experience with implementation of xpert mtb/rif in india
TRANSCRIPT
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
Urban Slum - 602,328 (1)
Urban – 2,862,482 (5)
Tribal - 1,611,537 (4)
Rural - 3,370,324 (7)
Hilly - 260,000 (1)
Population – 8,7 Mill (18 sites)
EXPANDx TB Xpert
project
Gene Xpert feasibility and Impact study
• Aim 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
• Feasibility and costs of solar powered back-up
Impact Outcomes
Detection of TB & DR-TB cases
Delay and treatment outcomes
HIV-TB & paediatric cases
Referral from the private sector
Cost effectiveness modelling
Project Timelines
Study conceived, funding approved by USAID March, 2010
APW by WHO to FIND in Sept, 2011 for 2 year project
Protocol approved and 18 projects sites finalized by NTP,
Jan, 2012
Ethical approval,
10th March, 2012
First site operational, 24 March, 2012
Project design
• Unit of implementation: RNTCP TB Unit- Approx. 500,000 population
• 18 TB Units identified by programme at Diverse settings; Pop.8.7 million
Project sites
• Data collection: 2-3 months for 14 sites
• Four sites directly started CBNAAT for early feasibility assessment
Baseline
• Training
• Referral linkages with all public health facilities
• Air Cond, Power Back-up, security aspects addressed
Preparatory activities
• 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 2nd line treatment; specimen sent to reference lab for confirmatory DST
Intervention
Preparatory Activities
• All project sites provided with:
– Air-conditioning
– 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
235 3 sites
785 5 sites
1917 13 sites
3423 15 sites
4046 16 sites
4397 18 sites
5297 18 sites
5113 18 sites
5074 18 sites
5071 18 sites
0
1000
2000
3000
4000
5000
6000
7000
March April May June July August September October November December
Total monthly TB suspects tested across sites
Impact Results- Case detection Comparison with Baseline
Baseline phase
• 10,841 TB suspects tested
– Average 241 TB
suspects/month/site
• 1555 Microbiologically
confirmed TB cases detected
– 14.3% smear positivity
– Average of 35 TB
cases/month/site
Intervention with CBNAAT
• 34,896 TB suspects tested
– Average of 265 TB
suspects/month/site
– Average increase of 15% per 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
241 265
35 55
0
50
100
150
200
250
300
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
– 2493 (7.2%) Additional microbiologically confirmed cases detected
– 689 TB cases found Rif resistant
CBNAAT ‘additional’ contribution of
microbiologically-confirmed cases
and DR-TB cases
47
154
410
753 791
929
1066 1010 1035 1015
19 92
275
495 532 600
718 662 670 654
9 23 35 57 84 99 87 93 110 92
0
200
400
600
800
1000
1200
CBNAAT Positive Smear Positive Rif Resistant
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
EXPANDx TB CBNAAT project
Objectives
• 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
• Decentralised labs to provide DST to a number districts
• Total 100 Districts covered; 168 Million
Project sites
• Training
• Referral linkages with all coverage districts
• Air Cond, Power Back-up, security aspects addressed
Preparatory activities
• 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
Activity
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
Scale up under the project
1707
3674
4411
6500
7900
9000
299 502 663 975
1200 1350
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
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