ArticleJournal of clinical microbiology2025
Comparison of manual and automated ultrasensitive assays for residual HIV-1 in plasma from individuals on suppressive antiretroviral therapy.
Article in Journal of clinical microbiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Immune activation during broadly neutralizing antibody-mediated HIV suppression prior to post-intervention control.bioRxiv : the preprint server for biology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors.
Funding
Abstract
Several nucleic acid and antigen assays have been developed to detect HIV in plasma at levels below the detection limit of standard clinical assays; however, comparative assessment of performance of these ultrasensitive assays on identical panels has been limited. Here, we report the relative performance characteristics of three manual (ultracentrifugation concentration and laboratory-developed PCR) and two automated commercial assays for single-copy detection of HIV RNA, as well as two ultrasensitive HIV p24 assays, using blinded panels of plasma samples containing HIV at low concentrations. Independent sample sets were studied in two phases: in the first phase, qualification panels consisted of analytic standards in serial dilution and clinical plasma samples from virologically suppressed people with HIV (PWH). HIV detection in clinical samples was infrequent using the ultrasensitive p24 assays (mean 11%). In contrast, a higher proportion of the same samples were detected using single-copy RNA assays (mean 61%). In the second phase, evaluation panels of clinical plasma samples ( IMPORTANCE: Most people with HIV (PWH) on antiretroviral therapy have viral loads below the detection limit of clinical assays, yet virus is often present and detectable at very low levels using ultrasensitive research assays. Clinical trials evaluating curative interventions and interpreting outcomes of analytical treatment interruptions depend on reliable assays to assess and quantify changes in HIV persistence often at very low levels. We conducted a two-stage head-to-head, blinded comparison of multiple ultrasensitive HIV RNA and p24 assays, first using 50 low viral load plasma samples, then further evaluating the top-performing assays on a 144-member blinded panel composed of duplicate contrived and clinical specimens from well-suppressed PWH. Single-copy RNA methods performed better than p24 assays, and a fully automated, 9-replicate commercial RNA assay demonstrated high sensitivity, reproducibility across laboratories, and practical scalability that can be applied to measure the impact of interventions in HIV cure trials.
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Registered trials
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