{
  "abstract": "Background\n\nSecond-generation HIV-1 integrase strand transfer inhibitors (INSTIs)-bictegravir (BIC), cabotegravir (CAB), and dolutegravir (DTG)-are leading components of highly potent antiretroviral therapy, and CAB is also used for long-acting chemoprevention. Rapid detection of clinically relevant INSTI concentrations could support point-of-care assessment and real-time clinical decision-making. We developed a lateral flow assay (LFA) that detects BIC, CAB, and DTG in whole blood and plasma and evaluated its performance against predefined concentration thresholds and high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS).Methods\n\nA single LFA cassette design was developed using a monoclonal antibody to distinguish BIC, CAB, and DTG concentrations below trough, at minimal-to-moderate trough, and at ideal concentrations. LFA results were read visually at 20 min and were compared with LC-MS/MS-quantified INSTI concentrations for 124 clinical plasma specimens.Results\n\nFor 24 plasma samples from US participants receiving treatment involving one of the three INSTIs, the LFA interpretations matched all LC-MS/MS results except for one DTG specimen, which was interpreted by LFA as 1.0-1.6 μg/mL but measured 2.1 μg/mL by LC-MS/MS. Among 100 plasma remnants from routine national surveillance in Eswatini, the LFA correctly interpreted DTG concentrations in 95 specimens. Four specimens had DTG LC-MS/MS concentrations slightly above the LFA-determined range, differing by ≤ 0.1 μg/mL, and one specimen measured at 1.20 μg/mL by LC-MS/MS was interpreted as ≥ 1.6 μg/mL by LFA. In total, 6 of 124 specimens (4.8%) had LFA-interpreted INSTI concentrations that varied slightly from the LC-MS/MS results, with no statistically significant difference in overall performance by Wilcoxon signed-rank test (W = 8.00, p = 0.94, one-tailed).Conclusions\n\nThe LFA design successfully provided clinically useful interpretations of BIC, CAB, and DTG concentrations with minor discrepancies in < 5% of samples. Importantly, all low-concentration samples of < 1 μg/mL were correctly interpreted by LFA. The assay shows promise as a point-of-care tool for assessing clinically relevant INSTI concentrations.",
  "abstract_shown": true,
  "affiliations": [
    "Division of HIV Prevention, Laboratory Branch CDC Atlanta Georgia USA cdc.gov.",
    "Division of Global HIV and TB, International Laboratory Branch CDC Atlanta Georgia USA cdc.gov."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Xierong Wei",
      "orcid": "0009-0001-0940-8008"
    },
    {
      "affs": [
        0
      ],
      "name": "Ae S Youngpairoj",
      "orcid": "0009-0000-1342-3086"
    },
    {
      "affs": [
        0
      ],
      "name": "Richard Haaland",
      "orcid": "0000-0001-8165-3879"
    },
    {
      "affs": [
        0
      ],
      "name": "Chuong Dinh",
      "orcid": "0000-0002-1749-4401"
    },
    {
      "affs": [
        1
      ],
      "name": "Hetal K Patel",
      "orcid": "0000-0002-5468-2591"
    },
    {
      "affs": [
        1
      ],
      "name": "Jose J Perez",
      "orcid": "0000-0002-9531-6408"
    },
    {
      "affs": [
        1
      ],
      "name": "Kristin Brown",
      "orcid": "0000-0001-9256-533X"
    },
    {
      "affs": [
        0
      ],
      "name": "Thomas H Vanderford",
      "orcid": "0000-0002-5068-0900"
    },
    {
      "affs": [
        0
      ],
      "name": "Jeffrey A Johnson",
      "orcid": "0000-0002-9202-846X"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/etegev5d0557s.bib",
  "cited_by": 0,
  "doi": "10.1155/arat/4809477",
  "fulltext_url": "https://europepmc.org/articles/PMC13695850",
  "id": "etegev5d0557s",
  "issns": [
    "2090-1240",
    "2090-1259"
  ],
  "landing_url": "https://europepmc.org/article/MED/42928809",
  "language": "eng",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2204|Biosensors and Analytical Detection"
    ]
  ],
  "openalex": "W7223567750",
  "pdf_url": "https://europepmc.org/articles/PMC13695850?pdf=render",
  "pmcid": "PMC13695850",
  "pmid": "42928809",
  "published": "2026-10-25",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/etegev5d0557s.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:21:18Z",
      "native_id": "MED:42928809",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42928809"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "journal-openalex:2725|HIV/AIDS Research and Interventions",
      "subfield": "infectious-disease"
    }
  ],
  "title": "A Highly Sensitive and Specific Rapid Lateral Flow Assay for the HIV Integrase Strand Transfer Inhibitors Bictegravir, Cabotegravir, and Dolutegravir.",
  "title_text": "A Highly Sensitive and Specific Rapid Lateral Flow Assay for the HIV Integrase Strand Transfer Inhibitors Bictegravir, Cabotegravir, and Dolutegravir.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:21:18Z",
  "url": "https://research.draconitic.com/paper/etegev5d0557s",
  "venue": "AIDS research and treatment",
  "versions": []
}