Discovery: Stem Cell Biology NIH Actions

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Workshop 6 On the Way to Improvement of Lab
Services in Developing Countries
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Improvement of in-vitro Diagnosis Monitoring of
Treatment of PID in Developing Countries
Nabila El-Sheikh MIU- Al-Azhar University
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Topics covered

• Laboratory evaluation in PID
• Causes of poor services in developing countries
• Steps necessary for improvement

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Introduction

• The WHO recognizes more than 200 primary
  immunodeficiency diseases - some are relatively
  common, others are quite rare.
• Some affect a single cell within the immune
  system others may affect one or more components
  of the system.

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Lab medicine

•  The clinical laboratory is increasingly
  integrated with patient care
• Automation, commercially produced reagents and
  computers
• Advances in genomics

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Diagnosis of IDS

• An accurate medical history, family history and
  physical examination are critical in developing
  the best strategy for laboratory evaluation
• The orderly use of laboratory testing is strongly
  recommended.

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In developing countries

• Opening a laboratory is as easy as opening a
  grocery store.
• Laboratories compromise on factors that determine
  the performance
• The managers earn money by using outdated
  machines, and by employing technicians in place
  of pathological tests

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In developing countries

• Opportunities for diagnosis and treatment of PIDD
  are deficient.
• The range of laboratory testing available to
  evaluate the immune system is limited.
• The clinical syndromes associated with recurrent
  and or chronic infections are underscored.

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Causes of poor lab services in developing
countries

• Low Budget
• Scarcity of Laboratory Staff
• Inadequate Training
• Lack of Appropriate Equipment and Infrastructure
• Lack of Regulatory Mechanisms

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Assessment of Normality
- intra-individual variation - variation within
a healthy population
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Qualitative Observations
Frequency
cut-offs
0 concentration
nonspecific scattering signals specific
reaction signals
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Quantitative measurement

• Key elements
• Reproducibility of results
• Tracability of results
• (comparability, commutability)

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Reference intervals

• RI may vary from one population to another
• The differences influence diagnosis and
  prognosis, but most importantly therapeutical
  decisions

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Normal Distribution
mean
Na K Cl Ca Mg
reference interval
conc.
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Reference intervals cont
Ethiopians
Dutch Lymphos 1032 - 3432 1120 -
3390 CD4 366 - 1235
509 - 1761 CD8 311 - 1618
200 - 1042 CD4/CD8 0,4 - 2,4
0,9 - 4,8 95 percentiles
per ml of whole blood
A. Tsegaye et al 1999

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Age-dependent changes
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Causes of modification ofsample properties

• Collection
• Transportation
• Preparation
• Storage

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Changes during blood storage
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Steps for improvement

• Understanding of the formulation of the clinical
  question and selection of tests.
• Control of the analytic Quality of laboratory
  methods.
• Establishment of the laboratory limits, and
  reference ranges for each laboratory indicator.

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Steps for Improvement

• External Quality Assessment (EQA)
• Training larger numbers of qualified laboratory
  staff
• Suitable technologies for developing

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Suitable Technologies

• There is a plethora of in vitro diagnostic
  devices
• Equipment and reagents appropriate to the needs
  of developing countries should be introduced
• A system similar to WHOs essential drug list
  (essential tests) can be proposed

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National Structures

• The placement of skilled laboratory
  scientists/managers
• Creation of a national laboratory quality office
  and appointment of a quality officer
• The allocation of adequate financial resources

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National Standards

• Each country should establish its own set of
  standards based on internationally agreed
  standards
• National laboratory standards need to take into
  account local factors
• The WHO recommends that countries with limited
  resources consider taking a staged approach

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Implementation

• Establish and revise national standards
• Establish strategy, aims and measures of
  progress
• Ensure that laboratory facilities and
  infrastructure are adequate and properly
  maintained for all testing being performed

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Implementation Cont

• Ensure safety in all health laboratory facilities
  to protect workers, and the general public
• Establish plans for ensuring sustainable numbers
  of properly trained personnel
• Apply appropriate quality systems to all
  operations, including procurement

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Implementation Cont

• Develop national resources for ensuring internal
  quality control and for external quality
  assessment
• Develop a process for monitoring laboratory
  performance improvement
• Encourage the development of a structured
  advisory network for laboratories.

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(No Transcript)
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Thank you