Point-of-Care Molecular Test for the Detection of 14 High-Risk Genotypes of Human Papillomavirus in a Single Tube

Seely, Spencer; Zingg, Jean-Marc; Joshi, Pratibha; Slomovitz, Brian; Schlumbrecht, Matthew; Kobetz, Erin; Deo, Sapna; Daunert, Sylvia

doi:10.1021/acs.analchem.3c01723

Anal. Chem.

2023

DOI: 10.1021/acs.analchem.3c01723

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Point-of-Care Molecular Test for the Detection of 14 High-Risk Genotypes of Human Papillomavirus in a Single Tube

Spencer Seely,

Jean-Marc Zingg,

Pratibha Joshi

et al.

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Cited by 2 publications

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A portable all-in-one microfluidic device with real-time colorimetric LAMP for HPV16 and HPV18 DNA point-of-care testing

Bai,

Liu,

Gao

et al. 2024

Biosensors and Bioelectronics

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A portable all-in-one microfluidic device with real-time colorimetric LAMP for HPV16 and HPV18 DNA point-of-care testing

Bai,

Liu,

Gao

et al. 2024

Biosensors and Bioelectronics

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A novel tailed primer nucleic acid test for detection of HPV 16, 18 and 45 DNA at the point of care

Chang,

Ma,

Novak

et al. 2023

Sci Rep

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Cervical cancer is a leading cause of death for women in low-resource settings despite being preventable through human papillomavirus (HPV) vaccination, early detection, and treatment of precancerous lesions. The World Health Organization recommends high-risk HPV (hrHPV) as the preferred cervical cancer screening strategy, which is difficult to implement in low-resource settings due to high costs, reliance on centralized laboratory infrastructure, and long sample-to-answer times. To help meet the need for rapid, low-cost, and decentralized cervical cancer screening, we developed tailed primer isothermal amplification and lateral flow detection assays for HPV16, HPV18, and HPV45 DNA. We translated these assays into a self-contained cartridge to achieve multiplexed detection of three hrHPV genotypes in a disposable cartridge. The developed test achieves clinically relevant limits of detection of 50–500 copies per reaction with extracted genomic DNA from HPV-positive cells. Finally, we performed sample-to-answer testing with direct lysates of HPV-negative and HPV-positive cell lines and demonstrated consistent detection of HPV16, HPV18, and HPV45 with 5000–50,000 cells/mL in < 35 min. With additional optimization to improve cartridge reliability, incorporation of additional hrHPV types, and validation with clinical samples, the assay could serve as a point-of-care HPV DNA test that improves access to cervical cancer screening in low-resource settings.

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Point-of-Care Molecular Test for the Detection of 14 High-Risk Genotypes of Human Papillomavirus in a Single Tube

Cited by 2 publications

References 41 publications

A portable all-in-one microfluidic device with real-time colorimetric LAMP for HPV16 and HPV18 DNA point-of-care testing

A portable all-in-one microfluidic device with real-time colorimetric LAMP for HPV16 and HPV18 DNA point-of-care testing

A novel tailed primer nucleic acid test for detection of HPV 16, 18 and 45 DNA at the point of care

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