# Presentation: 171054

## National Microbiology Reference Laboratory, Zimbabwe

- Progress and developments

## Where is it?

-   Second Floor
-       New Laboratory Buildings
- Harare Central Hospital
- Harare

##  Responsible to ?

-  Ministry of Health and Child Welfare
- Department of Disease Prevention
-     and Control

##    Mission statement

-    The NMRL in its role as a reference centre and national public health facility is committed to provide quality support for health services in Zimbabwe in disease prevention, control and surveillance
-    It strives to provide a solid scientific basis for the development  of population based public health policies and support for clinical laboratories in their endeavor to improve  quality and diagnostic capability

## Core Functions

-   Outbreak Investigation

-   Reference
-          Specialised Tests
-          Identify unknown  isolates

-   Surveillance

-   Public Health Related Research

## Core Functions

-  Improved data management

-   Laboratory improvement and
-      regulation

-  Training and education

##   Reference Network	

- National TB reference
- laboratory

- Virology
- Laboratory

- Mycology Laboratory

- Enteropathogens
- Laboratory

- NMRL

## Partnerships	

- Hospital Laboratories
-            Outbreak investigation
-        Surveillance
-     Quality assurance
-     New techniques
-     Validation of kits

## Partnerships	

-   Research Groups
-      Tests
-     Quality assurance
-     Expertise

## International Partnerships

-  CDC
-  APHL
-  WHO

-  University** **of Utrecht??

## Developments so far

- 1. Laboratory Site

- 3. Staffing

- 2. Equipment acquisition

- 4. Functions

## Laboratory site

- Most of space allocated transferred to NMRL
- Cold room installed
- Security doors in place to limit access to lab space
- One of two store rooms now in use
- Additional air conditioning added
- Coordinator and Secretary’s office converted

## Equipment

- On its way – ELISA equipment
-                    Flow Cytometer
-                    Bacteriology equipment

- Acquired – container load basic laboratory equipment
-                  courtesy of CDC including centrifuges,
-                  pH meter,  computers, freezers
-                  Roche equipment for PCR Chlamydia, GC, viral
-                  loads Automated puncher for dried blood spots
-                  Biorad Sanofi Concertino for automated ELISAs
- 	       Furniture

## Staff

- Current staff
- Coordinator
- 6+1 MLS
- 2 General hands
- 1 Secretary
- 1 Driver
- 1 Clerk

- Additional staff
- Pathologist (about to process)
- Chief MLS (in process)
- Ass. Chief MLS
- Information Officer(advertised)
- 5 State Certified Technicians (converting to 1or2  MLS)

##  Staff Training

- 6 week serology course - BRTI
- 2 week quality assurance course - BRTI
- Attachment of general hands to Dept. Med Micro UZ for training e.g. autoclaving
-    washing glassware.
- Training in hospital HIV laboratory
- Training from APHL + CDC (local visits
- Improvement of computer literacy (IDL)

## Funding

- Salaries MOHCW (CDC funds 3 posts)
- Equipment - CDC
- Consumables for specific tasks CDC
- Running costs + consumables + equipment – MOHCW
- Outbreak investigation WHO (to be developed)
- Research projects-individual donors (administration fee)

## FUNCTIONS

## Bacteriology laboratory

- Outbreak investigation
- Identification of unknowns
- Provision of specialised testing
-     e.g. MICs
-           Serotyping isolates from outbreaks

## Bacteriology laboratory

- Proposals under discussion:
-  Surveillance antibiotic resistance
-  Support for opportunistic infections
-    clinic at Harare Hospital
-  Surveillance *Streptococcus pneumoniae*

## Short term goals

- Establishment of laboratory
- Development of SOPs for support of opportunistic infections clinic
- Outbreak investigation and monitoring of isolates – establish QA

##        Current functions

-        Current functions
-      Future developments

- HIV Laboratory

## HIV Laboratory - Functions

-  Surveillance

-  Quality assurance

-  Evaluation of kits

-  Support for ARV Therapy

- Training

- Evaluation new technology

-  Research

## Surveillance

-  Young adult survey
-        HIV prevalence 15-29 yr olds
-   Prevalence HIV, syphilis in clients
-      attending ANC clinics
-  STI survey ??

