# Presentation: 550626

## Quality Assurance in Sero-Surveillance of HIV in Pregnant Women

- Experience in RWANDA
- 2002-2003
- Pierre Rugimbanya
- Biologist, National Reference Laboratory

- CDC – Atlanta
- 10/19/2004

## Rwanda

| Total Population
Women | 8,162,175
4,267,983 |
| --- | --- |
| Area | 26338 km2 |
| Rural Population | 83% |
| Official Languages | Kinyarwanda, French, English |
| HIV Prevalence in General Population | 9% (Government)
5% (UNAIDS) |
| Life Expectancy at Birth | Men: 47
Women: 50 |
| Annual Population Growth | 3% |
| Birth Rate | 45.2 per 1000 |
| Fertility Rate | 6.5 |

**Notes:**
Rwanda is an east-central African country in the Great Lakes Region.  It is quite mountainous and most of the country sits above 1,700 meters.  In the genocide of 1994, almost one million people were killed.  In the wake of the conflict Rwanda underwent a period of political instability.  Because of its history, Rwanda has had a particularly difficult struggle against HIV.

## Laboratory System Organization

**TANZANIE**

**RCD**

**BURUNDI**

**Ouganda**

-  *

- \

- *

- *

- *

- *

- *

- *

- *

- *

- *

- *

- *

- *

- **

- *

- *

- *

- *

- *

- *

- *

- *

- **

- *

- *

- *

- *

- *

- HIV Sentinel Sites 2002-2003

## Method

- Preliminary training of technicians and nurses at Surveillance sites
- Blood Drawing
- Patient Identification
- Coding System
- Sample Storage
- Sample Transportation
- Use of Laboratory Materials and Reagents
- Supervision
- Twice monthly

## Coordination

- TRAC

- Sentinel Sites

- NRL

- District Level

**Notes:**
Sentinel Sites deliver samples to the National Reference Laboratory
National Reference Laboratory tests samples
Results are provided to the Epidemiology department at the Treatment Research AIDS Center
TRAC is responsible for supervision on a district level in collaboration with the National Reference Laboratory
The National Reference Laboratory supervises the Sentinel Sites directly in collaboration with the District health facilities:
Blood Drawing
Sample Storage
Supervision Tools
Supervision Forms
Specimen transportation forms

## Health Center Responsibilities

- Blood drawing and sample collection
- Sample coding
- Sample storage – for ELISA tests -20 degrees C
- RPR testing for Syphilis

## National Reference Laboratory Responsibilities

- Sample registering and management of data
- Sample conservation during testing
- Sample conservation for 5 years after Surveillance completed
- ELISA testing of samples
- Supervision of Sentinel Sites

## Specimen Reception at NRL

- NRL Technician receives samples at reception
- Samples are registered in database
- Samples stored in freezer at -70 degrees C

## National Reference Laboratory ELISA Testing

- Testing Algorithm
- Screening:  **Vironostika** HIV Uni-Form II plus O (Biomerieux)
- Confirmation:  **Murex** HIV-1.2.0 (Abbott)
- Tie-Breaker:  **Enzygnost** Anti-HIV 1⁄2 Plus (Dade Behring)

## Testing Algorithm

- Vironostika

- Murex

- Repeat V, M

- Report -

- -

- +

- -

- +

- Report +

- M-, V+

- M+,V-

- M+,V+

- M-, V-

- Report +

- Report -

- Enzygnost

- Report -

- -

- +

- Report +

## Internal Quality Control

- In each ELISA plate, controls are used produced by both the NRL and the test manufacturer.
- 10% of samples screened as negative by Vironostika tests are tested with Murex for confirmation.
- Routine controls for calibration of ELISA machines and other laboratory apparatus.

## External Quality Control

- 5% of all negative samples and 50% of all positive samples are sent out of the country for quality control:
- CDC / UVRI in Entebe
- NICD / WHO / HIV – Serology South Africa
- NRL receives samples from NICD / WHO to analysis.  Concordance was 100%.

## Samples Analyzed for Sero-Surveillance in Pregnant Women

| Year | Number of Samples | Prevalence |
| --- | --- | --- |
| 2002 | 12,167 | 5.079 % |
| 2003 | 11,669 | 4.86 % |

## Overcoming Challenges

- Active supervision - note problems and immediately correct them
- Preliminary training and refresher training for both technicians and nurses
- Provide all materials necessary for sites to carry out responsibilities
- Ensure materials are appropriate for sites:
- i.e. Gas-powered freezers for sites without electricity

## Thank You for Visiting Rwanda!

**Thank You for Visiting Rwanda!**