Rapid scale up of integrated molecular diagnostic laboratories

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Rapid scale up of integrated molecular diagnostic
laboratories

• Giorgio Roscigno

Implementation Working Groups Partners
Forum Rio, March 2009
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Outline

• Rationale for integrated laboratory systems
• Evolution of molecular diagnostics platforms and
  their potential for integration of various
  diseases
• Positioning of integrated platforms in a tiered
  system approach
• In country examples of integrated molecular
  platforms for TB / HIV

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Strengthening of laboratory systems

• Call on national governments to support
  laboratory systems as a priority by developing a
  national laboratory policy within the national
  health development plan that will guide
  implementation of a national strategic laboratory
  plan. Governments should establish a department
  of laboratory systems within the Ministry of
  Health.

• Call on national governments with support of
  their donors and partners in resource-limited
  settings to develop national strategic laboratory
  plans that integrate laboratory support for the
  major diseases of public health importance
  including HIV, tuberculosis, and malaria.

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Integration of Public Health laboratory services
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Different levels of potential for integration of
laboratory services
Integration of reference laboratories
Integration of Molecular/ microbiology services
Integration of microscopy services
Integration of specimen collections and
transportation
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Decentralization of molecular diagnostics
1st generation MDR
Less complexity, more robustness
2nd generation automated MDR
1st generation manual detection
2nd generation manual detection
POC test
LPA
GenExpert
LAMP
2008 2009
2010
2015
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PCR / Line Probe Assay
3) Hybridization Reverse hybridization of
amplified nucleic acids to specific DNA probes
bound on strips

• DNA
• Extraction
• From NALC/NaOH
• Processed sputum

2) Amplification by PCR

• A technology platform for
• TB MDR (Rif INH resistance)
• TB XDR (Quinolone resistance)
• Potential for knowledge and know how transfer for
  Early Infant Diagnosis for HIV

4) Evaluation
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Automated high tech molecular testing in low tech
settings in Demonstration

• Workflow
• fully automated with 1-step external sample
  prep.
• time-to-result 1 1/2 h (walk away test)
• throughput up to 16 tests / module / run
• no bio-safety cabinet
• closed system (no contamination risk)
• Performance
• specific for MTB
• sensitivity similar to culture
• detection of rif-resistance via rpoB gene

Automated sample prep, amplification and
detection lt 120 minutes

• A technology platform for
• TB Rif Resistance
• TB Quinolone resistance
• Potential for HIV viral load

2009
2010
Demonstration
STAG
Access
Evaluation
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Molecular meets microscopy TB LAMP in Evaluation
LAMP demonstration at microscopy center in
Mumbai, India

• A technology platform for
• TB
• Malaria
• HAT
• HIV Early Infant Diagnosis

2009
2010
2011
STAG
Demonstration in microscopy centers
Development
Access
Evaluation

• Downstream challenges
• Implementation of disruptive technology
• Laboratory preparedness

Upstream challenges Reaching required accuracy
simplicity
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Patient-centered approach

• Surveillance
• Reference methods
• Network supervision
• Resolution testing (screening-test negative, drug
  resistance)
• Passive case finding
• Detect and treat
• Screening
• Primary
• care

Reference Labs

Regional Labs

District Level

Microscopy Level
Microscopy TB, Malaria, HAT

Community Level
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Integrating HIV-TB diagnostics platforms Lesotho
WHO (Policy)
Demonstration (Evidence)
Implementation (Practice)
November 2007 LC November 2008 LPA April 2009 EID
for HIV by PCR
March 2007 LC April 2008 LPA
June 2007 LC June 2009 LPA

• Partners
• WHO
• PIH
• MOH (Lesotho)
• CHAI
• CDC PEPFAR
• GLI
• UNITAID
• FIND
• UNICEF

Molecular laboratory in Maseru
Early Infant Diagnosis for HIV by PCR (molecular)
MDR-TB LPA (TB (RH) resistance)
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Integrating HIV-TB diagnostics platformsEthiopia,
central level
St. Peters Hospital, Addis Ababa, central
hospital for TB treatment failure cases

• 2009 January training on MDR-TB LPA
• 2009 March implementation of MDR-TB LPA
• 2009 April re-introducing HIV viral load testing
  to the refurbished (TB) molecular laboratory
• Partners JHU WHO EHNRI FIND GLI UNITAID CDC
  PEPFAR

Early infant HIV diagnosis
MDR TB with Line Probe Assay
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Integrating HIV-TB diagnostics platformsEthiopia
, regional level
Implementation of MDR-TB LPA in regional labs
with Early Infant Diagnosis (EID) molecular
testing capacity for HIV

• 2009 January training on MDR-TB LPA
• 2009 March-November implementation of MDR-TB LPA

MDR-TB LPA
Early Infant Diagnosis PCR
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• Thank you