Leveraging on the Gene Xpert Systems Expanded Menu

  • Slides: 23
Download presentation
Leveraging on the Gene. Xpert System’s Expanded Menu for the Integrated Management of HIV/HCV/TB

Leveraging on the Gene. Xpert System’s Expanded Menu for the Integrated Management of HIV/HCV/TB co-infections: Field Experience from MSF Emmanuel Fajardo HIV/HCV Diagnostics Advisor MSF Access Campaign emmanuel. fajardo@barcelona. msf. org

The Silo Approach -System organization -Funding -Reporting -M&E -Surveillance TB -System organization -Funding -Reporting

The Silo Approach -System organization -Funding -Reporting -M&E -Surveillance TB -System organization -Funding -Reporting -M&E -Surveillance HIV -System organization -Funding -Reporting -M&E -Surveillance HCV -System organization -Funding -Reporting -M&E -Surveillance MNCH

A Call for Diagnostic Integration June 2017 January 2018 http: //www. who. int/tb/publications/2017/considerations_multidisease_testing_devices_2017/en /

A Call for Diagnostic Integration June 2017 January 2018 http: //www. who. int/tb/publications/2017/considerations_multidisease_testing_devices_2017/en / https: //unitaid. eu/assets/multi-disease-diagnostics-landscape-for-integrated-management-of-HIV-HCV-TB-and-other-coinfections-january-2018. pdf

Multidisease Testing Gene. Xpert Critical Infectious diseases Healthcare associated infections o o o o

Multidisease Testing Gene. Xpert Critical Infectious diseases Healthcare associated infections o o o o o Xpert MRSA Nx. G Xpert SA Nasal Xpert MRSA/SA BC Xpert MRSA/SA SSTI Xpert C difficile Xpert C. difficile/Epi Xpert Carba-R Xpert van. A Xpert Norovirus o o o Xpert Xpress Strep A Xpert MTB/RIF Ultra Xpert Flu/RSV XC Xpert EV Xpert Xpress Flu/RSV Xpert Ebola Xpert HIV VL Xpert HIV EID Xpert HCV VL Oncology / Genetics Sexual Health o o o Xpert CT/NG Xpert GBS LB Xpert TV Xpert HPV o o Xpert BCR-ABL Ultra Xpert BCR-ABL Mon Xpert FII & FV Xpert Bladder Cancer

Multidisease Testing Gene. Xpert For different testing volumes 48 module 16 module 4 module

Multidisease Testing Gene. Xpert For different testing volumes 48 module 16 module 4 module 1 module

Rapid Expansion of Gene. Xpert for TB

Rapid Expansion of Gene. Xpert for TB

But…. Gene. Xpert Underutilized

But…. Gene. Xpert Underutilized

Zimbabwe: HIV VL & EID testing Centralized Testing Tertiary – Provincial Laboratories EID VL

Zimbabwe: HIV VL & EID testing Centralized Testing Tertiary – Provincial Laboratories EID VL

Xpert MTB/RIF Sputum Xpert HIV VL Plasma Xpert HIV EID DBS – 135 instruments

Xpert MTB/RIF Sputum Xpert HIV VL Plasma Xpert HIV EID DBS – 135 instruments in the country in more than 100 public health facilities. – Underutilized

Use of Gene. Xpert for VL, EID, TB Validation Buhera District Lab Gutu District

Use of Gene. Xpert for VL, EID, TB Validation Buhera District Lab Gutu District Lab Chimombe Rural Clinic Lab Refurbishment Installation User Training SOPs Additional work: Air-conditioner, Electrical backup, centrifuge (VL), thermomixer (EID), refrigerator, dust control, security upgrades

Testing Prioritization Xpert MTB/RIF Initial diagnostic test for TB testing “Xpert for All” –

Testing Prioritization Xpert MTB/RIF Initial diagnostic test for TB testing “Xpert for All” – 1 test – Xpert HIV EID Testing for All HIVexposed infants <18 months – 2 tests– Xpert HIV VL Routine VL for patients on ART at 6 -months, at 12 months, yearly. If VL >1000, repeat at 3 M § Pregnant women identify non-adherence, identify at risk infants § Children & Adolescents more frequent testing / higher rates of virological failure § Patients with advanced HIV disease treatment interrupters, virological failure, more rapid switch to second line § Patients with suspected treatment failure faster switch to second line

Gene. Xpert Utilization Gutu District Lab Buhera District Laboratory Technician TOTAL EID tested (DBS)

Gene. Xpert Utilization Gutu District Lab Buhera District Laboratory Technician TOTAL EID tested (DBS) GMH MMH Chimombe Rural Clinic Microscopist Clinic 205 (7%) 139 (11%) 80 (6%) 58 (13%) VL tested (Plasma) 1302 (42%) 640 (53%) 417 (27% 245 (59%) TB tested (Sputum) 1581 (51%) 438 (36%) 1028 (67%) 115 (28%) 3, 088 (100%) 1217 (100%) 1525 (100%) 418 (100%) TOTAL Theoretical capacity per device (12 tests/day) = 2, 640 tests in 10 M 46% 58% 16%

