1. Decade of field experience with TB GeneXpert IAS Satellite session Mexico, 22 July By Jean de Dieu IRAGENA Technical Officer Laboratory WHO/AFRO, HIV/TB and Hepatitis Programme

2. 2010 Policy Recommendation
WHO-endorsed Rapid Diagnostic Test for TB (1) Xpert MTB/RIF, 2010 and 2013
2010 Policy Recommendation
Xpert MTB/RIF is recommended rather than conventional microscopy, culture and DST as the initial diagnostic test in adults presumed to have MDR-TB or HIV-associated TB.
2013 Policy Update
Xpert MTB/RIF is recommended rather than conventional microscopy and culture as the initial diagnostic test in all adults and children with signs and symptoms of pulmonary and extrapulmonary TB
© Gerhard Jörén/ UNITAID

3. Placement of different tests at the levels of laboratory sophistication

4. Total number of sites with LPA (red) and Xpert MTB/RIF (blue), WHO African Region, MDG end 2015

5. WHO-endorsed Rapid Diagnosti Test for TB (2) Xpert MTB/RIF Ultra, 2017
Xpert MTB/RIF Ultra is recommended rather than conventional microscopy and culture as the initial diagnostic test in all adults and children with signs and symptoms of pulmonary and extrapulmonary TB (CSF, lymph nodes and tissue specimens)
Ultra has a higher sensitivity for detection of MTB than Xpert MTB/RIF particularly in:
Smear -/Culture + specimens (+17%)
Paediatric, extra-pulmonary specimens (CSF)
HIV + patients whose specimens are frequently paucibacillary
The expert group recognized that the impact of increased sensitivity results in decreased specificity for TB detection and becomes a trade-off between increased diagnosis and overtreatment.

6. Areas of diagnostic integrations Areas of diagnostic integration Additional Xpert assays, 2018
Xpert cartridges for other diseases and conditions can be used on the same GeneXpert instrument as for Xpert MTB/RIF
WHO Prequalified: Xpert HIV-1 Qual assay (EID), Xpert Hepatitis C and HIV Viral Load assays
Potential areas for integration: Testing site personnel, trainings, maintenance, supply systems, specimen referral, quality assurance, etc.
See WHO Information Note on adoption and use of multi-disease testing devices (Download the document on

7. South Africa Uganda Lesotho
Transition to Ultra: Xpert MTB/RIF and Ultra cartridges procured in 2018 (in 25 countries)
South Africa
Uganda
Lesotho
Cartridges

8. Annual number of GeneXpert modules procured under concessional pricing
Data: Cepheid

9. GeneXpert footprint in 136 countries (number of modules as of December 2018)
Data: Cepheid

10. Annual number of Xpert MTB/RIF cartridges procured under concessional pricing

11. Countries procuring the most Xpert MTB/RIF cartridges and GeneXpert modules, cumulatively since 2010
Country
Cartridges
South Africa
15,344,020
India
6,908,250
Indonesia
2,047,550
Brazil
1,690,930
Nigeria
1,482,090
Kenya
1,476,050
Philippines
1,457,510
Pakistan
1,456,020
Ethiopia
997,240
Tanzania
995,900
Uganda
942,790
Bangladesh
746,060
Country
Modules
India
5,408
South Africa
4,575
Indonesia
4,069
China
3,876
Pakistan
2,966
Nigeria
1,697
Philippines
1,692
Ethiopia
1,305
Bangladesh
1,168
Uganda
1,016
Kenya
1,011
Zambia
1,006
Data: Cepheid

12. Countries procuring the most Xpert MTB/RIF cartridges and GeneXpert modules in 2018
Country
Cartridges
South Africa
2,293,020
India
2,230,340
Indonesia
1,296,750
Philippines
584,230
Nigeria
551,550
Pakistan
495,470
Brazil
471,250
Ethiopia
375,400
Kenya
363,950
Tanzania
308,500
Uganda
288,150
Zambia
199,850
Country
Modules
Indonesia
926
Mozambique
430
Zambia
328
Myanmar
277
India
204
Philippines
176
Ukraine
Bangladesh
172
Benin
162
Thailand
144
Namibia
140
Tanzania
129
Data: Cepheid

13. Utilization rates for the top 25 countries procuring TB cartridges in 2018
Using Cepheid delivery data to estimate GeneXpert utilization rates
Major assumptions:
Modules are only used for TB testing (becoming less true with introduction of other testing)
All modules delivered are functioning
Module stockpiles are negligible
Cartridges delivered = cartridges used (shelf life of months…)

14. Partnership to assist countries in scale-up
Global Laboratory Initiative for Africa (GLI-Africa), 2014
Other partners

15. Tools developped for scale up
Framework of lab indicators and targets under End TB Strategy
GLI Model TB Diagnostic Algorithms
Quick Guide to TB Diagnostics Connectivity Solutions
Regional framework
for strengthening TB
lab network in Africa
GLI guide for
TB specimen referral system
GLI Planning for Country Transition to Ultra Cartridges
and

16. GeneXpert Omni/Edge The Edge is a single module
GeneXpert instrument connected to a tablet device
Evaluation the Omni instrument delayed until early 2020
Small and Portable
Durable
Low Power Consumption
Automatic Connectivity
Solid State
Integrated Battery

17. Challenges (1)
The uptake of Xpert technology has been slow in African countries in decade
Diagnostic policies have not been translated into practice at country levels
Country ownership for laboratory services is still weak:
No policy reform at country level, no budget allocated to laboratory services
Structures for laboratory services within Ministries of Health are poorly developed, hence HR issues in management
Lack of national laboratory strategic and operational plans and clear algorithm for the use of Xpert as the initial diagnostic test
Lack of uninterrupted power supply and sample referral system to optimise use of GeneXpert instruments
Lack of training of clinicians, which creates a gap in understanding and communication between lab technicians and clinicians

18. Challenges (2) GeneXpert instrument maintenance
End TB Strategy has very ambitious targets for increasing rapid testing
there is a considerable gap between the number of instruments that exist in a country and the number of instruments that are actually needed to provide nationwide coverage
Currently, efforts are focused on optimizing the too few instruments that are in place without a focus on access

19. Conclusion
Increasing access to rapid detection of TB using GeneXpert platform will require major efforts at country level
the goal should be the access for all people in need and the optimal utilisation rate should not be a barreer to ensuring or improving access
Efforts being made by TB programmes to increase utilization of their GeneXperts should not be overlooked when planning for introduction of new tests
Multi-disease testing platforms will provide opportunities for laboratory integration and Service and maintenance costs should be shared across disease programmes
Modeling suggests that all TB high burden countries require additional GeneXperts and tests to meet the potential demand for TB diagnosis.

20. Thank you