Who makes RTRI tests?
RTRI technology has been commercialized by two manufacturers (Figure 1) as:
1) Asante HIV-1 Rapid Recency Assay by Sedia Biosciences (Portland, OR) and
2) Swift Recent Infection Assay (RIA) by Maxim Biomedical (Rockville, MD).
Asante Rapid Recency Assay is available as 100 tests or 20 tests per kit. Swift RIA is available as 20 tests per kit. In addition, quality control specimens are available from Maxim that includes three specimens with HIV-negative, recent and long-term status.
Both RTRIs have undergone extensive in-house evaluation and validation at CDC. In addition, Asante has been evaluated independently in outside laboratories (Maxim Swift evaluation ongoing). In all settings, the test performed well with acceptable criteria for both HIV diagnosis and recent infection detection.
Figure 1. Rapid Tests for Recent Infection
For more details on several recency assays with different characteristics (e.g. rates of false recent infection and mean duration of recent infection [window period]), please see the WHO Working Group On HIV Incidence Measurement and Data Use Meeting Report from March 2018.