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

Bai, Hao; Liu, Yuqing; Gao, Linbo; Wang, Tao; Zhang, Xiaoli; Hu, Jie; Ding, Lisha; Zhang, Yueting; Wang, Qian; Wang, Lei; Li, Jianlong; Zhang, Zhifeng; Wang, Yang; Shen, Chenlan; Ying, Binwu; Niu, Xiaoyu; Hu, Wenchuang

doi:10.1016/j.bios.2023.115968

Biosensors and Bioelectronics

2024

DOI: 10.1016/j.bios.2023.115968

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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

Hao Bai,

Yuqing Liu,

Linbo Gao

et al.

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Cited by 3 publications

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An Injection Molded SlipChip with Self‐Sampling for Integrated Point‐of‐Care Testing of Human Papilloma Virus

Zhang,

Dong,

et al. 2024

Advanced Science

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High‐risk human papillomavirus (HPV) screening is crucial for cervical cancer prevention. However, laboratory‐based nucleic acid amplification tests (NAATs) require costly equipment, designated lab space, and skilled personnel. Additionally, cervical swabs collected by healthcare professionals can be inconvenient, uncomfortable, and reduce privacy, limiting broader application and patient compliance. A SlipChip‐based Integrated Point‐of‐Care (SIPOC) system featuring an injection‐molded SlipChip is presented with preloaded reagents for nucleic acid extraction and a portable four‐channel real‐time quantitative PCR instrument for detection. This system incorporates a self‐sampling method that allows participants to collect their own vaginal swabs, with the β‐Globin gene as a control. After testing 130 participants for HPV‐16 and HPV‐18, 97.7% of the self‐collected samples are valid. Among valid samples, 25 tested positive for HPV‐16 and 9 for HPV‐18. Compared to Roche's standard HPV PCR test, the SIPOC system shows 100% positive predictive value (PPV) for both HPV‐16 and HPV‐18 and negative predictive values (NPVs) of 99.0% and 99.1%, respectively. This system is promising for HPV screening in resource‐limited settings and adaptable for other point‐of‐care NAAT applications, including home testing.

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An Injection Molded SlipChip with Self‐Sampling for Integrated Point‐of‐Care Testing of Human Papilloma Virus

Zhang,

Dong,

et al. 2024

Advanced Science

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Recent advances on nanomaterials for personalized diagnostics in multiplex point-of-care testing

Baghal Behyar,

Nilghaz,

Bahari

et al. 2024

TrAC Trends in Analytical Chemistry

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Isothermal Technologies for HPV Detection: Current Trends and Future Perspectives

Flores-Contreras,

González-González,

Trujillo-Rodríguez

et al. 2024

Pathogens

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The human papillomavirus (HPV) is a non-enveloped DNA virus transmitted through skin-to-skin contact that infects epithelial and mucosal tissue. It has over 200 known genotypes, classified by their pathogenicity as high-risk and low-risk categories. High-risk HPV genotypes are associated with the development of different types of cancers, including cervical cancer, which is a leading cause of mortality in women. In clinical practice and the market, the principal tests used to detect HPV are based on cytology, hybrid detection, and qPCR. However, these methodologies may not be ideal for the required timely diagnosis. Tests have been developed based on isothermal nucleic acid amplification tests (INAATs) as alternatives. These tests offer multiple advantages over the qPCR, such as not requiring specialized laboratories, highly trained personnel, or expensive equipment like thermocyclers. This review analyzes the different INAATs applied for the detection of HPV, considering the specific characteristics of each test, including the HPV genotypes, gene target, the limit of detection (LOD), detection methods, and detection time. Additionally, we discuss the tests available on the market that are approved by the Food and Drug Administration (FDA). Finally, we address the challenges and potential solutions for the large-scale implementation of INAATs, particularly in rural or underserved areas.

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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

Cited by 3 publications

References 42 publications

An Injection Molded SlipChip with Self‐Sampling for Integrated Point‐of‐Care Testing of Human Papilloma Virus

An Injection Molded SlipChip with Self‐Sampling for Integrated Point‐of‐Care Testing of Human Papilloma Virus

Recent advances on nanomaterials for personalized diagnostics in multiplex point-of-care testing

Isothermal Technologies for HPV Detection: Current Trends and Future Perspectives

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