A Highly Sensitive and Specific Rapid Lateral Flow Assay for the HIV Integrase Strand Transfer Inhibitors Bictegravir, Cabotegravir, and Dolutegravir.
- 1Division of HIV Prevention, Laboratory Branch CDC Atlanta Georgia USA cdc.gov.
- 2Division of Global HIV and TB, International Laboratory Branch CDC Atlanta Georgia USA cdc.gov.
Abstract
Background
Second-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
A 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
For 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
The 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.
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BibTeX
@article{wei2026highly,
title = {{A Highly Sensitive and Specific Rapid Lateral Flow Assay for the HIV Integrase Strand Transfer Inhibitors Bictegravir, Cabotegravir, and Dolutegravir.}},
author = {Xierong Wei and Ae S Youngpairoj and Richard Haaland and Chuong Dinh and Hetal K Patel and Jose J Perez and Kristin Brown and Thomas H Vanderford and Jeffrey A Johnson},
journal = {AIDS research and treatment},
year = {2026},
month = oct,
doi = {10.1155/arat/4809477},
url = {https://europepmc.org/article/MED/42928809},
note = {CC BY},
}
RIS
TY - JOUR
TI - A Highly Sensitive and Specific Rapid Lateral Flow Assay for the HIV Integrase Strand Transfer Inhibitors Bictegravir, Cabotegravir, and Dolutegravir.
AU - Xierong Wei
AU - Ae S Youngpairoj
AU - Richard Haaland
AU - Chuong Dinh
AU - Hetal K Patel
AU - Jose J Perez
AU - Kristin Brown
AU - Thomas H Vanderford
AU - Jeffrey A Johnson
PY - 2026
DA - 2026/10/25
JO - AIDS research and treatment
DO - 10.1155/arat/4809477
UR - https://europepmc.org/article/MED/42928809
AB - Background Second-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 A 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 For 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 The 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.
SN - 2090-1240
SN - 2090-1259
ER -