1. World Health Organization, Western Pacific Regional Office Session 2 Laboratory strengthening Dr Cornelia Hennig Stop TB and Leprosy Elimination World Health Organization Regional Office for the Western Pacific Manila, Philippines 9-12 December 2014 The Ninth Technical Advisory Group and National TB Programme Managers Meeting Manila Philippines, 9-11 December 2014

2. World Health Organization, Western Pacific Regional Office Xpert MTB/Rif introduction and roll-out, impact Xpert MTB/Rif introduction and roll-out, impact

3. World Health Organization, Western Pacific Regional Office Incorporation of WHO policy guidance on Xpert MTB/Rif Initial diagnostic test for PLHIV (8/8) People at risk for MDR (8/8) Other risk groups and children (2/8) Up take for extrapulmonary TB –Culture laboratories

4. World Health Organization, Western Pacific Regional Office Xpert MTB/Rif operation Falcon tubes (3) –Transport –No leak Shipment –Graduation –Vortexing –Collection –Cost Sputum cups (5) –Collection –Cost –Leakage

5. World Health Organization, Western Pacific Regional Office Xpert MTB//Rif operation: status and comments Invalid/errors ~ 6 % –closely monitor, decreasing frequency after introduction Module failure: ~ 10 % (3/8) –System in place to quickly replace failed modules –Aim for replacement turn around time of 4 weeks Trouble-shooting: –Cascade of action from on site problem solving to national to service provider

6. World Health Organization, Western Pacific Regional Office Xpert MTB/Rif Q & A Questions List of acceptable EP samples and SOP Validation kit should come with swapping What maximum time can sample stay in cartridge before running the test – 30 minutes or more? Max 30 store processed sample in fridge,8 hours Warranty time of module after replacement Answers available for gastric, tissue, CSF Available 30 min maximum Store processed sample in fridge - 8 h 3 months

7. World Health Organization, Western Pacific Regional Office Xpert MTB / Rif : EQA Nil or internal controls only : 6/8 China: sputum with inactive TB strains VietNam: 4 rounds/y (CDC/GLI) Overall: –Need for global guidance beyond calibration

8. World Health Organization, Western Pacific Regional Office Xpert MTB/Rif and quality assurance requirements Module 12 Training and user competence assessment Instrument verification Quality indicator monitoring On-site supervision New lot (incoming) QC testing Proficiency testing (PT) www.stoptb.org/wg/gli/TrainingPackage_Xpert_MTB_RIF.asp

9. World Health Organization, Western Pacific Regional Office Xpert MTB/Rif Comments from –Tom Shinnick module failure EQA Xpert for second line drugs – when? –Other SRL’s