1
Introduction of New Laboratory Diagnostics especially liquid culture, line probe assay
and Xpert MTB/RIF diagnostic Test in Indonesia
BY DYAH ERTI MUSTIKAWATI, NTP Manager, MOH-Indonesia REGIONAL WORKSHOP ON TB CONTROL PLANNING,
IMPLEMENTATION AND MONITORINGJakarta, Indonesia, 29-31 May 2012
Background2
Earlier and improve TB case detection to reduce the diagnostic delays are global and national priorities for TB control
Alarming increases in MDR-TB TBMDR pilot implemetentation and KAP survey of Private Practitioners in 12 provinces
Low reported of HIV-associated TB largely goes undetected due to the limitations of current diagnostic techniques
WHO endorsed Xpert MTB/RIF in December 2010 and recommended to implement it in specific settings
Xpert MTB/RIF expect to improve TB diagnosis in HIV patient and expand capacity as proxy to diagnose MDR-TB.
6 Pilars Indonesia Public Private Mix (INA-PPM) Comprehensive Model
Toward Universal Access to Qualified TB care
Community System Strengthening
- Function as advocator raise fund and commitment,
- Increase public awareness, function as public watch to ensure deliveries of quality services,
- increasing awareness of right and responsibility of the patients (patient's charter).
- Social Mobilization, suspect identification, increasing demand creation, intensifying the
services of TB in slum areas and prison- Leading: NGO, FBO, CSO- TA: FHI, other partners
Qualified TB Diagnostic
- Approach: Strengthening lab network and Quality Assurance (public and
private) DST, Culture and Microscopic
- Leading: Directorate of Medical Support
- TA: KNCV and JATA
Pelayanan Rumah Sakit Publik/Swasta
- Approach: Hospital Accreditation, Implementation
TB DOTS as Minimum Standard requirement for accreditation of Hospitals
- Leading: Directorates of Referral Health Services
- TA: KNCV
Quality DOTS services by Private Practitioners and
Specialist
Quality of anti TB Drug Dispensing and rational
Use of Drug
- Approach: Implementation of ISTC for all TB care and treatment from
all care providers, increasing professional responsibility to cure TB patients, rewarding through
cumulative credits mechanism for licensing/certification- Leading: IMA
- TA: ATS,
- Approach: law enforcement, establishment of networking and
monitoring system, WHO prequalification
- Leading: Indonesian Pharmacist Association, DG of
Pharmaceutical Services, Indonesian FDA
- TA: USP and MSH
Basic DOTS ServicesAt Puskesmas
- Approach: Surveillance System Strengthening and MIFA, Improving quality of care,
increasing coverage of TBHIV, reaching un-reach pop at remote are (DTPK), increasing referral to
Quality DOTS Services- Leading: NTP
- TA: WHO, FHI and other partners
Current Lab Network/Services4
Microscopic Labs at all PHCs, Clinics and hospitals (around 10,000 centers) National EQA System is still under construction
5 labs have reach international performance and certified for 1st and 2nd line DST.
1. BBLK Surabaya, East java2. Microbiology UI, Jakarta3. RS Persahabatan, Jakarta4. BLK Bandung, West Java 5. NEHCRI Makassar, South Sulawesi
3 of those labs are National TB Reference Lab (NRL). 1. BBLK Surabaya (NRL for culture/DST)2. Microbiology UI (NRL for research and biomoleculer) 3. BLK Bandung (NRL for microscopic)
Certified Culture/DST Laboratories
Microbiology - UI
DKI Jakarta
BLK BandungPersahabatan Hosp.
West Java
East Java South Sulawesi
BBLK Surabaya NEHCRI Makassar
National TB Reference Laboratories
Microbiology - UI
NRL for research & Biomoleculer
BLK Bandung
NRL for Microscopic
NRL for Culture/DST
BBLK Surabaya
Microbiology - UI
BBLK Surabaya
NEHCRI Makassar
BLK Bandung
Persahabatan Hosp.
Adam Malik Hosp.
BBLK Palembang
BLK Jayapura
BLK Banjarmasin
UGM-DIY
BLK Semarang
Sanglah Hosp
BLK-Lampung
Rotinsulu Hosp.
