Performance evaluation of the Asante Rapid Recency Assay for verification of HIV diagnosis and detection of recent HIV-1 infections: Implications for epidemic control

Abstract

We previously described development of a rapid test for recent infection (RTRI) that can diagnose HIV infection and detect HIV-1 recent infections in a single device. This technology was transferred to a commercial partner as Asante Rapid Recency Assay (ARRA). We evaluated performance of the ARRA kits in the laboratory using a well-characterized panel of specimens. The plasma specimen panel (N = 1500) included HIV-1 (N = 570), HIV-2 (N = 10), and HIV-negatives (N = 920) representing multiple subtypes and geographic locations. Reference diagnostic data were generated using the Bio-Rad HIV-1-2-O EIA/Western blot algorithm with further serotyping performed using the Multispot HIV-1/2 assay. The LAg-Avidity EIA was used to generate reference data on recent and long-term infection for HIV-1 positive specimens at a normalized optical density (ODn) cutoff of 2.0 corresponding to a mean duration of about 6 months. All specimens were tested with ARRA according to the manufacturer’s recommendations. Test strips were also read for line intensities using a reader and results were correlated with visual interpretation. ARRA’s positive verification line (PVL) correctly classified 575 of 580 HIV-positive and 910 of 920 negative specimens resulting in a sensitivity of 99.1% (95% CI: 98.0–99.6) and specificity of 98.9% (95% CI: 98.1–99.4), respectively. The reader-based classification was similar for PVL with sensitivity of 99.3% (576/580) and specificity of 98.8% (909/920). ARRA’s long-term line (LTL) classified 109 of 565 HIV-1 specimens as recent and 456 as long-term compared to 98 as recent and 467 as long-term (LT) by LAg-Avidity EIA (cutoff ODn = 2.0), suggesting a mean duration of recent infection (MDRI) close to 6 months. Agreement of ARRA with LAg recent cases was 81.6% (80/98) and LT cases was 93.8% (438/467), with an overall agreement of 91.7% (kappa = 0.72). The reader (cutoff 2.9) classified 109/566 specimens as recent infections compared to 99 by the LAg-Avidity EIA for recency agreement of 81.8% (81/99), LT agreement of 9% (439/467) with overall agreement of 91.9% (kappa = 0.72). The agreement between visual interpretation and strip reader was 99.9% (95% CI: 99.6–99.9) for the PVL and 98.1% (95% CI: 96.6–98.9) for the LTL. ARRA performed well with HIV diagnostic sensitivity >99% and specificity >98%. Its ability to identify recent infections is comparable to the LA-Avidity EIA corresponding to an MDRI of about 6 months. This point-of-care assay has implications for real-time surveillance of new infections among newly diagnosed individuals for targeted prevention and interrupting ongoing transmission thus accelerating epidemic control.

Recent HIV infection among newly diagnosed cases and associated factors in the Amhara regional state, Northern Ethiopia: HIV case surveillance data analysis (2019-2021)

“…Recency test targets are those clients ≥15 years of age with HIV-1 infection only. As reported by the US CDC, the Asante recency test kit has a high diagnostic sensitivity (>99%) and specificity (> 98%) ( 10 ).…”

Characterising persons diagnosed with HIV as either recent or long-term using a cross-sectional analysis of recent infection surveillance data collected in Malawi from September 2019 to March 2020

“…All HIV testing was accompanied by pretest and post-test counselling and followed the national testing algorithm 18. As noted, only persons who were (1) reactive on the first HIV rapid test in the national algorithm (Determine) and (2) had provided verbal consent (ie, eligible for recency testing) were subsequently tested with Asanté HIV Rapid Recency Assay (Sedia Biosciences, Portland, Oregon, USA) simultaneously with the HIV rapid test UniGold 19 20. Verbal consent was the preferred consent format due to the low-risk nature of the surveillance and to better integrate recency testing into Government of Malawi-approved HIV testing guidelines.…”

Recent HIV Infection: Diagnosis and Public Health Implications

“…It is a strip-test that includes an additional line with the antigen at a limiting concentration to differentiate recent from long-standing HIV infection. The test uses the same peptide of the LAg-EIA but in a rapid test format and has both visual and reader-based interpretation [ 97 , 98 ]. According to the visual reading, the presence of all three lines (control line (CL), positive verification line (PVL), and long-term line (LTL)) indicate long-term HIV infection; the presence of the two lines CL and PVL indicate recent HIV infection; and the presence of only CL supports the absence of HIV infection.…”

“…The strip reader measures the intensity of the three lines (in intensity units-IU). A recent analysis of specimens representing multiple subtypes and diverse geographic origins showed that the sensitivity and specificity of that rapid recency test for HIV diagnosis were higher than 99% and 98.5%, respectively, an overall agreement with LAg-EIA higher than 91%, and a high-level concordance between visual and strip reader-based results [ 31 , 98 ].…”