## Surveillance

-  HIV and syphilis prevalence - ANC Clinics
-   6930 Clients:
-    19 collection sites: Commercial farming
- 	                       Urban, Urban-borderpost
- 	                       Rural
- 	                       Growthpoint
-     9 Testing centres

- HIV and syphilis prevalence - ANC Clinics
- Role of NMRL:
- Routine testing 2 collection sites
- QA 10% specimens
- Testing site visits for QA and trouble shooting
- Provide internal QC samples
- Liaise with ZINQAP for provision of EQA

- Surveillance

## Training others

- e.g.  PMTCT

- Rapid Testing

-  Procedures and QC

## Training for PMTCT

- Standard curriculum developed (practical+theory)
- Standardised training materials
- Competency assessed
- 170 Trained to date  (Nurse counsellors, MLS)
- Database established
-         Who to train???

## Role in quality assurance

- Evaluation of kits
- Training
- Internal quality control

- EQA/proficiency testing
- Standard operating procedure manuals

## Support for ARV therapy

-   CD4 counts

-   Viral Loads

-   Resistance monitoring

-  Evaluating and introduction of new
-    technologies

## CD4  T Cell  Counts

- Issues :
- 	Choice and cost of equipment
- 	Quality of testing
- 	Training availability
- 	Cost of running test
- 	Availability of QA and maintenance
-    Sustainability –reagents, staff

## CD4  T Cell Counts

- Equipment
-                 - FACSCalibur Flow Cytometer
- Training:
-  		1. Parirenyatwa Hospital
-        2. Beckton Dickinson training - end
-             of October
- 		3.  Further training

##   Viral Loads

- Proposed method Roche Amplicor HIV RNA PCR
- Training
-       Initial training Amplicor (GC and
-       Chlamydia) by Roche last year then
-       APHL in September
-       Uganda- November 2002

## Resistance testing

- Debate about resistance testing
- Consensus – better to have access to resistance testing within Zimbabwe
- Initial discussions with potential partners
- PhD proposal + M.Sc project (nevaripine resistance)

## Evaluating new technologies

- In the future:
- CD4 T cell counts
-      e.g. CD4/CD8 immunoassay
-  HIV p24 antigen assay
- Detuned assay for measuring incidence of HIV infection

## HIV lab - progress

- Appointment of a new head of HIV lab
- Appointment of a QA manager
- Development SOPs DBS, RAPID QA, ANC study
- Training in HIV testing of DBS including  QA
- Initial training in Roche Amplicor PCR technology including QA
- Initiation of QA for Rapid Testing -automated equipment will allow for increased number of specimens tested

## Short term Goals – by end of year

- Complete YAS and ANC
- Sustainable QA for Rapid Testing Centres
- Establish support testing for ARV
- Consolidation  of experience and QA in HIV lab in HIV testing, CD4 counts and PCR
- Address EQA issues for CD4 and viral loads
- Recruit short term experienced MLS -

## Long term goals

- Evaluation of new technologies
- Introduction of resistance testing
- Detuned assay

## HIV laboratory - problems

- Lack of expertise
- Retention of staff
- Lack of equipment
- Lack of a QA management culture

## HIV laboratory - assets

- Commitment
- Enthusiasm
- Some equipment – additional equipment will be in place by the end of November
- Partnerships  in finance, training - shared experience already bearing fruit

## HIV laboratory - Challenges

- QA Management once training completed
-        *Short term visits by experienced  personnel*
*	**     **Short term visits to other labs EQA*

##           Target for NMRL

-    Establishment of a high quality reference laboratory to support public health programmes and research initiatives