Experience establishing TB Laboratory Experience establishing TB Laboratory capacity in Lesothocapacity in Lesotho
Dr Vollepore
FIND
C.N.P FIND Board presentation 24th Oct.08
FIND ApproachFIND 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)
C.N.P FIND Board presentation 24th Oct.08
Lesotho: Situation analysisLesotho: 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
C.N.P FIND Board presentation 24th Oct.08
Lesotho: LocationsLesotho: Locations
1 reference lab: QEII hospital
1 regional lab: Mafeteng government hospital
C.N.P FIND Board presentation 24th Oct.08
Before Renovation After renovation
Office of Microbiologist
Toilet
Microscopy, centrifuge, Incubator
Storage of chemicals,
stains & inspissator
Staining area
BSC
Refrigerator
Culture room
28thMay to 22ndJune
3m
MGIT 960, Fridge & Incubator
BSC
A/CBSC
Cntfg
3
5
2.5 m
2m
Neg. Air Pressure
Specimen receipt & Microscopy room
Sink
Sterilization room
Autoclave4
1
6
Sink
3.75m 3.25m
Culture room
7
Hand-wash
Toilet
InspiMedia room
BSC2
Entry
NTRL ifrastructure was established in 2 months
Central TB Laboratory ,QE II Hospital, MaseruCentral TB Laboratory ,QE II Hospital, Maseru
C.N.P FIND Board presentation 24th Oct.08
Facility Requirement* Central Lab, Maseru
Isolation of laboratory Yes Yes
Laboratory at the blind-end of building Desirable Yes
Room sealable for decontamination Yes Yes
Ventilation -inward airflow Yes Yes
-controlled ventilating system Yes Yes
-HEPA-filtered air exhaust Yes Yes
-Existing building @ at least 6 APH HEPA exhaust Yes Yes
-Monitors to check air pressure of containment room Yes Yes
Double-door entry Yes Yes
Airlock No No
Access through Anteroom Yes Yes
Anteroom with shower No No
Anteroom with hand-wash Desirable Yes
Effluent treatment Yes/No No
Autoclave -on site Yes Yes
-in laboratory room Desirable No
-double-ended Desirable No
Biological safety cabinets (BSC) class I or II, ducted outside Yes Yes, class II Type B
Personnel safety Monitoring Capacity Desirable Yes
NRL as per the WHO Bio-Safety normNRL as per the WHO Bio-Safety norm
* WHO requirements for liquid cultures, CDC & other agencies specifications for handling M. tb. culture
C.N.P FIND Board presentation 24th Oct.08
HEPA In-flow HEPA Exhaust
Negative air pressure facility & monitoringNegative air pressure facility & monitoring
Magnehelic gauge
C.N.P FIND Board presentation 24th Oct.08
Assigning the lab serial numberVerifying sputum
quality
ZN staining Microscopy
Laboratory activities in progressLaboratory activities in progress
Addition of mineral salt soln. Addition of Drugs
InspissationFilling & Labeling
Culture examination
Inoculation
Washing
Media section
C.N.P FIND Board presentation 24th Oct.08
Foundation for the Mol. Lab: July, 2008Foundation for the Mol. Lab: July, 2008
Start of molecular diagnosis: Sep. 2008Start of molecular diagnosis: Sep. 2008
C.N.P FIND Board presentation 24th Oct.08
Locations of the Lab facilitiesLocations of the Lab facilities
1 reference lab: QEII hospital
1 regional lab: Mafeteng government hospital
C.N.P FIND Board presentation 24th Oct.08
LERIBELeribeMmamohauButha buthiSebocheMokhotlong
MASERU*Maseru labScott’sSt. Joseph’sMakoanyaneBereaMaluti AdventistsSt.JamesParay
MAFETENGMohale’s HoekQuthingMachabengTebellongMafeteng
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 networkSmear Microscopy: EQA network
C.N.P FIND Board presentation 24th Oct.08
NTRL: Month wise sputum NTRL: Month wise sputum
smear & culture (2008)smear & culture (2008)
0
500
1000
1500
2000
2500
3000
3500
4000
4500
5000
Ja
nu
ary
Fa
bru
ary
Ma
rch
Ap
ril
Ma
y
Ju
ne
Ju
ly
Au
gu
st
Se
pte
mb
er
Oc
tob
er
No
ve
mb
er
De
ce
mb
er
No
of
sp
ec
ime
n p
roc
es
se
d
0
10
20
30
40
50
60
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80
90
100
Cu
ltu
re c
on
tam
ina
tio
n (
%)
Total culture processed ZN smear Culture contamination
C.N.P FIND Board presentation 24th Oct.08
Number of TB diagnostic tests performed (2009 to July 2010)
Number of EID HIV* diagnostic tests performed (Jan- July 2010)
Total tests Positive Placed on treatment722 137 35
NTRL: Integrated TB-HIV (EID) laboratoryNTRL: 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
C.N.P FIND Board presentation 24th Oct.08
MDR-TB LPA
EID for HIV by PCR
Molecular lab. in Maseru
Demonstration(Evidence)
WHO(Policy)
Implementation(Practice)
March 2007 LCApril 2008 LPA
June 2007 LCJune 2009 LPA
November 2007 LCNovember 2008 LPAApril 2009 EID for HIV by PCR
Partners• WHO• PIH• MOH (Lesotho)
Integrating HIV-TB diagnostics platformsIntegrating HIV-TB diagnostics platforms::
C.N.P FIND Board presentation 24th Oct.08
LESOTHOLESOTHO
C.N.P FIND Board presentation 24th Oct.08
Key Partners & SupportKey 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