites 5071 18 sites 3000 2000 1000 0 235 3 sites 785 5 sites 1917 13 sites March April May June July August September October November December
Impact Results- Case detection Comparison with Baseline Baseline phase 10,841 TB suspects tested Average 241 TB suspects/month/site Intervention with CBNAAT 34,896 TB suspects tested Average of 265 TB suspects/month/site Average increase of 15% per site 1555 Microbiologically confirmed TB cases detected 14.3% smear positivity Average of 35 TB cases/month/site 7210 CBNAAT MTB positive cases detected 20.7% CBNAAT positivity Average of 55 TB cases/month/site
Impact Results- Case detection Comparison with Baseline 300 250 241 265 200 150 100 50 35 55 0 Baseline Intervention Average TB suspects per month Average microbiologically confirmed TB cases per month
Impact Results- Case detection Comparison with Sm. Microscopy results in Intervention phase March to Dec, 12 34,896 TB suspects tested on CBNAAT 7210 CBNAAT MTB positive cases detected 20.7% positivity 4717 were smear positive 13.5 % positivity 1200 1000 800 600 400 200 2493 (7.2%) Additional 0 microbiologically confirmed cases detected 689 TB cases found Rif resistant 1066 929 1010 1035 1015 753 791 718 600 495 532 662 670 654 410 275 154 92 47 19 9 23 35 57 84 99 87 93 110 92 CBNAAT Positive Smear Positive Rif Resistant CBNAAT additional contribution of microbiologically-confirmed cases and DR-TB cases
Impact Results Detection of Rif Resistance-TB Baseline data collection DST offered to all identified DR-TB suspects Total 238 DR-TB suspects identified under the programme 23 diagnosed with Rif Resistance-TB; Intervention phase CBNAAT test offered to all TB & DR-TB suspects in project Total 35,358 TB & DR-TB suspects tested (34,896TB suspects & 462 DR- TB suspects) 797 cases diagnosed with Rif Resistance-TB; 689 among TB suspects & 108 among DR-TB suspects
Interim Conclusions Testing all TB suspects using CBNAAT increased detection of microbiologically-confirmed TB and Rif Resistance-TB Significant increase in microbiologically-confirmed TB cases Significant increase in Rif Resistance-TB detection over baseline CBNAAT can be feasibly deployed at this decentralized level for all suspects in diverse settings in India Deployed at 18 public health clinics, doing 5000 tests per month with minimally-modified infrastructure and human resources 93% of patients with interpretable result from first test; 99% with repeat testing. With A/C availability, temperature errors negligible
Objectives EXPANDx TB CBNAAT project Establish 12 CBNAAT labs for Rif DST to supplement the efforts and capacity of the existing reference lab network of RNTCP Introduce CBNAAT at ICELT, NTI, Bangalore Thereby address the national training needs for CBNAAT Expected Outcome Further strengthen RNTCP by providing access to rapid DST in hard to reach areas Conduct more than 24000 Rapid DSTs across the 12 CBNAAT labs; Detect approx 7000 DR-TB cases, annually 15
Project design Project sites Decentralised labs to provide DST to a number districts Total 100 Districts covered; 168 Million Preparatory activities Training Referral linkages with all coverage districts Air Cond, Power Back-up, security aspects addressed Activity Specimen of DR-TB suspects transported from each district to CBNAAT lab for DST Transportation of sputum specimen to CBNAAT lab on transportation within 48 hours Same day testing Communication of results by SMS & E-mail on the same day
Current status S. No State Sites Functional status 1 Andhra Pradesh Medak 01 August 2012 2 Gujarat Surat 01 August 2012 3 Tamil Nadu Madurai 01 August 2012 4 Nagaland Kohima 8 August 2012 5 J& K Srinagar 28 August 2012 6 Punjab Patiala 24 August 2012 7 Uttar Pradesh Varanasi 10 January 2013 8 Uttar Pradesh Allahabad 11 January 2013 9 Karnataka NTI Bangalore 17 Sept2012 10 Karnataka ICELT (training) 18 Sept2012 11 Maharashtra Govandi, Mumbai 09 March 2013 12 Tamil Nadu CMC, Vellore 04 December 2012 13 Maharashtra B. J. medical College, Pune Site assessment done 14 Sikkim Gangtok Pending
10000 9000 8000 7000 6000 Scale up under the project 6500 7900 9000 5000 4000 3000 3674 4411 2000 1000 0 1707 1200 1350 975 299 502 663 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13 DR-TB suspects Rif Resistant
Acknowledgements Dr. Ashok Kumar, Dr Neeraj Raizada Dr. Sreenivas Dr. Catharina Boehme Dr. Param & Dr. Bala Project Coordinators- Dr. Bhavin, Dr. Shubhangi and Dr. Ameet Dr. Puneet Dewan Dr. Malik Parmar & Dr. Mayank, CTD Dr. Ranjani State and District RNTCP officials All RNTCP Consultants
THANKS