Is in-country validation of RTRI required?

No. Given that the test has been evaluated and validated in ILB/CDC and other independent laboratories (e.g., NICD, South Africa), in-country validation of the RTRI is not necessary prior to implementation of recent infection surveillance. Validation of this test may not be feasible in every country since it requires a well-characterized bank of specimens with known HIV status (positive or negative) and recent infection status (recent or long-term), including longitudinal panels from seroconverting persons. Close review of routinely available data helps to monitor performance of the test and progress of implementation. If necessary, CDC HQ may be able to provide a verification panel and support for in-country verification of the RTRI.