Evidence map›Paper›PMID 41337582›Full record

ArticleScience advances2025

Distinguishing active HIV-1 infection from vaccine-induced seropositivity in HIV vaccine trial participants.

Ketan Dighe, Oguzhan Colak, Parikshit Moitra, Maha Alafeef, David Skrodzki, Teresea Aditya, Pranay Saha, Nivetha Gunaseelan, John Hural, Casey Pinto and 1 more

Abstract read
In one paragraph

Article in Science advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Ketan DigheDepartment of Biomedical Engineering, The Pennsylvania State University, University Park, PA 16802, USA.ORCID 0000-0002-3970-0069
Oguzhan ColakHuck Institutes of Life Sciences, The Pennsylvania State University, University Park, PA 16802, USA.ORCID 0000-0003-3751-2272
Parikshit MoitraHuck Institutes of Life Sciences, The Pennsylvania State University, University Park, PA 16802, USA.ORCID 0000-0002-7679-7859
Maha AlafeefHuck Institutes of Life Sciences, The Pennsylvania State University, University Park, PA 16802, USA.ORCID 0000-0001-6603-2169
David SkrodzkiHuck Institutes of Life Sciences, The Pennsylvania State University, University Park, PA 16802, USA.ORCID 0000-0003-2838-6446
Teresea AdityaHuck Institutes of Life Sciences, The Pennsylvania State University, University Park, PA 16802, USA.ORCID 0000-0002-7829-9837
Pranay SahaHuck Institutes of Life Sciences, The Pennsylvania State University, University Park, PA 16802, USA.
Nivetha GunaseelanDepartment of Biomedical Engineering, The Pennsylvania State University, University Park, PA 16802, USA.ORCID 0000-0003-4939-1658
John HuralVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA 98109, USA.
Casey PintoDepartment of Public Health Sciences, Penn State College of Medicine, The Pennsylvania State University, Hershey, PA 17033, USA.ORCID 0000-0003-4355-7813
Dipanjan PanDepartment of Biomedical Engineering, The Pennsylvania State University, University Park, PA 16802, USA.ORCID 0000-0003-0175-4704

Funding

An integrated multiplexed electrochemical platform for the selective detection of viral protein and RNA to differentiate active HIV-1 infection from vaccine induced seropositivity75N93022C00031 · NIAID · VITRUVIAN BIO, LLC · PI SKRODZKI, DAVID · 2022 to 2022
$300k
NIMH SBIR PHASE 1 TOPIC 001- POINT-OF-CARE HIV VIRAL LOAD AND DRUG ADHERENCE ASSAYS75N95024C00040 · NIDA · VITRUVIAN BIO, LLC · PI SENPEN, ANGANA · 2024 to 2024
$300k
An Electrochemical Self-Monitoring Device for Rapid Nucleic Acid Based Testing of HIV-175N93024C00042 · NIAID · VITRUVIAN BIO, LLC · PI SENPAN, ANGANA · 2024 to 2024
$300k
NIAID NIH HHS 75N93022C00031NIAID NIH HHS 75N93024C00042NIDA NIH HHS 75N95024C00040
6 · The paper itself

Abstract

Vaccine-induced seropositivity (VISP) causes antibodies produced by HIV-1 vaccines to react with standard serological tests, complicating diagnosis and leading to false positives. To distinguish VISP from true HIV infections, we developed a rapid, multiplexed companion electrochemical assay that integrates a three-dimensional-printed device with screen-printed electrodes coated with antigen, antibody, and methylene blue-labeled antisense oligonucleotide probes. The test delivers quantitative results within 5 minutes with calculated analytical limits of detection of 5.88 picograms per milliliter for p24 antigen, 10.96 picograms per milliliter for anti-p24 antibody, and 1259 copies per milliliter for HIV-1 RNA, with minimal cross-reactivity. Clinical testing with 104 plasma samples obtained from vaccinated/unvaccinated, HIV-positive/negative individuals demonstrated 95% sensitivity and 98% specificity in distinguishing active HIV-1 infection from VISP cases. Receiver operating characteristic analysis produced area under the curve values of 0.9888 for HIV-1 RNA, 0.9705 for anti-p24 antibody, and 0.9356 for p24 antigen. These findings highlight the potential to reduce false-positive results caused by VISP by integrating this diagnostic test in clinical trials and large-scale vaccination programs.

Indexed as

AIDS VaccinesHIV-1HIV InfectionsHIV SeropositivityFemaleHIV AntibodiesHIV Core Protein p24HumansMaleRNA, ViralROC CurveSensitivity and SpecificityAIDS VaccinesHIV AntibodiesHIV Core Protein p24RNA, Viral

Identifiers

PMID41337582
PMCPMC12674122

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.