Impact of Gene. Xpert for EID Variable Total Xpert EID tested GMH 139 MMH

Impact of Gene. Xpert for EID Variable Total Xpert EID tested GMH 139 MMH 80 Clinic 58 Positivity Rate 2. 2% 2. 5% 12. 1% Error Rate 3. 2% 1. 4% 3. 4% 1 [IQR: 1 -3] 8 [IQR: 6 -15] 1 [IQR: 0 -1] Concordance with lab 100% 96. 9% Distance to lab 275 km 180 km 300 km TAT (days) to clinician Lab TAT to clinician 13 [IQR: 8 -14] 20 [IQR: 17 -23] 17 [IQR: 13 -30] Median age (weeks) 6, 9 [IQR: 6. 1 – 12, 7] EID+ infants Time to ART initiation 3 2 7 1 [IQR: 0 -1] NA 2 [IQR: 1 – 3]

Impact of Gene. Xpert for VL Variable Total Xpert VL tested GMH MMH Clinic

Impact of Gene. Xpert for VL Variable Total Xpert VL tested GMH MMH Clinic 640 417 245 Error Rate 3. 7% 3. 6% 3. 7% TAT (days) to clinician 0 [IQR: 0 -1] 1 [IQR: 0 – 2] 0 [0 – 1] Concordance with lab 98. 2% 98. 5% 96. 8% Distance to lab 240 km 250 km 265 km 26 [IQR: 18 -36] 23 [15 – 31] 33 [28 – 52] VL >1, 000 copies/m. L 73 (11. 4%) 25 (5. 9%) 23 (9. 3%) Median time to EAC 8 days NA 23 days VL re-suppressed 20 (27. 4%) NA 4 (17, 5%) VL un-suppressed 6 (8. 2%) NA 3 (13%) 41 (56. 2%) NA 12 (52%) 6 (100%) NA 3 (100%) Lab TAT to clinician No outcome in register Switched to 2 nd line

Use of Gene. Xpert for TB Variable Total samples tested GMH 438 MMH 1028

Use of Gene. Xpert for TB Variable Total samples tested GMH 438 MMH 1028 Clinic 115 MTB Positivity Rate 10. 6% 9. 6% 11. 3% RIF Positivity Rate 0. 50% 0. 54% 0% Inconclusive results 3. 4% 1. 9% 2. 6% 1 [IQR: 0 -1] 1 [IQR: 0 -2] 0 [IQR: 0 – 1] TAT to clinician

Lessons Learnt § Integration of testing was feasible and high user satisfaction § Testing

Lessons Learnt § Integration of testing was feasible and high user satisfaction § Testing volumes will dictate placement Hub & spoke model § Transport of plasma samples from the clinics limited decentralization of viral load testing. § One m. L of plasma is required for VL testing, this proved difficult to obtain in certain patients (children, patients with difficult veins); larger EDTA tubes may be needed. § Need to have separate work stations or very clear sample preparation workflow to avoid potential contaminations (Sputum, Plasma, DBS) Training § Human resources are important not only for testing: who can act on the results for clinical management e. g. switching to 2 nd line ART remains centralized.

Multidisease Testing Gene. Xpert Implementation of Gene. Xpert in MSF In 28 countries in

Multidisease Testing Gene. Xpert Implementation of Gene. Xpert in MSF In 28 countries in 71 sites Section 2017 2018 Multidisease OCP 18 9 4 sites OCB 13 8 6 sites OCG 9 3 1 site OCA 41 4 17 sites OCBA 1 1 0 sites TOTAL 82 devices 25 devices 28 sites

Multidisease Testing Gene. Xpert Rapid diagnostic methods are essential in control of Ebola outbreaks

Multidisease Testing Gene. Xpert Rapid diagnostic methods are essential in control of Ebola outbreaks and lead to timely isolation of cases and improved epidemiological surveillance.

MSF Evaluation of Xpert HCV VL [G 6] Detectable VL (n=454) Inconclusive Cambodia: Comparison

MSF Evaluation of Xpert HCV VL [G 6] Detectable VL (n=454) Inconclusive Cambodia: Comparison of HCV VL results between Xpert versus Roche in plasma specimens (N=590) 22 G 6 195 G 2 37 G 1 200 0 50 100 150 – All genotypes – Diagnosis – Monitoring (SVR) 200 250 Detectable ≥ 15 IU/m. L Detectable <15 IU/m. L Not detected Tota l Detectable ≥ 10 IU/m. L 454 2 0 456 Detectable <10 IU/m. L 0 3 6 9 Not detected 0 0 125 Total 454 5 131 590 Sensitivity = 100% (95% CI 99. 2, 100) Specificity = 98. 5% (95% CI 94. 8, 99. 8)

Challlenges: Waste Management

Challlenges: Waste Management

Challlenges: Service and Maintenance

Challlenges: Service and Maintenance

Challenges: Cepheid HBDC Pricing $18. 00 17. 95 17. 1 $17. 00 $16. 00

Challenges: Cepheid HBDC Pricing $18. 00 17. 95 17. 1 $17. 00 $16. 00 16. 8 16. 7 16. 65 16. 43 16. 08 15. 4 $15. 00 Virological cartridges ––Bundled pricing–– 17. 43 16. 08 15. 65 15. 3 15. 16 15. 15 HIV EID 14. 45 $14. 00 HIV VL 14. 45 14. 75 13. 45 13. 1 $13. 00 13. 35 12. 4 $12. 00 11. 98 $11. 00 11. 35 $10. 00 $9. 00 Ceiling price 500 K tests/year 1 M 1. 5 M tests/years tests/year 3 M tests/year 4 M tests/year HCV VL HPV MTB/RIF

THANK YOU

THANK YOU