1. Experience establishing TB Laboratory capacity in Lesotho Dr Vollepore FIND

2. C.N.P FIND Board presentation 24 th Oct.08 FIND Approach Based on Product needs Local needs and capacity Appropriate level of healthcare system Collaborative with partners International partners (WHO, GLI, GDF,UNITADAID, CDC, PEPFAR, USAID, Partners in Health, MSF, etc.) Local partners (National Disease Control Programmes, Government)

3. C.N.P FIND Board presentation 24 th Oct.08 Lesotho: Situation analysis New cases notified - 2007: 12,275 Estimated prevalence: 544 per 100,000 Estimated annual incidence : 691 per 100,000 Estimated incidence of New sm+ cases: 281 per 100,000 Estimated incidence of new TB cases (15-44 age group): 75% Estimated all TB deaths (annual): 107/100,000 The HIV prevalence rate (2005): 23.2% HIV positive among TB : 64% (WHO 2007), 80% (NTP 2008) MDR-TB cases among all TB cases (2007): 105

4. C.N.P FIND Board presentation 24 th Oct.08 Lesotho: Locations 1 reference lab: QEII hospital 1 regional lab: Mafeteng government hospital

5. C.N.P FIND Board presentation 24 th Oct.08 Before Renovation After renovation Office of Microbiologist Toilet Microscopy, centrifuge, Incubator Storage of chemicals, stains & inspissator Staining area BSCBSC Refrigerator Culture room 28 th May to 22 nd June 3m MGIT 960, Fridge & Incubator BSC A/C BSC Cntfg 3 5 2.5 m 2m Neg. Air Pressure Specimen receipt & Microscopy room Sink Sterilization room Autoclave 4 1 6 Sin k 3.75m 3.25m Culture room 7 Hand-wash Toilet Inspi Media room BSC 2 Entry NTRL ifrastructure was established in 2 months Central TB Laboratory,QE II Hospital, Maseru

6. C.N.P FIND Board presentation 24 th Oct.08 FacilityRequirement* Central Lab, Maseru Isolation of laboratoryYes Laboratory at the blind-end of buildingDesirableYes Room sealable for decontaminationYes Ventilation -inward airflowYes -controlled ventilating systemYes -HEPA-filtered air exhaustYes -Existing building @ at least 6 APH HEPA exhaustYes -Monitors to check air pressure of containment roomYes Double-door entryYes AirlockNo Access through AnteroomYes Anteroom with showerNo Anteroom with hand-washDesirableYes Effluent treatmentYes/NoNo Autoclave - on site Yes -in laboratory roomDesirableNo -double-endedDesirableNo Biological safety cabinets (BSC) class I or II, ducted outsideYesYes, class II Type B Personnel safety Monitoring CapacityDesirableYes NRL as per the WHO Bio-Safety norm * WHO requirements for liquid cultures, CDC & other agencies specifications for handling M. tb. culture

7. C.N.P FIND Board presentation 24 th Oct.08 HEPA In-flow HEPA Exhaust Negative air pressure facility & monitoring Magnehelic gauge

8. C.N.P FIND Board presentation 24 th Oct.08 Assigning the lab serial number Verifying sputum quality ZN stainingMicroscopy Laboratory activities in progress Addition of mineral salt soln.Addition of Drugs Inspissation Filling & Labeling Culture examination Inoculation Washing Media section

9. C.N.P FIND Board presentation 24 th Oct.08 Foundation for the Mol. Lab: July, 2008 Foundation for the Mol. Lab: July, 2008 Start of molecular diagnosis: Sep. 2008

10. C.N.P FIND Board presentation 24 th Oct.08 Locations of the Lab facilities 1 reference lab: QEII hospital 1 regional lab: Mafeteng government hospital

11. C.N.P FIND Board presentation 24 th Oct.08 LERIBE Leribe Mmamohau Butha buthi Seboche Mokhotlong MASERU* Maseru lab Scott’s St. Joseph’s Makoanyane Berea Maluti Adventists St.James Paray MAFETENG Mohale’s Hoek Quthing Machabeng Tebellong Mafeteng District Hospital Labs/ Peripheral labs (MCs)-17 National Reference Lab (NRL) Intermediate Reference Labs (Maseru*, Leribe & Mafeteng) NRL to IRL IRL to MCs Smear Microscopy: EQA network

12. C.N.P FIND Board presentation 24 th Oct.08 NTRL: Month wise sputum smear & culture (2008)

13. C.N.P FIND Board presentation 24 th Oct.08 Testing Platform ~ Tests performed MTB PositiveDST tests*MDR-TB MDR-patients placed on treatment MGIT 960- Liquid culture7081712241116102 Line probe assay**652563 11790 Number of TB diagnostic tests performed (2009 to July 2010) Number of EID HIV* diagnostic tests performed (Jan- July 2010) Total testsPositivePlaced on treatment 722137 35 NTRL: Integrated TB-HIV (EID) laboratory *Only MDR-TB suspects request for DST; ** rapid DST for 'rif' and 'inh’- data includes QA/Training activities ~ In addition: Solid culture and DST for 951 DRS samples and LED FM microscopy demonstration study in 2008-2009

14. C.N.P FIND Board presentation 24 th Oct.08 MDR-TB LPA EID for HIV by PCR Molecular lab. in Maseru Demonstration (Evidence) WHO (Policy) Implementation (Practice) March 2007 LC April 2008 LPA June 2007 LC June 2009 LPA November 2007 LC November 2008 LPA April 2009 EID for HIV by PCR Partners WHO PIH MOH (Lesotho) Integrating HIV-TB diagnostics platforms:

15. C.N.P FIND Board presentation 24 th Oct.08 LESOTHO A Model for Scale UP 1 reference lab: QEII hospital 1 regional lab: Mafeteng government hospital 1- 2006-2008: FIND, PIH and WHO renovated the NRL and reinforced microscopy services, streamlined culture and DST and introduced modern TB diagnostic methods. 2-2007: Established BSL3, solid culture and DST and an EQA for smear microscopy within 4 months. 3-Liquid culture and DST were introduced a month later. EQA & Accreditation by MRC,S. Africa 4-2008: A year later, introduced LPA for the rapid detection of MDR-TB 6- 2009: the National TB/HIV Strategic Plan for 2008 – 2012 was finalized 2009 FIND conducted retraining for laboratory technicians at the NRL Validation of new TB diagnostics algorithm presented 1 regional laboratory is currently being renovated, and biosafety facilities are being installed 7- Have started enrollment under ExpTB LC: 7081, FLD: 241, LPA: 452, 116 MDRTB reported to ExpTB, 200 Rx approved at GLC

16. C.N.P FIND Board presentation 24 th Oct.08 Key Partners & Support FIND/GLI/GDF (UNITAID): HR: (In- country consultant; 2 Technicians), reagents for MGIT liquid culture, rapid speciation, Molecular Diagnosis (LPA with reagents), knowledge sharing and mentoring PIH: Renovation of NTRL; Negative pressure facility; additional lab supplies; HR (3 technicians ) URC: HR (1 technician ) PEPFAR/CDC: Nation wide DRS SNRL, Borstel : Support DRS SNRL, MRC, Pretoria: EQA support for Smear, culture & Molecular Diagnosis CDC, Atlanta: EID Training, EQA BD: MGIT Instrument, HR support and reagents at the initial period