Is in-country validation of RTRI required?

Is in-country validation of RTRI required?

Given that the test has been extensively evaluated and validated in CDC and other independent laboratories (e.g., NICD, South Africa), in-country validation of the RTRI is notrequired. Validation of this test requires well-characterized bank of specimens with known HIV status (positive or negative) and recent infection status (recent or long-term) which most countries lack. The HQ team cannot support any further validation of the RTRI in country in terms of protocol development, reagent and kits, or data analysis. However, we will continue to assist in review of programmatic data generated during implementation to monitor performance of the test and success of implementation. HQ can also provide a verification panel and assist with in-country verification of the RTRI if needed.      

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