Title: Discovery: Stem Cell Biology NIH Actions
1 Workshop 6 On the Way to Improvement of Lab
Services in Developing Countries
2Improvement of in-vitro Diagnosis Monitoring of
Treatment of PID in Developing Countries
Nabila El-Sheikh MIU- Al-Azhar University
3Topics covered
- Laboratory evaluation in PID
- Causes of poor services in developing countries
- Steps necessary for improvement
4Introduction
- 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.
5Lab medicine
- Â The clinical laboratory is increasingly
integrated with patient care - Automation, commercially produced reagents and
computers - Advances in genomics
6Diagnosis 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.
7In 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the performance - The managers earn money by using outdated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
8In 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.
9Causes 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
10Assessment of Normality
- intra-individual variation - variation within
a healthy population
11Qualitative Observations
Frequency
cut-offs
0 concentration
nonspecific scattering signals specific
reaction signals
12Quantitative measurement
- Key elements
- Reproducibility of results
- Tracability of results
- (comparability, commutability)
13Reference intervals
- RI may vary from one population to another
- The differences influence diagnosis and
prognosis, but most importantly therapeutical
decisions
14Normal Distribution
mean
Na K Cl Ca Mg
reference interval
conc.
15Reference 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
16Age-dependent changes
17Causes of modification ofsample properties
- Collection
- Transportation
- Preparation
- Storage
18Changes during blood storage
19Steps 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.
20Steps for Improvement
- External Quality Assessment (EQA)
- Training larger numbers of qualified laboratory
staff - Suitable technologies for developing
21Suitable 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
22National 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
23National 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
24Implementation
- 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
25Implementation 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
26Implementation 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.
27(No Transcript)
28Thank you