BLK Samarinda
BBKPM Solo
BBLK Makassar
Note : Certified : 5 labs
Renovated: BSL 2 plus: 5 labs
Next expansion of C/DST labs: 7 labs
Expansion Plan of Culture/DST Lab until 2014
Key areas of progress since 2009
No
Key Areas 2009 2012
1 National TB Lab action Plan
- Available
2 National TB Reference Lab
- 3 labs
3 Certified FL DST Lab 3 labs 5 labs
4 Certified SL DST Lab - 5 labs
5 Improve Biosafety (Renovation of Culture/DST Lab to meet BSL 2 plus standard)
- 4 labs completed2 labs in progress
6 Implementation of LPA
- 3 labs
7 Implementation of GeneXpert
- 5 labs (up to March)
National TB Lab Action Plan, 2011-2014
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Cost Sharing in Establishing BSL 2 plus Lab for Culture/DST
10
Lab/Institutio
n
Design Renovation
Equipments
Training Technical
Assistance
Microbiology UGM
TBCAP TBCAP TBCAP TBCAP TBCAPTBCARE I
BLK Semarang
TBCAP APBD, TBCAP
APBN, TBCAP, GF-ATM
TBCAP TBCAP TBCARE I
BLK Jayapura
TBCAP TBCAP APBN, TBCAP, GF-ATM
TBCAP, GF-ATM
TBCAP TBCARE I
Adam Malik Hospital
TBCAP GF-ATM GF-ATM TBCAP, GF-ATM
TBCAP TBCARE I
BLK Banjarmasin
GF-ATM GF-ATM APBNGF-ATM
TBCAP, GF-ATM
TBCAP TBCARE I
Renovation of TB Culture/DST Lab:
Microbiology UGM 11
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Renovation of TB Culture/DST Lab:
BLK Jayapura, Papua
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Renovation of TB Culture/DST Lab:
BLK Semarang, Central Java
Introduction of liquid culture and LPA and roll out of Xpert MTB/RIF -
current status
2 out of 5 certified DST lab applying liquid culture (MGIT 960 and manual MGIT) Microbiology UI, Jakarta (MGIT 960) and NEHCRI Makassar (Manual MGIT)
Expand TB plan: will support MGIT 960 and HAIN for 2 labs BBLK Surabaya (NRL for culture/DST) and Persahabatan Hospital (MDR TB Treatment Centre)
3 Labs already implemented LPA (Hain test)Microbiology UI, Jakarta; NEHCRI Makassar; Soetomo Hospital, Surabaya
GeneXpert: 17 unit GeneXpert machines and 1700 cartidges have been procured.
Implementation of GeneXpert will be done in step wise manner. 5 iniatial sites are operating on March 2012.
Introduction of LPA: Study of GenoType®MTBDR (FL & SL) from HAIN Life
Science
The studies are performed in Microbiology, Medical Faculty, University of Indonesia (NRL for TB research and molecular) GenoType®MTBDRplus evaluation for
rapid detection of MDR-TB in TB isolates (phase I)
GenoType®MTBDRplus Evaluation for rapid detection of MDR-TB in patients with sputum smear positive pulmonary TB (phase II)
Performance of Genotype® MTBDRsl assay for ethambutol, ofloxacin, amikacin and kanamycin resistance testing in MDR and rifampicin resistant M. tuberculosis strains (in progress)
Result of GenotypeMTBDRplus study for rapid detection of MDR-TB in TB isolates
(phase I)*
Rif resistanc
e
INH resistance
MDR TB
Sensitivity
90.63% 69.49% 67.02 %
Specificity
95.31% 92.86% 95.45 %
PPV 96.67% 96.47% 95.45 %
NPV 87.14% 52.00% 67.02 %Notes: • Isolates/Strains come from several provinces in Indonesia
On going research of Genotype® MTBDRplus (Phase II)
Setting: 300 samples sputum from MDR-TB
suspect Term: Februari 2011-end of March 2012 Compare GenotypeMTBDRplus result with
liquid culture (MGIT960) Observe: Sensitivity, specificity, positive
predictive value, and negative predictive value
Data analysis: in progress
On going research of Genotype® MTBDRsl
Setting: 235 MDR-TB isolates sample from
confirmed MDR-TB patients Term: August 2011-end of March 2012 Compare GenotypeMTBDRsl with liquid
culture (MGIT960). Observe: sensitivity, specificity, positive
predictive value, and negative predictive value
Data: in progress
Introduction of Xpert MTB/Rif (GeneXpert)
GeneXpert Implementation Steps
Step1: workshop
Step 2: select the team Xpert focal person Country GeneXpert Advisory team (C-GAT) Research institutes for OR
Step 3: Selection of sitesStep 4: developing country specific implementation action plan and agree roles
