Investigator(s)
| WHO Technical Officer |
Tiara Mahatmi Nisa WHO SEARO/CDS/HHS Unit Tiara Mahatmi Nisa 
|
| Principal Investigator |
Jayanthi P Elwitigala National STD/AIDS Control Programme, Sri Lanka Jayanthi P Elwitigala
|
Title(s) and abstract
| Scientific title | Selecting appropriate HIV serology assays and assessing the level of shared false reactivity to optimize HIV testing algorithms in Sri Lanka: verification |
| Public title | Selecting appropriate HIV serology assays and assessing the level of shared false reactivity to optimize HIV testing algorithms in Sri Lanka: verification |
| Background | Sri Lanka is a country with a low HIV prevalence.By end 2020, estimated 3700 people were living with HIV in the country. It is very important to revise the HIV testing strategy of the country to improve testing services. This is in order to reach difficult to reach groups, to assure the HIV testing services are easily accessible, acceptable and affordable to all affected populations especially for key affected populations. Currently the country uses laboratory based immunoassays and point of care rapid HIV tests for HIV screening. The tests are carried out through STD clinics, government hospitals, prison settings, in outreach programmes in the field, community based testing centres as well as in private sector health institutions. In current practice ,when the screening is reactive, the samples are sent to the National reference laboratory for confirmation. This could contribute to, not know the HIV confirmatory status on the same day. Therefore, loss to follow up; delay in link to care and delay in initiation of ART could take place. In order to overcome the above , it was decided to revise the existing guideline and to adopt recommendations given by WHO 2019 HIV testing guidelin |
| Objectives | General objective Identify optimum combinations of HIV serology assays for diagnosis of HIV infection. Identify any operational issues of algorithm implementation before wide-spread national adoption. Specific objectives Assess the level of shared false reactivity among individual assays/products Construct testing algorithms of assays/products that share the least or no common cross-reactivity Pilot the new testing algorithms in selected sites, in parallel with existing testing algorithm prior to national roll-out |
| Study Methods | A prospective and cross-sectional verification will be performed in 3 phases. Phase 1- - Candidate products will be shortlisted. A verification panel will be established using clinical serum or plasma specimens collected prospectively from individuals attending routine HIV testing services (STD clinic attendees, ANC mothers, TB patients, blood donors and outreach testing site clients). The specimens will be characterized using a reference testing algorithm. (250 specimens) Phase 2 - Shortlisted HIV products will be tested using specimens that have been characterized for the absence of HIV. The assays/products that share the lowest number of false-reactive results will be selected for use in the 3-assay testing strategy, with the most sensitive assay used as assay 1 (A1) and the most specific assays as assay 2 (A2) and assay 3 (A3), as recommended by WHO. Phase 3 - The new testing algorithm will be run in parallel with the status quo testing algorithm in selected clinical sites before national roll-out. For the verification , WHO quality-assured products will be shortlisted. Quality-assured assays/products that have been evaluated or approved by the national regulatory agency as part of the registration process and that are readily available in the country will be prioritized in order to expedite the procurement process. Although different specimen types could be used in the verification study, for practical purposes only plasma specimens will be used in this. |
| Expected outcomes and use of results | This verification aims to select individual HIV assays/products that work best together as part of an HIV testing algorithm for the diagnosis of HIV. The revision of national HIV testing guidelines will be enrolled accordingly. The final aim is to expedite the diagnosis and enhance the implementation of test and treat policy of the country |
| Keywords | HIV testing, algorithm, verification |
Research Details
| Student research | No |
| Start Date | 09-Oct-2023 |
| End Date | 30-Nov-2023 |
| Key Implementing Institution | National STD/AIDS control programme of the Ministry of Health, Sri Lanka |
| Multi-country research | No |
| Nationwide research | Yes |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | HIV/AIDS |
| Involves human subjects | Yes |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Final decision available |