Laboratory Issues in TB Control

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Laboratory Issues in TB Control
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WHO-recommended Stop TB Strategy to reach the
2015 MDGs

• Pursuing quality DOTS expansion and enhancement
• Political commitment
• Case detection through Quality controlled
  bacteriology
• Standardised treatment, with supervision and
  patient support
• Effective drug supply system
• Monitoring system and impact evaluation
• Additional components
• Addressing TB/HIV and MDR-TB
• Contributing to health system strengthening
• 4. Engaging all care providers
• 5. Empowering patients and communities
• 6. Enabling and promoting research

Stop TB Department
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General RecommendationsCulture, DST, TB/HIV

• Clear policy for culture and DST should be
  developed based on country situations and
  priorities
• The diagnostic process, including all laboratory
  tests, should be free of charge
• Access to laboratory tests, such as culture and
  DST, should be controlled to prevent misuse.
• Culture and DST should only be expanded in
  countries that have adequately implemented EQA
  systems for microscopy

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General RecommendationsCulture, DST, TB/HIV

• There is a need for more emphasis on laboratory
  strengthening in the GFATM
• The budget for laboratory should be earmarked to
  prevent transfer for other program areas.
• Establish improved transport for cultures and
  specimens
• Explore bulk procurement for equipment (GDF)
• Establish regional subcommittees to help
  establish policies for culture and DST to provide
  support. This regional process should be
  supported by the GFATM.

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General RecommendationsCulture, DST, TB/HIV

• Human resource development should be an essential
  component of the laboratory strengthening plan
  and specifically address expansion of diagnostics
• Short term needs are training for staff
• Long term training needs should be explored with
  academic and other partners to increase technical
  capacity
• Quality Assurance
• develop EQA systems for new diagnostics
• Increase support for technical assistance and
  training opportunities with regional centers of
  excellence

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TB/HIV

• There is a need to re-evaluate the timing and
  role of X-ray in the diagnostic algorithm for
  SM(-) TB, standardize methods, and assure quality
• Further define indicators and operational issues
  for the use of fluorescence microscopy (FM)
• Contribution of culture for the diagnosis of SM
  (-) TB should be assessed

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HIV/Anti-TB Drug Resistance Surveillance and
Testing

• Overview of strategies, available data,
  challenges in both Anti-TB drug resistance and
  HIV surveillance in TB patients
• Rationale for conducting joint surveillance and
  results from South Africa experience (N6,000)

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Joint surveillanceBackground

• Compelling evidence from MDR TB outbreaks in
  combination with HIV results in bad outcomes
  (The Perfect Storm)
• Need better understanding of epidemiology of HIV
  and anti-TB drug resistance
• Find synergies between two types of surveillance
  within the same population

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Experience in surveillance and testing in four
countries

• Tanzania- Provider initiated testing and
  counseling experience, provides successful model
  for expansion
• Botswana- experience of joint surveillance, and
  summary of challenges, where surveillance data
  has impact on policy (FDCs)
• Vietnam- effort to understand link between DR and
  HIV in area with existing HIV sentinel
  surveillance
• Ukraine- experience in linking a drug resistance
  survey with routine HIV testing

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Conclusions

• Era of treatment, moving from periodic
  surveillance to routine diagnostic data- not
  quite there yet.
• Variety of country experience available to
  build upon
• Lab issues, especially for DRS, numerous, as
  well as applications of new test technologies
• Ethical issues numerous, e.g. linked/unlinked
  anonymous, and treatment availability,
  counseling.
• Different settings require different
  recommendations for designing and implementing
  joint surveys in general population and risk
  groups

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The Way Forward

• WHO Secretariat to move forward in conjunction
  with TB/HIV, DOTS-Plus, DOTS Expansion working
  groups to develop a consultation of experts to
  explore issues in Anti-TB drug resistance and HIV
  in TB patients.
• Consultation to result in guidance on joint
  surveillance of Anti-TB drug resistance and HIV
  among TB patients and related issues.

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New and Rapid Diagnostics for TB Control
Priorities and key issues.

• Sustainability The sustainability of new
  diagnostics in low resource countries should be a
  focus for research and models should be developed
  to assess sustainability factors before ahead of
  scale-up. Sustainability should be addressed
  across TB, HIV and malaria as an urgent priority
  preparing the way for diagnostics in the
  pipeline.
• Role of laboratory in expansion. New diagnostics
  should be introduced using a the systems
  approach to laboratory networks, including
  quality management issues, training, EQA, and
  patient orientation of services. NRLs have a key
  role to play in this. International organizations
  provide an essential role of convening country
  experts for policymaking development of technical
  guides, and training materials.

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Matching the pipeline with diagnostic needs A
large number of innovative new diagnostics are
currently at various points in the pipeline. The
development process has been catalytic in
engaging NTPs and other stakeholders (including
WGs of STOP-TB Partnership), leading to increased
capacity for diagnostics evaluation and
implementation. This is considered to be a
win-win approach and should guide future
diagnostics development activities.
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MOVING FORWARD

• FIND/TDR Demo projects. Large scale
  demonstration projects are ongoing in Africa,
  Asia, Americas and Europe on the use of rapid
  culture methods and rapid DST methods. These
  incorporate cost-effectiveness and impact
  analyses.
• Evaluating New Diagnostics in DOTS-Plus
  Programmes.
• Efforts must continue to shorten the pathway
  from the clinician ordering a sputum specimen to
  the modification of patient treatment in response
  to DST results. This can take 6 months. Much of
  the delay is not related to laboratory
  investigations per se, but activities before
  submission of specimen to lab and after report
  has been issued to the clinic.