Step 5: develop OR plan and agree on roles
Step 6: ToT and training
Step 7: implementation
Placement plan of 17 GeneXpert machines
1. Microbiology – UI2. Persahabatan Hosp3. Pengoyoman Hosp. (Prison)
DKI Jakarta
South Sulawesi
1. Soetomo Hosp.2. BBLK Surabaya3. Saiful Anwar Hosp.
1. Labuang Baji Hosp.2. NEHCRI Makassar
Papua
1. BLK Papua
Nort Sumatera
1. Adam Malik Hosp
1. Hasan sadikin Hosp.2. BLK Bandung
c
1. Microbiology UGM
DIY
West Java
Central Java
1. Moewardi Hosp.2. Kariadi Hosp.
3. Cilacap Hosp. (Prison)
Bali
East Java
1. Sanglah Hosp.
Certified DST Lab. for confirmation of Xpert result
Microbiology - UI
DKI Jakarta
BLK BandungPersahabatan Hosp.
West Java
East Java South Sulawesi
BBLK Surabaya NEHCRI Makassar
North Sumatera
Adam Malik Hosp.
Papua
BLK PapuaSouth Sumatera
BBLK PalembangCentral Java
BLK Semarang
DIY
UGM
Province
Lab
Lab
ProvinceCertified lab
Under capacity building process towards certified lab
South KalimantanBLK Banjarmasin
GeneXpert Workshop TOT22
MoU Signing between MoH and GeneXpert Sites
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GeneXpert On site training
24Soetomo Hospital
Moewardi Hospital Persahabatan Hospital
The Data of Genexpert Examination up to 31 Mar 2012
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No SitesDate start
implementation
Number of Suspects MTB
positive/Rif
resistant
Patient put
on treatment
Remark
MDR TB
TB HIV Total
1Persahabatan Hosp.
05 March 2012 69 0 69 31 16
15 patient are under
evaluation from the clinicians expert team
2Moewardi Hosp.
08 March 2012 18 3 21 6 6
3Microbiology UI
12 March 2012 0 18 18 1 1
1 patient reffer to RS
Persahabatan
4Soetomo Hosp.
20 March 2012 4 2 6 2 2
Total 11440
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The Data of Genexpert Examination up to 30 April 2012
No SitesDate start
implementation
Number of Suspects MTB
positive/Rif
resistant
Patient put on
treatment
Remark
MDR TB
TB HIV
MDR TB-HIV
Total
1Persahabatan Hosp.
05 March 2012 59 0 0 59 21 7
14 Patient are under
evaluation from the clinician
expert team
2Moewardi Hosp.
08 March 2012 27 2 2 31 4 4
3Microbiology UI
12 March 2012 0 48 0 48 0 0
4 Soetomo Hosp.20 March
2012 29 10 0 39 15 5
10 Patient are under
evaluation from the clinician
expert team
5Hasan Sadikin Hosp. 03 April 2012 7 19 0 26 2 2
Total 203 42
The logistic of cartridge27
Sites Total number of
cartridge received
Micro UI 260
Persahabatan Hospital 240
RSUD DR Moewardi 220
RSUD DR Soetomo 340
RS Hasan Sadikin 220Totally number cartridge distribution 1280
• Totally number cartridge in wire house (PT Fajar Mas Murni) = 420• The total number of cartridge received for each sites (for examination and Keeping in sites wire house)
Challenges in introduction and roll out of newer diagnostics
(LPA &Xpert MTB/RIF) Expensive machines and consumables .
Quality assurance, maintenance and calibration. Capacity to treat more MDR TB patients (Human
Resources, infrastructure, funding etc)
Availability of SL Drugs, not only in country level but also globally
Limited Quality assured Culture/DST lab to support confirmation of LPA and Xpert TB/Rif result.
Limited MDR TB treatment centre.
Conclusion TB Laboratory plays main role in MDR TB diagnosis
to support PMDT program.
Expansion of quality assured culture/DST lab and MDR TB treatment centre are crucial to achieve national target.
Utilizing new TB diagnostic tools as a breakthrough to avoid delays in treatment.
Increasing in diagnosis capacity must be followed by increasing of treatment capacity as well.
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Thank You