Performance evaluation of the Asante Rapid Recency Assay for verification of HIV diagnosis and detection of recent HIV-1 infections
Implications for epidemic control
Bibliographic Data
| ID | 19592197 |
|---|---|
| Authors | Ernest L Yufenyuy (0000-0002-0613-1373, Centers for Disease Control and Prevention), Mervi Detorio (0009-0000-8114-2112, Centers for Disease Control and Prevention), Trudy Dobbs (0000-0002-3289-6011, Centers for Disease Control and Prevention), Hetal K Patel (0000-0002-5468-2591, Centers for Disease Control and Prevention), Keisha Jackson (0000-0001-9093-9991, Centers for Disease Control and Prevention), Vedapuri Shanmugam (0000-0003-3612-1085, Centers for Disease Control and Prevention), Shanmugam Vedapuri, Bharat Parekh (0000-0002-1088-4263, Centers for Disease Control and Prevention, corresponding author) |
| Editors | Sanghyuk Shin |
| Year | 2022 |
| Volume | 2 |
| Issue | 5 |
| Pages | e0000316 |
| Publication date | 2022-05-03 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | PLOS Global Public Health (JOURNAL) |
| Journal identifiers | ISSN: 2767-3375 • E-ISSN: 2767-3375 |
| Publisher | Public Library of Science (PLoS) (PUBLISHER) |
| DOI | 10.1371/journal.pgph.0000316 |
| PMID | 36962217 |
| OpenAlex | W4229378999 |
| Language | EN |
| Citations received | 3 |
| References cited | 50 |
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
Antibody · Avidity · HIV screening · Hiv test · Men who have sex with men · Population · HIV Research and Treatment · HIV/AIDS drug development and treatment · HIV/AIDS Research and Interventions · Medicine · Immunology · Internal Medicine · Virology
Recent HIV infection among newly diagnosed cases and associated factors in the Amhara regional state, Northern Ethiopia
Viral Suppression Following Same-day Initiation Antiretroviral Therapy among Persons Aware of their Classification as Recent or Long-term Infected with HIV Per Recent Infection Testing Algorithm, Rwanda 2021–2022
Continuous quality evaluation of the Asanté rapid test for recent infection for robust kit lot quality verification
| Citations per year | 0.75 |
|---|---|
| Citation span | 2022 - 2025 (4) |
| Highly cited | No |