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Article: Evaluation of an Isothermal Amplification HPV Assay on Self-Collected Vaginal Samples as Compared to Clinician-Collected Cervical Samples
Title | Evaluation of an Isothermal Amplification HPV Assay on Self-Collected Vaginal Samples as Compared to Clinician-Collected Cervical Samples |
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Authors | |
Keywords | BD Onclarity cervical cancer screening Hong Kong human papilloma virus (HPV) isothermal amplification self-sampling Sentis HPV |
Issue Date | 24-Oct-2023 |
Publisher | MDPI |
Citation | Diagnostics, 2023, v. 13, n. 21, p. 3297 How to Cite? |
Abstract | This study aimed to evaluate the concordance of HPV results between the SentisTM HPV assay (Sentis) (BGI Group, Shenzhen, China), an isothermal amplification-based HPV assay, on self-collected and clinician-collected samples and the agreement of Sentis on self-collected samples with the BD OnclarityTM HPV assay (Onclarity) (Becton, Dickinson, and Company, Franklin Lakes, New Jersey, USA), a PCR-based HPV assay, on clinician-collected samples. This was a prospective study of 104 women attending the colposcopy clinic for abnormal smears. After informed consent, participants self-collected vaginal samples before having clinician-collected cervical samples. Self-collected samples underwent HPV testing with Sentis (Self-Sentis HPV) and clinician-collected samples were tested with Sentis (Clinician-Sentis HPV) and Onclarity (Clinician-Onclarity), which was used as a reference standard. The concordance was assessed using Cohen's kappa. The prevalence of HPV and the acceptability of self-sampling were also evaluated. The concordance rate between Self-Sentis HPV and Clinician-Sentis HPV was 89.8% with a kappa of 0.769. The concordance rate between Self-Sentis HPV and Clinician-Onclarity was 84.4% with a kappa of 0.643. The prevalence of HPV was 26.0% on Clinician-Onclarity, 29.3% on Clinician-Sentis HPV, and 35.6% on Self-Sentis HPV. Overall, 65% of participants would undergo self-sampling again. This was attributed to mainly not feeling embarrassed (68%) and being convenient (58%). Our study showed a substantial agreement between Self-Sentis HPV with Clinician-Sentis HPV and Clinician-Onclarity. Self-sampling was also shown to be a generally well-accepted method of screening. |
Persistent Identifier | http://hdl.handle.net/10722/340621 |
ISSN | 2023 Impact Factor: 3.0 2023 SCImago Journal Rankings: 0.667 |
ISI Accession Number ID |
DC Field | Value | Language |
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dc.contributor.author | Chan, Aaron H Y | - |
dc.contributor.author | Ngu, Siew-Fei | - |
dc.contributor.author | Lau, Lesley S K | - |
dc.contributor.author | Tsun, Obe K L | - |
dc.contributor.author | Ngan, Hextan Y S | - |
dc.contributor.author | Cheung, Annie N Y | - |
dc.contributor.author | Chan, Karen K L | - |
dc.date.accessioned | 2024-03-11T10:45:57Z | - |
dc.date.available | 2024-03-11T10:45:57Z | - |
dc.date.issued | 2023-10-24 | - |
dc.identifier.citation | Diagnostics, 2023, v. 13, n. 21, p. 3297 | - |
dc.identifier.issn | 2075-4418 | - |
dc.identifier.uri | http://hdl.handle.net/10722/340621 | - |
dc.description.abstract | <p>This study aimed to evaluate the concordance of HPV results between the SentisTM HPV assay (Sentis) (BGI Group, Shenzhen, China), an isothermal amplification-based HPV assay, on self-collected and clinician-collected samples and the agreement of Sentis on self-collected samples with the BD OnclarityTM HPV assay (Onclarity) (Becton, Dickinson, and Company, Franklin Lakes, New Jersey, USA), a PCR-based HPV assay, on clinician-collected samples. This was a prospective study of 104 women attending the colposcopy clinic for abnormal smears. After informed consent, participants self-collected vaginal samples before having clinician-collected cervical samples. Self-collected samples underwent HPV testing with Sentis (Self-Sentis HPV) and clinician-collected samples were tested with Sentis (Clinician-Sentis HPV) and Onclarity (Clinician-Onclarity), which was used as a reference standard. The concordance was assessed using Cohen's kappa. The prevalence of HPV and the acceptability of self-sampling were also evaluated. The concordance rate between Self-Sentis HPV and Clinician-Sentis HPV was 89.8% with a kappa of 0.769. The concordance rate between Self-Sentis HPV and Clinician-Onclarity was 84.4% with a kappa of 0.643. The prevalence of HPV was 26.0% on Clinician-Onclarity, 29.3% on Clinician-Sentis HPV, and 35.6% on Self-Sentis HPV. Overall, 65% of participants would undergo self-sampling again. This was attributed to mainly not feeling embarrassed (68%) and being convenient (58%). Our study showed a substantial agreement between Self-Sentis HPV with Clinician-Sentis HPV and Clinician-Onclarity. Self-sampling was also shown to be a generally well-accepted method of screening.</p> | - |
dc.language | eng | - |
dc.publisher | MDPI | - |
dc.relation.ispartof | Diagnostics | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.subject | BD Onclarity | - |
dc.subject | cervical cancer screening | - |
dc.subject | Hong Kong | - |
dc.subject | human papilloma virus (HPV) | - |
dc.subject | isothermal amplification | - |
dc.subject | self-sampling | - |
dc.subject | Sentis HPV | - |
dc.title | Evaluation of an Isothermal Amplification HPV Assay on Self-Collected Vaginal Samples as Compared to Clinician-Collected Cervical Samples | - |
dc.type | Article | - |
dc.identifier.doi | 10.3390/diagnostics13213297 | - |
dc.identifier.scopus | eid_2-s2.0-85176721511 | - |
dc.identifier.volume | 13 | - |
dc.identifier.issue | 21 | - |
dc.identifier.spage | 3297 | - |
dc.identifier.eissn | 2075-4418 | - |
dc.identifier.isi | WOS:001100232400001 | - |
dc.identifier.issnl | 2075-4418 | - |