1. QUALITY ASSURANCE GUIDELINES HONWANI F.J Q.A ON RAPID HIV TESTING 10 AUGUST 2010

2. PURPOSE OF THE GUIDELINES Most of the rapid HIV tests used today are single-use, disposable devices that may be used to directly test whole blood, serum/plasma samples. These simple HIV tests present unique challenges – testing is often performed by persons without formal laboratory training, there is no residual sample that can be checked or re- tested, conventional quality control methods cannot be used, and there are special problems associated with efforts to provide conventional external quality assessments (e.g. proficiency testing

3. CONT. The purpose of these guidelines is to facilitate adoption of a quality system approach that encompasses all aspects essential to assuring accurate and reliable rapid HIV testing. It is intended to provide assistance to all persons involved in rapid HIV testing service (quality planners/managers, programme managers, trainers and testers ).

4. CONT. With the expansion of rapid HIV testing to large numbers of testing sites, it will be very important to implement these guidelines, and monitor the processes to assure quality and reliability of the rapid HIV test results. April 2010- June 2011 target of 15 Mil there is need to make sure the results issued are accurate. there is need to make sure the results issued are accurate.

5. Challenges and the need for guidelines Discordant results Discordant results Test taking longer than 30 minutes to give results. Test taking longer than 30 minutes to give results. No line on the control bend. Reaction bend always faint/ weak but stronger with the other test kit. No migration of sample on the reaction window. No migration of sample on the reaction window. Test has to be repeated in most occasion to get a result Poor quality HIV rapid test kits

6. Q.A guidelines & program Q.A guidelines & program Aims Aims The aim of this guideline is: To provide a framework for the implementation of a quality assurance program around the HIV rapid testing process. The aim of the QA programme is: To ensure that the process of HIV rapid testing is performed accurately and reliably in a safe and professional manner.

7. BASIC CONCEPTS APPLIED Quality systems Organizational structures ( NDOH, NICD, PROV etc) ResponsibilitiesResources Processes and procedures needed to implement

8. QC and EQA  QC A set of procedures used internally to validate test performance and reagents stability. Facilities will have to analyze samples with known controls. Just completed a pilot in Limpopo. Facilities will have to analyze samples with known controls. Just completed a pilot in Limpopo. This will be a requirement to all facilities implementing HCT. This will be a requirement to all facilities implementing HCT.  EQA Defined as a set of activities performed through an external source to evaluate testing site operations. To follow once the QC is rolled out in all provinces.

9. QC and EQA CONT. Proficiency testing (PT) Re- testing On-site assessment

10. THE OVERALL GOAL Improvement in Occurrence managementOccurrence management Process improvementProcess improvement Information managementInformation management InventoryInventory Safety in all facilitiesSafety in all facilities Eventually service and satisfactionEventually service and satisfaction

11. CONCLUSSION Identify Problems Identify Problems Take Corrective Action Take Corrective Action