# Presentation: 216407

## An overview of LIFE-GAP laboratory activities

**                  ****Austin Demby PhD**

## Estimated annual number of new HIV infections by region, 1980 to 1999

**Estimated annual number of new HIV infections by region, 1980 to 1999**

## Estimated number of people living with HIV/AIDS by region, 1980 to 1999

**Estimated number of people living with HIV/AIDS by region, 1980 to 1999**

## HIV prevalence among pregnant womenin South Africa, 1990 to 1999

**Source:  *****Department of Health, South Africa***

**0.7**

**1.7**

**2.1**

**4**

**7.6**

**10.4**

**14.2**

**17**

**22.8**

**22.4**

**0**

**5**

**10**

**15**

**20**

**25**

**90**

**91**

**92**

**93**

**94**

**95**

**96**

**97**

**98**

**99**

***HIV prevalence (%)***

## Expanding and strengthening HIV/STI/TB surveillance programs
Strengthening laboratory support for HIV/STD/TB/OI  
               -   Surveillance
               -   Diagnosis 
               -   Screening for blood safety
Monitoring and evaluation
Strengthening information systems
Training

- Strengthening laboratory support for HIV/STD/TB/OI
-                -   Surveillance
-                -   Diagnosis
-                -   Screening for blood safety
- Monitoring and evaluation
- Strengthening information systems
- Training

- GAA Program Area -Surveillance and Infrastructure Development

## CDC-LIFE Planning and implementation process

**Technical**
**Strategies**

**Country **
**Program**
**Planning Visits**

**Implementation**

## Most frequently proposed technical strategies

## Situation analysis in GAP countries

- Downturn in local economies
-  Management and resource constraints
- Increased disease burden
- Institutions diminishing ability to cope

## Situation Report - laboratory

- Loss of trained personnel
- Training of lab staff inadequate
- Lack of oversight
- Training materials not updated
- Intermittent supply of reagents
- Congested and in some cases unsafe laboratory environment
- Health reforms

## Rationale for GAP support

- Strong scientific basis for GAP programs
- Biological markers a priority to monitor program
-     successes or failures
- Additional work load – GAP programs
- Overwhelmed laboratory system
-        (polyvalent lab techs)
- Need to create safe work environment

## Laboratory assessment

- National lab assessment a prerequisite for support
-           - lab organization
-           - review recent assessment
-           - current lab activities
-           - communication
-           - reagents, test kits and test algorithms
-           - MoH input
-           - Partners – local and international

## GAP approach to lab support

- Laboratory technical strategy based on best practices
- Strong partnership with host nation and regional organizations
- Prevention focus with rapid demonstration of success while building long term infrastructure
- Rational use of limited USG resources

## Focus of GAP lab support

- Balance between:
- Supporting quality technical laboratory services at national level –HIV/STI/TB/OI
- Supporting the creation/strengthening of PH laboratory systems to support quality testing

## Laboratory technical support

- Strengthen National Reference laboratories:
-          - Quality Reference work – national level
-              (hub for GAA program activities)
-         - Set national standards, guidelines and protocols
-         - Perform QA/QC and national oversight
- Support District level laboratory capacity/capability
- Advocate Rapid Testing: point-of-service for programs
- Training

**Notes:**
Support National Reference Laboratories to retain technical staff and to assure minimum standards.
Since no basic research is anticipated, advocate a change in role to:
                  - Reference work for HIV/TB/STI drug resistance
                  - Test kit evaluation and validation
                  - Supervisory national QA role to assure quality of testing
                  - Supervisory national QC and proficiency testing
Rapid HIV tests to support GAA program areas.
Assure minimum standards for TB diagnosis and monitoring - basic smear microscopy and periodic culture to monitor resistance
Rapid tests for STI
Possible cooperative agreement with APHL to foster linking laboratories in Africa with sister laboratories in the United States

## Support for HIV activities

- Based on in-country capacity and coverage
-  High priority
-            - Rapid tests with appropriate algorithms
-            - Dried blood spots for surveillance
-            - EIA based serological assays
- Low priority
-            - Incidence assays
-            - Viral load assays
-            - Monitoring CD4/CD8 cell counts

## Support for TB activities

- Smear microscopy at all levels
-               - diagnosis and monitoring
- National surveillance for drug resistance
-               - conventional
-               - molecular

## Support for STI activities

- High priority
- Evaluation of syndromic management
- Basic serology RPR, FTA-ABS, TPHA
- Basic microbiology – gram stain
- Low priority
- Molecular methods for diagnosis
- Surveillance for STI drug resistance

## Priorities for Technical capacity building

- Proper staff recruitment and retention
- Appropriate training and backstopping
- Appropriate technology transfer

## Priorities for physical infrastructure development

- Provision of appropriate equipment
- Providing reliable reagent supplies
- Safe and efficient physical space
-             - water, electricity
- Logistics and transportation

## GAA Laboratory Support Structure

**GAA Laboratory Support Structure**

**Steering Committee**
- Austin Demby – GAP (Chair)
- Robert Martin – PHPPO
- Mark Rayfield – NCID

- APHL

- Botswana
- South Africa
- Mozambique

- Côte d’Ivoire
- Senegal
- Rwanda

- Ethiopia
- Nigeria
- India

- Kenya
- Uganda
- Malawi

- Zambia
- Zimbabwe
- Tanzania

- Laboratory Technical Review Group
- CDC/CIOs, Lab Leaders in Africa, WHO-Afro

- NCID

- PHPPO

## GAA Laboratory Support Structure

- Technical laboratory support working groups
-  Surveillance
-  Rapid tests, VCT and MTCT
-  TB
-  STI
-  QA/QC
- Informatics

## Why a Quality Assurance Workshop?

- Matrix of professionals
-      NCID, PHPPO, NCEH, APHL, WHO, GAP
- Varied experience in resource limited countries
- Countries looking for strong partnership in a crisis situation
- A united US response
- Clear unambiguous messages from partners
- Results of tests could be life-altering

## Quality Assurance workshop exit competency

- Common understanding of laboratory QA systems
- Clear guidelines on the utility of QA in LIFE countries
- The added value QA systems bring to the fight          against HIV/STI/TB/OI
- A plan of action for implementation in GAP    programs
-         -  institutional and non-institutional
-         - priority VCT/MTCT/Surveillance